EMRO

WHO Regional Publications Eastern Mediterranean Series 30
A Practical Guide
for
Health Researchers
Mahmoud F. Fathalla
3URIHVVRURI2EVWHWULFVDQG*\QDHFRORJ\
$VVLXW8QLYHUVLW\(J\SW
&KDLUPDQ:+2*OREDO$GYLVRU\&RPPLWWHHRQ+HDOWK5HVHDUFK
)RUPHU'LUHFWRU81'381)3$:+2:RUOG%DQN6SHFLDO3URJUDPPHRI5HVHDUFK'HYHORSPHQWDQG
5HVHDUFK7UDLQLQJLQ+XPDQ5HSURGXFWLRQ
Mohamed M. F. Fathalla
'HSDUWPHQWRI2EVWHWULFVDQG*\QDHFRORJ\
$VVLXW8QLYHUVLW\(J\SW

World Health Organization
Regional Office for the Eastern Mediterranean
Cairo, 2004
:+2/LEUDU\&DWDORJXLQJLQ3XEOLFDWLRQ'DWD
)DWKDOOD0DKPRXG)
$SUDFWLFDOJXLGHIRUKHDOWKUHVHDUFKHUVE\0DKPRXG))DWKDOODDQG0RKDPHG0))DWKDOOD
S:+25HJLRQDO3XEOLFDWLRQV(DVWHUQ0HGLWHUUDQHDQ6HULHV
,6%1
5HVHDUFK±6FLHQWLILF:ULWLQJ±*XLGHOLQHV3XEOLVKLQJ±*XLGHOLQHV:+25HJLRQDO2IILFHIRUWKH(DVWHUQ
0HGLWHUUDQHDQ ,)DWKDOOD0RKDPHG0) ,,7LWOH
>1/0&ODVVLILFDWLRQ4@
:RUOG+HDOWK2UJDQL]DWLRQ
$OOULJKWVUHVHUYHG
7KHGHVLJQDWLRQVHPSOR\HGDQGWKHSUHVHQWDWLRQRIWKHPDWHULDOLQWKLVSXEOLFDWLRQGRQRWLPSO\WKHH[SUHVVLRQRIDQ\
RSLQLRQZKDWVRHYHURQWKHSDUWRIWKH:RUOG+HDOWK2UJDQL]DWLRQFRQFHUQLQJWKHOHJDOVWDWXVRIDQ\FRXQWU\WHUULWRU\FLW\
RUDUHDRURILWVDXWKRULWLHVRUFRQFHUQLQJWKHGHOLPLWDWLRQRILWVIURQWLHUVRUERXQGDULHV'RWWHGOLQHVRQPDSVUHSUHVHQW
DSSUR[LPDWHERUGHUOLQHVIRUZKLFKWKHUHPD\QRW\HWEHIXOODJUHHPHQW
7KHPHQWLRQRIVSHFLILFFRPSDQLHVRURIFHUWDLQPDQXIDFWXUHUV¶SURGXFWVGRHVQRWLPSO\WKDWWKH\DUHHQGRUVHGRU
UHFRPPHQGHGE\WKH:RUOG+HDOWK2UJDQL]DWLRQLQSUHIHUHQFHWRRWKHUVRIDVLPLODUQDWXUHWKDWDUHQRWPHQWLRQHG(UURUV
DQGRPLVVLRQVH[FHSWHGWKHQDPHVRISURSULHWDU\SURGXFWVDUHGLVWLQJXLVKHGE\LQLWLDOFDSLWDOOHWWHUV
7KH:RUOG+HDOWK2UJDQL]DWLRQGRHVQRWZDUUDQWWKDWWKHLQIRUPDWLRQFRQWDLQHGLQWKLVSXEOLFDWLRQLVFRPSOHWHDQGFRUUHFW
DQGVKDOOQRWEHOLDEOHIRUDQ\GDPDJHVLQFXUUHGDVDUHVXOWRILWVXVH
7KHQDPHGDXWKRUVDORQHDUHUHVSRQVLEOHIRUWKHYLHZVH[SUHVVHGLQWKLVSXEOLFDWLRQ
3XEOLFDWLRQVRIWKH:RUOG+HDOWK2UJDQL]DWLRQFDQEHREWDLQHGIURP'LVWULEXWLRQDQG6DOHV:RUOG+HDOWK2UJDQL]DWLRQ
5HJLRQDO2IILFHIRUWKH(DVWHUQ0HGLWHUUDQHDQ32%R[1DVU&LW\&DLUR(J\SWWHOID[
HPDLO'6$#HPURZKRLQW5HTXHVWVIRUSHUPLVVLRQWRUHSURGXFH:+2(052SXEOLFDWLRQVLQSDUWRU
LQZKROHRUWRWUDQVODWHWKHP±ZKHWKHUIRUVDOHRUIRUQRQFRPPHUFLDOGLVWULEXWLRQ±VKRXOGEHDGGUHVVHGWRWKH5HJLRQDO
$GYLVHU+HDOWKDQG%LRPHGLFDO,QIRUPDWLRQDWWKHDERYHDGGUHVVID[HPDLO+%,#HPURZKRLQW
&RYHUGHVLJQE\$KPHG+DVVDQHLQ
3ULQWHGLQ&DLUR(J\SWE\'DU0RXUDGIRU3ULQWLQJ
Contents
Foreword ...........................................................................................................7
Preface .......................................................................................................................... 9
Acknowledgements ..................................................................................................... 10
Chapter 1. Introduction and overview .......................................................................... 11

References and additional sources of information ...................................................... 19
Chapter 2. Ethics in health research ........................................................................... 20

2.1 Introduction......................................................................................................... 20
2.2 General ethical principles ................................................................................... 21
2.3 Responsibility for ethics in health research ........................................................ 22
2.4 Ethics committees .............................................................................................. 22
2.5 Ethical considerations throughout the research process.................................... 23
Chapter 3. What research to do? ................................................................................ 25

3.1 Introduction......................................................................................................... 25
3.2 Selection of a field for research.......................................................................... 26
3.3 Drivers for health research ................................................................................. 29
3.4 Participation in collaborative international research ........................................... 32
3.5 Participation in pharmaceutical company research............................................ 34
3.6 Where do research ideas come from? ............................................................... 36
3.7 Criteria for a good research topic ....................................................................... 39
Chapter 4. Planning the research ................................................................................ 43

4.1 Introduction ........................................................................................................ 43
4.2 Types of research design ................................................................................... 44
4.3 Selecting a research design ............................................................................... 47
4.4 Defining and refining the research question....................................................... 49
4.5 Generating the research hypothesis .................................................................. 50
4.6 Study sample...................................................................................................... 50
4.7 Sample size........................................................................................................ 52
4.8 Measurement ..................................................................................................... 54
4.9 Planning qualitative research ............................................................................. 55
4.10 A note on questionnaire design.......................................................................... 57
4.11 A note on research in health economics ............................................................ 58
4.12 Ethics in research design ................................................................................... 59
Chapter 5. Writing the research protocol ..................................................................... 65
5.1 Introduction......................................................................................................... 65
5.2 Format for the protocol ....................................................................................... 66
Chapter 6. Submitting a research proposal ................................................................. 72

6.1 Introduction......................................................................................................... 72
6.2 How to get your research project funded ........................................................... 72
6.3 Components of a research proposal .................................................................. 75
Chapter 7. Implementing the research project ............................................................ 79

7.1 Introduction......................................................................................................... 79
7.2 Scientific rigour................................................................................................... 79
7.3 Pre-testing the protocol ...................................................................................... 80
7.4 Monitoring of the study....................................................................................... 80
7.5 Periodic tabulations and reports......................................................................... 82
7.6 Validation of results in qualitative research ........................................................ 82
7.7 Good clinical practice ......................................................................................... 82
7.8 Research on new pharmaceutical products ....................................................... 83
7.9 Termination of the study ..................................................................................... 84
7.10 Changes in the protocol ..................................................................................... 84
7.11 Ethical issues in the implementation of the study .............................................. 85
Chapter 8. Describing and analysing research results ................................................ 87

8.1 Introduction ........................................................................................................ 87
8.2 Descriptive statistics........................................................................................... 87
8.3 Tabulation ........................................................................................................... 88
8.4 Calculations ....................................................................................................... 89
8.5 Graphs/figures.................................................................................................... 91
8.6 Correlation.......................................................................................................... 91
8.7 Inferential statistics ............................................................................................ 93
8.8 What statistical tests tell us ................................................................................ 95
8.9 Selection of statistical test ................................................................................. 98
8.10 Examples of some common statistical tests..................................................... 101
8.11 Description and analysis of results of qualitative research............................... 102
References and additional sources of information .................................................... 105
Chapter 9. Interpreting research results .................................................................... 106

9.1 Introduction....................................................................................................... 106
9.2 Interpreting descriptive statistics ...................................................................... 106
9.3 Interpreting “statistical significance” ................................................................. 107
9.4 Bias .................................................................................................................. 107
9.5 Confounding ..................................................................................................... 109
9.6 Making the case for causation......................................................................... 110
9.7 Interpreting end points to measure the outcome ........................................... 112
9.8 Interpreting studies of risk factors ................................................................... 112
9.9 Interpreting studies of diagnostic tests............................................................ 114
9.10 Interpreting studies that report the results of interventions ............................. 116
9.11 Interpreting results of qualitative research ..................................................... 116
Chapter 10. Communicating research ....................................................................... 119

10.1 Introduction...................................................................................................... 119
10.2 Communicating to scientists ........................................................................... 120
10.3 Communicating to funding agencies ............................................................... 123
10.4 Communicating to health professionals .......................................................... 124
10.5 Communicating to policy-makers .................................................................... 125
10.6 Communicating to patients.............................................................................. 127
10.7 Communicating to the community ................................................................... 127
10.8 Communicating to the public ........................................................................... 127
10.9 Communicating to the public media ................................................................ 128
Chapter 11. Writing a scientific paper........................................................................ 130

11.1 Introduction...................................................................................................... 130
11.2 Selecting a title for the paper........................................................................... 131
11.3 Writing the abstract and key words ................................................................. 131
11.4 Article structure ............................................................................................... 132
11.5 Writing the Introduction ................................................................................... 132
11.6 Writing the Methods section ............................................................................ 132
11.7 Writing the Results .......................................................................................... 134
11.8 Writing the Discussion and Conclusions ......................................................... 137
11.9 Acknowledgements ........................................................................................ 138
11.10 Citation of references ...................................................................................... 139
11.11 Steps in the process of writing a paper ........................................................... 140
11.12 Revision of the manuscript for scientific content ............................................. 141
11.13 Revision of the manuscript for style ................................................................ 142
11.14 Writing a case report ....................................................................................... 144
11.15 Writing a secondary scientific paper ............................................................... 145
11.16 Writing a paper on qualitative research ........................................................... 147
11.17 The dissertation or thesis ................................................................................ 147
Chapter 12. Publishing a scientific paper .................................................................. 151

12.1 Introduction...................................................................................................... 151
12.2 How to get your paper published..................................................................... 151
12.3 Uniform requirements for manuscripts submitted to biomedical journals........ 153
12.4 Summary of technical instructions for submission of papers .......................... 154
12.5 Sending the manuscript to the journal.............................................................. 155
12.6 After submitting the manuscript ....................................................................... 155
12.7 Authorship in scientific papers.......................................................................... 156
12.8 Patents and publication .................................................................................... 157
12.9 Ethics in scientific publication........................................................................... 157
Chapter 13. Making a scientific presentation............................................................. 162

13.1 Introduction....................................................................................................... 162
13.2 Planning of the presentation ............................................................................ 162
13.3 Preparation....................................................................................................... 163
13.4 Presentation ..................................................................................................... 167
13.5 Guide to how to give a “bad” presentation........................................................ 169
Chapter 14. Assessment and evaluation of research ................................................ 172

14.1 Introduction....................................................................................................... 172
14.2 Assessment and evaluation by researchers..................................................... 173
14.3 Assessment and evaluation by health professionals ........................................ 175
14.4 Assessment and evaluation by policy-makers.................................................. 177
14.5 Assessment and evaluation by investors in research....................................... 180
Annex 1. World Medical Association Declaration of Helsinki Ethical

principles for medical research involving human subjects ...................... 185
Annex 2. International ethical guidelines for biomedical research involving

human subjects ....................................................................................... 191
Annex 3. Searching the literature ........................................................................... 201
Annex 4. Guidelines on how to write references for scientific papers .................... 210
Annex 5. Bangkok Declaration on Health Research for Development ................... 214
Glossary of terms in health research ........................................................................ 216

Foreword
7KHFHQWUDOUROHRIKHDOWKUHVHDUFKLQLPSURYLQJKHDOWKDQGVWLPXODWLQJQDWLRQDO
HFRQRPLFJURZWKLVQRZZHOOHVWDEOLVKHG+HDOWKUHVHDUFKVXSSRUWVKHDOWKV\VWHPVLQ
WKHGHOLYHU\RIEHWWHUIDLUHUDQGPRUHHTXLWDEOHKHDOWKFDUHWRSHRSOH,WGRHVVRE\
LGHQWLI\LQJFKDOOHQJHVDQGSURYLGLQJEHVWVROXWLRQVPRQLWRULQJKRZKHDOWKV\VWHPV
SHUIRUPDQGSURGXFLQJQHZNQRZOHGJHIRUEHWWHUWHFKQRORJLHVDQGLPSURYHGDSSURDFKHV
WRSXEOLFKHDOWK7KH:RUOG+HDOWK2UJDQL]DWLRQ:+2KDVWLPHDQGDJDLQDIILUPHG
WKDWDOOQDWLRQDODQGLQWHUQDWLRQDOKHDOWKSROLFLHVVKRXOGEHEDVHGRQYDOLGVFLHQWLILF
HYLGHQFHWKDWVXFKHYLGHQFHUHTXLUHVUHVHDUFKDQGWKDWWKHDSSOLFDWLRQRIWKHNQRZOHGJH
LQIRUPDWLRQDQGWHFKQRORJ\HPDQDWLQJIURPKHDOWKUHVHDUFKKDVHQRUPRXVSRWHQWLDOLQ
SURPRWLQJKHDOWK
6KLIWLQJHSLGHPLRORJLFDOWUHQGVLQGLVHDVHSDWWHUQVUDSLGLQFUHDVHLQSRSXODWLRQV
QHZDQGHPHUJLQJKHDOWKSUREOHPVLQFUHDVLQJFRPPHUFLDOLQWHUHVWVRIWKHSULYDWHKHDOWK
VHFWRUDQGHYHUVKULQNLQJILQDQFLDOUHVRXUFHVDOOFRQWULEXWHWRWKHJOREDOLQHTXLW\LQKHDOWK
FDUH,WLVWKHUHIRUHH[WUHPHO\LPSRUWDQWWKDWUHVHDUFKDGGUHVVHVSULRULWLHVDQGIRFXVHV
RQWKHPRVWLPSRUWDQWKHDOWKLVVXHVFRQGLWLRQVDQGGHWHUPLQDQWV+HDOWKUHVHDUFKPXVW
VHUYHDVDGULYHUIRUKHDOWKSROLF\DQGSUDFWLFH)RUWKLVWRKDSSHQWKHKHDOWKUHVHDUFK
V\VWHPVQRWRQO\KDYHWREHIXOO\DFFRXQWDEOHIRUWKHVDNHRIWUDQVSDUHQF\EXWDOVRKDYH
WREHFDSDEOHRIGHOLYHULQJWKHGHVLUHGUHWXUQVWRMXVWLI\WKHDOORFDWLRQRIVFDUFHUHVRXUFHV
WRUHVHDUFKDQGGHYHORSPHQW
,QDGHTXDF\LQFDSDFLWLHVIRUUHVHDUFKDQGGHYHORSPHQWUHPDLQVDPDMRULPSHGLPHQW
IRUWKHGHYHORSLQJZRUOG'HVSLWHRYHUWKUHHGHFDGHVRIHIIRUWVWREXLOGFDSDFLWLHVGXULQJ
ZKLFKWKRXVDQGVRIVFLHQWLVWVIURPGHYHORSLQJFRXQWULHVKDYHEHHQWUDLQHGPRVWRI
WKHH[SHFWHGEUHDNWKURXJKVKDYHQRWKDSSHQHG/DUJHQXPEHUVRIWUDLQHGVFLHQWLVWVDUH
QRWZRUNLQJLQWKHLUFRXQWULHVRIRULJLQ7KHUHIRUHEXLOGLQJLQGLJHQRXVFDSDFLW\IRU
KHDOWKUHVHDUFKPXVWPRYHWRFHQWUHVWDJHDVWKLVLVYLWDOIRUVXVWDLQDEOHGHYHORSPHQW
7KH:+2
V5HJLRQDO2IILFHIRUWKH(DVWHUQ0HGLWHUUDQHDQUHFRJQL]HVWKLVDFXWHQHHG
6XSSRUWLQJKHDOWKUHVHDUFKIRUEHWWHUKHDOWKDQGEXLOGLQJUHJLRQDOFDSDFLWLHVIRUEHWWHU
TXDOLW\UHVHDUFKLVDQLPSRUWDQWSULRULW\
7KH OLWHUDWXUH RQ UHVHDUFK PHWKRGRORJLHV LV YDVW 5HVHDUFKHUV DQG VFLHQWLVWV
ZRUOGZLGHQRZDGD\VKDYHDFFHVVWRHQRUPRXVDQGJURZLQJLQIRUPDWLRQUHVRXUFHV
ZKLFKSURYLGHLQGHSWKNQRZOHGJHWUDLQLQJDQGHGXFDWLRQWRHQKDQFHDQGLPSURYH
UHVHDUFK7KLV3UDFWLFDO*XLGHIRU+HDOWK5HVHDUFKHUVLVKRZHYHUTXLWHXQLTXH,W
LVGLIIHUHQWLQWKDWLWLVQRWDFODVVLFDOWH[WERRNRQUHVHDUFKPHWKRGRORJ\EXWIRFXVHV
GLUHFWO\RQWKRVHZKRFDUU\RXWKHDOWKUHVHDUFKRUDVSLUHWRGRVRLQWKHIXWXUH,WHPERGLHV
WKHVHULRXVQHVVWKHVLQFHULW\DQGWKHSDVVLRQRIWKHDXWKRUVDVWKH\WU\WRJXLGHDQGGLUHFW
WKHUHDGHULQKHURUKLVSXUVXLWRIUHVHDUFKWRVHHNQHZNQRZOHGJHLGHQWLI\SUREOHPV
DQGSURYLGHDQVZHUV7KHDXWKRUVZLWKJUHDWVNLOOKDYHDUWLFXODWHGDQGVKRZQWKHZD\
IRUZDUGIRUDQ\RQHZKRVHHNVWKHYDOXHRIUHVHDUFKGHVLUHVWRXQGHUWDNHJRRGTXDOLW\
UHVHDUFKDQGDVSLUHVWRGUDZEHQHILWVIURPLW
7KHERRNEHJLQVZLWKDYHU\VWURQJPHVVDJHKHDOWKUHVHDUFKLVQRWDOX[XU\EXW
DQHVVHQWLDOQHHGWKDWQRQDWLRQFDQDIIRUGWRLJQRUH7KHDXWKRUVILUVWUHDVRQRXWZK\
LWLVVRLPSRUWDQWHVSHFLDOO\IRUWKHGHYHORSLQJFRXQWULHVWRGRUHVHDUFKDQGH[SODLQ
WKHFRQVHTXHQFHVRILJQRULQJUHVHDUFKDVDWRROIRUHYLGHQFHRQZKLFKWREDVHSODQQLQJ
SUDFWLFHDQGDFWLRQV7KH\GHVFULEHWKHUHVHDUFKSURFHVVEHJLQQLQJZLWKWKHVHOHFWLRQ
RIDUHVHDUFKWRSLFWKHQDUURZLQJGRZQRIVSHFLILFREMHFWLYHVDQGKRZEHVWWRDFKLHYH
WKHVWDWHGREMHFWLYHV7KH\GHVFULEHWKHFKDUDFWHULVWLFVRIDJRRGUHVHDUFKSURSRVDO²
RQHWKDWKDVSRWHQWLDOIRUREWDLQLQJWKHUHTXLUHGILQDQFLQJLVIHDVLEOHDQGZLOOSURGXFH
YDOLGLQIRUPDWLRQDQGNQRZOHGJHWKDWZLOOXOWLPDWHO\KDYHDQLPSDFWRQKHDOWK7KH
YDULRXVRSWLRQVDUHGLVFXVVHGZLWKUHJDUGWRUHVHDUFKPHWKRGRORJLHVDQGVWUDWHJLHVDQG
LQYDOXDEOHJXLGDQFHLVSURYLGHGRQGDWDFROOHFWLRQDQGLWVDQDO\VLV
7KHUHDUHRWKHUXQLTXHDVSHFWVWRWKLVERRN,QGHVFULELQJWKHGLIIHUHQWUHVHDUFK
DSSURDFKHV DQG PHWKRGV LW XQGHUVFRUHV WKH PHULWV DV ZHOO DV GHPHULWV RI ERWK
TXDQWLWDWLYHDQGTXDOLWDWLYHUHVHDUFKPHWKRGVDQGUHPLQGVWKHUHDGHURIKRZDQGXQGHU
ZKDWVLWXDWLRQVRQHRUWKHRWKHUVWUDWHJ\RUERWKFDQEHKHOSIXOWRWKHUHVHDUFKTXHVWLRQ
LQPLQG$QRWKHUVWUHQJWKLVWKHDXWKRUV
HPSKDVLVRQWKHHWKLFVRIKHDOWKUHVHDUFK
7KURXJKRXWWKHUHDGHULVUHPLQGHGFRQVWDQWO\RIWKHHWKLFDOSULQFLSOHVWKDWJRYHUQKHDOWK
UHVHDUFKDQGWKHQHHGIRUXSKROGLQJDQGGHIHQGLQJPRUDODQGHWKLFDOYDOXHVLQVXFK
SUDFWLFHV6RPHNH\LQWHUQDWLRQDOJXLGHOLQHVDUHLQGH[HGIRUWKHEHQHILWRIWKHUHDGHU
7KHERRNSURYLGHVXVHIXOWLSVIRUWKHKHDOWKUHVHDUFKHUZKLFKDUHRUGLQDULO\DEVHQWLQ
FODVVLFDOWH[WERRNVRQKHDOWKUHVHDUFKPHWKRGRORJ\,WWHOOVWKHPKRZWRILQGLQIRUPDWLRQ
SHUWLQHQWWRWKHLUUHVHDUFKDQGKRZWRVHHNIXQGVIRUWKHLUUHVHDUFK,WGLVFXVVHVWKHYDULRXV
ZD\VRIFRPPXQLFDWLQJUHVHDUFKUHVXOWVWRGLIIHUHQWDXGLHQFHVDVZHOODVSUHSDUDWLRQ
RIPDQXVFULSWVIRUVXEPLVVLRQWRPHGLFDOMRXUQDOVDQGSUHVHQWDWLRQVZLWKDQRYHUDOO
UHPLQGHUWKDWWKHFXOPLQDWLRQRIWKHUHVHDUFKHIIRUWVKRXOGEHLQLWVDSSOLFDWLRQLQRUGHU
WREULQJDERXWWKHUHTXLUHGFKDQJHVLQSROLFLHVDFWLRQVDQGSUDFWLFHV
7KHJUHDWHVWVWUHQJWKRIWKLVERRNLVWKDWLWUHIOHFWVWKHILUVWKDQGH[SHULHQFHRIWKH
DXWKRUVHVSHFLDOO\3URI0DKPRXG)DWKDOOD,WLVKHDUWHQLQJWRQRWHWKDWKHFKRVHWR
VKDUHKLVH[SHUWLVHDQGWKHULFKQHVVRIKLVH[SHULHQFHLQKHDOWKUHVHDUFKLQWKLVPDQQHU
7KHERRNLVHDV\DQGVLPSOHWRIROORZ,WGHP\VWLILHVKHDOWKUHVHDUFK,WLVDERRNWKDW
HYHU\KHDOWKUHVHDUFKHUZLOOWUHDVXUHDQGDUHDG\UHIHUHQFHWKDWKHRUVKHZLOOZDQWWR
NHHSFORVHE\
+XVVHLQ$*H]DLU\0')5&6
5HJLRQDO'LUHFWRUIRUWKH(DVWHUQ0HGLWHUUDQHDQ
Preface
7KHLQWHQGHGDXGLHQFHRIWKLVERRNDVLQGLFDWHGLQLWVWLWOHLVKHDOWKUHVHDUFKHUV
+HDOWKUHVHDUFKHUVDUHQRWOLPLWHGWRVFLHQWLVWVSXUVXLQJDUHVHDUFKFDUHHU+HDOWK
UHVHDUFKFDQDQGVKRXOGEHSXUVXHGE\DEURDGUDQJHRISHRSOH+HDOWKUHVHDUFKFDQ
EHVLPSO\GHILQHGDVWKHSURFHVVIRUV\VWHPDWLFFROOHFWLRQGHVFULSWLRQDQDO\VLVDQG
LQWHUSUHWDWLRQRIGDWDWKDWFDQEHXVHGWRLPSURYHWKHKHDOWKRILQGLYLGXDOVRUJURXSV
+HDOWKSURIHVVLRQDOVKHDOWKDGPLQLVWUDWRUVKHDOWKSROLF\PDNHUVDQGQRQJRYHUQPHQWDO
RUJDQL]DWLRQVDPRQJRWKHUVFDQDQGVKRXOGXVHWKHVFLHQWLILFPHWKRGWRJXLGHWKHLUZRUN
IRULPSURYLQJWKHKHDOWKRILQGLYLGXDOVDQGFRPPXQLWLHV(YHQLIWKH\GRQRWSXUVXH
PXFKUHVHDUFKWKHPVHOYHVWKH\QHHGWRJUDVSWKHSULQFLSOHVRIWKHVFLHQWLILFPHWKRGWR
XQGHUVWDQGWKHYDOXHDQGDOVROLPLWDWLRQVRIVFLHQFHDQGWREHDEOHWRDVVHVVDQGHYDOXDWH
UHVXOWVRIUHVHDUFKEHIRUHDSSO\LQJWKHP
0RVWWH[WERRNVRQWKHVXEMHFWRIKHDOWKUHVHDUFKDUHZULWWHQLQDODQJXDJHWKDWLV
KLJKO\WHFKQLFDODQGIRUDQDXGLHQFHRIWUDLQHGVFLHQWLVWV7KHUHLVDQHHGWRGHP\VWLI\WKH
UHVHDUFKSURFHVVIRUDEURDGHUFRPPXQLW\RIKHDOWKUHVHDUFKHUV7KHUHVHDUFKSURFHVVLV
ODUJHO\DERXWJRRGVHQVHDQGUHDVRQ:HKDYHWULHGWRPDNHWKLVERRNDVUHDGHUIULHQGO\
DVSRVVLEOHEXWQRWDWWKHH[SHQVHRIVFLHQWLILFDFFXUDF\
:HKDYHDWWHPSWHGLQWKLVJXLGHWRFRYHUWKHEURDGVSHFWUXPRIWKHUHVHDUFK
SURFHVV7KHUHVHDUFKSURFHVVLVQRWVLPSO\DERXWWKHPHWKRGRORJ\RIUHVHDUFKGHVLJQ
%HIRUHFRQVLGHULQJUHVHDUFKGHVLJQUHVHDUFKHUVQHHGWRNQRZKRZWRGHILQHDQGUHILQH
WKHUHVHDUFKTXHVWLRQ$IWHUVHWWOLQJRQUHVHDUFKGHVLJQWKH\QHHGWREHDEOHWRZULWHD
UHVHDUFKSURWRFROVXEPLWDSURSRVDOIRUIXQGLQJSURSHUO\FRQGXFWWKHUHVHDUFKGHVFULEH
DQDO\VHDQGFDUHIXOO\LQWHUSUHWWKHUHVHDUFKUHVXOWVDQGILQDOO\FRPPXQLFDWHWKHILQGLQJV
WRDOOZKRVWDQGWREHQHILWIURPWKHUHVHDUFKWKURXJKZULWLQJDQGSXEOLVKLQJSDSHUVDQG
PDNLQJVFLHQWLILFSUHVHQWDWLRQV5HVHDUFKHUVQHHGDOVRWKHVNLOOVWREHDEOHWRDVVHVV
DQGHYDOXDWHWKHUHVHDUFKGRQHE\RWKHUV%HJLQQHUVLQKHDOWKUHVHDUFKKDYHWRFRQVXOW
GLIIHUHQWVRXUFHVLIWKH\ZDQWWRJHWDFRPSOHWHJUDVSRIWKLVZKROHVSHFWUXPRIWKH
UHVHDUFKSURFHVV2XUREMHFWLYHZDVWRSURYLGHDFRQFLVHSUDFWLFDOJXLGHWRFRYHUWKHVH
DUHDVUDWKHUWKDQDFRPSUHKHQVLYHPDQXDO7REHDEOHWRREWDLQPRUHWHFKQLFDOGHWDLO
DQGLQIRUPDWLRQRQWKHLVVXHVGLVFXVVHGZHKDYHSURYLGHGDOLVWRIXVHIXOVRXUFHVIRU
HDFKFKDSWHUDVZHOODVDQXPEHURIDQQH[HV
:HKRSHWKDWWKLVJXLGHZLOOKHOSLQH[SDQGLQJWKHFRPPXQLW\RIKHDOWKUHVHDUFKHUV
EH\RQGWKHWUDGLWLRQDOJURXSVRIWUDLQHGVFLHQWLVWV:HKRSHLWZLOOKHOSKHDOWKUHVHDUFKHUV
WRSODQFRQGXFWDQGGLVVHPLQDWHJRRGUHVHDUFK
0DKPRXG))DWKDOOD
0RKDPHG0))DWKDOOD
Acknowledgements
:HDUHJUDWHIXOIRU'U0RKDPHG$EGXU5DE5HJLRQDO$GYLVHU5HVHDUFKDQG3ROLF\
&RRUGLQDWLRQ:+25HJLRQDO2IILFHIRUWKH(DVWHUQ0HGLWHUUDQHDQIRUHQFRXUDJLQJXVWR
FRPSOHWHWKHWDVNRIZULWLQJWKLVJXLGHIRUSURYLGLQJXVHIXOFRPPHQWVDQGVXJJHVWLRQV
DQGIRUEULQJLQJLWEHIRUHWKHUHJLRQDOSXEOLFDWLRQVFRPPLWWHH0V-DQH1LFKROVRQ(GLWRU
DWWKH5HJLRQDO2IILFHIRUWKH(DVWHUQ0HGLWHUUDQHDQZDVH[WUHPHO\KHOSIXOWKURXJKRXW
WKHSURFHVVRISUHSDULQJWKHERRNIRUSXEOLFDWLRQ
0DQ\FROOHDJXHVSHUVXDGHGXVDERXWWKHQHHGIRUVXFKDJXLGHDQGSURYLGHGXV
ZLWKFRQVWUXFWLYHFRPPHQWV,WZRXOGEHGLIILFXOWWRWU\WRQDPHWKHPDOO7KHVRXUFHV
ZULWWHQE\SUHYLRXVDXWKRUVDQGOLVWHGXQGHUWKHUHIHUHQFHVDQGDGGLWLRQDOVRXUFHVKDYH
EHHQYHU\KHOSIXOLQSXWWLQJWRJHWKHUWKHPDWHULDOIRUWKLVERRN
)LQDOO\ZHDUHJUDWHIXOWRRXUVWXGHQWVZKRWDXJKWXVKRZWRWHDFKDQGWRRXU
IDPLOLHVRQZKRVHWLPHWKLVERRNZDVZULWWHQ
Chapter 1
Introduction and overview
7KHKHDOWKJDLQVLQWKHODVWFHQWXU\KDYHEHHQXQSUHFHGHQWHG$GYDQFHVPDGH
LQKHDOWKUHVHDUFKDFFRXQWIRUDVLJQLILFDQWSDUWRIWKHVHKHDOWKJDLQV1HZVFLHQWLILF
IURQWLHUVQRZRSHQLQJXSSURPLVHWRWUDQVIRUPPHGLFDOSUDFWLFHLQZD\VQHYHULPDJLQHG
EHIRUHDQGWRFRQWULEXWHWRIXUWKHULPSURYHPHQWVLQKHDOWK+RZHYHUKHDOWKUHVHDUFK
LVQRWRQO\DERXWWKHGHYHORSPHQWRIQHZWRROVDQGDGYDQFLQJRXUXQGHUVWDQGLQJDERXW
KHDOWKDQGGLVHDVH+HDOWKUHVHDUFKLVLPSRUWDQWWRLQIRUPSROLF\DQGGHFLVLRQPDNLQJ
LQKHDOWKV\VWHPV
+HDOWKUHVHDUFKLVQRWDOX[XU\WREHFRQGXFWHGRQO\E\FRXQWULHVZLWKWKHUHVRXUFHV
WRVSDUH:KHQ,QGLDJDLQHGLQGHSHQGHQFHWKHFRXQWU\IDFHGWKHSUREOHPRIKRZWR
DOORFDWHLWVVFDUFHUHVRXUFHVWRDUHDVRIPRVWQHHG-DZDKDU/DO1HKUXLQWKLVFRQWH[W
PDGHWKHIROORZLQJVWDWHPHQW³%HFDXVHZHDUHDSRRUFRXQWU\ZHFDQQRWDIIRUGQRW
WRGRUHVHDUFK´7KHSDUWLFLSDWLRQDQGFRQWULEXWLRQRIGHYHORSLQJFRXQWULHVLQVFLHQWLILF
UHVHDUFKKDVEHHQZHOOH[SUHVVHGE\WKH3DNLVWDQL1REHO/DXUHDWH$EGXO6DODPDV
IROORZV³6FLHQFHDQGWHFKQRORJ\DUHDVKDUHGKHULWDJHRIDOOPDQNLQG(DVWDQG:HVW
6RXWKDQG1RUWKKDYHDOOHTXDOO\SDUWLFLSDWHGLQWKHLUFUHDWLRQLQWKHSDVWDVZHKRSH
WKH\ZLOOLQWKHIXWXUH²WKHMRLQWHQGHDYRXULQVFLHQFHEHFRPLQJRQHRIWKHXQLI\LQJ
IRUFHVDPRQJWKHGLYHUVHSHRSOHVRQWKHJOREH´6DODP
+HDOWK UHVHDUFK PD\ EH SXUVXHG DV D FDUHHU LQ D SXEOLF RU SULYDWH UHVHDUFK
RUJDQL]DWLRQ5HVHDUFKPD\EHGRQHLQSXUVXLWRISUHVWLJHRUXQGHUWKHSUHVVXUHRIWKH
WKUHDWRI³SXEOLVKRUSHULVK´ZKHQFOLPELQJWKHODGGHURIDVXFFHVVIXODFDGHPLFFDUHHU
$VWURQJDUJXPHQWFDQKRZHYHUEHPDGHWKDWDOOKHDOWKSURIHVVLRQDOVVKRXOGGRVRPH
UHVHDUFKRUDWOHDVWJHWHQRXJKNQRZOHGJHDERXWWKHUHVHDUFKSURFHVVHYHQLIWKH\ZLVK
WRVSHQGWKHUHVWRIWKHLUOLYHVGHDOLQJZLWKSDWLHQWVRUKHDOWKDGPLQLVWUDWLRQ$VFLHQWLILF
DSSURDFKLVHVVHQWLDOIRUKHDOWKSURIHVVLRQDOV$VWKHSUDFWLFHRIPHGLFLQHLVDGYDQFLQJ
UDSLGO\WKHQHHGIRUFULWLFDOHYDOXDWLRQRIQHZGHYHORSPHQWVEHFRPHVPRUHXUJHQW
7KHPHGLFDOSDVWLVOLWWHUHGZLWKH[DPSOHVRISRVVLEOHPDMRUDGYDQFHVHYHQWXDOO\EHLQJ
VKRZQWREHRIQRYDOXHRUHYHQWREHKDUPIXO5HVHDUFKKHOSVWRGHYHORSDVFLHQWLILF
FULWLFDODWWLWXGH$FOLQLFLDQZLOOILQGWKDWWKHIDFXOWLHVGHYHORSHGE\GRLQJUHVHDUFKDUH
WKRVHPRVWQHHGHGLQFOLQLFDOGLDJQRVLV
+HDOWKSROLF\PDNHUVSDUWLFXODUO\LQGHYHORSLQJFRXQWULHVPD\QRWDSSUHFLDWHWKH
FRQWULEXWLRQZKLFKUHVHDUFKFDQPDNH7KHUHLVVWLOODGLYLGHEHWZHHQWKHXQLYHUVHRI
UHVHDUFKDQGWKHXQLYHUVHRISROLF\PDNLQJ7KHVWHUHRW\SHRIWKHUHVHDUFKHULQKHURU
12 A practical guide for health researchers
KLVLYRU\WRZHUVWLOOSUHYDLOV,QIDFWKHDOWKPDQDJHUVDQGSROLF\PDNHUVPD\EHGRLQJ
UHVHDUFKZLWKRXWNQRZLQJLW5HVHDUFKFDQEHGHILQHGDVWKHV\VWHPDWLFFROOHFWLRQ
GHVFULSWLRQDQDO\VLVDQGLQWHUSUHWDWLRQRIGDWDWRDQVZHUDFHUWDLQTXHVWLRQRUVROYHD
SUREOHP+HDOWKUHVHDUFKFDQDOVREHGHILQHGDVWKHSURFHVVIRUV\VWHPDWLFFROOHFWLRQ
GHVFULSWLRQDQDO\VLVDQGLQWHUSUHWDWLRQRIGDWDWKDWFDQEHXVHGWRLPSURYHWKHKHDOWKRI
LQGLYLGXDOVRUJURXSV7KHUHVHDUFKSURFHVVFKDQJHV³LQIRUPDWLRQ´LQWR³NQRZOHGJH´
WKURXJKFULWLFDODVVHVVPHQWDQGUHODWLQJLWWRRWKHUH[LVWLQJKXPDQNQRZOHGJH$VWKH\
JRWKURXJKWKLVUHVHDUFKH[HUFLVHKHDOWKPDQDJHUVDQGSROLF\PDNHUVQHHGWRXQGHUVWDQG
PRUHDERXWWKHSURFHVVRIUHVHDUFK
7KHUHLVDQHHGWRGHP\VWLI\WKHVFLHQWLILFSURFHVV6FLHQWLILFLQTXLU\LVEDVLFDOO\D
SRWHQWLDWLRQRIFRPPRQVHQVHZKLFKLVSUREDEO\RQHRIWKHPRVWHTXLWDEO\GLVWULEXWHG
KXPDQJLIWV(LQVWHLQVDLG³7KHZKROHRIVFLHQFHLVQRWKLQJPRUHWKDQDUHILQHPHQWRI
HYHU\GD\WKLQNLQJ´,QDVHQVHPRVWRIXVPD\EHFRQGXFWLQJVRPHUHVHDUFKLQRXUGDLO\
OLIH:KHQZHIRUH[DPSOHZDQWWREX\DFDULQDSURSHUZD\ZHFROOHFWLQIRUPDWLRQ
DERXWPRGHOVDQGGHDOHUVDQDO\VHLWWKHQWU\WRUHDFKD³VFLHQWLILF´FRQFOXVLRQRQZKLFK
FDUWREX\7KHXVHRIFRPSOH[LQVWUXPHQWDWLRQLVQRWDQHFHVVDU\UHTXLUHPHQWIRUJRRG
UHVHDUFK.H\DWWULEXWHVRIJRRGUHVHDUFKDUHSURSHUSODQQLQJDFFXUDF\LQGDWDFROOHFWLRQ
DQGSURSHUXQELDVHGLQWHUSUHWDWLRQ
7KHUHLVRQO\RQHW\SHRIUHVHDUFKJRRGUHVHDUFK%DGUHVHDUFKGRHVQRWGHVHUYH
WKHQDPHRIUHVHDUFK%DGO\GRQHUHVHDUFKLVQRWRQO\DZDVWHRIWLPHPRQH\DQGHIIRUW
,WFDQEHFRQVLGHUHGXQHWKLFDOLILWH[SRVHVUHVHDUFKVXEMHFWVWRWKHLQKHUHQWULVNVRI
H[SHULPHQWDWLRQZLWKQRUHZDUGWRWKHPWRRWKHUVRUWRWKHLUFRPPXQLWLHV7KLVERRNLV
DERXWKRZWRGRKHDOWKUHVHDUFKDQGKRZWRGRLWZHOO
7KHUHVHDUFKSURFHVVEHJLQVZLWKVHOHFWLQJDILHOGDQGWRSLFIRUUHVHDUFKWKHQ
SODQQLQJWKHUHVHDUFKZULWLQJXSWKHSODQDVDUHVHDUFKSURWRFRODQGZKHUHDSSURSULDWH
VXEPLWWLQJLWDVDUHVHDUFKSURSRVDOIRUIXQGLQJ,PSOHPHQWDWLRQRIWKHUHVHDUFKSURMHFW
LVIROORZHGE\GHVFULELQJDQGDQDO\VLQJWKHUHVHDUFKUHVXOWV7KHUHVHDUFKUHVXOWV
WKHQQHHGWREHFDUHIXOO\DQGREMHFWLYHO\LQWHUSUHWHG5HVHDUFKLVQRWFRPSOHWHXQWLO
LWLVFRPPXQLFDWHGWRWKRVHZKRPD\EHQHILWIURPLW7KLVFRPPRQO\LQYROYHVEXW
LVQRWOLPLWHGWRZULWLQJDQGSXEOLVKLQJDVFLHQWLILFSDSHUDQGRUPDNLQJDVFLHQWLILF
SUHVHQWDWLRQ7KHUHVHDUFKSURFHVVQRWRQO\LQYROYHVGRLQJWKHUHVHDUFKEXWDOVR
DVVHVVLQJDQGHYDOXDWLQJUHVHDUFKGRQHE\RWKHUV7KURXJKRXWWKHUHVHDUFKSURFHVVDQG
SDUWLFXODUO\ZKHUHWKHUHVHDUFKLQYROYHVKXPDQVXEMHFWVUXOHVRIHWKLFDOFRQGXFWPXVW
EHFDUHIXOO\REVHUYHG$OOWKHVHVWHSVLQWKHUHVHDUFKSURFHVVDUHGHDOWZLWKLQGHWDLOLQ
WKHGLIIHUHQWFKDSWHUVRIWKHERRN
%HFDXVHRIWKHLPSRUWDQFHRIHWKLFVLQKHDOWKUHVHDUFKWKHQH[WFKDSWHURIWKH
ERRNRXWOLQHVWKHFRQFHUQVDERXWHWKLFVLQKHDOWKUHVHDUFKJHQHUDOHWKLFDOSULQFLSOHV
UHVSRQVLELOLW\IRUPDLQWDLQLQJHWKLFDOVWDQGDUGVDQGWKHGXWLHVRIHWKLFVFRPPLWWHHVZKLFK
UHYLHZDQGDSSURYHUHVHDUFK$IWHUWKLVLQWURGXFWLRQWRHWKLFVHWKLFDOFRQVLGHUDWLRQVDUH
Introduction and overview 13
GLVFXVVHGLQPRUHGHWDLOLQVXEVHTXHQWFKDSWHUVGHDOLQJZLWKGLIIHUHQWVWDJHVRIWKH
UHVHDUFKSURFHVV,QDGGLWLRQ$QQH[HVDQGSURYLGHGRFXPHQWDWLRQRQWKHWRSLF7KH
:RUOG0HGLFDO$VVRFLDWLRQ'HFODUDWLRQRI+HOVLQNLLQLWVODWHVWYHUVLRQDQG,QWHUQDWLRQDO
(WKLFDO*XLGHOLQHVIRU%LRPHGLFDO5HVHDUFK,QYROYLQJ+XPDQ6XEMHFWVSUHSDUHGE\WKH
&RXQFLOIRU,QWHUQDWLRQDO2UJDQL]DWLRQVRI0HGLFDO6FLHQFHV&,206LQFROODERUDWLRQ
ZLWKWKH:RUOG+HDOWK2UJDQL]DWLRQ:+2
7KHILUVWGHFLVLRQDUHVHDUFKHUQHHGVWRPDNHLVZKDWUHVHDUFKWRGR7KLVLVGHDOW
ZLWKLQ&KDSWHU7KHUHDUHGLIIHUHQWILHOGVRIKHDOWKUHVHDUFKDOORIZKLFKFDQPDNHD
FRQWULEXWLRQWRLPSURYHPHQWRIKHDOWKDQGDOODUHQHHGHG,QWKHVHGD\VRIVSHFLDOL]DWLRQ
DQGVXEVSHFLDOL]DWLRQWKHLQYHVWLJDWRUPD\KDYHDOUHDG\ODQGHGLQRQHRIWKHGLVFLSOLQHV
%XWLWLVLPSRUWDQWWKDWVKHVKRXOGEHDZDUHRIWKHRWKHUGLVFLSOLQHVDQGZKDWWKH\
FDQFRQWULEXWH&ROODERUDWLRQEHWZHHQUHVHDUFKHUVIURPGLIIHUHQWGLVFLSOLQHVLVRQHRI
WKHPRVWHIIHFWLYHPHFKDQLVPVLQDGYDQFLQJKHDOWKUHVHDUFK7KHGLVWLQFWLRQEHWZHHQ
EDVLFDQGDSSOLHGUHVHDUFKLVSUREDEO\PRUHDIXQFWLRQRIWLPH%DVLFUHVHDUFKSURYLGHV
WKHSRRORINQRZOHGJHIURPZKLFKOHDGVIRUDSSOLHGUHVHDUFKFDQEHSLFNHGXS$OVR
WKHVWURQJLQWHUHVWLQTXDQWLWDWLYHUHVHDUFKVKRXOGQRWOHDGXVWRLJQRUHWKHSRWHQWLDO
FRQWULEXWLRQRITXDOLWDWLYHUHVHDUFK4XDOLWDWLYHUHVHDUFKFDQSURYLGHLQVLJKWVWKDWZLOO
QRWEHDSSDUHQWIURPTXDQWLWDWLYHPHWKRGRORJLHV
7KHVHOHFWLRQRIDWRSLFIRUUHVHDUFKLVLQIOXHQFHGE\ZKDWGULYHVWKHUHVHDUFK
5HVHDUFKLVGULYHQE\FXULRVLW\KHDOWKQHHGVSURILWDQGRURSSRUWXQLW\6FLHQWLVWVRQ
WKHRQHKDQGDUHKDSS\WRSXUVXHWKHLURZQOLQHVRILQWHUHVWHQMR\DFDGHPLFIUHHGRP
DQGIROORZVFLHQWLILFFXULRVLW\7KH\FDQVD\DQGWKH\DUHULJKWWKDWPDQ\VLJQLILFDQW
GLVFRYHULHVLQWKHILHOGRIKHDOWKZHUHPDGHE\VHUHQGLSLW\DQGQRWWKURXJKWDUJHWHG
UHVHDUFK3ROLF\PDNHUVDQGIXQGHUVRIUHVHDUFKRQWKHRWKHUKDQGZRXOGOLNHWRVHH
UHVHDUFKWDUJHWHGWRUHVSRQGWRSULRULW\KHDOWKQHHGV3ULYDWHLQGXVWU\QRZDPDMRUDFWRU
LQKHDOWKUHVHDUFKLVGULYHQE\SURILWDQGSXUVXHVOLQHVRIUHVHDUFKWKDWDUHOLNHO\WR
OHDGWRWKHGHYHORSPHQWRISURGXFWVWKDWVHOOLQODUJHSURILWDEOHPDUNHWV*RYHUQPHQWV
LQGHYHORSHGFRXQWULHVRIWHQHQFRXUDJHDQGVXSSRUWUHVHDUFKIRUZHDOWKFUHDWLRQQRW
MXVWIRUKHDOWK7KHVHOHFWLRQRIWRSLFVIRUUHVHDUFKPD\EHGULYHQE\WKHRSSRUWXQLW\IRU
IXQGLQJ$PDMRUFRQFHUQLQKHDOWKUHVHDUFKWRGD\LVWKHJDS2IWKHWRWDOIXQGV
VSHQWZRUOGZLGHHDFK\HDURQKHDOWKUHVHDUFKE\ERWKWKHSULYDWHDQGSXEOLFVHFWRUVLW
KDVEHHQHVWLPDWHGWKDWRQO\DERXWDUHGHYRWHGWRWKHKHDOWKSUREOHPVRIRI
WKHZRUOG¶VSRSXODWLRQ2SSRUWXQLWLHVIRUUHVHDUFKPD\DULVHWKURXJKSDUWLFLSDWLRQLQ
FROODERUDWLYHLQWHUQDWLRQDOUHVHDUFK)RUGHYHORSLQJFRXQWU\UHVHDUFKHUVWKLVLVDJRRG
RSSRUWXQLW\EXWQRWZLWKRXWFRQFHUQV&RQFHUQVLQFOXGHGLVWRUWLRQRIFRXQWU\SULRULWLHVLQ
UHVHDUFKLQWHUQDOEUDLQGUDLQZKHUHWKHEUDLQVRIUHVHDUFKHUVLQWKHFRXQWU\DUHZRUNLQJ
IRUWKHSUREOHPVRIRWKHUFRXQWULHVDQGHWKLFDOFRQVLGHUDWLRQVWKDWQHHGWREHDGGUHVVHG
3DUWLFLSDWLRQLQSKDUPDFHXWLFDOFRPSDQ\UHVHDUFKLVDQRWKHURSSRUWXQLW\&ROODERUDWLRQ
EHWZHHQDFDGHPLDDQGLQGXVWU\LVWREHHQFRXUDJHGEXWWKHUHDUHFRQFHUQVWKDWQHHGWR
EHDGGUHVVHGZKHWKHUWKHFROODERUDWLYHUHVHDUFKLVDWWKHGLVFRYHU\VWDJHGXULQJFOLQLFDO
WHVWLQJRUDIWHUPDUNHWLQJRIWKHSURGXFW
,GHDVIRUWRSLFVIRUUHVHDUFKFRPHIURPGLIIHUHQWVRXUFHVWKDWQHHGWREHSXUVXHGE\
UHVHDUFKHUV)DPLOLDULW\ZLWKWKHUHVHDUFKOLWHUDWXUHLVLPSRUWDQWQRWRQO\IRULGHQWLI\LQJ
ZKHUHJDSVIRUUHVHDUFKDUHEXWDOVRGXULQJWKHSODQQLQJLPSOHPHQWDWLRQDQGZULWLQJ
XSRIWKHUHVHDUFK$QQH[SURYLGHVQRWHVRQVHDUFKLQJWKHOLWHUDWXUHXVLQJGLIIHUHQW
VRXUFHVLQWKHQHZLQIRUPDWLRQDJH$VZLOOEHGLVFXVVHGLQ&KDSWHUZKDWHYHUWKHWRSLF
RIUHVHDUFKVHOHFWHGPD\EHLWVKRXOGVDWLVI\WKHFULWHULDRIEHLQJIHDVLEOHLQWHUHVWLQJ
QRYHOHWKLFDODQGUHOHYDQW
$IWHUGHFLGLQJRQZKDWUHVHDUFKWRGR&KDSWHUGHDOVZLWKWKHSODQQLQJRIWKH
UHVHDUFK7LPHVSHQWRQSURSHUSODQQLQJLVQHYHUORVW7KHUHDUHGLIIHUHQWW\SHVRI
UHVHDUFKGHVLJQZKHWKHUIRUREVHUYDWLRQDORUH[SHULPHQWDOLQWHUYHQWLRQVWXGLHV$OO
W\SHVRIUHVHDUFKGHVLJQKDYHWKHLUSODFH7KHLQYHVWLJDWRUKDVWRVHOHFWWKHW\SHRI
UHVHDUFKGHVLJQWKDWZLOOJLYHWKHPRVWGHILQLWLYHDQVZHUWRWKHUHVHDUFKTXHVWLRQDQG
DWWKHVDPHWLPHZRXOGEHIHDVLEOHWRFRQGXFW,QPRVWFDVHVPRUHWKDQRQHGHVLJQZLOO
EHSRVVLEOHEXWDWUDGHRIIKDVWREHPDGHEHWZHHQWKHLGHDODQGWKHSRVVLEOH,QWKLV
FRQWH[WDVLQRWKHUVWKHEHVWVKRXOGQRWEHPDGHWKHHQHP\RIWKHJRRG,QSODQQLQJ
WKHUHVHDUFKWKHUHVHDUFKWRSLFKDVWREHQDUURZHGGRZQLQWRDZHOOGHILQHGUHVHDUFK
TXHVWLRQ7KHPRUHUHILQHGWKHTXHVWLRQWKHEHWWHUZLOOEHWKHSODQ,QYHVWLJDWRUVVKRXOG
UHVLVWWKHWHPSWDWLRQWREURDGHQWKHVFRSHRILQTXLU\EH\RQGZKDWFDQUHDOLVWLFDOO\EH
DQVZHUHGE\WKHUHVHDUFK
:LWKDZHOOGHILQHGDQGUHILQHGUHVHDUFKTXHVWLRQDUHVHDUFKK\SRWKHVLVFDQEH
JHQHUDWHG,QSURSHUVFLHQWLILFPHWKRGRORJ\ZHGRQRWGHYHORSDUHVHDUFKK\SRWKHVLV
LQRUGHUWRSURYHLWZHGHYHORSDK\SRWKHVLVLQRUGHUWRWHVWLW6FLHQWLVWVGRLQJUHVHDUFK
DGRSWDVFHSWLFDODWWLWXGH7KH\VWDUWZLWKWKHDVVXPSWLRQWKDWWKHUHVHDUFKK\SRWKHVLV
LVQRWWUXHXVLQJWKHWHUP³QXOOK\SRWKHVLV´,IWKHUHVXOWVGRQRWVXSSRUWWKH³QXOO
K\SRWKHVLV´WKHQWKHUHVHDUFKK\SRWKHVLVLVPRUHOLNHO\WREHWUXH3UREDELOLW\LVDQRWKHU
IHDWXUHRIWKHVFLHQWLILFPHWKRGRORJ\7KHUHLVXVXDOO\QRFHUWDLQW\DERXWWKHYDOLGLW\RI
VFLHQWLILFUHVXOWV,WLVRQO\DKLJKOHYHORISUREDELOLW\WKDWLVVRXJKW7KLVOHYHOGHSHQGV
RQWKHPDJQLWXGHRIWKHILQGLQJDVZHOODVWKHVL]HRIWKHVWXG\$QDO\WLFDOVWDWLVWLFDO
PHWKRGVKHOSLQDVVHVVLQJWKHOHYHORISUREDELOLW\
,QSODQQLQJWKHUHVHDUFKDFUXFLDOTXHVWLRQLVWKHW\SHDQGVL]HRIVDPSOHWREH
VWXGLHG:HFDQQRWVWXG\DOOWKHSRSXODWLRQ:HQHHGWRGHILQHDWDUJHWSRSXODWLRQDV
ZHOODVDQDFFHVVLEOHSRSXODWLRQ7KHWHUPSRSXODWLRQLQVFLHQWLILFPHWKRGRORJ\GRHVQRW
QHFHVVDULO\UHIHUWRSHRSOHLWUHIHUVWRWKHPDWHULDOIRUWKHUHVHDUFKEHLWSHRSOHDQLPDOV
RUQRQDQLPDWHV7KHUHDUHGLIIHUHQWZD\VRIVDPSOLQJ7KHVDPSOHVL]HDSSURSULDWHWR
SURYLGHWKHDQVZHUWRWKHUHVHDUFKTXHVWLRQKDVWREHGHILQHG$ODUJHUVDPSOHVL]HWKDQ
QHHGHGLVDQLQDSSURSULDWHXVHRIUHVHDUFKUHVRXUFHV$VPDOOHUVDPSOHVL]HWKDQQHHGHG
LVDZDVWHRIHIIRUWDQGPRQH\RQDVWXG\WKDWZLOOQRWSURYLGHGHILQLWLYHDQVZHUV7KH
W\SHVRIPHDVXUHPHQWVWREHXVHGKDYHWREHFDUHIXOO\LGHQWLILHGLQWKHSODQQLQJVWDJHRI
WKHUHVHDUFKWRHQVXUHYDOLGLW\DQGUHOLDELOLW\7KHPHWKRGRORJLHVIRUTXDOLWDWLYHUHVHDUFK
QHHGWREHDSSUHFLDWHGDQGDSSOLHGDVDSSURSULDWHE\UHVHDUFKHUV$UHVHDUFKWRSLFPD\
EHEHWWHUDGGUHVVHGE\TXDQWLWDWLYHUHVHDUFKTXDOLWDWLYHUHVHDUFKRUERWK
7KHSODQQLQJSKDVHLVDOVRWKHWLPHWRWKLQNFDUHIXOO\DERXWHWKLFDOFRQVLGHUDWLRQV
'LIIHUHQW FDWHJRULHV RI KHDOWK UHVHDUFK KDYH WKHLU HWKLFDO LPSOLFDWLRQV7KHUH DUH
LPSRUWDQWFRQVLGHUDWLRQVLQUHVHDUFKGHVLJQVLQYROYLQJH[SHULPHQWDWLRQRQKXPDQ
VXEMHFWVLQHSLGHPLRORJLFDOILHOGDQGTXDOLWDWLYHVWXGLHVDQGLQUHVHDUFKLQYROYLQJ
H[SHULPHQWDWLRQRQDQLPDOV
&KDSWHUGHDOVZLWKZULWLQJWKHUHVHDUFKSURWRFRO$IWHUGHYHORSLQJWKHSODQIRU
WKHUHVHDUFKLWKDVWREHZULWWHQGRZQDVDSURWRFRO7KLVLVSDUWLFXODUO\LPSRUWDQWLIWKH
VWXG\LVGRQHE\DWHDPRILQYHVWLJDWRUVEXWLVDOVRLPSRUWDQWLIWKHUHLVRQO\DVLQJOH
LQYHVWLJDWRU,WKHOSVWRFODULI\WKHWKLQNLQJDERXWWKHSODQDQGLVQHFHVVDU\IRUJHWWLQJ
DSSURYDOIURPHWKLFVUHYLHZFRPPLWWHHV7KHUHLVDWUDGLWLRQDOIRUPDWIRUZULWLQJUHVHDUFK
SURWRFROV,WVWDUWVZLWKDWLWOHDQGDVXPPDU\7KHSURMHFWGHVFULSWLRQVKRXOGWKHQ
LQFOXGHWKHUDWLRQDOHIRUWKHVWXG\LWVREMHFWLYHDQGPHWKRGRORJ\LQFOXGLQJVWDWLVWLFDO
PHWKRGVXVHGIRUVDPSOHVL]HFDOFXODWLRQDQGIRUGDWDPDQDJHPHQWDQGDQDO\VLV(WKLFDO
FRQVLGHUDWLRQVVKRXOGEHVSHOWRXWZKHUHDSSURSULDWHXVLQJDQHWKLFVFKHFNOLVW:KHUH
UHOHYDQWJHQGHULVVXHVVKRXOGDOVREHDGGUHVVHG7KHSURWRFROVKRXOGLQFOXGHDVPDOO
QXPEHURIUHFHQWDQGUHOHYDQWUHIHUHQFHVWRSUHYLRXVZRUNRQWKHWRSLF
&KDSWHUGHDOVZLWKWKHTXHVWLRQRIKRZWRJHWIXQGLQJIRUWKHUHVHDUFKSURMHFW
,QYHVWLJDWRUVPXVWPDNHWKHPVHOYHVIDPLOLDUZLWKSRWHQWLDOVRXUFHVRIIXQGLQJWKHLUOLQHV
RILQWHUHVWDQGWKHLUSURFHGXUHV$UHVHDUFKSURSRVDOKDVWREHSUHSDUHGDQGVXEPLWWHG,W
VKRXOGLQFOXGHLQDGGLWLRQWRWKHSURWRFROLQIRUPDWLRQWRSHUVXDGHWKHIXQGLQJDJHQF\
DERXWWKHLPSRUWDQFHRIWKHSURMHFWWKHUHOHYDQFHRIWKHUHVHDUFKWRWKHSULRULWLHVRIWKH
DJHQF\DQGWKHFDSDFLW\RIWKHLQYHVWLJDWRUVWRXQGHUWDNHLW,WVKRXOGRXWOLQHDWLPHWDEOH
DQGDQ\SUREOHPVDQWLFLSDWHG$EXGJHWVKRXOGEHVXEPLWWHGSURSHUO\LWHPL]HGDQG
MXVWLILHG ,QIRUPDWLRQ DERXW WKH UHVHDUFK LQVWLWXWLRQ WKH FXUULFXOXP YLWDH RI WKH
LQYHVWLJDWRUVDQGDQ\SUHYLRXVZRUNRQWKHWRSLFZLOOEHQHHGHGWRVKRZWKHFDSDELOLW\
IRUFDUU\LQJRXWWKHUHVHDUFK
,Q&KDSWHUZHPRYHWRWKHTXHVWLRQRIKRZWKHSURMHFWVKRXOGEHLPSOHPHQWHG
ZLWKVFLHQWLILFULJRXU7KHSURWRFROPD\QHHGWREHSUHWHVWHG(OHPHQWVPXVWEHLQ
SODFHIRUPRQLWRULQJWKHVWXG\GXULQJLPSOHPHQWDWLRQLQFOXGLQJUHFRUGNHHSLQJDQG
KDQGOLQJRIGDWDTXDOLW\DVVXUDQFHDQGTXDOLW\FRQWUROSHULRGLFWDEXODWLRQVDQGUHSRUWV
FKHFNLQJRIODERUDWRU\SURFHGXUHVDQGFKHFNLQJWKHDFFXUDF\RIGDWD,QFOLQLFDOWULDOV
WKHSULQFLSOHVRI*RRG&OLQLFDO3UDFWLFH*&3VKRXOGEHREVHUYHGDQGWKHWULDOPD\
EHVXEMHFWHGWRDXGLWLQJ5HVHDUFKRQQHZSKDUPDFHXWLFDOSURGXFWVVKRXOGSURFHHGLQ
FRQVHFXWLYHSKDVHVDVWKHVDIHW\DQGHIILFDF\RIWKHSURGXFWLVSURJUHVVLYHO\HVWDEOLVKHG
2QFHWKHSURGXFWLVVKRZQQRWWREHVDIHRUHIIHFWLYHWKHWULDOVKRXOGEHWHUPLQDWHGDQG
QRWDOORZHGWRFRQWLQXH,QWKHLPSOHPHQWDWLRQRIDQ\VWXG\WKHSURWRFRORQFHDSSURYHG
VKRXOGQRWEHFKDQJHG3DUWLFXODUO\LQPXOWLFHQWUHVWXGLHVYLRODWLRQVRIWKHSURWRFRO
FDQQRWEHWROHUDWHGDQGZLOODIIHFWWKHYDOLGLW\RIWKHVWXG\
(WKLFDOFRQVLGHUDWLRQVDUHLPSRUWDQWLQWKHLPSOHPHQWDWLRQRIWKHVWXG\ZKHWKHU
LQYROYLQJKXPDQVXEMHFWVRUH[SHULPHQWDWLRQRQDQLPDOV7KHVWXG\VKRXOGEHPRQLWRUHG
IRUDGKHUHQFHWRHWKLFDOSULQFLSOHV,QDGGLWLRQVFLHQWLILFKRQHVW\LQUHFRUGLQJWKHUHVXOWV
DQGILVFDOKRQHVW\LQUHVHDUFKH[SHQGLWXUHDUHEDVLFHWKLFDOSULQFLSOHV
&KDSWHUGHDOVZLWKGHVFULSWLRQDQGDQDO\VLVRIUHVHDUFKUHVXOWV'HVFULSWLYH
VWDWLVWLFVDUHXVHIXOWRVXPPDUL]HDQGSUHVHQWWKHGDWDLQDZD\WKDWDOORZVVXEVHTXHQW
DQDO\VLV7RROVRIGHVFULSWLYHVWDWLVWLFVLQFOXGHWDEXODWLRQFDOFXODWLRQVJUDSKVDQG
FRUUHODWLRQ7DEXODWLRQVLQFOXGHIUHTXHQF\GLVWULEXWLRQWDEOHVDQGFURVVWDEXODWLRQV
&DOFXODWLRQVHVWLPDWHWKHFHQWUDOWHQGHQF\LQQXPHULFDOGDWDWKHPHDQPHGLDQDQG
PRGHWKHYDULDELOLW\UDQJHVWDQGDUGGHYLDWLRQDQGSHUFHQWLOHVDVZHOODVUDWLRVDQG
UDWHV'LIIHUHQWZD\VDUHDYDLODEOHWRGLVSOD\WKHGDWDYLVXDOO\LQJUDSKV7KHIUHTXHQF\
GLVWULEXWLRQFXUYHLVSDUWLFXODUO\LPSRUWDQWWRVKRZKRZWKHGDWDDUHGLVWULEXWHGZLWK
LPSOLFDWLRQVIRUVXEVHTXHQWVWDWLVWLFDODQDO\VLV$VFDWWHUGLDJUDPZLOOVKRZZKHWKHU
WKHUHLVFRUUHODWLRQEHWZHHQWKHYDULDEOHVIRUZKLFKDFRUUHODWLRQFRHIILFLHQWDQGD
UHJUHVVLRQHTXDWLRQFDQWKHQEHFDOFXODWHG
,QIHUHQWLDOVWDWLVWLFVWU\WRDQVZHUWKHTXHVWLRQVRIZKHWKHUZHFDQLQIHUZLWKDJRRG
SUREDELOLW\IURPWKHVWXG\ILQGLQJVZKHWKHUWKHILQGLQJVIURPWKHVDPSOHRIWKHVWXG\FDQ
EHJHQHUDOL]HGEH\RQGWKHSRSXODWLRQVWXGLHGDQGZKHWKHUGLIIHUHQFHVRUDVVRFLDWLRQV
IRXQGFDQEHSRVVLEO\H[SODLQHGE\FKDQFH6WDWLVWLFVDUHEDVHGRQSULQFLSOHVRIFRPPRQ
VHQVHZKLFKQHHGWREHXQGHUVWRRGPRUHWKDQRQPDWKHPDWLFV7KHLQYHVWLJDWRUPD\QRW
GRWKHHODERUDWHPDWKHPDWLFVEXWPXVWIXOO\JUDVSWKHXQGHUO\LQJFRQFHSWVEHKLQGWKH
VWDWLVWLFDOPHWKRGDQGPXVWPDNHGHFLVLRQVDERXWWKHTXHVWLRQVWKDWQHHGWREHDQVZHUHG
E\VWDWLVWLFDODQDO\VLVDQGWKHGHJUHHRIXQFHUWDLQW\WKDWFDQEHDFFHSWDEOH7KHFKDSWHU
LQFOXGHVDGHVFULSWLRQRIWKHFRQFHSWRI³VWDQGDUGHUURU´WHVWVRIVWDWLVWLFDOVLJQLILFDQFH
WKHXVHRI³FRQILGHQFHLQWHUYDOV´WKHFRQFHSWRI³VWDWLVWLFDOSRZHU´DVZHOODVDQRWHRQ
VRPHFRPPRQVWDWLVWLFDOPHWKRGV
'HVFULSWLRQDQGDQDO\VLVRIUHVHDUFKUHVXOWVLVPXFKHDVLHUDQGOHVVWULFN\WKDQWKHLU
LQWHUSUHWDWLRQ&KDSWHUGHDOVZLWKWKHPDQ\SLWIDOOVVKRUWFRPLQJVDQGPLVFRQFHSWLRQV
LQWKHLQWHUSUHWDWLRQRIUHVXOWV,WGHVFULEHVSLWIDOOVLQWKHLQWHUSUHWDWLRQRIGHVFULSWLYH
VWDWLVWLFVZKHWKHUWKH\GHDOZLWKWKHPHDQJUDSKVRUFRUUHODWLRQ7KHWHUP³VWDWLVWLFDO
VLJQLILFDQFH´VKRXOGEHXQGHUVWRRGRQO\IRUZKDWLWVWDQGVIRU,WVLPSO\PHDQVWKDWWKH
ILQGLQJRUGLIIHUHQFHLVXQOLNHO\WREHGXHWRFKDQFH,WGRHVQRWQHFHVVDULO\PHDQWKDW
WKHILQGLQJLVLPSRUWDQW%LDVZKHWKHULQVHOHFWLRQRUPHDVXUHPHQWDQGFRQIRXQGLQJ
IDFWRUVPXVWEHH[FOXGHGEHIRUHGUDZLQJDQ\FRQFOXVLRQV$VVRFLDWLRQRIWZRYDULDEOHV
VKRXOGQRWEHWDNHQWRPHDQDFDXVDOUHODWLRQVKLS6FLHQWLILFFULWHULDIRUPDNLQJWKHFDVH
IRUFDXVDWLRQPXVWEHIXOILOOHG&DUHVKRXOGEHWDNHQLQWU\LQJWRH[WUDSRODWHIURPUHVXOWV
XVLQJRWKHUHQGSRLQWVDVDVXUURJDWHIRUWKHRXWFRPHLQTXHVWLRQ
6SHFLDOVWXGLHVQHHGFDUHIXOLQWHUSUHWDWLRQWRDYRLGDQ\PLVFRQFHSWLRQVDERXWWKH
UHVXOWV:KHQVWXGLHVRIULVNIDFWRUVDUHLQWHUSUHWHGZHQHHGWRXQGHUVWDQGWKHFRQFHSWV
RIEDVLFULVNUHODWLYHULVNFRQILGHQFHLQWHUYDOVDWWULEXWDEOHULVNDVZHOODVWKHQHHGWR
EDODQFHULVNVDQGEHQHILWV,QUHSRUWLQJVWXGLHVRIGLDJQRVWLFWHVWVWKHLQYHVWLJDWRUVPXVW
UHSRUWRQVHQVLWLYLW\VSHFLILFLW\SUHGLFWLYHYDOXHDQGHIILFLHQF\$WUDGHRIIPD\QHHGWR
EHPDGHEHWZHHQVHQVLWLYLW\DQGVSHFLILFLW\6WXGLHVUHSRUWLQJWKHUHVXOWVRILQWHUYHQWLRQV
QHHGFDUHIXOLQWHUSUHWDWLRQLQFOXGLQJFRVWFRQVLGHUDWLRQV7KHFRQFHSWRI³WKHQXPEHU
QHHGHGWRWUHDW´LQRUGHUWRDFKLHYHWKHDGYDQWDJHRIWKHLQWHUYHQWLRQLVDXVHIXOWRROWKDW
LVQRWDOZD\VFRQVLGHUHG
5HVHDUFKLVQRWFRPSOHWHEHIRUHLWVUHVXOWVDUHFRPPXQLFDWHG7KLVLVGHDOWZLWKLQ
&KDSWHU0RVWRIWKHFRPPXQLFDWLRQGRQHLVWRIHOORZVFLHQWLVWV%XWWKHEHQHILFLDULHV
RIKHDOWKUHVHDUFKDUHPXFKEURDGHUWKDQWKHVFLHQWLILFFRPPXQLW\DQGWKH\DUHHQWLWOHG
WRWKHLQIRUPDWLRQ&RPPXQLFDWLRQWRVFLHQWLVWVLVFRPPRQO\LQWKHIRUPRISXEOLFDWLRQ
LQSHHUUHYLHZHGVFLHQWLILFMRXUQDOV7KHDYDLODELOLW\RIH[SHQVLYHVFLHQWLILFMRXUQDOV
LVOLPLWHGSDUWLFXODUO\LQGHYHORSLQJFRXQWULHV7KDQNVWRWKHLQWHUQHWQHZLQLWLDWLYHV
DUHXQGHUZD\WRDOORZUHVHDUFKHUVWRFRPPXQLFDWHWKHLUUHVHDUFKILQGLQJVWRDPXFK
ZLGHUDXGLHQFHZLWKWKHXOWLPDWHKRSHWKDWVFLHQWLILFLQIRUPDWLRQZLOOEHPDGHIUHHO\
DYDLODEOHWRDOOZKRZDQWLW7KHDJHRISDSHUOHVVSDSHUVLVQRZVSHHGLQJXSWKHSURFHVV
RIVXEPLVVLRQUHYLHZDQGSXEOLFDWLRQPDNLQJVFLHQWLILFLQIRUPDWLRQPRUHXSWRGDWH
DSDUWIURPVDYLQJPDQ\WUHHVLQWKHSURFHVV3UHVHQWDWLRQRIWKHUHVXOWVRIVFLHQWLILF
UHVHDUFKLQVFLHQWLILFPHHWLQJVLVDQRWKHUDSSURDFKIRUH[FKDQJLQJVFLHQWLILFLQIRUPDWLRQ
ZLWKDGYDQWDJHVDQGGLVDGYDQWDJHVUHODWLYHWRSXEOLFDWLRQ5HVHDUFKUHVXOWVVKRXOGDOVR
EHFRPPXQLFDWHGSHULRGLFDOO\WRWKHIXQGLQJDJHQF\5HOHDVHRIIXQGLQJLVJHQHUDOO\
FRQWLQJHQWRQUHFHLSWRIVDWLVIDFWRU\SURJUHVVDQGILQDQFLDOUHSRUWV
)RUKHDOWKUHVHDUFKWRLQIOXHQFHWKHZD\KHDOWKSURIHVVLRQDOVSUDFWLFHLWVKRXOG
EHFRPPXQLFDWHGLQDXVHUIULHQGO\EXWDFFXUDWHZD\7KHUHVHDUFKILQGLQJVPD\QHHG
WREHV\QWKHVL]HGLQV\VWHPDWLFUHYLHZV3UDFWLFHJXLGHOLQHVGHYHORSHGDIWHUULJRURXV
UHYLHZRIYDULRXVVWXGLHVFDQEHYHU\XVHIXO)RUPDQ\VWXGLHVLWLVPRUHLPSRUWDQW
WRFRPPXQLFDWHWKHUHVXOWVWRSROLF\PDNHUV6XEPLVVLRQRIDUHSRUWLVJHQHUDOO\QRW
HQRXJK*XLGHOLQHVRQKRZWRPDNHDSUHVHQWDWLRQWRSROLF\PDNHUVDUHJLYHQ,IWKH
UHVHDUFKZDVEDVHGRQDFRPPXQLW\VWXG\WKHFRPPXQLW\LQYROYHGKDVDULJKWQRWRQO\
WRNQRZEXWDOVRWRGLVFXVVWKHUHVHDUFKUHVXOWV
7KHPLOOHQQLXPRIF\EHUPHGLFLQHSURPLVHVDUHYROXWLRQLQWKHDYDLODELOLW\RIKHDOWK
LQIRUPDWLRQQRWRQO\IRUKHDOWKSURIHVVLRQDOVEXWDOVRIRUSDWLHQWVDQGIRUWKHSXEOLFDW
ODUJH6FLHQWLVWVVKRXOGDOVROHDUQKRZWRFRPPXQLFDWHZLWKWKHSXEOLFZKRDUHRIWHQ
SD\LQJWKHELOOIRUWKHUHVHDUFK$FRQVWUXFWLYHGLDORJXHEHWZHHQVFLHQWLVWVDQGWKH
SXEOLFLVEHFRPLQJLQFUHDVLQJO\LPSRUWDQW$IDYRXUDEOHVFLHQWLILFSXEOLFHQYLURQPHQW
LVHVVHQWLDOIRUVFLHQFHWRWKULYH5HFHQWO\WKHUHKDYHEHHQLQFUHDVLQJVLJQVRISXEOLF
PLVWUXVWLQVFLHQFH7KLVKDVWREHRYHUFRPHWKURXJKEHWWHUFRPPXQLFDWLRQEHWZHHQ
VFLHQWLVWVDQGWKHSXEOLF7KHSXEOLFQHHGVWREHDGHTXDWHO\LQIRUPHGWRPDNHDSSURSULDWH
GHFLVLRQV
%HFDXVH RI WKH LPSRUWDQFH RI WKH VFLHQWLILF SDSHU DV D ZD\ RI VFLHQWLILF
FRPPXQLFDWLRQGHWDLOHGJXLGHOLQHVDUHSURYLGHGLQ&KDSWHURQKRZWRZULWHLW
*XLGHOLQHVGHDOZLWKWKHVHOHFWLRQRIWKHWLWOHZULWLQJWKHDEVWUDFWDQGIROORZLQJWKH
FODVVLFDODUWLFOHVWUXFWXUHRILQWURGXFWLRQPHWKRGVUHVXOWVLQFOXGLQJWKHXVHRIWDEOHV
DQGLOOXVWUDWLRQVDQGGLVFXVVLRQ$QQH[SURYLGHVGHWDLOHGLQVWUXFWLRQRQKRZWRFLWHWKH
UHIHUHQFHVIURPGLIIHUHQWVRXUFHVLQWKHSDSHU7KHVWHSVLQZULWLQJWKHVFLHQWLILFSDSHU
VKRXOGVWDUWEHIRUHWKHUHVHDUFKLVLPSOHPHQWHG7KHSURFHVVVKRXOGFRQWLQXHGXULQJWKH
UHVHDUFKDQGLVWREHFRPSOHWHGDIWHUWKHUHVHDUFK$IWHUZULWLQJWKHPDQXVFULSWVKRXOG
EHUHYLVHGIRUVFLHQWLILFFRQWHQWXVLQJDFKHFNOLVW$IWHUUHYLVLRQRIWKHPDQXVFULSWIRU
VFLHQWLILFFRQWHQWLWVKRXOGEHFDUHIXOO\UHYLVHGIRUVW\OHUHYLVLQJSDUDJUDSKVVHQWHQFHV
DQGZRUGV5HYLVLRQIRUVW\OHLVSDUWLFXODUO\LPSRUWDQWIRUWKRVHZULWLQJLQDODQJXDJH
WKDWLVQRWWKHLUILUVWODQJXDJHEXWVKRXOGQRWEHLJQRUHGE\WKRVHZULWLQJLQWKHLUILUVW
ODQJXDJH:ULWLQJDFDVHUHSRUWDQGZULWLQJVHFRQGDU\VFLHQWLILFSDSHUVQDUUDWLYH
UHYLHZV\VWHPDWLFUHYLHZDQGPHWDDQDO\VLVUHTXLUHVGLIIHUHQWIRUPDWV7KHUHDUH
DOVRVSHFLDOFRQVLGHUDWLRQVIRUZULWLQJDSDSHURQTXDOLWDWLYHUHVHDUFKDQGIRUZULWLQJD
GLVVHUWDWLRQRUWKHVLV
$IWHUZULWLQJWKHVFLHQWLILFSDSHUFRPHVWKHWDVNRIJHWWLQJLWSXEOLVKHG&KDSWHU
JLYHVDGYLFHRQKRZWRJHWDSDSHUSXEOLVKHGEDVHGRQGHILQLQJLWVPHVVDJHPDWFKLQJWKH
WRSLFZLWKWKHLQWHUHVWRIWKHMRXUQDOFKHFNLQJVFLHQWLILFYDOLGLW\RIWKHUHVXOWVDQGHQVXULQJ
TXDOLW\RIWKHPDQXVFULSW7KH,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUV
KDVDJUHHGRQXQLIRUPUHTXLUHPHQWVIRUPDQXVFULSWVWREHVXEPLWWHGIRUSXEOLFDWLRQ$
VXPPDU\RIWKHWHFKQLFDOUHTXLUHPHQWVLVJLYHQDVZHOODVJXLGDQFHRQKRZWRVHQGWKH
PDQXVFULSWDQGKRZWRGHDOZLWKUHYLHZHUV¶FRPPHQWV7KH,QWHUQDWLRQDO&RPPLWWHHRI
0HGLFDO-RXUQDO(GLWRUVKDVDOVRUHFRPPHQGHGJXLGHOLQHVRQDXWKRUVKLSHPSKDVL]LQJ
WKDWLQWHOOHFWXDOLQSXWLQWKHVWXG\LVDUHTXLVLWHIRUTXDOLI\LQJIRUDXWKRUVKLS,VVXHVRI
SRWHQWLDOO\SDWHQWDEOHILQGLQJVQHHGWREHDGGUHVVHGZKHUHDSSURSULDWHSUHIHUDEO\E\
DVSHFLDORIILFHLQWKHLQVWLWXWLRQEHIRUHVXEPLWWLQJWKHILQGLQJVIRUSXEOLFDWLRQWREH
DYDLODEOHLQWKHSXEOLFGRPDLQ(WKLFDOFRQVLGHUDWLRQVDSSO\WRUHVHDUFKFRPPXQLFDWLRQ
DQGLQFOXGHTXHVWLRQVRIFUHGLWFRQIOLFWRILQWHUHVWUHGXQGDQWRUGXSOLFDWHSXEOLFDWLRQ
SURWHFWLRQRISDWLHQW¶VULJKWVWRSULYDF\UHOHDVHRILQIRUPDWLRQWRSXEOLFPHGLDEHIRUH
WKHSXEOLFDWLRQDQGWKHVHULRXVDFFXVDWLRQRIVFLHQWLILFIUDXG
&KDSWHUSURYLGHVGHWDLOHGJXLGHOLQHVRQKRZWRPDNHDSUHVHQWDWLRQWRDVFLHQWLILF
PHHWLQJE\JRRGSODQQLQJJRRGSUHSDUDWLRQLQFOXGLQJSUHSDUDWLRQRIWH[WDQGYLVXDO
DLGVDVZHOODVUHKHDUVDODQGSUHVHQWLQJLQVW\OHJHWWLQJUHDG\VSHDNLQJZHOOPDQDJLQJ
WKHYLVXDODLGVNHHSLQJWRWKHWLPHDQGDQVZHULQJTXHVWLRQV
5HVHDUFKHUVQHHGWRDFTXLUHWKHDELOLW\WRDVVHVVDQGHYDOXDWHVFLHQFHDQGWR
GHYHORSDFULWLFDODWWLWXGH6FLHQFHLVQRWWREHDGPLUHGVFLHQFHLVWREHTXHVWLRQHG
&KDSWHUSURYLGHVJXLGDQFHRQKRZWRUHDGDQGUHYLHZDVFLHQWLILFSDSHUKRZWR
HYDOXDWHWKHVFLHQWLILFHYLGHQFHKRZWRDVVHVVVFLHQWLILFUHYLHZVDQGPHWDDQDO\VHV
KRZWRDSSO\HYLGHQFHWRSUDFWLFHDQGKRZWRDVVHVVWKHDSSURSULDWHQHVVRIKHDOWK
WHFKQRORJLHV(YDOXDWLRQRIWKHLQYHVWPHQWLQUHVHDUFKVKRXOGWDNHLQWRFRQVLGHUDWLRQ
QRWRQO\WKHLPSDFWRQWKHDGYDQFHPHQWRIVFLHQFHDQGWKHLPSDFWRQZHDOWKFUHDWLRQ
EXWDOVRLPSRUWDQWO\WKHLPSDFWRQKHDOWKSURPRWLRQ7KHVFLHQWLILFTXDOLW\RIUHVHDUFK
DVDVVHVVHGE\VFLHQWLVWVGRHVQRWQHFHVVDULO\JRKDQGLQKDQGZLWKWKHLPSDFWRQKHDOWK
SURPRWLRQ
,WVKRXOGDOVREHUHFRJQL]HGWKDWKHDOWKLVZHDOWKDQGWKDWKHDOWKUHVHDUFKLV
LPSRUWDQWIRURYHUDOOGHYHORSPHQW$QQH[SURYLGHVWKH%DQJNRN'HFODUDWLRQRQ+HDOWK
5HVHDUFKIRU'HYHORSPHQW
1RWDOOLVVXHVDERXWKHDOWKUHVHDUFKFDQEHFRYHUHGLQGHWDLOLQWKLVVKRUWJXLGH
7KHERRNHQGVZLWKDOLVWRIVRXUFHVIRUHDFKFKDSWHUIRUWKRVHZKRZDQWWRJHWPRUH
LQIRUPDWLRQRQWKHSDUWLFXODUVXEMHFW
References and additional sources of information

Commission on Health Research for Development. Health research: essential link to
equity in development. Oxford, Oxford University Press, 1990.
Einstein A. http://www.memorablequotations.com/einstein.htm (accessed 30/3/2004).
Global Forum for Health Research. The 10/90 report on health research 2000. Geneva,
Global Forum for Health research, 2000.
Medawar PB. Advice to a young scientist. New York, Basic Books, 1979.
Investing in health research and development: Report of the Ad Hoc Committee on Health
Research Relating to Future Intervention Options. Geneva, World Health Organization,
1996.
Sustaining the strength of the UK in healthcare and life sciences R&D: competition,
cooperation and cultural change. A report on the third SmithKline Beecham R&D Policy
Symposium. Oxted, ScienceBridge, 1996: 17.
Salam A. Notes on science, technology and science education in the development of
the south. Prepared for the fifth meeting of the South Commission, May 27–30, 1989,
Maputo, Mozambique. Trieste, The Third World Academy of Sciences.
Chapter 2
Ethics in health research
2.1 Introduction
1RRQHVKDOOEHVXEMHFWHGWRWRUWXUHRUWRFUXHOLQKXPDQRUGHJUDGLQJWUHDWPHQW
RUSXQLVKPHQW,QSDUWLFXODUQRRQHVKDOOEHVXEMHFWHGZLWKRXWKLVIUHHFRQVHQWWR
PHGLFDORUVFLHQWLILFH[SHULPHQWDWLRQ
,QWHUQDWLRQDO&RYHQDQWRQ&LYLODQG3ROLWLFDO5LJKWV$UWLFOH
$QXPEHURIGHYHORSPHQWVKDYHEURXJKWWKHVXEMHFWRIHWKLFVLQPHGLFDOUHVHDUFKWR
WKHIURQWOLQHRIFRQFHUQVRIWKHKHDOWKSURIHVVLRQDQGWKHVRFLHW\DWODUJH7KHVHLQFOXGH
DPDMRUH[SDQVLRQLQKHDOWKUHVHDUFKWKHVLJQLILFDQWSXEOLFLQYHVWPHQWLQUHVHDUFKWKH
LQFUHDVLQJQHHGIRUH[SHULPHQWDWLRQRQKXPDQVXEMHFWVSXEOLFL]HGFDVHVRIHWKLFDO
YLRODWLRQLQWHUQDWLRQDOL]DWLRQRIUHVHDUFKDQGWKHH[SDQGLQJUROHRISULYDWHLQGXVWU\
7KLVFHQWXU\KDVZLWQHVVHGDPDMRUH[SDQVLRQLQKHDOWKUHVHDUFK0HGLFDOUHVHDUFKKDV
RSHQHGQHZDUHDVIRULQYHVWLJDWLRQIRUZKLFKVRFLHW\KDVQRW\HWEHHQIXOO\SUHSDUHG
PRUDOO\OHJDOO\DQGVRFLDOO\7KHVHLQFOXGHDUHDVVXFKDVRUJDQWUDQVSODQWDWLRQDVVLVWHG
FRQFHSWLRQDGYDQFHVLQIHUWLOLW\UHJXODWLRQDQGWKHQHZHUDRIJHQRPLFV6RFLHWLHVPDNHD
VLJQLILFDQWLQYHVWPHQWLQKHDOWKUHVHDUFK7KH\KDYHEHFRPHVKDUHKROGHUVDQGWKXVKDYH
DVD\LQKRZWKHLULQYHVWPHQWLVPDGH
$GYDQFHPHQWRIPHGLFDONQRZOHGJHGHSHQGVWRDODUJHH[WHQWRQH[SDQVLRQRI
UHVHDUFKLQYROYLQJH[SHULPHQWDWLRQRQKXPDQVXEMHFWV:LWKWKHLQFUHDVLQJDFFHSWDQFH
DQGDSSUHFLDWLRQRILQGLYLGXDOKXPDQULJKWVDQGRIWKHQHHGWRUHVSHFWDQGSURWHFWWKHPLW
LVQRWDFFHSWDEOHWKDWWKHZHOIDUHDQGWKHUHVSHFWRIWKHLQGLYLGXDOVEHFRPSURPLVHGLQWKH
SXUVXLWRIEHQHILWVWKDWPD\DFFUXHWRVFLHQFHDQGVRFLHW\,QVWDQFHVRIYLRODWLRQRIHWKLFDO
SULQFLSOHVIRUWKHVDNHRIDGYDQFHPHQWRIVFLHQFHKDYHRFFXUUHG7KHPRVWRXWUDJHRXV
FDVHVZHUHUHYHDOHGLQWKH1XUHPEHUJWULDOVDIWHUWKH6HFRQG:RUOG:DU7KHVHUHVXOWHGLQ
WKHHODERUDWLRQRIWKH1XUHPEHUJ&RGHLQIRUUHJXODWLQJH[SHULPHQWDWLRQRQKXPDQ
VXEMHFWV7KHPHGLFDOSURIHVVLRQWKHQWRRNFKDUJHDQGWKH:RUOG0HGLFDO$VVRFLDWLRQ
VWDUWLQJLQGHYHORSHGDGRSWHGDQGXSGDWHGWKH+HOVLQNL'HFODUDWLRQVZKLFKWRGD\
SURYLGHJXLGDQFHWRWKHPHGLFDOUHVHDUFKFRPPXQLW\$QQH[
,QWHUQDWLRQDOL]DWLRQKDVEHHQDUHFHQWSKHQRPHQRQLQPHGLFDOUHVHDUFK5HVHDUFK
QRZNQRZVQRQDWLRQDOIURQWLHUV7KHUHLVDQHHGIRUDJUHHPHQWRQWKHEDVLFYDOXHVWKDW
Ethics in health research 21
JRYHUQPHGLFDOUHVHDUFKVRWKDWWKHVDPHVWDQGDUGVDSSO\WRVXEMHFWVSDUWLFLSDWLQJLQ
WKHVDPHUHVHDUFKLQGLIIHUHQWFRXQWULHV,WLVIHDUHGVRPHWLPHVIRUJRRGUHDVRQWKDW
DGYDQWDJHPD\EHWDNHQRIFRXQWULHVWKDWGRQRWKDYHRUGRQRWHQIRUFHKLJKHWKLFDO
VWDQGDUGVLQRUGHUWRDGYDQFHPHGLFDONQRZOHGJHDQGSDUWLFXODUO\LIWKHEHQHILWZLOOJR
SULPDULO\WRRWKHUSRSXODWLRQV
0HGLFDOUHVHDUFKLVQRZDPDMRULQYHVWPHQWIRUSULYDWHLQGXVWU\(FRQRPLFJDLQVDUH
DQWLFLSDWHG7KHVWURQJGULYHWRPDNHKHDOWKUHVHDUFKDQHQJLQHRIHFRQRPLFGHYHORSPHQW
UXQVWKHULVNRISXVKLQJUHVHDUFKEH\RQGDFFHSWDEOHHWKLFDOVWDQGDUGV
7KLVFKDSWHUSURYLGHVRQO\DEULHIJHQHUDOLQWURGXFWLRQRIWKHVXEMHFWRIHWKLFV
LQKHDOWKUHVHDUFK(WKLFDOFRQVLGHUDWLRQVDUHGLVFXVVHGLQPRUHGHWDLOLQVXEVHTXHQW
FKDSWHUVGHDOLQJZLWKZKDWUHVHDUFKWRGRSODQQLQJRIWKHUHVHDUFKZULWLQJWKHUHVHDUFK
SURWRFROVXEPLWWLQJDUHVHDUFKSURSRVDOLPSOHPHQWLQJWKHUHVHDUFKDVZHOOSXEOLFDWLRQ
HWKLFV
2.2 General ethical principles

(WKLFVDUHSULQFLSOHVRIULJKWFRQGXFW7KHUHDUHJHQHUDOO\QRGLVDJUHHPHQWVRQWKH
HWKLFDOSULQFLSOHVLQWKHPVHOYHVVLQFHWKH\UHSUHVHQWEDVLFKXPDQYDOXHV7KHUHFDQ
KRZHYHUEHGLIIHUHQFHVRQKRZWKH\DUHLQWHUSUHWHGDQGLPSOHPHQWHGLQVSHFLILFFDVHV
%DVLFSULQFLSOHVLQFOXGHEHQHILFHQFHQRQPDOHILFHQFHUHVSHFWDQGMXVWLFH
:KHUHUHVHDUFKLQYROYHVH[SHULPHQWDWLRQRQKXPDQVXEMHFWVHYHU\HIIRUWVKRXOG
EHPDGHWRPD[LPL]HWKHEHQHILWVWRWKHVXEMHFWVEHQHILFHQFHDQGWKHVXEMHFWVVKRXOG
VXIIHUQRKDUPQRQPDOHILFHQFH7KHSULQFLSOHRIUHVSHFWLPSOLHVWKDWSDUWLFLSDWLRQ
LQWKHUHVHDUFKVKRXOGEHFRPSOHWHO\YROXQWDU\DQGEDVHGRQLQIRUPHGFRQVHQW:KHUH
UHVHDUFKLQYROYHVFROOHFWLRQRIGDWDRQLQGLYLGXDOVSULYDF\VKRXOGEHSURWHFWHGE\
HQVXULQJFRQILGHQWLDOLW\5HVSHFWWRWKHFRPPXQLW\PHDQVUHVSHFWLQJLWVYDOXHVDQG
KDYLQJLWVDSSURYDOIRUWKHUHVHDUFK7KHSULQFLSOHRIMXVWLFHGLVWULEXWLYHMXVWLFHLPSOLHV
WKDWSDUWLFLSDWLRQLQWKHUHVHDUFKVKRXOGFRUUHODWHZLWKH[SHFWHGEHQHILWV1RSRSXODWLRQ
JURXSVKRXOGFDUU\DQXQGXHEXUGHQRIUHVHDUFKIRUWKHEHQHILWRIDQRWKHUJURXS
$SDUWIURPWKHEDVLFSULQFLSOHVRIEHQHILFHQFHQRQPDOHILFHQFHUHVSHFWDQG
GLVWULEXWLYHMXVWLFHRWKHUSULQFLSOHVDOVRDSSO\:KHUHUHVHDUFKLQYROYHVH[SHULPHQWDWLRQ
RQDQLPDOVPHUF\LVDQHWKLFDOLPSHUDWLYH)RUUHVHDUFKLQJHQHUDOPHGLFDORUQRQ
PHGLFDOKRQHVW\LVDQLQGLVSHQVDEOHYDOXH,QWHUQDWLRQDOHWKLFDOJXLGHOLQHVIRUELRPHGLFDO
UHVHDUFKLQYROYLQJKXPDQVXEMHFWVKDYHEHHQLVVXHGE\WKH&RXQFLOIRU,QWHUQDWLRQDO
2UJDQL]DWLRQVRI0HGLFDO6FLHQFHV&,206LQFROODERUDWLRQZLWKWKH:RUOG+HDOWK
2UJDQL]DWLRQ7KHODWHVWHGLWLRQZDVLVVXHGLQ$QQH[
2.3 Responsibility for ethics in health research

5HVSRQVLELOLW\IRUHQVXULQJWKDWHWKLFDOVWDQGDUGVDUHREVHUYHGLQUHVHDUFKUHVWV
FROOHFWLYHO\ZLWKWKHLQYHVWLJDWRUVUHVHDUFKLQVWLWXWLRQVQDWLRQDOGUXJUHJXODWRU\
DJHQFLHVHGLWRUVRIPHGLFDOMRXUQDOVDQGIXQGLQJDJHQFLHVDQGRUJDQL]DWLRQV(WKLFDO
DSSURYDOE\RQHGRHVQRWUHOLHYHWKHRWKHUVRIUHVSRQVLELOLW\
,QYHVWLJDWRUV7KHSULPDU\DQGXOWLPDWHUHVSRQVLELOLW\UHVWVZLWKWKHLQYHVWLJDWRUV
ZKRVKRXOGDVDSDUWRIWKHLUWUDLQLQJEHPDGHDZDUHRIDQGVHQVLWLYHWRWKHHWKLFDO
LPSHUDWLYHVLQUHVHDUFK1RUHVHDUFKSURWRFROLVFRPSOHWHRUDFFHSWDEOHLILWGRHV
QRWGLVFXVVWKHHWKLFDODVSHFWVRIDVWXG\LQYROYLQJKXPDQVXEMHFWVRUH[SHULPHQWDO
DQLPDOV
5HVHDUFKLQVWLWXWLRQ7KHUHVHDUFKLQVWLWXWLRQLVUHVSRQVLEOHIRUWKHHWKLFDOTXDOLW\RI
WKHUHVHDUFKSHUIRUPHGE\LWVVWDIIDQGLQLWVIDFLOLWLHV$Q\LQVWLWXWLRQLQYROYHGLQ
UHVHDUFKRQKXPDQVXEMHFWVVKRXOGKDYHDQLQVWLWXWLRQDOHWKLFVUHYLHZFRPPLWWHH
7KHFRPPLWWHHDFWVDVDJDWKHULQJRIWKHLQYHVWLJDWRUV¶SHHUVDQGRWKHUVWRSURYLGH
DGYLFHRQHWKLFDODVSHFWVRIWKHVWXG\DQGWRDSSURYHLWRUGLVDSSURYHLWRQEHKDOIRI
WKHLQVWLWXWLRQ7KHPHPEHUVKLSPD\LQFOXGHRWKHUKHDOWKSURIHVVLRQDOVSDUWLFXODUO\
QXUVHVDVZHOODVOD\PHQTXDOLILHGWRUHSUHVHQWWKHFRPPXQLW\¶VFXOWXUDODQGPRUDO
YDOXHV7KHFRPPLWWHHVKRXOGEHFRPSOHWHO\LQGHSHQGHQWIURPWKHLQYHVWLJDWRUV$Q\
PHPEHUZLWKDGLUHFWLQWHUHVWLQDSURSRVDOVKRXOGQRWSDUWLFLSDWHLQLWVDVVHVVPHQW
7KHQH[WVHFWLRQSURYLGHVPRUHLQIRUPDWLRQRQHWKLFVFRPPLWWHHV
1DWLRQDO'UXJ5HJXODWRU\$JHQF\1HZGUXJVRUGHYLFHVWKDWDUHQRW\HWDSSURYHGLQ
WKHFRXQWU\VKRXOGQRWEHXVHGRQKXPDQVXEMHFWVZLWKRXWDSSURYDOEHLQJREWDLQHG
IRUWKHLUXVHXQGHUWKHFRQGLWLRQVRIWKHVWXG\
(GLWRUVRIPHGLFDOMRXUQDOV5HSRUWVRIUHVHDUFKQRWFRPSO\LQJZLWKHWKLFDOVWDQGDUGV
VKRXOGQRWEHDFFHSWHGIRUSXEOLFDWLRQ
)XQGLQJ DJHQFLHV DQG RUJDQL]DWLRQV 1R UHVHDUFK SURSRVDO VKRXOG EH IXQGHG E\
DQDWLRQDORULQWHUQDWLRQDODJHQF\XQOHVVLWKDVFOHDUO\RXWOLQHGWKHHWKLFDODVSHFWV
RIWKHVWXG\DQGKDVSURYLGHGDVVXUDQFHVWKDWHWKLFDOSULQFLSOHVZLOOEHREVHUYHG
LQFOXGLQJDVDSSURSULDWHWKHDSSURYDORIDQLQVWLWXWLRQDOUHYLHZFRPPLWWHH
2.4 Ethics committees

&RXQWULHVDQGLQVWLWXWLRQVVKRXOGHVWDEOLVKHWKLFDOUHYLHZV\VWHPVWRHQVXUHWKH
SURWHFWLRQRISRWHQWLDOUHVHDUFKSDUWLFLSDQWVDQGFRQWULEXWHWRWKHKLJKHVWDWWDLQDEOH
TXDOLW\LQWKHVFLHQFHDQGHWKLFVRIKHDOWKUHVHDUFK(WKLFVFRPPLWWHHVVKRXOGEH
HVWDEOLVKHGDVDSSURSULDWHDWWKHQDWLRQDOUHJLRQDODQGLQVWLWXWLRQDOOHYHOV
Ethics in health research 23
7KH:RUOG +HDOWK 2UJDQL]DWLRQ KDV LVVXHG RSHUDWLRQDO JXLGHOLQHV IRU HWKLFV

FRPPLWWHHVWKDWUHYLHZELRPHGLFDOUHVHDUFKRXWOLQLQJWKHLUUROHKRZWKH\FDQEH
FRQVWLWXWHGSURFHGXUHIRUVXEPLWWLQJDQDSSOLFDWLRQHOHPHQWVIRUUHYLHZGHFLVLRQ
PDNLQJIROORZXSDQGGRFXPHQWDWLRQDQGDUFKLYLQJ:+27KHHOHPHQWVRI
HWKLFDOUHYLHZLQFOXGHVFLHQWLILFGHVLJQDQGFRQGXFWRIWKHVWXG\UHFUXLWPHQWFDUHDQG
SURWHFWLRQRIUHVHDUFKSDUWLFLSDQWVSURWHFWLRQRISDUWLFLSDQWFRQILGHQWLDOLW\LQIRUPHG
FRQVHQWSURFHVVDQGFRPPXQLW\FRQVLGHUDWLRQV6RPHDVSHFWVRIWKHZRUNRIHWKLFV
FRPPLWWHHVQHHGWREHKLJKOLJKWHG
(WKLFVFRPPLWWHHVVKRXOGEHVRFRQVWLWXWHGDVWRHQVXUHWKHFRPSHWHQWUHYLHZDQG
HYDOXDWLRQRIDOOHWKLFDODVSHFWVRIWKHUHVHDUFKSURMHFWVWKH\UHFHLYHDQGWRHQVXUH
WKDWWKHLUWDVNFDQEHH[HFXWHGIUHHIURPDQ\ELDVDQGLQIOXHQFHWKDWFRXOGDIIHFW
WKHLULQGHSHQGHQFH
(WKLFVFRPPLWWHHVVKRXOGEHPXOWLGLVFLSOLQDU\DQGPXOWLVHFWRUDOLQFRPSRVLWLRQ
LQFOXGLQJUHOHYDQWVFLHQWLILFH[SHUWLVHEDODQFHGDJHDQGJHQGHUGLVWULEXWLRQDQG
OD\SHUVRQVUHSUHVHQWLQJWKHLQWHUHVWVDQGFRQFHUQVRIWKHFRPPXQLW\
(WKLFVFRPPLWWHHVVKRXOGEHHVWDEOLVKHGLQDFFRUGDQFHZLWKWKHDSSOLFDEOHODZVDQG
UHJXODWLRQVRIWKHFRXQWU\DQGLQDFFRUGDQFHZLWKWKHYDOXHVDQGSULQFLSOHVRIWKH
FRPPXQLWLHVWKH\VHUYH
(WKLFVFRPPLWWHHVVKRXOGHVWDEOLVKSXEOLFO\DYDLODEOHVWDQGDUGRSHUDWLQJSURFHGXUHV
WKDWVWDWHWKHDXWKRULW\XQGHUZKLFKWKHFRPPLWWHHLVHVWDEOLVKHGWKHIXQFWLRQVDQG
GXWLHVRIWKHFRPPLWWHHPHPEHUVKLSUHTXLUHPHQWVWKHWHUPVRIDSSRLQWPHQWWKH
FRQGLWLRQVRIDSSRLQWPHQWWKHRIILFHVWKHVWUXFWXUHRIWKHVHFUHWDULDWLQWHUQDOSUR
FHGXUHVDQGTXRUXPUHTXLUHPHQWV7KH\VKRXOGDFWLQDFFRUGDQFHZLWKWKHLUZULWWHQ
RSHUDWLQJSURFHGXUHV
,WPD\EHKHOSIXOWRVXPPDUL]HWKHDFWLYLWLHVRIWKHHWKLFVFRPPLWWHHVLQDUHJXODU
DQQXDOUHSRUW
2.5 Ethical considerations throughout the research process

7KHUHVHDUFKSURFHVVEHJLQVZLWKWKHFKRLFHRIWKHUHVHDUFKWRSLFIROORZHGE\
VHOHFWLRQRIWKHDSSURSULDWHUHVHDUFKGHVLJQGHYHORSPHQWRIWKHUHVHDUFKSURWRFRO
ZULWLQJ DQG VXEPLWWLQJ D UHVHDUFK SURSRVDO IRU IXQGLQJ LPSOHPHQWLQJ WKH VWXG\
GHVFULSWLRQDQGDQDO\VLVRIWKHUHVHDUFKUHVXOWVLQWHUSUHWDWLRQRIWKHUHVHDUFKUHVXOWV
DQGILQDOO\FRPPXQLFDWLQJWKHUHVHDUFKLQFOXGLQJLWVSXEOLFDWLRQ(WKLFDOFRQVLGHUDWLRQV
DSSO\WKURXJKRXWWKHUHVHDUFKSURFHVVDQGZLOOEHGLVFXVVHGLQWKHUHOHYDQWFKDSWHUV
7KHREMHFWLYHRIWKLVDSSURDFKLVWRGHPRQVWUDWHWKDWHWKLFDOFRQVLGHUDWLRQVDUHLQWHJUDO
FRPSRQHQWVRIWKHUHVHDUFKSURFHVVDQGDUHQRWDVXEMHFWWREHGLVFXVVHGVHSDUDWHO\
,QIDFWVFLHQWLILFDVVHVVPHQWRIWKHSODQQHGUHVHDUFKLVDQLPSRUWDQWSDUWRIWKHHWKLFDO
UHYLHZSURFHVV,WLVXQHWKLFDOWRH[SRVHVXEMHFWVWRUHVHDUFKWKDWLVQRWVFLHQWLILFDOO\
VRXQGLVQRWSHUIRUPHGE\TXDOLILHGLQYHVWLJDWRUVLQTXDOLILHGIDFLOLWLHVDQGLVQRWOLNHO\
WRSURYLGHYDOLGVFLHQWLILFDQVZHUV

Angell M. The ethics of clinical research in the Third World. New England Journal of
Medicine, (editorial). 1997, 337, 847–849.
International ethical guidelines for biomedical research involving human subjects. Geneva,
Council for International Organizations of Medical Sciences (CIOMS), 2002.
International guiding principles for biomedical research involving animals. Geneva, Council
for International Organizations of Medical Sciences (CIOMS), 1985.
Research ethics training curriculum. [CD-ROM teaching aid appropriate for international
biomedical and social science researchers]. Family Health International, 2001. (E-mail:
publications@fhi.org).
Fluss S.S. International guidelines on bioethics: informal listing of selected international
codes, declarations, guidelines, etc. on medical ethics/ bioethics/ health care ethics/
human rights aspects of health. Geneva, Council for International Organizations of
Medical Sciences, 2000.
Lansang MA, Crawley FP. The ethics of international biomedical research (editorial).
British Medical Journal, 2000, 321: 777–778.
Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of
the human immunodeficiency virus in developing countries. New England Journal of
Medicine, 1997, 337: 853–855.
Resnik DB. The ethics of science: an introduction. London and New York, Routledge,
1999.
Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics (editorial). British
Medical Journal, 2001, 322: 747–748.
Operational guidelines for ethics committees that review biomedical research. Geneva,
World Health Organization, 2000 (TDR/PRD/Ethics/2000/1 available from http:
//www.who.int/tdr/publications/publications/pdf/ethics.pdf accessed 22/7/2004).
World Medical Association Declaration of Helsinki. Ethical principles for medical research
involving human subjects. World Medical Association, 2000 (http://www.wma.net/e/policy/
b3.htm accessed 22/7/2004).
Chapter 3
What research to do?
3.1 Introduction
7KHTXHVWLRQRIZKDWUHVHDUFKWRGRLVQRWIDFHGE\UHVHDUFKHUVRQO\3ROLF\PDNHUV
DQGIXQGHUVDOVRKDYHWRPDNHGHFLVLRQVRQZKDWUHVHDUFKWRHQFRXUDJHDQGVXSSRUW
+HDOWKUHVHDUFKFDQEHGRQHLQGLIIHUHQWILHOGVRIVFLHQFHLQFOXGLQJELRPHGLFDO
VFLHQFHV SRSXODWLRQ VFLHQFHV DQG KHDOWK SROLF\ VFLHQFHV &ROODERUDWLRQ LV WR EH
HQFRXUDJHGDPRQJUHVHDUFKHUVLQWKHVHILHOGVRIVFLHQFHZKLFKDUHDOOUHOHYDQWWRWKH
LPSURYHPHQWRIKHDOWK0XOWLGLVFLSOLQDU\UHVHDUFKLVEHFRPLQJDQHFHVVLW\7KHUHLVD
QHHGIRUERWKEDVLFDQGDSSOLHGUHVHDUFKDVZHOODVIRUERWKTXDQWLWDWLYHDQGTXDOLWDWLYH
UHVHDUFK
:KDWGULYHVKHDOWKUHVHDUFK"+HDOWKUHVHDUFKPD\EHFXULRVLW\GULYHQQHHGVGULYHQ
SURILWGULYHQRURSSRUWXQLW\GULYHQ6FLHQWLVWVOLNHWRSXUVXHUHVHDUFKRXWRIFXULRVLW\LQ
WKHLURZQOLQHVRILQWHUHVWDFFRUGLQJWRWUDGLWLRQVRIDFDGHPLFIUHHGRP%XWUHVHDUFKLV
EHFRPLQJDPRUHDQGPRUHH[SHQVLYHXQGHUWDNLQJ7KRVHZKRFRQWUROWKHSXUVHZRXOG
OLNHWRGLFWDWHWKHW\SHRIUHVHDUFKWREHVXSSRUWHG*RYHUQPHQWVDUHUHVSRQVLYHWRWKH
FRQFHUQVRIWKHLUFRQVWLWXHQFLHVDQGZRXOGOLNHWRVXSSRUWUHVHDUFKWKDWZLOOSURPRWH
WKHKHDOWKRIWKHLUSRSXODWLRQVRUZLOOJHQHUDWHZHDOWK3ULYDWHLQGXVWU\LVEHFRPLQJ
WKHPDMRUDFWRULQKHDOWKUHVHDUFKLQWHUPVRIIXQGLQJ%HLQJDFFRXQWDEOHWRWKHLU
VKDUHKROGHUVFRPSDQLHVSXUVXHUHVHDUFKIRUSURILW7KHVHIDFWVRIOLIHOHDGWRDJDS
EHWZHHQWKHUHVHDUFKQHHGVLQGHYHORSLQJFRXQWULHVDQGWKHOHYHORIIXQGLQJDYDLODEOH
WRDGGUHVVWKHVHQHHGV
$VIDUDVWKHLQGLYLGXDOUHVHDUFKHULVFRQFHUQHGUHVHDUFKPD\DOVREHRSSRUWXQLW\
GULYHQ,WPD\EHGULYHQE\WKHRSSRUWXQLW\IRUIXQGLQJIURPQDWLRQDORULQWHUQDWLRQDO
VRXUFHVE\WKHRSSRUWXQLW\WRSDUWLFLSDWHLQPXOWLFHQWUHLQWHUQDWLRQDOUHVHDUFKRUE\
RSSRUWXQLWLHVWRSDUWLFLSDWHLQLQGXVWU\VSRQVRUHGUHVHDUFK7KHVHRSSRUWXQLWLHVUDLVH
FRQFHUQVZKLFKQHHGWREHFRQVLGHUHGEHIRUHXQGHUWDNLQJWKHUHVHDUFK
*RRGUHVHDUFKLGHDVFRPHIURPWKHNQRZOHGJHZRUNDQGDWWLWXGHVRIUHVHDUFKHUV
7KH\DOVRQHFHVVLWDWHDQDELOLW\WRQDYLJDWHWKHH[SDQGLQJMXQJOHRIDOUHDG\DYDLODEOH
VFLHQWLILFLQIRUPDWLRQ:KDWHYHUUHVHDUFKWRSLFLVVHOHFWHGLWPXVWEHIHDVLEOHLQWHUHVWLQJ
QRYHOHWKLFDODQGUHOHYDQWDVZLOOEHGLVFXVVHGODWHULQWKLVFKDSWHU
3.2 Selection of a field for research

3.2.1 Categories of health research
+HDOWKUHVHDUFKKDVEHHQEURDGO\GHILQHGDVWKHJHQHUDWLRQRIQHZNQRZOHGJH
XVLQJWKHVFLHQWLILFPHWKRGWRLGHQWLI\DQGGHDOZLWKKHDOWKSUREOHPV&RPPLVVLRQ
RQ+HDOWK5HVHDUFKIRU'HYHORSPHQW+HDOWKUHVHDUFKLVWKXVQRWOLPLWHGWRWKH
ELRPHGLFDOILHOG2WKHUILHOGVRIVFLHQFHFDQFRQWULEXWHPXFKWRWKHLPSURYHPHQWRIRXU
XQGHUVWDQGLQJDERXWKHDOWKLVVXHV%URDGO\VSHDNLQJWKHIROORZLQJFDWHJRULHVRIVFLHQFH
DUHLQYROYHGLQKHDOWKUHVHDUFK8QGHUHDFKFDWHJRU\WKHUHDUHDJURZLQJQXPEHURI
VSHFLDOWLHVDQGVXEVSHFLDOWLHV
%LRPHGLFDOVFLHQFHV7KHVHLQFOXGHDOOELRORJLFDOPHGLFDODQGFOLQLFDOUHVHDUFK
DQGELRPHGLFDOSURGXFWGHYHORSPHQWDQGHYDOXDWLRQ
3RSXODWLRQ VFLHQFHV 7KHVH LQFOXGH HSLGHPLRORJ\ GHPRJUDSK\ DQG WKH VRFLR
EHKDYLRXUDOVFLHQFHV
+HDOWKSROLF\VFLHQFHV7KHVHLQFOXGHKHDOWKSROLF\UHVHDUFKKHDOWKV\VWHPVUHVHDUFK
DQGKHDOWKVHUYLFHVUHVHDUFK(FRQRPLFDQDO\VLVVWXGLHVDUHQRZDQLPSRUWDQWVXE
FDWHJRU\RIKHDOWKSROLF\UHVHDUFK
5HVHDUFKHUVLQWKHVHGLIIHUHQWILHOGVRIVFLHQFHZKLFKDUHUHOHYDQWWRWKHLPSURYHPHQW
RIKHDOWKDUHHQFRXUDJHGWRFROODERUDWH
,WVKRXOGDOVREHDFNQRZOHGJHGWKDWWKHSURJUHVVRIVFLHQFHLQRWKHUILHOGVFRXOG
KDYHVLJQLILFDQWLPSDFWRQWKHKHDOWKRISHRSOH$JULFXOWXUDODQGHQYLURQPHQWVFLHQFHV
DUHMXVWWZRVXFKH[DPSOHVDPRQJRWKHUV
3.2.2 Multidisciplinary research

:LWKWKHH[SDQVLRQRIVFLHQFHWKHUHKDVEHHQWKHLQHYLWDEOHWUHQGIRUVSHFLDOL]DWLRQ
DQG VXEVSHFLDOL]DWLRQ7KLV KDV LWV PHULWV ,W DOVR KDV GUDZEDFNV EHFDXVH FURVV
IHUWLOL]DWLRQEHWZHHQWKHGLIIHUHQWGLVFLSOLQHVFDQEHQHILWWKHDGYDQFHPHQWRIVFLHQFH
7KHUHLVDQLQFUHDVLQJWUHQGIRUGRLQJPXOWLGLVFLSOLQDU\UHVHDUFK
$VWXG\E\WKH:HOOFRPH7UXVWVKRZHGWKDWWKHSURSRUWLRQRISDSHUVLQELRPHGLFDO
UHVHDUFKZLWKDVLQJOHDXWKRUGHFUHDVHGLQWKH8QLWHG.LQJGRPIURPWR
RISDSHUVSXEOLVKHGEHWZHHQWKH\HDUVDQGUHVSHFWLYHO\'DZVRQHWDO
7KHDYHUDJHQXPEHURIDXWKRUVSHUSDSHUURVHIURPWRDQLQGLFDWLRQRI
DQLQFUHDVLQJOHYHORIFROODERUDWLRQLQELRPHGLFDOUHVHDUFKDQGDQLQGLFDWLRQWKDWLWKDV
EHFRPHPRUHPXOWLGLVFLSOLQDU\7KHPHDQQXPEHURIDGGUHVVHVSHUSDSHUURVHIURP
WR7KHUHZDVHYLGHQFHWKDWERWKWKHQXPEHURIDXWKRUVDQGWKHQXPEHURIIXQGLQJ
RUJDQL]DWLRQVRQDSDSHUZHUHDVVRFLDWHGZLWKLQFUHDVHGLPSDFWDVLQGLFDWHGE\WKH
QXPEHURIVXEVHTXHQWFLWDWLRQVRIWKHSDSHULQRWKHUSXEOLFDWLRQV
What research to do? 27
3.2.3 Basic versus applied research

)UDQFLV%DFRQLQWKHWKFHQWXU\PDGHWKHGLVWLQFWLRQEHWZHHQVFLHQWLILFH[SHULPHQWV
IRUOLJKWLHNQRZOHGJHDQGH[SHULPHQWVIRUIUXLWLHUHVXOWV0HGDZDU:HFDQ
DGGWRWKLVVWDWHPHQWWKDWZHQHHGWRKDYH³OLJKW´LQRUGHUWREHDEOHWRVHDUFKIRU³IUXLW´
+RZHYHULQWKHILHOGRIKHDOWKUHVHDUFKDQGVFLHQFHLQJHQHUDOWKH³SXUHÉDVLFYHUVXV
³DSSOLHG´GHEDWHKDVUDJHGIRUGHFDGHVDQGVKRZVQRVLJQVRIDEDWLQJ
7KH FUHDWLRQ RI NQRZOHGJH KDV EHHQ VHHQ DV DQ HQG LQ LWVHOI LPSURYLQJ RXU
XQGHUVWDQGLQJRIWKHQDWXUDOZRUOG:LWKWKHULVLQJFRVWRIUHVHDUFKDQGWKHFRPSHWLWLYH
GHPDQGVIRUIXQGLQJWKHUHKDVEHHQDPRYHWRHPSKDVL]HDQGSURPRWHUHVHDUFKWKDWKDV
WKHSRWHQWLDOWRLPSURYHKHDOWKRUTXDOLW\RIOLIHLHDSSOLHGUHVHDUFK
,WVKRXOGEHUHFRJQL]HGKRZHYHUWKDWZHQHHGDODUJHSRRORIEDVLFUHVHDUFK
:LWKRXWWKHDYDLODELOLW\RIWKLVSRROZHZLOOKDYHQROHDGVWRSXUVXHLQRXUDSSOLHG
UHVHDUFK,WFDQWKHUHIRUHEHULJKWO\UHPDUNHGWKDWWKHUHDUHRQO\WZRW\SHVRIVFLHQFH
³DSSOLHG´VFLHQFHDQG³QRW\HWDSSOLHG´VFLHQFH
3.2.4 Quantitative versus qualitative research

&OLQLFLDQVDUHWUDLQHGWRWKLQNPHFKDQLVWLFDOO\DQGFOLQLFLDQVDUHWKHUHIRUHPRVW
IDPLOLDUZLWKTXDQWLWDWLYHUHVHDUFK+RZHYHUPHGLFLQHLVQRWRQO\DPHFKDQLVWLFDQG
TXDQWLWDWLYHVFLHQFH3DWLHQWVDUHQRWEURNHQGRZQPDFKLQHVRUPDOIXQFWLRQLQJELRORJLFDO
V\VWHPV'RFWRUVGRQRWWUHDWGLVHDVHVGRFWRUVWUHDWSDWLHQWV+HDOWKLVPRUHLQWKHKDQGV
RISHRSOHWKDQLQWKHKDQGVRIKHDOWKSURIHVVLRQDOV4XDOLWDWLYHUHVHDUFKLVQHHGHGWR
SURYLGHLQVLJKWVLQWRSHRSOH¶VOLIHVW\OHEHKDYLRXUWKHLUNQRZOHGJHWKHLUIHHOLQJVDQG
DWWLWXGHVWKHLURSLQLRQVDQGYDOXHVDQGWKHLUH[SHULHQFH
+DYLQJDJRRGKHDOWKV\VWHPVWUXFWXUHLQSODFHLVQRWHQRXJKWRHQVXUHJRRGTXDOLW\
KHDOWKFDUH+RZWKHV\VWHPIXQFWLRQVDQGWKHDWWLWXGHVRIKHDOWKFDUHSURYLGHUVFDQPDNH
DOOWKHGLIIHUHQFH4XDQWLWDWLYHUHVHDUFKJLYHVDGHTXDWHUHVXOWVDERXWWKHDQDWRP\RI
WKHV\VWHP4XDOLWDWLYHUHVHDUFKJLYHVLQVLJKWVLQWRWKHSK\VLRORJ\RIWKHV\VWHP*RRG
DQDWRP\GRHVQRWDOZD\VPHDQJRRGSK\VLRORJ\
4XDOLWDWLYHDQGTXDQWLWDWLYHUHVHDUFKDUHQRWDOWHUQDWLYHV5DWKHUWKDQWKLQNLQJ
RITXDOLWDWLYHDQGTXDQWLWDWLYHVWUDWHJLHVDVLQFRPSDWLEOHWKH\VKRXOGEHVHHQDV
FRPSOHPHQWDU\7KH\PD\KHOSWRDQVZHUWKHVDPHTXHVWLRQV7KHLQYHVWLJDWRUVPD\VWDUW
ZLWKTXDOLWDWLYHUHVHDUFKZKLFKZLOOWKHQSDYHWKHZD\IRUWKHGHVLJQRIDTXDQWLWDWLYH
VWXG\$TXDQWLWDWLYHVWXG\PD\EHFRPSOHPHQWHGZLWKDTXDOLWDWLYHVWXG\WRSURYLGH
IXUWKHULQVLJKWVLQWRWKHILQGLQJV)RUH[DPSOHDTXDQWLWDWLYHVWXG\PD\UHYHDOILQGLQJV
DERXWWKHSUHYDOHQFHRIWREDFFRVPRNLQJDPRQJGLIIHUHQWVHJPHQWVRISRSXODWLRQ
$VXSSOHPHQWDU\TXDOLWDWLYHVWXG\FDQWKHQH[SORUHLQGHSWKDQGLQVPDOOHUJURXSVRI
SHRSOHZK\WKH\VPRNHZKDWWKH\NQRZDERXWWKHULVNVRIVPRNLQJDQGZKDWZDVWKHLU
H[SHULHQFHLQWU\LQJWRVWRSVPRNLQJ$VWXG\RQ+,9KXPDQLPPXQRGHILFLHQF\YLUXV
LQIHFWLRQSUHYHQWLRQPD\VKRZWKDWSHRSOHNQRZDERXWWKHPHWKRGVRISUHYHQWLRQEXW
WKDWPDQ\GRQRWSUDFWLVHWKHP$QLQGHSWKTXDOLWDWLYHVWXG\FDQH[SORUHWKHUHDVRQV
EHKLQGWKLVDWWLWXGH:KLOHTXDOLWDWLYHDQGTXDQWLWDWLYHUHVHDUFKPD\LQYHVWLJDWHWKHVDPH
WRSLFHDFKZLOODGGUHVVDGLIIHUHQWW\SHRITXHVWLRQ)RUH[DPSOHDGKHUHQFHWRGUXJ
WUHDWPHQWFDQEHH[DPLQHGLQDTXDQWLWDWLYHVWXG\DVZHOODVDTXDOLWDWLYHVWXG\
4XDOLWDWLYHUHVHDUFKFDQKHOSLQFORVLQJWKHJDSEHWZHHQWKHVFLHQFHRIGLVFRYHU\
DQGWKHLPSOHPHQWDWLRQRIUHVXOWV4XDOLWDWLYHUHVHDUFKLVRIWHQQHHGHGWRILQGRXWZK\
UHVHDUFKUHVXOWVDUHRIWHQQRWWUDQVODWHGLQWRSUDFWLFH,QFRUSRUDWLQJTXDOLWDWLYHUHVHDUFK
PHWKRGRORJLHVLQWRUHVHDUFKWKLQNLQJHQVXUHVWKDWWKHULJKWPHWKRGRORJ\LVEURXJKWWR
EHDURQWKHULJKWTXHVWLRQ
3.2.5 Action research

$FWLRQUHVHDUFKLVDVW\OHRIUHVHDUFKUDWKHUWKDQDVSHFLILFPHWKRGRORJ\,QDFWLRQ
UHVHDUFKWKHUHVHDUFKHUVZRUNZLWKWKHSHRSOHDQGIRUWKHSHRSOHUDWKHUWKDQXQGHUWDNH
UHVHDUFKRQWKHP7KHIRFXVRIDFWLRQUHVHDUFKLVRQJHQHUDWLQJVROXWLRQVWRSUREOHPV
LGHQWLILHGE\WKHSHRSOHZKRDUHJRLQJWRXVHWKHUHVXOWVRIUHVHDUFK$FWLRQUHVHDUFKLV
QRWV\QRQ\PRXVZLWKTXDOLWDWLYHUHVHDUFK%XWLWW\SLFDOO\GUDZVRQTXDOLWDWLYHPHWKRGV
VXFKDVLQWHUYLHZVDQGREVHUYDWLRQV
3.2.6 Research in health economics

,WZDVRQO\UHFHQWO\WKDWHFRQRPLVWVEHJDQWRJLYHDWWHQWLRQDQGDSSO\FODVVLF
HFRQRPLFWKHRU\WRWKHLVVXHRIWKHXVHRIKHDOWKFDUHUHVRXUFHV1RPDWWHUKRZULFK
DQDWLRQEHFRPHVWKHDPRXQWRIUHVRXUFHVLWGHYRWHVWRKHDOWKLVDQGDOZD\VZLOOEH
OLPLWHGDQGLQFRPSHWLWLRQZLWKRWKHUSRVVLEOHXVHV$VUHVRXUFHVDUHVFDUFHHDFK
GHFLVLRQWRXVHUHVRXUFHVLQRQHZD\LPSOLHVDVDFULILFHRIDQRWKHURSSRUWXQLW\WRXVHWKH
UHVRXUFHVLQDQDOWHUQDWLYHZD\,QHFRQRPLFHYDOXDWLRQFRVWVDUHUHJDUGHGDVRSSRUWXQLW\
FRVWV$FRPPRQPLVFRQFHSWLRQLVWKDWKHDOWKHFRQRPLFVLVDERXWFXWWLQJFRVWV+HDOWK
HFRQRPLFVLVDORJLFIUDPHZRUNZKLFKDOORZVXVWRUHDFKFRQFOXVLRQVDERXWWKHEHVWZD\
WKDWUHVRXUFHVFDQEHDOORFDWHG
3.2.7 Big science

7KHQDWXUHRIKHDOWKUHVHDUFKKDVEHHQHYROYLQJ5HODWLYHO\VPDOOSURMHFWVLQLWLDWHG
E\VLQJOHRUVPDOOJURXSVRILQYHVWLJDWRUVKDYHWUDGLWLRQDOO\EHHQDQGFRQWLQXHWREH
DPDLQVWD\RIVFLHQFH5HFHQWWHFKQRORJLFDODGYDQFHVQRZDOORZWKHH[SORUDWLRQRIELJ
TXHVWLRQVZKLFKFDQQRWEHDQVZHUHGE\VPDOOVFDOHUHVHDUFK7KHKXPDQJHQRPHSURMHFW
LVWKHELJJHVWDQGEHVWNQRZQODUJHVFDOHELRPHGLFDOUHVHDUFKSURMHFWXQGHUWDNHQWRGDWH
7KHLPSOLFDWLRQVRI³ELJVFLHQFHÍRUIXWXUHKHDOWKUHVHDUFKZHUHH[SORUHGLQDUHSRUWE\
WKH8QLWHG6WDWHV,QVWLWXWHRI0HGLFLQHDQG1DWLRQDO5HVHDUFK&RXQFLOXQGHUWKHWLWOH
³/DUJHVFDOHELRPHGLFDOVFLHQFH²H[SORULQJVWUDWHJLHVIRUIXWXUHUHVHDUFK´1DVVDQG
6WLOPDQ
3.3 Drivers for health research

3.3.1 Curiosity-driven research
6FLHQWLVWVHQMR\GRLQJUHVHDUFK7KH\DUHDWWUDFWHGE\WKHIXQRIWKHFKDVH,QPDQ\
W\SHVRIELRPHGLFDOUHVHDUFKGLVFRYHU\LVWKHSUL]HLQWKHUHVHDUFKJDPH%XWKXQWLQJ
IRUGLVFRYHU\LVQRWDVWUDLJKWIRUZDUGXQGHUWDNLQJ
,WLVWUXHWKDWPDQ\LPSRUWDQWGLVFRYHULHVLQVFLHQFHZHUHQRWIRXQGEHFDXVHWKH\
ZHUHDFWLYHO\VRXJKWWKH\ZHUHIRXQGEHFDXVHLWZDVSRVVLEOHWRILQGWKHP6FLHQFH
LVXQSUHGLFWDEOH7KHUHLVQRJXDUDQWHHWKDWUHVHDUFKDFWLYHO\DQGPHWKRGRORJLFDOO\
SXUVXHGZLOOOHDGWRWKHGLVFRYHU\RIZKDWLWVHWRXWWRGLVFRYHU,WPD\GRDOWHUQDWLYHO\
VRPHWKLQJFRPSOHWHO\GLIIHUHQWPD\EHIRXQG0DQ\RIWKHGUXJVZHXVHWRGD\KDYHEHHQ
GLVFRYHUHGLQUHVHDUFKSURJUDPPHVGHVLJQHGIRURWKHUSXUSRVHV0LQR[LGLOWKHGUXJIRU
PDOHEDOGQHVVZDVRULJLQDOO\GHYHORSHGDQGWHVWHGIRUWKHWUHDWPHQWRIK\SHUWHQVLRQ
6LOGHQDILO9LDJUDXVHGIRUWKHWUHDWPHQWRIHUHFWLOHG\VIXQFWLRQZDVGLVFRYHUHGLQD
FDUGLRYDVFXODUUHVHDUFKSURJUDPPH
,QIDFWVHUHQGLSLW\SOD\VDQLPSRUWDQWUROHLQVFLHQWLILFGLVFRYHU\6HUHQGLSLW\LVWKH
IDFXOW\RIPDNLQJKDSS\GLVFRYHULHVE\DFFLGHQWDQGLVGHULYHGIURPWKHWLWOHRIWKHIDLU\
WDOH7KH7KUHH3ULQFHVRI6HUHQGLSDQDQFLHQWQDPHIRU6UL/DQNDWKHKHURHVRIZKLFK
ZHUHDOZD\VPDNLQJVXFKGLVFRYHULHV(QGOHVVH[DPSOHVH[LVWLQZKLFKFKDQFHSOD\HG
WKHLPSRUWDQWUROHLQGLVFRYHU\%XWWKUHHSRLQWVDUHLPSRUWDQW)LUVWWKHVHRSSRUWXQLWLHV
FRPHPRUHRIWHQWRDFWLYHEHQFKZRUNHUVDQGWRWKRVHLQYROYHGLQUHVHDUFK6HFRQG
FKDQFHSUHVHQWVRQO\DIDLQWFOXHWKDWDSRWHQWLDORSSRUWXQLW\H[LVWVEXWWKHRSSRUWXQLW\
ZLOOEHRYHUORRNHGH[FHSWE\WKDWRQHSHUVRQZLWKWKHVFLHQWLILFFXULRVLW\DQGWKHWDOHQWWR
JUDVSLWVVLJQLILFDQFH7KLUGWKHGLVFRYHU\PDGHE\VHUHQGLSLW\ZLOOQHHGWREHULJRURXVO\
SXUVXHGWRDIUXLWIXOHQG
2QHHPLQHQWVFLHQWLVWDGYLVHG³.HHSRQJRLQJDQGWKHFKDQFHVDUHWKDW\RXZLOO
VWXPEOHRQVRPHWKLQJSHUKDSVZKHQ\RXDUHOHDVWH[SHFWLQJLW,KDYHQHYHUKHDUGRI
DQ\RQHVWXPEOLQJRQVRPHWKLQJVLWWLQJGRZQ´+HDWK
3DVWHXUVDLG³,QWKHILHOGVRIREVHUYDWLRQFKDQFHIDYRXUVRQO\WKHSUHSDUHGPLQG´
5REHUWV,WKDVEHHQVDLGWKDWWKHVHHGVRIJUHDWGLVFRYHU\DUHFRQVWDQWO\IORDWLQJ
DURXQGXVEXWWKDWWKH\RQO\WDNHURRWLQPLQGVZHOOSUHSDUHGWRUHFHLYHWKHP$OH[DQGHU
)OHPLQJLQWKHVXPPHURIZRUNLQJLQ6W0DU\¶V+RVSLWDOLQ/RQGRQZDVQRW
ORRNLQJIRUDQDQWLEDFWHULDODJHQWDWWKHWLPHDVSRUHIORDWHGLQWRKLV3HWULGLVK%XWKH
ZDVH[WUHPHO\ZHOOUHDGDQGWUDLQHGLQPLFURELRORJ\DQGFRXOGHDVLO\UHFRJQL]HWKH
PHDQLQJRIWKHFOHDUDUHDLQWKHEDFWHULDOFXOWXUHSURGXFHGE\WKHDFFLGHQWDOLPSODQWDWLRQ
RIWKHPRXOG,WLVSRVVLEOHWKDWPDQ\EDFWHULRORJLVWVKDYHHQFRXQWHUHGVLPLODULQFLGHQWV
DQGVLPSO\GLVFDUGHGWKRVHFRQWDPLQDWHGFXOWXUHV,QIDFWWKHXVHRIPRXOGVDJDLQVW
LQIHFWLRQVZDVQRWWRWDOO\QHZ7KHUHDUHUHFRUGVRIPRXOGVIURPEUHDGEHLQJXVHGE\
WKHDQFLHQW(J\SWLDQV)OHPLQJPDGHWKHGLVFRYHU\LQEXWLWZDVQRWXQWLOWKHODWH
VWKDW+RZDUG)ORUH\LQ2[IRUGVXFFHHGHGLQFRQFHQWUDWLQJDQGSXULI\LQJSHQLFLOOLQ
5REHUWV
,QLQ6WUDVERXUJZKLOHVWXG\LQJWKHIXQFWLRQRIWKHSDQFUHDVLQGLJHVWLRQ
-RVHSKYRQ0HULQJDQG2VFDU0LQNRZVNLUHPRYHGWKHSDQFUHDVIURPDGRJ2QHGD\
ODWHUDODERUDWRU\DVVLVWDQWFDOOHGWKHLUDWWHQWLRQWRDVZDUPRIIOLHVDURXQGWKHXULQH
IURPWKLVGRJ&XULRXVDERXWZK\WKHIOLHVZHUHDWWUDFWHGWRWKHXULQHWKH\DQDO\VHGLW
DQGIRXQGLWZDVORDGHGZLWKVXJDUDFRPPRQVLJQRIGLDEHWHV%XWLWZDVRQO\LQ
WKDW&DQDGLDQUHVHDUFKHUV)UHGULFN%DQWLQJD\RXQJPHGLFDOGRFWRU&KDUOHV%HVW
DPHGLFDOVWXGHQWDQG-RKQ0DFOHRGDSURIHVVRUFRXOGH[WUDFWWKHVHFUHWLRQIURP
WKHSDQFUHDVRIGRJVLQMHFWLWLQWRGRJVUHQGHUHGGLDEHWLFDQGSURYHLWVHIIHFWLYHQHVV
5REHUWV
3.3.2 Needs-driven research

+HDOWKSROLF\PDNHUVDWWKHQDWLRQDODQGLQWHUQDWLRQDOOHYHOZRXOGOLNHWRVHHUHVHDUFK
GULYHQE\WKHKHDOWKQHHGVZLWKDUHWXUQRQWKHLQYHVWPHQWWKDWFDQGHFUHDVHWKHGLVHDVH
EXUGHQRQWKHLUSHRSOH7KHUHODWLYHPDJQLWXGHRIDKHDOWKSUREOHPLVGHWHUPLQHGE\LWV
SUHYDOHQFHDQGLWVVHULRXVQHVV$KHDOWKSUREOHPPD\EHSUHYDOHQWEXWQRWVHULRXVDQG
PD\EHVHULRXVEXWQRWZLGHO\SUHYDOHQW7KHWUDGLWLRQLQWKHSDVWKDVEHHQWRFRQVLGHU
PRUWDOLW\DVWKHPHDVXUHIRUWKHVHULRXVQHVVRIDKHDOWKSUREOHP7KLVKDVWZRGUDZEDFNV
)LUVWPRUWDOLW\DWD\RXQJDJHFDQQRWEHHTXDWHGZLWKPRUWDOLW\DWROGDJH,WLVWKH
QXPEHURIOLIH\HDUVORVWWKDWFRXQWVUDWKHUWKDQWKHPRUWDOLW\UDWH6HFRQGPRUELGLW\
FDQQRWEHLJQRUHG'LVDELOLW\DVDUHVXOWRIWKHKHDOWKSUREOHPVKRXOGEHZHLJKHGDQG
WDNHQLQWRIXOOFRQVLGHUDWLRQ0RUWDOLW\GRHVQRWDOZD\VJRZLWKPRUELGLW\6RPHGLVHDVH
FRQGLWLRQVOHDYHWKHSDWLHQWVHULRXVO\PRUELGEXWGRQRWNLOO&RQYHUVHO\VRPHGLVHDVHV
HLWKHUNLOORUOHDYHQRORQJWHUPLPSDLUPHQWLQKHDOWK,QWKHILHOGRILQWHUQDWLRQDOKHDOWK
QRZWKHEXUGHQRIGLVHDVHDVDUHVXOWRIDQ\KHDOWKSUREOHPLVFRPPRQO\H[SUHVVHGDV
WKHGLVDELOLW\DGMXVWHGOLIH\HDUV'$/<VORVW7KLVPHDVXUHH[SUHVVHVERWKWLPHORVW
WKURXJKSUHPDWXUHGHDWKDQGWLPHOLYHGZLWKDGLVDELOLW\
7KHIDFWWKDWDKHDOWKSUREOHPLVRIKLJKPDJQLWXGHGRHVQRWQHFHVVDULO\PHDQWKDWLW
VKRXOGEHDSULRULW\IRUUHVHDUFK7KHNQRZKRZWRGHDOZLWKWKHSUREOHPPD\EHDOUHDG\
DYDLODEOHEXWLWLVQRWDSSOLHGDQGPDGHDYDLODEOH7KHQHHGPD\EHIRUDFWLRQDQGQRW
IRUUHVHDUFK5HVHDUFKVKRXOGQRWEHDQH[FXVHIRUGHOD\LQJDFWLRQ
$KHDOWKSUREOHPPD\DOVREHRIKLJKPDJQLWXGHDQGWKHUHPD\EHDQHHGIRU
UHVHDUFKWREHDEOHWRDGGUHVVLW+RZHYHUEHIRUHLWFDQEHSXWDVDSULRULW\IRUUHVHDUFK
RWKHUTXHVWLRQVQHHGWREHDVNHG,VHQRXJKNQRZQDERXWWKHSUREOHPQRZWRFRQVLGHU
ORRNLQJIRUSRVVLEOHLQWHUYHQWLRQV"'RHVWKHVWDWHRIWKHDUWDOORZDPRYHIRUZDUGWR
GHYHORSQHZLQWHUYHQWLRQV"+RZFRVWHIIHFWLYHZLOOWKHVHLQWHUYHQWLRQVEH"&DQWKH\EH
GHYHORSHGVRRQDQGIRUDUHDVRQDEOHRXWOD\"7KLVPD\QRWDOZD\VEHWKHFDVH)LQDOO\
LVWKLVQHHGIRUUHVHDUFKDOUHDG\EHLQJPHWE\FXUUHQWO\RQJRLQJUHVHDUFKWRZKLFKQRW
PXFKFDQEHDGGHG"
3.3.3 Profit-driven research

,QGXVWU\KDVEHFRPHDPDMRUDFWRULQKHDOWKUHVHDUFK7KHUHVHDUFKDQGGHYHORSPHQW
VKDUHRIVDOHVUHYHQXHVYDULHVDPRQJSKDUPDFHXWLFDOFRPSDQLHVEXWLVHVWLPDWHGRQ
DYHUDJHWREH,QWKHVVHYHQFRXQWULHV²8QLWHG6WDWHVRI$PHULFD-DSDQ
8QLWHG.LQJGRP*HUPDQ\6ZLW]HUODQG)UDQFHDQG,WDO\LQGHFUHDVLQJRUGHU²
FRQGXFWHGRIDOOZRUOGZLGHSKDUPDFHXWLFDOUHVHDUFKDQGGHYHORSPHQW0XUUD\HW
DO3KDUPDFHXWLFDOLQGXVWU\LQYHVWPHQWVLQUHVHDUFKDQGGHYHORSPHQWVXUSDVVHG
SXEOLFLQYHVWPHQWVLQIRXURIWKHFRXQWULHV)UDQFH-DSDQ6ZLW]HUODQGDQG8QLWHG
.LQJGRP
7KHGLUHFWLRQIRUUHVHDUFKDQGGHYHORSPHQWLQLQGXVWU\LVSXVKHGE\WKHQHZ
GHYHORSPHQWVLQWHFKQRORJ\ZKLFKSURYLGHQHZOHDGVIRUGHYHORSLQJQHZGUXJV7KH
PDUNHWSXOOLPSDFWVKRZHYHURQWKHWHFKQRORJ\SXVKDQGWKXVRQWKHRSSRUWXQLWLHVIRU
UHVHDUFK)RUH[DPSOHLQWKHLQGXVWULDOL]HGFRXQWULHVSHRSOHRYHU\HDUVROGVSHQGWKH
PRVWRQGUXJV7KLVDJLQJSRSXODWLRQLVGULYLQJQHZDQGH[SDQGLQJPDUNHWV1HZGUXJV
DUHWDUJHWLQJDJHUHODWHGGLVRUGHUVDQGHQKDQFLQJTXDOLW\RIOLIHIRUWKHHOGHUO\%XUULOO
7KHUHFHQWWRSVHOOLQJGUXJVZHUHPRVWO\LQWKLVFDWHJRU\IRUH[DPSOH(OL/LOO\¶V
(YLVWDIRURVWHRSRURVLV0HUFN¶V3URSHFLDIRUPDOHSDWWHUQEDOGQHVV3IL]HU¶VHUHFWLOH
G\VIXQFWLRQSLOO9LDJUDZLWKHVWLPDWHGVDOHVRI86ELOOLRQE\DQG0RQDVWR¶V
&HOHEUDIRUDUWKULWLFSDLQ
2QO\DYHU\VPDOOVKDUHRIWKHODUJHUHVHDUFKLQYHVWPHQWE\LQGXVWU\LVDGGUHVVHGWR
WKHKHDOWKSUREOHPVRIGHYHORSLQJFRXQWULHV
3.3.4 Opportunity-driven research

6HOHFWLRQRIDWRSLFIRUUHVHDUFKPD\EHGULYHQE\RSSRUWXQLW\7KHRSSRUWXQLW\FRPHV
ZLWKWKHDYDLODELOLW\RIIXQGLQJWKHFKDQFHWRSDUWLFLSDWHLQFROODERUDWLYHLQWHUQDWLRQDO
UHVHDUFKDQGZRUNLQJZLWKWKHSKDUPDFHXWLFDOLQGXVWU\7KHVHRSSRUWXQLWLHVSURYLGH
DGYDQWDJHVWRWKHLQYHVWLJDWRUEXWWKH\DOVRUDLVHVRPHFRQFHUQV
Availability of funding
5HVHDUFKLVRIWHQGULYHQE\WKHDYDLODELOLW\RIIXQGLQJZKLFKPD\RUPD\QRW
FRUUHVSRQGWRORFDOSULRULW\QHHGVRUWRWKHFXULRVLW\RIVFLHQWLVWV0RGHUQUHVHDUFKLV
EHFRPLQJPRUHDQGPRUHH[SHQVLYHDQGH[WHUQDOIXQGLQJLVQHHGHGWRFRQGXFWJRRG
UHVHDUFK7KHWUHQGLQUHVHDUFKLVLQFUHDVLQJO\PRYLQJDZD\IURPORFDODXWRQRP\DQG
SOXUDOLVPWRZDUGVVRPHVRUWRIFHQWUDOLVPDQGGLULJLVP$VWXG\E\WKH:HOOFRPH
7UXVWVKRZHGWKDWIURPWRWKHUHZDVDUHGXFWLRQIURPWRLQWKH
QXPEHURIUHVHDUFKDQGGHYHORSPHQWSDSHUVLQWKH8QLWHG.LQJGRPZLWKRXWDIXQGLQJ
DFNQRZOHGJHPHQW'DZVRQHWDO
)XQGLQJIRUKHDOWKUHVHDUFKEDVLFDOO\FRPHVIURPHLWKHUSXEOLFVRXUFHVLQFOXGLQJ
JRYHUQPHQWVDQG8QLWHG1DWLRQVLQWHUJRYHUQPHQWDORUJDQL]DWLRQVRUSULYDWHVRXUFHV
LQFOXGLQJ IRUSURILW SKDUPDFHXWLFDO LQGXVWU\ DQG QRWIRUSURILW DJHQFLHV VXFK DV
SKLODQWKURSLFIRXQGDWLRQVDQGQRQJRYHUQPHQWDORUJDQL]DWLRQV*OREDOLQYHVWPHQWLQ
KHDOWKUHVHDUFKDQGGHYHORSPHQWLQWRWDOOHGDQHVWLPDWHG86ELOOLRQRUDERXW
RIKHDOWKH[SHQGLWXUHVZRUOGZLGH*OREDO)RUXPIRU+HDOWK5HVHDUFK
86ELOOLRQRUIURPJRYHUQPHQWVLQGHYHORSHGFRXQWULHV86ELOOLRQRU
IURPWKHSKDUPDFHXWLFDOLQGXVWU\86ELOOLRQRUIURPWKHSULYDWHQRWIRU
SURILWVHFWRU86ELOOLRQRUIURPJRYHUQPHQWVLQGHYHORSLQJFRXQWULHV
)XQGLQJ KDV QHYHU EHHQ PRUH DYDLODEOH IRU KHDOWK UHVHDUFK WKDQ LW LV WRGD\
+RZHYHUWKHUHLVDJURVVLPEDODQFHLQKRZLWLVGLUHFWHG%RWKWKHSXEOLFVHFWRUDQG
WKHSKDUPDFHXWLFDOLQGXVWU\DUHOLNHO\WREHPRVWUHVSRQVLYHWRWKHEXUGHQRIGLVHDVH
LQGHYHORSHGFRXQWULHV,QYHVWPHQWIRUUHVHDUFKE\JRYHUQPHQWVRIULFKFRXQWULHVLV
GULYHQE\WKHEDOORWER[7KH\KDYHWREHUHVSRQVLYHWRWKHQHHGVRIWKHLURZQHOHFWRUDWH
,QYHVWPHQWIRUUHVHDUFKE\LQGXVWU\LVGULYHQE\PDUNHWIRUFHV
3.4 Participation in collaborative international research

3.4.1 Models for participation in international health research
5HVHDUFKLVDQLQWHUQDWLRQDODFWLYLW\.QRZOHGJHLVFUHDWHGDQGEXLOWXSLQFUHPHQWDOO\
WKURXJKWKHZRUNRIVFLHQWLVWVRIGLIIHUHQWQDWLRQV7KHUHLVQRVXFKWKLQJDVVHOIUHOLDQFH
LQVFLHQFH6FLHQFHLVDFROODERUDWLYHHIIRUWLQYROYLQJVFLHQWLVWVRIWKHSDVWSUHVHQW
DQGIXWXUH6FLHQFHLVLQWHUQDWLRQDO7KHUHLVQRQDWLRQDOVFLHQFHWKHUHLVDQDWLRQDO
FRQWULEXWLRQWRWKHSRRORIVFLHQFH
7KHUH DUH GLIIHUHQW PRGHOV IRU SDUWLFLSDWLRQ LQ LQWHUQDWLRQDO KHDOWK UHVHDUFK
LQFOXGLQJSDUWLFLSDWLRQLQPXOWLFHQWUHFOLQLFDOWULDOVWKHQHWZRUNDSSURDFKDQGWKH
WZLQQLQJDSSURDFK
Participation in multi-centre clinical trials

0XOWLFHQWUHFOLQLFDOWULDOVDOORZUHFUXLWPHQWRIWKHUHTXLUHGODUJHQXPEHURIVXEMHFWV
IRUDWULDOLQDUHDVRQDEOHWLPH7KH\DOVRDOORZWKHSHUVSHFWLYHVRIDQXPEHURIFRXQWULHV
WREHWDNHQLQWRFRQVLGHUDWLRQ7KHGLVSDWFKRIUHVHDUFKIRUPVFDQQRZEHIXUWKHUVSHHGHG
XSWKURXJKHOHFWURQLFFRPPXQLFDWLRQ
,WLVLPSRUWDQWWKDWFHQWUHVLQYROYHGLQFOLQLFDOWULDOVPDNHDQLQWHOOHFWXDOLQSXW
LQWRWKHVWXG\DQGQRWMXVWDFWDVGDWDFROOHFWRUV7KHSDUWLFLSDWLRQRILQYHVWLJDWRUVLQ
WKHFROOHFWLRQRIWKHGDWDDORQHGRHVQRWTXDOLI\WKHPWREHDXWKRUVRIWKHSXEOLVKHG
UHVXOWV
7KHWULDOKDVWRIROORZDSURWRFROWKDWVKRXOGQRWEHYLRODWHGLQDQ\RIWKHFHQWUHV
0DQ\WULDOVKRZHYHUDOORZIRUVRPHDGGLWLRQVWREHPDGHE\GLIIHUHQWFHQWUHVSURYLGHG
WKH\DUHUHOHYDQWWRWKHORFDOFRQWH[WGRQRWELDVWKHRXWFRPHRIWKHVWXG\DQGDUHDJUHHG
XSRQ
'DWDDQDO\VLVLVXVXDOO\FHQWUDOL]HGLQDFRRUGLQDWLQJFHQWUH%XWDIWHUFRPSOHWLRQ
RIWKHWULDODFHQWUHFDQGRIXUWKHUDQDO\VLVRQLWVRZQGDWD
Network approach
,QDQHWZRUNDSSURDFKDQXPEHURIFHQWUHVFROODERUDWHLQRQHUHVHDUFKSURMHFW
HDFKFHQWUHGHDOLQJZLWKRQHSDUWRIWKHSURMHFW2QHRIWKHEHVWNQRZQH[DPSOHVLVWKH
YHU\H[WHQVLYHQHWZRUNRIFHQWUHVLQDQXPEHURIFRXQWULHVZKLFKSDUWLFLSDWHGLQWKH
KXPDQJHQRPHSURMHFW7KHSURMHFWZDVWRRYDVWIRURQHFRXQWU\WRFRQVLGHUEXWLWZDV
VXFFHVVIXOO\DFKLHYHGZLWKWKLVQHWZRUNDSSURDFK0DQ\VFLHQWLILFHQWHUSULVHVDUHRQO\
IHDVLEOHRQDPXOWLQDWLRQDOVFDOH7KHUHDUHFXUUHQWO\DQXPEHURIQHWZRUNVLQERWK
GHYHORSHGDQGGHYHORSLQJFRXQWULHVFROODERUDWLQJLQGLIIHUHQWUHVHDUFKSURJUDPPHV
Twinning approach
6FLHQWLVWVDQGUHVHDUFKLQVWLWXWLRQVLQGHYHORSHGFRXQWULHVVKRXOGEHHQFRXUDJHG
WRGHYHORSKHDOWK\SDUWQHUVKLSVZLWKGHYHORSLQJFRXQWU\LQVWLWXWLRQV,QWKLVZD\WKH\
ZLOOQRWRQO\FRQWULEXWHWRVROYLQJSUREOHPVLQWKHGHYHORSLQJSDUWRIRXU³JOREDOKHDOWK
YLOODJHÉXWWKH\ZLOODOVROHDUQOHVVRQVWKDWFDQEHDSSOLHGLQWKHLURZQFRXQWULHV
6FLHQWLVWVLQGHYHORSLQJFRXQWULHVVKRXOGDOVREHHQFRXUDJHGDQGVXSSRUWHGWRSDUWLFLSDWH
DQGPDNHDFRQWULEXWLRQWRWKHJOREDOUHVHDUFKHIIRUW6FLHQWLVWVLQGHYHORSLQJFRXQWULHV
FDQOLYHZLWKWKHLUVPDOOVDODU\LQDFRXQWU\ZKHUHVPDOOVDODU\LVWKHQRUPDQGQRW
WKHH[FHSWLRQEXWWKH\GUHDGDVVFLHQWLVWVRYHUDQGDERYHPDQ\WKLQJVWKHVHQVHRI
LVRODWLRQ
3.4.2 Concerns in developing countries about international health

research
,QWHUQDWLRQDOKHDOWKUHVHDUFKSURYLGHVJRRGRSSRUWXQLWLHVIRUGHYHORSLQJFRXQWU\
UHVHDUFKHUV7KHUHDUHKRZHYHUFHUWDLQFRQFHUQVWRFRQVLGHU&RXQWU\SULRULWLHVIRU
UHVHDUFKVKRXOGQRWEHGLVWRUWHG7KHUHLVWKHSRWHQWLDOIRULQWHUQDOEUDLQGUDLQ7KHUHDUH
DOVRYDOLGHWKLFDOFRQFHUQV
7KHDYDLODELOLW\RIH[WHUQDOIXQGLQJFDQGLVWRUWWKHQDWLRQDOSULRULWLHVIRUKHDOWK
UHVHDUFK(DFKGHYHORSLQJFRXQWU\VKRXOGHVWDEOLVKDQGVWUHQJWKHQDQDSSURSULDWHKHDOWK
UHVHDUFKEDVHWRXQGHUVWDQGLWVRZQSUREOHPVLPSURYHKHDOWKSROLF\DQGPDQDJHPHQW
HQKDQFHWKHHIIHFWLYHQHVVRIOLPLWHGUHVRXUFHVIRVWHULQQRYDWLRQDQGH[SHULPHQWDWLRQ
DQGSURYLGHWKHIRXQGDWLRQIRUDVWURQJHUGHYHORSLQJFRXQWU\YRLFHLQVHWWLQJLQWHUQDWLRQDO
SULRULWLHV7KLVKDVEHHQJLYHQWKHWHUPHVVHQWLDOQDWLRQDOKHDOWKUHVHDUFK&RPPLVVLRQ
RQ+HDOWK5HVHDUFKIRU'HYHORSPHQW
$QRWKHUFRQFHUQLVWKHLQWHUQDOEUDLQGUDLQSUREOHP7KHEUDLQGUDLQLVQRWVLPSO\
JHRJUDSKLFDO%UDLQGUDLQFDQWDNHSODFHZKLOHWKHVFLHQWLVWVDUHLQWKHLURZQFRXQWULHV
LIWKHLULQWHUHVWVDQGVFLHQWLILFSXUVXLWVDUHFRPSOHWHO\LUUHOHYDQWWRWKHLUFRXQWU\¶V
SUREOHPV
7KHVDPHHWKLFDOVWDQGDUGVWKDWDSSO\WRUHVHDUFKLQGHYHORSHGFRXQWULHVVKRXOG
DSSO\WRUHVHDUFKLQGHYHORSLQJFRXQWULHV$GYDQWDJHVKRXOGQRWEHWDNHQRIGHYHORSLQJ
FRXQWU\FHQWUHVWRGRUHVHDUFKWKDWZRXOGQRWEHFRQVLGHUHGHWKLFDOLQRWKHUFRXQWULHV
5HVHDUFKVKRXOGQRWEHGRQHLQRQHFRXQWU\IRUWKHEHQHILWRIDQRWKHUFRXQWU\
5HVHDUFKVXEMHFWVDQGRUWKHLUFRPPXQLWLHVVKRXOGVWDQGWREHQHILWIURPWKHUHVHDUFK
FRQGXFWHGRQWKHP
7KHUHVKRXOGEHQRSODFHIRUVRFDOOHG³VDIDULUHVHDUFK´ZKHUHH[SDWULDWHVFLHQWLVWV
SDUDFKXWHLQGRWKHUHVHDUFKWKH\DUHLQWHUHVWHGLQDQGOHDYHZKLOHWKHORFDOFRPPXQLW\
LVOHIWZRQGHULQJDWZKDWZDVJRLQJRQ,WPD\EHFKHDSHUDQGIDVWHUWKLVZD\EXWLW
OHDYHVOLWWOHRQWKHJURXQG,WFDQQRWEHHWKLFDOO\MXVWLILHG
3.5 Participation in pharmaceutical company research

3.5.1 Collaboration between industry and academia
,WKDVEHHQWKHWUDGLWLRQRISKDUPDFHXWLFDOFRPSDQLHVLQWKHSDVWWRGRPRVWRIWKHLU
UHVHDUFKDQGGHYHORSPHQWLQKRXVH1RZDGD\VDJURZLQJQXPEHURISKDUPDFHXWLFDO
FRPSDQLHV FRPPLVVLRQ WKHLU UHVHDUFK WR UHSXWDEOH FHQWUHV LQ XQLYHUVLWLHV 0DQ\
FRPSDQLHVWRGD\RXWVRXUFHPRUHWKDQRIWKHLUUHVHDUFKDQGGHYHORSPHQWEXGJHW
DQGDOORUSDUWRIWKHLUFOLQLFDOUHVHDUFKDQGGHYHORSPHQW%XUULOO
,WPXVWEHQRWHGWKDWUHVHDUFKIRUSURILWLVQRORQJHUWKHGRPDLQRILQGXVWU\RQO\7KH
P\WKDERXWWKHDFDGHPLD±LQGXVWU\GLYLGHLVEHLQJGHEXQNHG7KHWUDGLWLRQDOVWHUHRW\SH
RIVFLHQWLVWVZRUNLQJRQREVFXUHSUREOHPVLQLYRU\WRZHUVLVEHFRPLQJREVROHWH
$OWKRXJKVRPHSHRSOHPD\VWLOOKROGDVWHUHRW\SHGYLHZWKDWFRPPHUFLDOH[SORLWDWLRQ
LVDOLHQWRDFDGHPLFUHVHDUFKXQLYHUVLWLHVDQGRWKHUSXEOLFVHFWRUUHVHDUFKRUJDQL]DWLRQV
DUHQRZZRUNLQJFORVHO\ZLWKLQGXVWU\VFDQQLQJUHVHDUFKSRUWIROLRVIRUGHYHORSPHQW
RSSRUWXQLWLHV
&ROODERUDWLRQZLWKLQGXVWU\LVWREHHQFRXUDJHGEHFDXVHRIWKHLPSRUWDQWUROH
LQGXVWU\SOD\VLQWKHLQQRYDWLRQSURFHVV7KHDGYDQWDJHRISDUWLFLSDWLRQLQLQGXVWU\
VSRQVRUHGUHVHDUFKLVWKDWLWLVXVXDOO\ZHOOIXQGHGDQGLVPRUHOLNHO\WREHSXUVXHGIRU
FOLQLFDODSSOLFDWLRQ7KHUHDUHKRZHYHULPSRUWDQWFRQFHUQVWRFRQVLGHU
3.5.2 Concerns about participation in industry-sponsored

research
7KHUHDUHLPSRUWDQWLVVXHVIRUWKHLQGHSHQGHQWLQYHVWLJDWRUWRFRQVLGHUZKHQLQYROYHG
LQLQGXVWU\VSRQVRUHGUHVHDUFK3DUWLFLSDWLRQLQUHVHDUFKVSRQVRUHGE\SKDUPDFHXWLFDO
FRPSDQLHVJHQHUDOO\WDNHVSODFHDWRQHRUDQRWKHURIWKHGLIIHUHQWVWDJHVRIGHYHORSPHQW
RIWKHGUXJGLVFRYHU\UHVHDUFKFOLQLFDOWHVWLQJDQGSRVWPDUNHWLQJUHVHDUFK
'LVFRYHU\UHVHDUFK)RUUHVHDUFKDWWKHVWDJHRIGLVFRYHU\DJUHHPHQWPXVWEHUHDFKHG
EHWZHHQWKHUHVHDUFKLQVWLWXWLRQDQGWKHLQGXVWU\DERXWSDWHQWDQGOLFHQVLQJULJKWVIRU
DQ\SDWHQWDEOHGLVFRYHU\WKDWLVPDGHGXULQJWKHUHVHDUFK0RVWDGYDQFHGLQVWLWXWLRQV
KDYHOHJDOFRXQVHOVWRDGYLVHRQGUDIWLQJWKHODQJXDJHRIWKHVHDJUHHPHQWV
&OLQLFDOWHVWLQJ)RUUHVHDUFKDWWKHFOLQLFDOWULDOVWDJHVWKHUHVHDUFKVKRXOGEHGRQH
DFFRUGLQJWRHVWDEOLVKHGJXLGHOLQHVRQ*RRG&OLQLFDO3UDFWLFH*&3DVRXWOLQHG
ODWHU LQ WKH FKDSWHU RQ LPSOHPHQWLQJ WKH UHVHDUFK 6FLHQWLVWV VKRXOG UHWDLQ WKHLU
REMHFWLYLW\LQZRUNLQJZLWKLQGXVWU\$VWKHSHUVRQVGLUHFWO\UHVSRQVLEOHIRUWKHLU
ZRUNUHVHDUFKHUVVKRXOGQRWHQWHULQWRDJUHHPHQWVWKDWLQWHUIHUHZLWKWKHLUDFFHVV
WRWKHGDWDRUWKHLUDELOLW\WRDQDO\VHLWLQGHSHQGHQWO\WRSUHSDUHPDQXVFULSWVDQGWR
SXEOLVKWKHP,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUV3UHVWLJLRXV
MRXUQDOVUHTXLUHLQYHVWLJDWRUVVXEPLWWLQJSDSHUVIRUSXEOLFDWLRQWRGHFODUHZKRKDV
VSRQVRUHGWKHVWXG\DQGZKHWKHUWKH\KDGDQ\QRQVFLHQWLILFIRUH[DPSOHFRPPHUFLDO
LQWHUHVWLQWKHRXWFRPHRIWKHVWXG\,IWKHFOLQLFDOUHVHDUFKLVSDUWO\VXSSRUWHGE\D
SXEOLFVHFWRUUHVHDUFKRUJDQL]DWLRQDQDJUHHPHQWVKRXOGEHUHDFKHGZLWKLQGXVWU\
RQWKHEHQHILWLQUHWXUQIRUWKHSXEOLFVHFWRULQGHYHORSLQJFRXQWULHVLIWKHUHVHDUFK
LVVXFFHVVIXO7KLVXVXDOO\PHDQVFRQFHVVLRQDU\SULFHVIRUWKHSURGXFW
3RVWPDUNHWLQJ UHVHDUFK 3RVWPDUNHWLQJ UHVHDUFK VSRQVRUHG E\ SKDUPDFHXWLFDO
FRPSDQLHVXVXDOO\KDVDSURPRWLRQDOREMHFWLYH,WDLPVDWPDNLQJWKHFOLQLFLDQVPRUH
IDPLOLDUZLWKWKHGUXJ&OLQLFLDQVLQYROYHGLQWKLVUHVHDUFKVKRXOGGRLWZLWKVFLHQWLILF
ULJRXU,QSDUWLFXODUWKHGUXJLQTXHVWLRQVKRXOGEHFRPSDUHGLQDUDQGRPL]HGZD\
ZLWKWKHFXUUHQWO\EHVWDYDLODEOHDOWHUQDWLYHWUHDWPHQW,WVKRXOGDOVRWDNHDVSHFWVRWKHU
WKDQVLPSOHHIILFDF\LQWRFRQVLGHUDWLRQ2QHRIWKHVHDVSHFWVLVFRVWFRQVLGHUDWLRQ
3.6 Where do research ideas come from?

3.6.1 Searching the medical literature
)RUDQLQYHVWLJDWRUWREHDEOHWRFRQFHLYHJRRGUHVHDUFKWRSLFVVKHLVDGYLVHGWR
UHDGWKHPHGLFDOOLWHUDWXUHLQFOXGLQJUHYLHZVZKLFKRXWOLQHJDSVLQUHVHDUFK
DWWHQGVFLHQWLILFPHHWLQJV
WHDFK²TXHVWLRQVDVNHGE\VWXGHQWVFDQRIWHQJLYHLGHDVIRUUHVHDUFK
EHDWHDPSOD\HU²LGHDVFDQFRPHIURPFROOHDJXHVRUPHQWRUVLQWKHVDPHRUGLIIHUHQW
GLVFLSOLQHV
DFTXDLQW KHUVHOIKLPVHOI ZLWK WKH OLQHV RI LQWHUHVW RI IXQGLQJ UHVHDUFK
RUJDQL]DWLRQV
GHYHORS VSHFLILF DUHDV RI VFLHQWLILF LQWHUHVW²LW LV D JRRG LGHD WR EH DQ H[SHUW LQ
DVPDOOILHOGLWLVEHWWHUWREHDELJILVKLQDVPDOOSRQGWKDQDVPDOOILVKLQDODUJH
ODNH
JHWQHZLGHDVRXWRIKHUKLVRZQSUHYLRXVUHVHDUFK
EHDJRRGREVHUYHU
EHLPDJLQDWLYH
KDYHDVFHSWLFDODWWLWXGHZKHQUHDGLQJVFLHQWLILFILQGLQJV²VFLHQFHVKRXOGQRWEH
DGPLUHGVFLHQFHVKRXOGEHTXHVWLRQHG
$VHDUFKRIWKHOLWHUDWXUHLVHVVHQWLDOEHIRUHGHFLGLQJZKHWKHUUHVHDUFKLVZRUWK
GRLQJDQGZKDWWKHJDSVDUHWKDWQHHGWREHDGGUHVVHG7KHFXUUHQWPHGLFDOOLWHUDWXUHLVD
MXQJOHWKDWLVQRWHDV\WRQDYLJDWH,WLVGLIILFXOWWRFRSHZLWKWKHLQIRUPDWLRQH[SORVLRQ
LQWKHOLWHUDWXUH7KHUHDUHRYHUPLOOLRQDUWLFOHVSXEOLVKHGHYHU\\HDULQRYHU
ELRPHGLFDOMRXUQDOV7KLVKDVOHGWRWKHHPHUJHQFHRILQGH[LQJVHUYLFHVDQGDEVWUDFWLQJ
VHUYLFHV7KHQXPEHURIMRXUQDOVWKDWQRZH[LVWVROHO\WRVXPPDUL]HDUWLFOHVSUREDEO\
H[FHHGV:KLOHHSKHPHUDOOLWHUDWXUHOLWHUDWXUHMXGJHGWRKDYHDVKRUWSHULRGRI
XVHIXOQHVVDQGRQO\IRUDVPDOODXGLHQFHLVQRWQRUPDOO\FRQVLGHUHGZRUWKLQGH[LQJRU
FDWDORJLQJLWPD\KRZHYHUEHLPSRUWDQW,WLQFOXGHVUHSRUWVSURFHHGLQJVRIFRQIHUHQFHV
DQGRWKHUW\SHVRISXEOLFDWLRQ
(QJOLVKKDVEHFRPHWKHFRPPRQODQJXDJHRIVFLHQWLILFFRPPXQLFDWLRQDQGDOO
UHVHDUFKHUVZRUNLQJLQWKHLQWHUQDWLRQDODUHQDQHHGWRKDYHDWOHDVWDUHDGLQJNQRZOHGJH
RILW&RPSXWHUOLWHUDF\KDVQRZEHFRPHDQRWKHUUHTXLUHPHQWDVPDQXDOVHDUFKLVEHLQJ
UHSODFHGE\RQOLQHVHDUFK
7KHUROHRIOLEUDULHVKDVHYROYHG0RGHUQOLEUDULHVDUHQRORQJHUUHSRVLWRULHVRI
RQO\SULQWHGPDWHULDOV7KH\QRUPDOO\KDYHFRPSXWHUL]HGFDWDORJXHVRIWKHLUKROGLQJV
ILOHGE\VXEMHFWDXWKRUDQGWLWOH0DQ\FROOHJHDQGSXEOLFOLEUDULHVDUHSDUWRIDQHWZRUN
RIOLEUDULHV7KLVQHWZRUNH[SDQGVWKHKROGLQJVRIHYHU\OLEUDU\EHFDXVHRQHOLEUDU\
ZLOOORDQERRNVWRRWKHUOLEUDULHVWKURXJKDQLQWHUOLEUDU\ORDQV\VWHP3KRWRFRSLHVRI
DUWLFOHVQRWDYDLODEOHLQRQHOLEUDU\FDQEHUHTXHVWHGDQGVHQWE\ID[IURPDQRWKHUOLEUDU\$
PRGHUQOLEUDU\ZLOODOVRSURYLGHFRPSXWHUDFFHVVWRUHVRXUFHVRQWKHLQWHUQHWZLWKKHOS
IURPOLEUDULDQVDYDLODEOHLIQHHGHG
$QQH[SURYLGHVDWHFKQLFDOQRWHRQVHDUFKLQJWKHOLWHUDWXUHXVLQJWKHUHVRXUFHV
RIWKH8QLWHG6WDWHV1DWLRQDO/LEUDU\RI0HGLFLQH1/0DQGWKHKHDOWKLQIRUPDWLRQ
DYDLODEOHRQWKHLQWHUQHW
3.6.2 New initiatives for expanding access to the scientific

literature
Open access
2SHQDFFHVVWRVFLHQWLILFLQIRUPDWLRQZDVKLJKRQWKHDJHQGDDWWKH:RUOG6XPPLW
RQWKH,QIRUPDWLRQ6RFLHW\KHOGLQ*HQHYDLQ'HFHPEHU'HOHJDWHVIURP
QDWLRQVHQGRUVHGD'HFODUDWLRQRI3ULQFLSOHVWKDWLQFOXGHGDFRPPLWPHQWWR³VWULYHWR
SURPRWHXQLYHUVDODFFHVVZLWKHTXDORSSRUWXQLWLHVIRUDOOWRVFLHQWLILFNQRZOHGJHDQG
WKHFUHDWLRQDQGGLVVHPLQDWLRQRIVFLHQWLILFDQGWHFKQLFDOLQIRUPDWLRQLQFOXGLQJRSHQ
DFFHVVLQLWLDWLYHVIRUVFLHQWLILFSXEOLVKLQJ´KWWSZZZELRPHGFHQWUDOFRPRSHQDFFHVV
DFFHVVHG)HEUXDU\$QQH[DOVRSURYLGHVLQIRUPDWLRQRQRUJDQL]DWLRQVZKLFK
SURYLGHIUHHDFFHVVWRVFLHQWLILFMRXUQDOV
Health InterNetwork Access to Research Initiative (HINARI)

+HDOWKSUREOHPVLQGHYHORSLQJFRXQWULHVDUHPRUHOLNHO\WREHVROYHGE\UHVHDUFKHUV
LQWKRVHFRXQWULHVZKREHWWHUNQRZWKHULJKWTXHVWLRQVWRDVNDQGZKRFDQORRNIRU
IHDVLEOHVROXWLRQV)RUWKLVWKH\QHHGDFFHVVWRWKHJOREDOSRRORIVFLHQWLILFNQRZOHGJH
8QWLOYHU\UHFHQWO\PRVWKHDOWKLQVWLWXWLRQVLQGHYHORSLQJFRXQWULHVKDGOLWWOHRUQRDFFHVV
WRLQWHUQDWLRQDOVFLHQWLILFMRXUQDOV7KHIHZWKDWZHUHDYDLODEOHZHUHRIWHQRXWRIGDWH
,QVWLWXWLRQVFRXOGQRWDIIRUGWKHFRVWRIWKHVXEVFULSWLRQV
7KH:RUOG+HDOWK2UJDQL]DWLRQ:+2JLYHVKLJKSULRULW\WRLPSURYLQJDFFHVVWR
VFLHQWLILFLQIRUPDWLRQ+,1$5,EHJDQDVDYROXQWDU\SDUWQHUVKLSEHWZHHQ:+2DQG
ILYHOHDGLQJSXEOLVKHUV²%ODFNZHOO(OVHYLHULQFOXGLQJ+DUFRXUW6SULQJHU9HUODJ

-RKQ:LOH\DQG:ROWHUV.OXPHU²WRSURYLGHLQVWLWXWLRQVLQGHYHORSLQJFRXQWULHVZLWK
IUHHDFFHVVWRMRXUQDOV7KHILUVWSKDVHZDVODXQFKHGRQ-DQXDU\VXSSO\LQJ
FRXQWULHVZLWKIUHHDFFHVVRQWKHLQWHUQHWWRMRXUQDOV$WRWDORILQVWLWXWLRQVLQ
FRXQWULHVKDYHUHJLVWHUHGDQGPRUHWKDQLQVWLWXWLRQVDUHDFFHVVLQJWKHMRXUQDOV
UHJXODUO\7KHQXPEHURILQVWLWXWLRQVLVJURZLQJDQGWKHQXPEHURIMRXUQDOVKDVLQFUHDVHG
WRRYHUVLQFHIXUWKHUSXEOLVKHUVKDYHMRLQHG+,1$5,
,Q-DQXDU\DFFHVVZDVH[WHQGHGWRDQRWKHUPLGGOHLQFRPHFRXQWULHV
,QVWLWXWLRQVLQWKHVHFRXQWULHVPXVWSD\86IRUDFFHVVWRDERXWHOHFWURQLF
MRXUQDOVZKLFKZRXOGEX\VXEVFULSWLRQVWRRQO\DERXWWKUHHMRXUQDOVDWQRUPDOSULFHV
DQGWKHSXEOLVKHUVDUHGRQDWLQJWKHUHYHQXHWR:+2WRXVHIRUWUDLQLQJOLEUDULDQVLQ
XVLQJ+,1$5,
,PSURYHGIXQFWLRQDOLW\KDVSURYLGHGDGLUHFWOLQNWRWKH+,1$5,MRXUQDOVIURP
3XE0HGWKHGDWDEDVHIRUWKH8QLWHG6WDWHV1DWLRQDO/LEUDU\RI0HGLFLQH$QQH[
SURYLGHVLQIRUPDWLRQRQKRZWRVHDUFKWKHOLWHUDWXUHWKURXJK+,1$5,0RUHLQIRUPDWLRQ
RQ+,1$5,LVDYDLODEOHIURPWKHZHEVLWHKWWSZZZKHDOWKLQWHUQHWZRUNQHW
Eastern Mediterranean Region Virtual Health Sciences Library

7KH:+25HJLRQDO2IILFHIRUWKH(DVWHUQ0HGLWHUUDQHDQVWDUWHGDQLQLWLDWLYHWR
OLQNOLEUDULHVLQWKH5HJLRQLQDYLUWXDOQHWZRUN7KHREMHFWLYHRIWKHQHWZRUNLVWR
PDNHDYDLODEOHDQGRUDFFHVVLEOHWKHZLGHVWUDQJHRIKHDOWKDQGELRPHGLFDOOLWHUDWXUH
WRSRWHQWLDOXVHUVLQDFRVWHIIHFWLYHZD\LQWKH5HJLRQ7KHLQWHUQHWQRZDYDLODEOHLQ
PRVW0HPEHU6WDWHVLQWKH5HJLRQDOORZVWKHRSHUDWLRQRIWKHQHWZRUNDVDYLUWXDO
QHWZRUN$FRUHJURXSRIOLEUDULHVKDYHDOUHDG\H[SUHVVHGLQWHUHVWWRSDUWLFLSDWHLQWKH
QHWZRUN5HVHDUFKHUVFDQDFFHVVWKHVHUYLFHVDWKWWSZZZHPURZKRLQW+,69+6/
,QGH[KWP
PubMed Central
7KLV LQLWLDWLYH RI WKH 8QLWHG 6WDWHV 1DWLRQDO /LEUDU\ RI 0HGLFLQH 1/0
SURYLGHV IUHH RQOLQHDFFHVVWRWKHIXOOWH[WRIOLIHVFLHQFHUHVHDUFKDUWLFOHVKWWS
SXEPHGFHQWUDOQLKJRY$VDSXEOLFZHEEDVHGDUFKLYHLWRIIHUVEDUULHUIUHHDFFHVVWR
SHHUUHYLHZHGSULPDU\UHVHDUFKUHSRUWVLQWKHOLIHVFLHQFHVDQGSURYLGHVWKHZRUOGZLGH
VFLHQWLILFFRPPXQLW\DQGXVHUVRIWKH:RUOG:LGH:HELQJHQHUDOWKHRSSRUWXQLW\WR
VHDUFKWKHOLIHVFLHQFHVOLWHUDWXUHDQGUHWULHYHQRWRQO\DUWLFOHWLWOHVDQGDEVWUDFWVEXW
HQWLUHUHVHDUFKUHSRUWVIUHH
3XE0HG&HQWUDOFDQEHORRNHGDWDVDORJLFDOH[WHQVLRQRI0('/,1(ZKLFKRIIHUV
WKHELEOLRJUDSKLFGHWDLOVRIDUWLFOHVDQGWKHLUDEVWUDFWV,WGHSHQGVRQSXEOLVKHUVDQG
VFLHQWLILFVRFLHWLHVWUDQVIHUULQJSHHUUHYLHZHGDUWLFOHVWR3XE0HG&HQWUDOZKLFKOLNH
0('/,1(LVIXQGHGE\WKH861DWLRQDO,QVWLWXWHVRI+HDOWK,WV/LQN2XWFDSDELOLW\
DOORZVHDV\QDYLJDWLRQWRWKHIXOOWH[WFRQWHQWDYDLODEOHE\K\SHUOLQNLQJWRWKHKRVWHG
FRQWHQWRIPDQ\SXEOLVKHUVRIVFLHQFHWHFKQRORJ\DQGPHGLFLQH
Eastern Mediterranean Region Index Medicus

7KH(DVWHUQ0HGLWHUUDQHDQ5HJLRQ,QGH[0HGLFXVSURMHFWVWDUWHGLQZLWK
LQGH[LQJRIWKHKHDOWKDQGELRPHGLFDOMRXUQDOVSXEOLVKHGLQWKHFRXQWULHVRI:+2
(DVWHUQ0HGLWHUUDQHDQ5HJLRQIURPRQZDUGV7KHGDWDEDVHLVQRZFXUUHQWDQGDV
XSWRGDWHDVWKHMRXUQDOVWKHPVHOYHVDQGFDQSURYLGHDFXUUHQWDZDUHQHVVVHUYLFHWR
ZKDWKDVEHHQSXEOLVKHGLQWKH5HJLRQ7KH,QGH[LVGLVWULEXWHGLQWKUHHIRUPVLQDSULQW
YHUVLRQRIWKHFXUUHQWFRQWHQWVRQDTXDUWHUO\EDVLVRQOLQHWKURXJKWKH5HJLRQDO2IILFH
ZHEVLWHRQWKHLQWHUQHWKWWSZZZHPURZKRLQWOLEUDU\DQGLQD&'520XSGDWH
RQDVL[PRQWKO\EDVLV
3.7 Criteria for a good research topic

$JRRGUHVHDUFKWRSLFVKRXOGEHIHDVLEOHFDQEHGRQHLQWHUHVWLQJQRYHOHWKLFDO
DQGUHOHYDQWKDVDQLPSOLFDWLRQ7KHVHFULWHULDKDYHEHHQFROOHFWLYHO\FDOOHGWKH),1(5
IRUPXOD+XOOH\HWDO7KHLQYHVWLJDWRUFDQWHVWKRZJRRGWKHSURSRVHGUHVHDUFK
TXHVWLRQLVE\XVLQJWKHVHILYHFULWHULD
Feasibility
%HIRUHGHFLGLQJRQDUHVHDUFKWRSLFWKHLQYHVWLJDWRUPXVWEHVXUHWKDWWKHUHVHDUFK
FDQEHGRQHDQGFRPSOHWHG7KHIROORZLQJDUHH[DPSOHVRIIDFWRUVWREHFRQVLGHUHG
GHSHQGLQJRQWKHFDWHJRU\RIUHVHDUFK
,WVKRXOGEHSRVVLEOHWRUHFUXLWWKHQXPEHURIVXEMHFWVUHTXLUHGWRSURYLGHWKHDQVZHU
WRWKHUHVHDUFKTXHVWLRQZLWKLQWKHWLPHIUDPHRIWKHSODQQHGUHVHDUFK
7KHUHVHDUFKIDFLOLW\DYDLODEOHWRWKHLQYHVWLJDWRUVVKRXOGKDYHWKHHTXLSPHQWVXSSOLHV
DQGRWKHUUHTXLUHPHQWVWRXQGHUWDNHWKHUHVHDUFK
7KHLQYHVWLJDWRUVPXVWKDYHWKHUHTXLUHGH[SHUWLVH
7KH FRVW RI GRLQJ WKH UHVHDUFK PXVW EH DIIRUGDEOH DQG WKH ILQDQFLDO UHVRXUFHV
DYDLODEOH
7KHUHVHDUFKREMHFWLYHVPXVWQRWEHWRRPDQ\RUWRRDPELWLRXV,WLVDOZD\VDGYLVDEOH
WRHVWDEOLVKDVLQJOHSULPDU\REMHFWLYHDURXQGZKLFKWRIRFXVWKHGHYHORSPHQWRI
WKHVWXG\SODQ7KLVFDQEHVXSSOHPHQWHGZLWKVHFRQGDU\REMHFWLYHVWKDWPD\DOVR
SURGXFHYDOLGFRQFOXVLRQV
6LU3HWHU0HGDZDUD%ULWLVK1REHO/DXUHDWHXVHGWRGHVFULEHVFLHQWLILFUHVHDUFKDV
³WKHDUWRIWKHVROXEOH´LQDQDQDORJ\WR2WWRYRQ%LVPDUFN¶VGHVFULSWLRQRISROLWLFVDV
³WKHDUWRIWKHSRVVLEOH´0HGDZDU+HZDVFDUHIXOWRSRLQWRXWWKDWKHZDVQRW
DGYRFDWLQJWKHVWXG\RIHDV\SUREOHPV\LHOGLQJTXLFNVROXWLRQV:KDWKHPHDQWZDVWKDW
WKHDUWRIUHVHDUFKLVDERXWPDNLQJDSUREOHPVROXEOHE\ILQGLQJRXWZD\VRIJHWWLQJDW
LWDQGE\GHILQLQJUHVHDUFKTXHVWLRQVWKDWFDQEHDQVZHUHG
Interest
7KHUHVHDUFKWRSLFPXVWEHRILQWHUHVWWRWKHLQYHVWLJDWRUVDQGWRWKHVFLHQWLILF
FRPPXQLW\,IWKHLQYHVWLJDWRUVDUHQRWH[FLWHGDERXWWKHWRSLFRUFDQQRWJHWFROOHDJXHV
LQWHUHVWHGLQLWWKHSURMHFWLVSUREDEO\QRWZRUWKGRLQJ
Novelty
,WLVHVVHQWLDOWKDWWKHLQYHVWLJDWRULVIDPLOLDUZLWKWKHXSWRGDWHOLWHUDWXUHRQ
WKHSODQQHGWRSLFIRUWKHUHVHDUFK7KHUHVHDUFKPXVWEHH[SHFWHGWRFRQWULEXWHQHZ
LQIRUPDWLRQ1RYHOGRHVQRWQHFHVVDULO\PHDQWKDWWKHUHVHDUFKKDVQRWEHHQGRQH
EHIRUH7KHSUHIL[³UH´LQWKHZRUGUHVHDUFKLPSOLHVVHDUFKLQJDJDLQ0RVWJRRGVWXGLHV
DUHQHLWKHURULJLQDOQRUVLPSOHGXSOLFDWLRQRIRWKHUVWXGLHV7KHSURJUHVVRIVFLHQFHLV
LQFUHPHQWDOZLWKNQRZOHGJHJUDGXDOO\EXLOGLQJXSIURPGLIIHUHQWVWXGLHV7KHTXHVWLRQ
VKRXOGQRWEHDERXWZKHWKHUWKHVWXG\KDVEHHQGRQHEHIRUHEXWZKHWKHULWZLOODGGWR
WKHH[LVWLQJERG\RINQRZOHGJH7KHDGGLWLRQWRSUHYLRXVVWXGLHVPD\EHFRQILUPDWRU\
HVSHFLDOO\LIWKHUHZDVZHDNQHVVLQWKHRULJLQDOUHSRUWVFRQWUDGLFWRU\RUH[WHQG
SUHYLRXVILQGLQJV
Ethics
(WKLFDOLVVXHVPXVWEHDGGUHVVHGDWWKHHDUO\VWDJHRIVHOHFWLQJWKHUHVHDUFKWRSLF
2WKHUHWKLFDOLVVXHVZLOOQHHGWREHDGGUHVVHGLQSODQQLQJWKHUHVHDUFK6RPHHWKLFDO
SUREOHPVPD\LQGLFDWHWKDWWKHUHVHDUFKVKRXOGQRWEHFRQVLGHUHGIURPWKHEHJLQQLQJ
,IWKHUHVHDUFKWRSLFLQYROYHVH[SHULPHQWDWLRQRQKXPDQVXEMHFWVWKHIROORZLQJ
LVVXHVVKRXOGEHFRQVLGHUHG
,IWKHWRSLFLVDERXWWHVWLQJDQHZWKHUDS\RUSURFHGXUHHYLGHQFHVKRXOGDOUHDG\EH
DYDLODEOHWRVXJJHVWWKDWLWFDQEHVXSHULRUWRFXUUHQWO\DYDLODEOHDOWHUQDWLYHV
$GHTXDWHGDWDPXVWEHDYDLODEOHIURPDQLPDOVWXGLHVDQGIURPVWXGLHVRQDVPDOO
QXPEHURIKXPDQVXEMHFWVWRFRQILUPVDIHW\DQGWRVXJJHVWHIIHFWLYHQHVVEHIRUH
VXEMHFWLQJSDWLHQWVWRDQHZGUXJRUSURFHGXUH7KHHWKLFDOO\DFFHSWDEOHSUDFWLFHLV
WRVWHSXSFOLQLFDOWULDOVLQVXFFHVVLYHSKDVHVVWDUWLQJILUVWZLWKDVPDOOQXPEHURI
VXEMHFWVDQGRQO\PRYLQJWRWKHQH[WSKDVHDIWHUWKHVXFFHVVIXOFRPSOHWLRQRIWKH
SUHYLRXVSKDVH
,WLVXQMXVWLILDEOHWRGRFOLQLFDOWULDOVRQWKHUDSLHVWKDWDUHXQOLNHO\WREHFRPHDYDLODEOH
WRSHRSOHLQWKHFRXQWU\RUFRPPXQLW\)RUH[DPSOHGUXJVWKDWDUHOLNHO\WREHQRQ
DIIRUGDEOHRUQRQPDUNHWDEOHVKRXOGQRWEHWHVWHGLQDJLYHQSRSXODWLRQ7KLVDSSOLHV
LQSDUWLFXODUWRSKDUPDFHXWLFDOFRPSDQ\UHVHDUFKDQGWRLQWHUQDWLRQDOUHVHDUFK
7KHUHVHDUFKVKRXOGQRWFRQIOLFWZLWKWKHVRFLHW\¶VFXOWXUDOPRUDOUHOLJLRXVDQG
OHJDOYDOXHV
,IWKHUHVHDUFKLQYROYHVH[SHULPHQWDWLRQRQYROXQWHHUKXPDQVXEMHFWVIRUZKRP
WKHUHVHDUFKKDVQRLPPHGLDWHEHQHILWWKHUHVHDUFKVKRXOGRQO\EHFDUULHGRXWLIWKH
LQIRUPDWLRQQHHGHGLVOLNHO\WRDGYDQFHVFLHQWLILFNQRZOHGJHDQGPHGLFDOSUDFWLFHDQG
LIWKHLQIRUPDWLRQFDQQRWEHREWDLQHGRWKHUZLVHHJWKURXJKDQLPDOH[SHULPHQWDWLRQ
5HVHDUFK LQYROYLQJ H[SHULPHQWDWLRQ RQ DQLPDOV VKRXOG EH MXVWLILHG ,QYLWUR
ELRORJLFDOV\VWHPVRUFRPSXWHUVLPXODWLRQPRGHOVVKRXOGEHFRQVLGHUHGZKHUHYHU
SRVVLEOHDVVXEVWLWXWHVWRDQLPDOUHVHDUFK7KHDQLPDOH[SHULPHQWVPXVWEHUHOHYDQWWR
WKHDGYDQFHPHQWRINQRZOHGJHRUDUHDQHVVHQWLDOVWHSEHIRUHKXPDQH[SHULPHQWDWLRQ
Relevance
7KLVFULWHULRQFDQEHFDOOHGWKH³VRZKDW"´WHVW)RUWKHUHVHDUFKWREHFRQVLGHUHG
UHOHYDQWLWPXVWKDYHWKHSRWHQWLDOWRDGYDQFHVFLHQWLILFNQRZOHGJHLQIOXHQFHFOLQLFDO
PDQDJHPHQWLQIOXHQFHKHDOWKSROLF\RUJXLGHIXUWKHUUHVHDUFK

Burrill GS. Biotech 98: tools, techniques and transition. San Francisco, Burrill and Company
LLC, 1998: 36.
Commission on Health Research for Development. Health research: essential link to
equity in development. Oxford University Press, 1990: 13; 20–22.
Cummings SR, Browner WS, Hulley SB. Conceiving the research question. In: Hulley SB,
Cumming SR, eds. Designing clinical research: an epidemiologic approach. 2nd edition.
Philadelphia, Lippincott Williams & Wilkins, 2001: 17–23.
Dawson G, Lucocq B, Cottrell R, Lewinson G. Mapping the landscape. National biomedical
research outputs 1988-95. Policy report No.9. London, The Wellcome Trust, 1998: 21:
39.
Fathalla MF. Promotion of research in human reproduction: global needs and perspectives.
Human Reproduction, 1988: 3;7–10.
Global Forum for Health Research. Monitoring financial flows for health research. Geneva,
Global Forum for Health Research, 2001.
Heath DA. (Quoting Kettering, the automotive engineer). Research: Why do it? In: Hawkins
C, Sorgi M. Research–How to plan, speak and write about it. Berlin, Springer-Verlag,
1985: 2.
International Committee of Medical Journal Editors. Uniform requirements for manuscripts
submitted to biomedical journals: writing and editing for biomedical publication. Updated
November 2003. (http://www.icmje.org accessed 24/2/2004).
Jefferson T, Demicheli V, Mugford M. Elementary economic evaluation in health care. 2nd
edition. London, British Medical Journal Books, 2000.
Marcondes CH and Sayao LF. The SciELO Brazilian Scientific Journal Gateway and
Open Archives, D-Lib Magazine, 2003. 9:1–12
(http://www.dlib.org/march03/macondes/o3marcondes.html accessed 24/2/2004).
Medawar PB. Advice to a young scientist. New York, Basic Books, 1979: 18; 47.
Murray CJL, Govindaraj R, Musgrove P. National health expenditures: a global analysis.
Bulletin of the World Health Organization, 1994, 72: 623–637.
Nass SJ, Stillman BW, eds. Large-scale biomedical science: exploring strategies for future
research. Washington, DC, The National Academies Press, 2003.
Investing in health research and development: Report of the Ad Hoc Committee on Health
Research Relating to Future Intervention Options. Geneva, World Health Organization,
1996.
Roberts RM. Serendipity: accidental discoveries in science. New York, John Wiley & Sons,
Inc, 1989: 159–164; 123–125; 244.
Chapter 4
Planning the research
4.1 Introduction
$IWHUGHFLGLQJRQWKHUHVHDUFKWRSLFWKHLQYHVWLJDWRUVKDYHWRWKLQNFDUHIXOO\DERXW
WKHSODQRIWKHUHVHDUFK,QWKLVSURFHVVWKH\FRQVLGHUWKHRSWLRQVWKH\KDYHDERXW
GLIIHUHQWZD\VLQZKLFKWKHUHVHDUFKWRSLFFDQEHLQYHVWLJDWHGLHDUHVHDUFKGHVLJQ,Q
PDNLQJWKLVFKRLFHWKH\KDYHWRZHLJKWZRIDFWRUV7KH\VKRXOGWU\WRFKRRVHDGHVLJQ
WKDWZLOOJLYHPRVWGHILQLWLYHDQVZHUVDERXWWKHUHVHDUFKWRSLF%XWWKH\KDYHWRZHLJK
WKLVDJDLQVWWKHIHDVLELOLW\RIGRLQJWKHVWXG\7KH\KDYHWRFRQVLGHUDPRQJRWKHUWKLQJV
WKHLURZQFDSDELOLWLHVWKHDYDLODELOLW\RIPDWHULDORUVXEMHFWVIRUWKHUHVHDUFKDQGWKH
DYDLODELOLW\RIUHVRXUFHV2IWHQDWUDGHRIIKDVWREHPDGHEHWZHHQWKHLGHDODQGWKH
SRVVLEOH7KHEHVWVKRXOGQRWEHPDGHWKHHQHP\RIWKHJRRG
$IWHUGHFLGLQJRQDUHVHDUFKGHVLJQWKDWLVDSSURSULDWHWRGHDOZLWKWKHUHVHDUFKWRSLF
DQGWKDWLVIHDVLEOHWKH\KDYHWRORRNDJDLQDWWKHEURDGUHVHDUFKWRSLFDQGGHILQHDQG
UHILQHLWLQWRDUHVHDUFKTXHVWLRQZKLFKFDQEHDQVZHUHGE\WKHUHVHDUFKGHVLJQ)RUPDQ\
VWXGLHVWKLVZLOOLQYROYHJHQHUDWLQJDUHVHDUFKK\SRWKHVLVWKDWFDQEHWHVWHG
$PRQJWKHLVVXHVWKHLQYHVWLJDWRUVKDYHWRGHDOZLWKLQGHVLJQLQJWKHUHVHDUFKLV
WKHTXHVWLRQRIVDPSOLQJ6LQFHWKHVWXG\FDQQRWLQFOXGHDOOWKHWDUJHWSRSXODWLRQWKH\
KDYHWRGHSHQGRQWKHDFFHVVLEOHSRSXODWLRQDQGVHOHFWDVDPSOHWKDWLVDVUHSUHVHQWDWLYH
DVSRVVLEOHRIWKLVSRSXODWLRQ7KHVL]HRIWKHVDPSOHLVDQLPSRUWDQWGHFLVLRQWRPDNH
,IRQWKHRQHKDQGWKHVDPSOHLVWRRVPDOOWKHUHVXOWVREWDLQHGZLOOQRWEHUHOLDEOHWKH
UHVRXUFHVIRUWKHUHVHDUFKZLOOEHZDVWHGDQGLIKXPDQVXEMHFWVDUHLQYROYHGLWZRXOG
KDYHEHHQXQHWKLFDOWRVXEMHFWWKHPWRUHVHDUFKWKDWGRHVQRWJLYHXVHIXOUHVXOWV,IRQWKH
RWKHUKDQGWKHVDPSOHLVWRRODUJHLWSURORQJVWKHVWXG\DQGPDNHVLWPRUHH[SHQVLYH
ZLWKQRDGGHGVFLHQWLILFYDOXH7KHLQYHVWLJDWRUVDOVRKDYHWRJLYHDWWHQWLRQWRKRZWKH
VWXG\UHVXOWVZLOOEHPHDVXUHGE\FKRRVLQJPHWKRGVWKDWDUHUHOLDEOHDQGYDOLG
7KHGHVLJQRITXDOLWDWLYHUHVHDUFKQHHGVGLIIHUHQWDSSURDFKHVIURPWKDWRITXDQWLWDWLYH
UHVHDUFK7KHVHDSSURDFKHVLQFOXGHREVHUYDWLRQLQGHSWKLQWHUYLHZVDQGIRFXVJURXS
GLVFXVVLRQV,IDTXHVWLRQQDLUHLVXVHGWRFROOHFWLQIRUPDWLRQIURPUHVSRQGHQWVWKHUHDUH
DQXPEHURIRSWLRQVIRUWKHLQYHVWLJDWRUVDQGWKHUHDUHJXLGHOLQHVWRIROORZ
/DVWEXWQRWOHDVWSODQQLQJLVWKHWLPHWRWKLQNFDUHIXOO\DERXWHWKLFDOLPSOLFDWLRQV
EHIRUHWKHVWXG\LVLPSOHPHQWHG
$OOWKHVHWRSLFVZLOOEHGLVFXVVHGLQWKHQH[WVHFWLRQV)RUPRUHGHWDLOWKHUHIHUHQFHV
DQGDGGLWLRQDOVRXUFHVOLVWHGIRUWKHFKDSWHUFDQEHFRQVXOWHG
4.2 Types of research design

7KHVWXG\W\SHPD\GLFWDWHFHUWDLQUHVHDUFKGHVLJQV0RUHFRPPRQO\WKHVWXG\
REMHFWLYHVFDQEHDFKLHYHGWKURXJKDQXPEHURIDOWHUQDWLYHGHVLJQV7KHLQYHVWLJDWRUV
KDYHWRVHOHFWWKHPRVWDSSURSULDWHDQGPRVWIHDVLEOHGHVLJQ
*HQHUDOO\WKHUHDUHWZRPDLQFDWHJRULHVRIUHVHDUFKGHVLJQREVHUYDWLRQDOVWXG\
DQGH[SHULPHQWDORULQWHUYHQWLRQVWXG\,QWKHREVHUYDWLRQDOVWXG\WKHLQYHVWLJDWRUV
VWDQGDSDUWIURPHYHQWVWDNLQJSODFHLQWKHVWXG\7KH\VLPSO\REVHUYHDQGUHFRUG,Q
WKHH[SHULPHQWDORULQWHUYHQWLRQVWXG\WKHLQYHVWLJDWRUVLQWURGXFHDQLQWHUYHQWLRQDQG
REVHUYHWKHHYHQWVZKLFKWDNHSODFHLQWKHVWXG\
Observational studies
$QREVHUYDWLRQDOVWXG\PD\EHGHVFULSWLYHRUDQDO\WLFDO$GHVFULSWLYHVWXG\LV
DQREVHUYDWLRQDOVWXG\WKDWVLPSO\GHVFULEHVWKHGLVWULEXWLRQRIDFKDUDFWHULVWLF$Q
DQDO\WLFDOVWXG\LVDQREVHUYDWLRQDOVWXG\WKDWGHVFULEHVDVVRFLDWLRQVDQGDQDO\VHVWKHP
IRUSRVVLEOHFDXVHDQGHIIHFW
$QREVHUYDWLRQDOVWXG\PD\EHFURVVVHFWLRQDORUORQJLWXGLQDO,QDFURVVVHFWLRQDO
VWXG\PHDVXUHPHQWVDUHPDGHRQDVLQJOHRFFDVLRQ,QDORQJLWXGLQDOVWXG\PHDVXUHPHQWV
DUHPDGHRYHUDSHULRGRIWLPH
$ORQJLWXGLQDOREVHUYDWLRQDOVWXG\PD\ EH UHWURVSHFWLYH RU SURVSHFWLYH ,Q D
UHWURVSHFWLYHVWXG\WKHLQYHVWLJDWRUVVWXG\SUHVHQWDQGSDVWHYHQWV,QDORQJLWXGLQDO
SURVSHFWLYHVWXG\WKHLQYHVWLJDWRUVIROORZVXEMHFWVIRUIXWXUHHYHQWV
&DVH±FRQWUROVWXGLHVDUHDW\SHRIREVHUYDWLRQDODQDO\WLFDOUHWURVSHFWLYHVWXGLHV
RYHUWLPHLQZKLFKDJURXSRIVXEMHFWVZLWKDVSHFLILHGRXWFRPHFDVHVDQGDJURXS
ZLWKRXWWKDWRXWFRPHFRQWUROVDUHLGHQWLILHG,QYHVWLJDWRUVWKHQFRPSDUHWKHH[WHQW
WRZKLFKHDFKVXEMHFWZDVSUHYLRXVO\H[SRVHGWRWKHYDULDEOHRILQWHUHVWVXFKDVDULVN
IDFWRUDWUHDWPHQWRUDQLQWHUYHQWLRQ&DVH±FRQWUROVWXGLHVDUHXVHIXOIRUVWXG\LQJUDUH
FRQGLWLRQVDQGFRQGLWLRQVZLWKORQJLQWHUYDOVEHWZHHQH[SRVXUHDQGRXWFRPHVXFKDV
IRUH[DPSOHULVNRIGHYHORSLQJQHRSODVLD,QVXFKVLWXDWLRQVDSURVSHFWLYHVWXG\ZLOO
EHGLIILFXOW&DVH±FRQWUROVWXGLHVFDQEHHIILFLHQWDQGHFRQRPLFDOEXWGRQRWKDYHWKH
VWUHQJWKRIHYLGHQFHRIDSURVSHFWLYHVWXG\
,QFOLQLFDODQGHSLGHPLRORJLFDOUHVHDUFKDORQJLWXGLQDOREVHUYDWLRQDOVWXG\LV
XVXDOO\FDOOHGDFRKRUWVWXG\7KHZRUGFRKRUWZDVWKHDQFLHQW5RPDQWHUPIRUDJURXS
RIVROGLHUVZKRPDUFKHGWRJHWKHULQWREDWWOH7KHSURVSHFWLYHFRKRUWGHVLJQLVJHQHUDOO\
FRQVLGHUHGWREHWKH³FUqPHGHODFUqPH´RIREVHUYDWLRQDOPHWKRGRORJLHVIRUWKH
IROORZLQJUHDVRQV
Planning the research 45
'DWDDUHJDWKHUHGSURVSHFWLYHO\
5HFDOOELDVLVQRWDSUREOHPUHVHDUFKVXEMHFWVDUHQRWDVNHGWRUHFDOOSDVWHYHQWV
7LPH±RUGHUUHODWLRQVKLSVDUHFOHDULWLVHDV\WRGHFLGHWKDWDQRXWFRPHIROORZHG
UDWKHUWKDQSUHFHGHGDSRVVLEOHFDXVH
,QYHVWLJDWRUVKDYHPXFKPRUHFRQWURORQWKHTXDOLW\RIWKHGDWD
7KHUHDUHKRZHYHUVRPHGUDZEDFNV
7KHELJJHVWVLQJOHSUREOHPRIWKHVHIROORZXSGHVLJQLQYHVWLJDWLRQVLVWKHORVVRI
YDOXDEOHLQIRUPDWLRQWKURXJKDWWULWLRQGXHWRORVVWRIROORZXSRUVXEMHFWVRSWLQJ
RXWRIWKHVWXG\
6XEMHFWVPD\FKDQJHWKHLUEHKDYLRXURYHUWLPH
$ELDVFDQRFFXULIWKHUHLVXQHTXDOVXUYHLOODQFHRIVXEMHFWVLQWKHWZRFRPSDUHG
JURXSVGXULQJIROORZXS
2QHRIWKHEHVWH[DPSOHVRIDSURVSHFWLYHFRKRUWVWXG\ZDVLQLWLDWHGE\$XVWLQ
%UDGIRUG+LOODQG5LFKDUG'ROOWRLQYHVWLJDWHWKHUHODWLRQVKLSEHWZHHQVPRNLQJDQGOXQJ
FDQFHU7KH\IROORZHGXS%ULWLVKGRFWRUVZKRZHUHGLYLGHGLQWRIRXUFRKRUWV
QRQVPRNHUVDQGOLJKWPRGHUDWHDQGKHDY\VPRNHUV'HDWKZDVWKHRXWFRPHWKH\
UHFRUGHG7KH\XVHGERWKDOOFDXVHGHDWKDQ\GHDWKDQGFDXVHVSHFLILFGHDWKGHDWK
IURPDSDUWLFXODUGLVHDVH3XEOLFDWLRQRIWKHLULQWHULP\HDUUHVXOWVLQVKRZHGD
VXEVWDQWLDOH[FHVVLQERWKPRUWDOLW\IURPOXQJFDQFHUDQGDOOFDXVHPRUWDOLW\LQVPRNHUV
ZLWKD³GRVHUHVSRQVHÚHODWLRQWKDWLVWKHPRUHWKHVXEMHFWVVPRNHGWKHJUHDWHUZHUH
WKHLUFKDQFHVRIJHWWLQJOXQJFDQFHU7KHVWXG\ZHQWDORQJZD\LQGHPRQVWUDWLQJWKDW
WKHOLQNEHWZHHQVPRNLQJDQGLOOKHDOWKZDVFDXVDOUDWKHUWKDQFRLQFLGHQWDO7KH\HDU
DQG\HDUUHVXOWVRIWKLVPRPHQWRXVVWXG\ZKLFKDFKLHYHGIROORZXSRIWKRVH
UHFUXLWHGLQDQGQRWNQRZQWRKDYHGLHGLOOXVWUDWHWKHVWUHQJWKRIHYLGHQFHWKDW
FDQEHREWDLQHGIURPDSURSHUO\FRQGXFWHGFRKRUWVWXG\'ROODQG+LOO'ROODQG
3HWR'ROOHWDO
Experimental or intervention studies

,QWKHH[SHULPHQWDORULQWHUYHQWLRQVWXG\WKHLQYHVWLJDWRUVWHVWWKHHIIHFWRIDQ
LQWHUYHQWLRQRQWKHHYHQWVWDNLQJSODFHLQWKHVWXG\$QH[SHULPHQWDORULQWHUYHQWLRQ
VWXG\PD\EHFRQWUROOHGRUQRQFRQWUROOHG*LYLQJDWUHDWPHQWWRDSDWLHQWRUJURXSRI
SDWLHQWVDQGILQGLQJWKDWWKHWUHDWPHQWZRUNVJLYHVRQO\SUHOLPLQDU\DQGQRQGHILQLWLYH
LQIRUPDWLRQ:HGRQRWNQRZZKDWZRXOGKDYHKDSSHQHGLIQRWUHDWPHQWRUDGLIIHUHQW
WUHDWPHQWZDVJLYHQ)RUDPRUHGHILQLWLYHDQVZHUZHQHHGD³FRQWURO´JURXSRISDWLHQWV
ZKRGRQRWJHWWKHWUHDWPHQWXQGHUVWXG\
+DZWKRUQHHIIHFW,QWKHODWHVDJURXSRIUHVHDUFKHUVDWWKH:HVWHUQ(OHFWULF
+DZWKRUQH:RUNVLQ&KLFDJRZHUHLQYHVWLJDWLQJWKHHIIHFWVRIOLJKWLQJKHDWLQJDQG
RWKHUSK\VLFDOFRQGLWLRQVXSRQWKHSURGXFWLYLW\RIZRUNHUV0XFKWRWKHVXUSULVHRIWKH
UHVHDUFKHUVWKHSURGXFWLYLW\RIWKHZRUNHUVNHSWLPSURYLQJHYHQZKHQWKHDFWXDOSK\VLFDO
FRQGLWLRQVZHUHQRWLPSURYHG7KH+DZWKRUQHHIIHFWFDQEHPDQLIHVWHGLQFOLQLFDO
UHVHDUFKVHWWLQJV(YHQ³LQHUW´WUHDWPHQWVPLJKWUHVXOWLQVLJQLILFDQWLPSURYHPHQWVLQ
WKHSDWLHQW¶VFRQGLWLRQ3ROJDUDQG7KRPDV
$FRQWUROOHGH[SHULPHQWDOVWXG\PD\EHUDQGRPL]HGRUQRQUDQGRPL]HG,QWHVWLQJ
WKHRXWFRPHLQDJURXSRISDWLHQWVZKRUHFHLYHWKHWUHDWPHQWDQGDQRWKHUJURXSZKRGR
QRWZHDUHVWLOOQRWVXUHZKHWKHUDQ\GLIIHUHQFHREVHUYHGLVEHFDXVHRIWKHWUHDWPHQW
RUEHFDXVHWKHFKDUDFWHULVWLFVRIWKHSDWLHQWVLQWKHWZRJURXSVZHUHGLIIHUHQW7KHEHVW
ZD\WREHVXUHLVWRUDQGRPL]HWKHDOORFDWLRQRISDWLHQWVWRHLWKHUWUHDWPHQWRUWRQR
WUHDWPHQW
5DQGRPL]HG FRQWUROOHG WULDOV DUH LQWHUYHQWLRQ VWXGLHV FKDUDFWHUL]HG E\ WKH
SURVSHFWLYHDVVLJQPHQWRIVXEMHFWVWKURXJKDUDQGRPPHWKRGLQWRDQH[SHULPHQWDO
JURXSDQGDFRQWUROJURXS,QDFOLQLFDOWULDOWKHH[SHULPHQWDOJURXSUHFHLYHVWKHGUXJRU
WUHDWPHQWWREHHYDOXDWHGZKLOHWKHFRQWUROJURXSUHFHLYHVDSODFHERQRWUHDWPHQWRUWKH
VWDQGDUGRIFDUH%RWKJURXSVDUHIROORZHGIRUWKHRXWFRPHVRILQWHUHVW5DQGRPL]DWLRQ
LVWKHPRVWUHOLDEOHPHWKRGWRHQVXUHWKDWWKHSDUWLFLSDQWVLQERWKJURXSVDUHVLPLODUDVIDU
DVSRVVLEOHZLWKUHVSHFWWRDOONQRZQRUXQNQRZQIDFWRUVWKDWPLJKWDIIHFWWKHRXWFRPH
:LWKUDQGRPL]DWLRQRQO\FKDQFHGHWHUPLQHVWKHDVVLJQPHQWRIVXEMHFWVWRVWXG\JURXSV
5DQGRPDOORFDWLRQGRHVQRWPHDQKDSKD]DUGDOORFDWLRQ,WLVDFDUHIXOO\SODQQHGPHWKRG
RIDVVLJQLQJVXEMHFWVWRVLPLODUJURXSV,ILPSRUWDQWULVNIDFWRUVFDQEHLGHQWLILHGDWWKH
RXWVHWVXEMHFWVPD\EHJURXSHGRUVWUDWLILHGSULRUWRDVVLJQPHQW:KHQHYHULWLVHWKLFDO
DQGSUDFWLFDODUDQGRPL]HGGHVLJQVKRXOGEHFRQVLGHUHGLQFRQWUROOHGLQWHUYHQWLRQ
VWXGLHV
&RQWUROOHGWULDOVZLWKRXWUDQGRPL]DWLRQDUHLQWHUYHQWLRQVWXGLHVLQZKLFKDOORFDWLRQ
WRHLWKHUH[SHULPHQWDORUFRQWUROJURXSLVQRWEDVHGRQUDQGRPL]DWLRQPDNLQJDVVLJQPHQW
VXEMHFWWRSRVVLEOHELDVHVWKDWPD\LQIOXHQFHVWXG\UHVXOWV
$FURVVRYHUVWXG\LVDVSHFLDOGHVLJQRIFRQWUROOHGLQWHUYHQWLRQVWXG\WKDWLV
VRPHWLPHVXVHGLQGUXJWULDOV,QWKLVGHVLJQKDOIRIWKHSDUWLFLSDQWVDUHUDQGRPO\
DVVLJQHGWRVWDUWZLWKWKHSODFHERDQGWKHQVZLWFKWRDFWLYHWUHDWPHQWZKLOHWKHRWKHUKDOI
GRHVWKHRSSRVLWH,WKDVWKHDGYDQWDJHRIUHGXFLQJWKHQXPEHURIVXEMHFWVUHTXLUHGVLQFH
HDFKVXEMHFWVHUYHVDVERWKDQH[SHULPHQWDOVXEMHFWDQGDFRQWURO,WDOVRGHFUHDVHVWKH
ELRORJLFDOYDULDELOLW\LQKHUHQWLQFRPSDULQJGLIIHUHQWVXEMHFWVE\FRPSDULQJHDFKVXEMHFW
ZLWKKLPVHOIRUKHUVHOI,WKDVWKHGLVDGYDQWDJHRILQFUHDVLQJWKHGXUDWLRQRIWKHVWXG\
7KHUHZLOODOVREHDSUREOHPLIWKHWUHDWPHQWKDVDFDUU\RYHUHIIHFWDIWHULWLVVWRSSHG
$EHIRUHDQGDIWHUVWXG\LVDPHWKRGRIFRQWUROLQZKLFKUHVXOWVIURPH[SHULPHQWDO
VXEMHFWVDUHFRPSDUHGZLWKRXWFRPHVIURPSDWLHQWVWUHDWHGEHIRUHWKHQHZLQWHUYHQWLRQ
ZDVDYDLODEOH7KHVHDUHFDOOHGKLVWRULFFRQWUROV
$UDQGRPL]HGFRQWUROOHGWULDOPD\EHEOLQGHGLISDUWLFLSDQWVLQWKHWULDODUHOLNHO\WR
FKDQJHWKHLUEHKDYLRXULQDV\VWHPDWLFZD\WKDWPD\LQIOXHQFHWKHRXWFRPHRIWKHVWXG\
ZKHQWKH\DUHDZDUHRIZKLFKLQWHUYHQWLRQWKH\UHFHLYH2SKWKDOPRORJLVWVSUHIHUWKH
WHUP³PDVNLQJ´WRWKHWHUP³EOLQGLQJ´
%OLQGLQJFDQWDNHSODFHDWDQXPEHURIOHYHOV$WRQHOHYHOWKRVHUHVSRQVLEOHIRU
DVVLJQLQJWKHVXEMHFWVWRJURXSVGRQRWNQRZWRZKLFKJURXSWKHQH[WVXEMHFWZLOOEH
DVVLJQHG,QDQRWKHUOHYHOUHVHDUFKVXEMHFWVDUHDOVRQRWDZDUHRIZKLFKLQWHUYHQWLRQWKH\
DUHUHFHLYLQJ7KHQKHDOWKZRUNHUVZKRWDNHFDUHRISDWLHQWVLQWKHVWXG\PD\QRWEH
DOORZHGWRNQRZZKDWWUHDWPHQWWKHGLIIHUHQWSDWLHQWVDUHUHFHLYLQJ/DVWO\UHVHDUFKHUV
ZKRDVVHVVWKHRXWFRPHDUHDOVRQRWDEOHWRGLVWLQJXLVKWKHVXEMHFWVLQWKHGLIIHUHQW
JURXSV
7KHWHUPGRXEOHEOLQGLVXVHGZKHQQHLWKHUUHVHDUFKHUVQRWVXEMHFWVDUHDZDUHRI
WKHW\SHRILQWHUYHQWLRQ$WULDOLQZKLFKWKHUHLVQRDWWHPSWDWEOLQGLQJPD\EHFDOOHG
RSHQRURSHQODEHO
7KH5RVHQWKDOHIIHFW5RVHQWKDODQGKLVFROOHDJXHVLQSHUIRUPHGDQH[SHULPHQW
LQYROYLQJWKHWUDLQLQJRIWZRJURXSVRIUDWVLQDPD]HOHDUQLQJWDVN$EULJKWVWUDLQ
DQGDGXOOVWUDLQRIUDWVHVSHFLDOO\EUHGIRUWKHSXUSRVHZHUHWUDLQHGE\XQGHUJUDGXDWH
VWXGHQWH[SHULPHQWHUVWRQHJRWLDWHWKHPD]H$IWHUDVXLWDEOHWUDLQLQJLQWHUYDOWKH
UHODWLYHSHUIRUPDQFHVRIWKHJURXSVZHUHFRPSDUHG1RWVXUSULVLQJO\WKHEULJKWVWUDLQ
VLJQLILFDQWO\RXWSHUIRUPHGWKHGXOOVWUDLQ:KDWZDVVXUSULVLQJKRZHYHUZDVWKDWWKH
WZRVWUDLQVZHUHDFWXDOO\QRWGLIIHUHQW7KHWZRJURXSVRIUDWVZHUHDFWXDOO\JHQHWLFDOO\
LGHQWLFDO7KHUHVHDUFKHUVKDGGHFHLYHGWKHVWXGHQWH[SHULPHQWHUVIRUWKHSXUSRVHVRI
WKHVWXG\DQGWKHVWXGHQWV¶H[SHFWDWLRQVRIWKHUDWVKDGUHVXOWHGLQGLIIHUHQWPHWKRGVRI
WUHDWPHQWZKLFKKDGDIIHFWHGWKHUDWV¶OHDUQLQJDELOLW\7KHVHUHVXOWVKDYHEHHQFRQILUPHG
WLPHDQGWLPHDJDLQLQDYDULHW\RIH[SHULPHQWDOVHWWLQJVDQGZLWKDYDULHW\RIVXEMHFWV
7KH\FRQILUPWKHQHHGIRUEOLQGLQJ3ROJDUDQG7KRPDV
4.3 Selecting a research design

$UHVHDUFKTXHVWLRQPD\EHDQVZHUHGE\PRUHWKDQRQHUHVHDUFKGHVLJQ7KH
UHVHDUFKHUKDVWRVHOHFWWKHDSSURSULDWHGHVLJQIRUWKHSDUWLFXODUVWXG\$OOW\SHVRI
UHVHDUFKGHVLJQKDYHDSODFHDQGDOOKDYHDGYDQWDJHVDQGGLVDGYDQWDJHV%XWQRWDOO
W\SHVRIGHVLJQDUHDOZD\VSRVVLEOHIRUDSDUWLFXODUVWXG\
)RUH[DPSOHWKHLQYHVWLJDWRUVPD\ZDQWWRVWXG\LIWKHUHLVDUHODWLRQVKLSEHWZHHQ
SRVWPHQRSDXVDOKRUPRQHUHSODFHPHQWWKHUDS\DQGVXEVHTXHQWGHYHORSPHQWRIXWHULQH
HQGRPHWULDOFDUFLQRPD7KHLQYHVWLJDWRUVFDQGHVLJQDQREVHUYDWLRQDOVWXG\RUDQ
H[SHULPHQWDOVWXG\,IWKHGHFLVLRQZDVIRUDQREVHUYDWLRQDOVWXG\WKHLQYHVWLJDWRUV
PD\GRDGHVFULSWLYHVWXG\RUDQDQDO\WLFDOVWXG\
)RUDGHVFULSWLYHVWXG\WKH\ZLOOUHYLHZWKHFOLQLFDOUHFRUGVRIDOOSDWLHQWVGLDJQRVHG
DVKDYLQJHQGRPHWULDOFDUFLQRPD7KH\ZLOOORRNIRUDKLVWRU\RISRVWPHQRSDXVDO
KRUPRQDOWKHUDS\7KLVVWXG\ZLOOEHXVHIXOEXWFDQQRWEHGHILQLWLYH,WVKRZVZKHWKHU
IXUWKHUVWXG\LVQHHGHGWRFRQILUPRUUHIXWHWKHLPSUHVVLRQJDLQHGIURPWKHGHVFULSWLYH
VWXG\7KHLQIRUPDWLRQDERXWWKHVWUHQJWKRIWKHDVVRFLDWLRQZLOODOVRKHOSLQWKHGHVLJQ
RIIXUWKHUDQDO\WLFDOVWXGLHV7KHILQGLQJWKDWPDQ\RIWKHZRPHQZKRGHYHORSHG
HQGRPHWULDOFDUFLQRPDKDGDKLVWRU\RIKRPRQDOWKHUDS\FDQQRWOHDGWRDQ\FRQFOXVLRQ
,WPD\VLPSO\PHDQWKDWWKLVWKHUDS\LVZLGHO\XVHGLQWKHFRPPXQLW\ERWKE\ZRPHQ
ZKRGHYHORSDQGZKRGRQRWGHYHORSHQGRPHWULDOFDUFLQRPD7KLVVKRZVWKHQHHGIRU
IXUWKHUVWXGLHV
)RU DQ DQDO\WLFDO VWXG\ WKH LQYHVWLJDWRUV PD\ GR D FURVVVHFWLRQDO VWXG\ RU
DORQJLWXGLQDOVWXG\,QDFURVVVHFWLRQDOVWXG\WKHLQYHVWLJDWRUVPD\VWXG\DOOSRVW
PHQRSDXVDOZRPHQDGPLWWHGWRKRVSLWDORYHUDGHILQHGWLPHSHULRG)RUHDFKZRPDQ
WKH\UHFRUGZKHWKHUVKHUHFHLYHGRUGLGQRWUHFHLYHKRUPRQDOWKHUDS\DQGZKHWKHUVKH
KDGRUGLGQRWKDYHHQGRPHWULDOFDQFHU7KHDGYDQWDJHRIWKLVVWXG\LVWKDWLWFDQEH
GRQHUDSLGO\,WJLYHVPRUHHYLGHQFHWKDQWKHVLPSOHGHVFULSWLYHVWXG\+RZHYHUWKHWZR
JURXSVRISDWLHQWVPD\QRWEHFRPSDUDEOH
,QDORQJLWXGLQDOREVHUYDWLRQDOVWXG\WKHLQYHVWLJDWRUVPD\GRDSURVSHFWLYH
VWXG\RUDUHWURVSHFWLYHVWXG\)RUDSURVSHFWLYHVWXG\DFRKRUWRIWZRJURXSVRISRVW
PHQRSDXVDOZRPHQLVIROORZHGXSRQHJURXSDOUHDG\UHFHLYLQJKRUPRQHUHSODFHPHQW
WKHUDS\DQGDQRWKHUPDWFKHGJURXSQRWUHFHLYLQJWKLVWKHUDS\)RUDUHWURVSHFWLYHVWXG\
DFDVH±FRQWUROGHVLJQFDQEHVHOHFWHG$JURXSRIZRPHQZKRKDYHUHFHQWO\GHYHORSHG
HQGRPHWULDOFDQFHUFDVHVDQGDJURXSRIZRPHQZLWKVLPLODUFKDUDFWHULVWLFVDQGGLGQRW
GHYHORSHQGRPHWULDOFDQFHUFRQWUROVDUHLGHQWLILHG7KHXVHRIKRUPRQHUHSODFHPHQW
WKHUDS\LQHDFKZRPDQLQWKHFDVHJURXSDQGLQWKHFRQWUROJURXSLVGHWHUPLQHGWRDVVHVV
H[SRVXUHKLVWRU\7KHDGYDQWDJHLVWKDWWKHVWXG\FDQEHGRQHUHODWLYHO\TXLFNO\7KH
GLVDGYDQWDJHLVWKDWWKHWZRJURXSVPD\VWLOOQRWEHFRPSOHWHO\VLPLODU2WKHUYDULDEOHV
PD\LQIOXHQFHWKHRXWFRPHDQGPD\EHGLIILFXOWWRH[FOXGH
,IWKHLQYHVWLJDWRUVGHFLGHRQDQH[SHULPHQWDORULQWHUYHQWLRQVWXG\WKH\PD\
VHOHFWDUDQGRPL]HGRUDQRQUDQGRPL]HGGHVLJQ,QDUDQGRPL]HGFRQWUROOHGVWXG\
SRVWPHQRSDXVDOZRPHQLGHQWLILHGIURPDSRSXODWLRQDUHUDQGRPO\DVVLJQHGHLWKHUWRD
VWXG\JURXSWKDWZLOOUHFHLYHKRUPRQHUHSODFHPHQWWKHUDS\RUWRDFRQWUROJURXSWKDWZLOO
EHSUHVFULEHGDSODFHER%RWKJURXSVZLOOWKHQEHIROORZHGSURVSHFWLYHO\WRGHWHUPLQH
KRZPDQ\LQHDFKJURXSZLOOGHYHORSHQGRPHWULDOFDQFHU7KLVVWXG\LIVXFFHVVIXOO\
FRQGXFWHGZLOOSURYLGHDPRUHGHILQLWLYHDQVZHUWRWKHUHVHDUFKTXHVWLRQ+RZHYHU
LWZLOOUDLVHHWKLFDOFRQFHUQV$GGLWLRQDOGLIILFXOWLHVDUHWKHODUJHVDPSOHVL]HQHHGHG
EHFDXVHRIWKHUHODWLYHO\ORZLQFLGHQFHRIWKHGLVHDVHWKHORQJIROORZXSEHFDXVHRI
WKHORQJODWHQWSHULRGEHIRUHWKHGHYHORSPHQWRIWKHGLVHDVHDQGWKHSRVVLELOLW\RISRRU
FRPSOLDQFHRUORVVWRIROORZXS$OWHUQDWLYHO\DQRQUDQGRPL]HGFRQWUROOHGGHVLJQPD\
EHFRQVLGHUHG7KLVPD\EHHDVLHUZLOODOORZZRPHQWRPDNHDQLQIRUPHGFKRLFHEXW
WKHUHZLOOEHDQHHGWRFRQVLGHURWKHUSRVVLEOHYDULDEOHVWKDWPD\LQIOXHQFHWKHRXWFRPH
VLQFHWKHWZRJURXSVPD\QRWEHVLPLODU
'LIIHUHQWW\SHVRIUHVHDUFKGHVLJQDUHQRWFRQVLGHUHGHTXDOLQWKHVWUHQJWKRI
HYLGHQFHWKH\SURYLGH,QWKHWUDGLWLRQDOKLHUDUFK\RIHYLGHQFHUDQGRPL]HGFRQWUROOHG
VWXGLHVDUHJHQHUDOO\UDQNHGKLJKIROORZHGE\FRKRUWDQGFDVH±FRQWUROVWXGLHVZKLOH
REVHUYDWLRQDOGHVFULSWLYHVWXGLHVDUHUDQNHGDWDORZHUOHYHO7KHLQYHVWLJDWRUVPD\
KRZHYHUQRWEHDEOHWRVHOHFWWKHGHVLJQWKDWJLYHVDKLJKOHYHORIHYLGHQFHEHFDXVH
LWZLOOQRWEHIHDVLEOHWRGRRUZLOOQRWEHHWKLFDOWRGR,QWKLVFDVHWKHLUVHOHFWLRQRI
DQRWKHUGHVLJQZLOOEHDFFHSWDEOHDQGMXVWLILHG
4.4 Defining and refining the research question

,QRUGHUWRGHYHORSWKHUHVHDUFKGHVLJQWKHUHVHDUFKWRSLFRIWHQKDVWREHFKDQJHG
WRDUHVHDUFKTXHVWLRQDQGWKHUHVHDUFKTXHVWLRQVKRXOGEHGHILQHGDQGUHILQHGVRWKDWLW
FDQEHDQVZHUHGZLWKSUHFLVLRQ
,IZHWDNHDJDLQWKHH[DPSOHRIWKHUHODWLRQVKLSEHWZHHQSRVWPHQRSDXVDOKRUPRQH
UHSODFHPHQWWKHUDS\DQGVXEVHTXHQWGHYHORSPHQWRIHQGRPHWULDOFDUFLQRPDWKHUHVHDUFK
TXHVWLRQZLOOEH'RHVSRVWPHQRSDXVDOKRUPRQHUHSODFHPHQWWKHUDS\SUHGLVSRVH
ZRPHQWRGHYHORSHQGRPHWULDOFDQFHU"
)RUWKHSXUSRVHRIWKHUHVHDUFKGHVLJQWKHTXHVWLRQQHHGVWREHEHWWHUGHILQHG
7KHKRUPRQHUHSODFHPHQWWKHUDS\VKRXOGEHVSHFLILFDOO\VWDWHG,VLWRHVWURJHQDORQHRU
RHVWURJHQLQFRPELQDWLRQZLWKDSURJHVWDJHQ"'RHVWKHGXUDWLRQRIWKHUDS\QHHGWREH
GHILQHGDVIRUH[DPSOHPRUHWKDQRQH\HDU"6KRXOGWKHGLDJQRVLVRIHQGRPHWULDOFDQFHU
EHVSHFLILHGDVKLVWRORJLFDOO\FRQILUPHG"
)RUWKHSXUSRVHRIWKHUHVHDUFKGHVLJQWKHTXHVWLRQDOVRQHHGVWREHUHILQHG7KH
UHVHDUFKZLOORQO\EHDEOHWRGHWHUPLQHLIWKHUHLVDQDVVRFLDWLRQRUQRW7KHUHILQHG
TXHVWLRQ VKRXOG WKHUHIRUH EH ,V SRVWPHQRSDXVDO KRUPRQH UHSODFHPHQW WKHUDS\
DVGHILQHGDVVRFLDWHGZLWKDVXEVHTXHQWLQFUHDVHGULVNRIHQGRPHWULDOFDQFHU"7KH
DVVRFLDWLRQLIIRXQGZLOOQHHGDQH[SODQDWLRQEXWFDQQRWEHWDNHQDVPHDQLQJFDXVDWLRQ
ZLWKRXWIXUWKHUTXHVWLRQLQJ
,IZHWDNHDQRWKHUH[DPSOHIRUDUHVHDUFKTXHVWLRQ³,VSDVVLYHVPRNLQJKDUPIXOWR
WKHIRHWXV"´WKHTXHVWLRQQHHGVWREHEHWWHUGHILQHGDQGDOVRUHILQHG
7KHILUVWGHILQLWLRQLVDERXWSDVVLYHVPRNLQJ:KDWDUELWUDU\GHILQLWLRQVKRXOG
EHDFFHSWHGLQWHUPVRIQXPEHURIFLJDUHWWHVVPRNHGHYHU\GD\"7KLVLVFDOOHGDQ
RSHUDWLRQDOGHILQLWLRQ7KHRSHUDWLRQDOGHILQLWLRQLVDVWDWHPHQWRIKRZWKHUHVHDUFKHUVLQ
DSDUWLFXODUVWXG\FKRRVHWRPHDVXUHWKHYDULDEOHLQTXHVWLRQ,WVKRXOGEHXQDPELJLRXV
DQGKDYHRQO\RQHSRVVLEOHLQWHUSUHWDWLRQ$QRWKHUGHILQLWLRQWKDWQHHGVWREHPDGHLV
DERXWHIIHFWRQWKHIRHWXV&RXOGLWEHGHILQHGDVHIIHFWRQLQWUDXWHULQHJURZWKUHWDUGDWLRQ
ELRSK\VLFDOSURILOHDVGHWHUPLQHGE\XOWUDVRXQGH[DPLQDWLRQORZELUWKZHLJKWRUWKH
FRQGLWLRQDWELUWK$SJDUVFRUHIRUH[DPSOH"&KRLFHRIDQ\RIWKHVHRXWFRPHVZLOODIIHFW
WKHVL]HRIWKHVDPSOHWREHVWXGLHG,WZLOODOVRQHHGFRQWUROIRURWKHUYDULDEOHVZKLFK
ZLOOKDYHWREHH[FOXGHG
$IWHUFRQVLGHULQJWKHVHGHILQLWLRQVWKHUHLVDQHHGWRUHILQHWKHUHVHDUFKTXHVWLRQWR
EHIRUH[DPSOH³$UHWKHFKLOGUHQERUQWRZRPHQZKRVHKXVEDQGVVPRNHPRUHWKDQ
FLJDUHWWHVDGD\RIORZHUELUWKZHLJKWWKDQFKLOGUHQERUQWRZRPHQZKRVHKXVEDQGVGR
QRWVPRNH´"7KLVUHVHDUFKTXHVWLRQLVQRZVXLWDEOHWRWXUQLQWRDVSHFLILFK\SRWKHVLVWKDW
FDQSURYLGHDJRRGEDVLVIRUWKHGHYHORSPHQWRIDQDSSURSULDWHGHVLJQDQGFDOFXODWLRQ
RIWKHVDPSOHVL]HQHHGHG
4.5 Generating the research hypothesis

,IWKHUHVHDUFKTXHVWLRQLVFRQFHUQHGZLWKUHODWLRQVKLSVEHWZHHQREVHUYDWLRQVRU
YDULDEOHVDUHVHDUFKK\SRWKHVLVZLOOQHHGWREHGHYHORSHG7KHUHVHDUFKK\SRWKHVLVLVD
WHQWDWLYHVWDWHPHQWWKDWFDQEHWHVWHGE\DVFLHQWLILFUHVHDUFKGHVLJQ8VLQJWKHSUHYLRXV
WZRH[DPSOHVWKHUHVHDUFKK\SRWKHVHVFRXOGEHDVIROORZV
3RVWPHQRSDXVDOZRPHQZKRUHFHLYHGKRUPRQHUHSODFHPHQWWKHUDS\RIDVSHFLILHG
W\SHDQGGXUDWLRQDUHPRUHOLNHO\WRGHYHORSHQGRPHWULDOFDQFHUWKDQSRVWPHQRSDXVDO
ZRPHQZKRGLGQRWUHFHLYHVXFKWKHUDS\
&KLOGUHQERUQWRZRPHQZKRVHKXVEDQGVVPRNHPRUHWKDQFLJDUHWWHVDGD\DUH
RIORZHUELUWKZHLJKWWKDQFKLOGUHQERUQWRZRPHQZKRVHKXVEDQGVGRQRWVPRNH
4.6 Study sample

4.6.1 Target population and accessible population
$QLPSRUWDQWLVVXHLQWKHGHVLJQRIWKHUHVHDUFKLVWKHTXHVWLRQRIVDPSOLQJ,GHDOO\
WKHVWXG\GHVLJQVKRXOGLQFOXGHDOOWKHWDUJHWSRSXODWLRQ7KHWHUPSRSXODWLRQLQVFLHQWLILF
PHWKRGRORJ\UHIHUVWRWKHPDWHULDORIWKHVWXG\ZKHWKHULWLVKXPDQVXEMHFWVDQLPDOVRU
LQDQLPDWHREMHFWV,QFOXGLQJDOOWKHWDUJHWSRSXODWLRQLVJHQHUDOO\QRWSRVVLEOHEHFDXVH
RIWKHODUJHQXPEHUVWKHFRVWDQGWKHWLPH$VXEVHWRIWKHSRSXODWLRQLVVWXGLHGLQVWHDG
IURPZKLFKFRQFOXVLRQVRULQIHUHQFHVDUHGUDZQDVDSSO\LQJWRWKHWDUJHWSRSXODWLRQ
7KHVDPSOHKDVWREHVHOHFWHGWREHDVUHSUHVHQWDWLYHDVSRVVLEOHRIWKHWDUJHWSRSXODWLRQ
DQGLQHQRXJKQXPEHUVWRSURYLGHYDOLGDQVZHUV
7KHSRSXODWLRQFHQVXVLVDQH[DPSOHRIDVWXG\LQZKLFKDOOPHPEHUVRIWKH
SRSXODWLRQDUHVWXGLHG(YHQLQDVPDOOFRXQWU\LWLVDYHU\PDMRUXQGHUWDNLQJ%HFDXVH
RILWVH[SHQVHLWLVQRUPDOO\FDUULHGRXWHYHU\\HDUVRUVR,WQRUPDOO\WDNHVVHYHUDO
\HDUVWRDQDO\VHWKHUHVXOWV6RPHFRXQWULHVGRDQLQWHUYDOFHQVXVEDVHGRQVXEVHWVRI
WKHSRSXODWLRQLQEHWZHHQ
$QLOOXVWUDWLYHH[DPSOHRIVDPSOLQJIURPDQRWKHUILHOGLVWKDWRISROOVEHIRUH
SDUOLDPHQWDU\RUSUHVLGHQWLDOHOHFWLRQVZKHUHVSHFLDOL]HGDJHQFLHVPDNHSUHGLFWLRQV
EDVHGRQDUHODWLYHO\VPDOOVDPSOHUHSUHVHQWDWLYHRIWKHSRSXODWLRQ6LQFHRSLQLRQV
RIYRWHUVYDU\ZLWKWLPHEHIRUHWKHHOHFWLRQWKHVHVDPSOLQJVDUHFRPPRQO\GRQH
SHULRGLFDOO\2QWKHGD\RIWKHHOHFWLRQVDPSOHVRIH[LWSROOVDUHRIWHQDFFXUDWHLQ
SUHGLFWLQJWKHRXWFRPHRIWKHHOHFWLRQ
,QVWHDGRIWKH³WDUJHWSRSXODWLRQ´WKHLQYHVWLJDWRURIWHQGHSHQGVRQWKH³DFFHVVLEOH
SRSXODWLRQ´7KHDFFHVVLEOHSRSXODWLRQPXVWEHUHSUHVHQWDWLYHRIWKHWDUJHWSRSXODWLRQ
LQRUGHUWRGUDZFRQFOXVLRQVDERXWWKHWDUJHWSRSXODWLRQ,IZHWDNHWKHDERYHH[DPSOHRI
YRWHURSLQLRQVDSROOLQJDJHQF\PD\XVHWKHWHOHSKRQHERRNDVWKHDFFHVVLEOHSRSXODWLRQ
IURPZKLFKWKHVDPSOHLVGUDZQ7KLVZLOOEHDFFHSWDEOHLQDFRXQWU\ZKHUHSUDFWLFDOO\DOO
SHRSOHKDYHWHOHSKRQHV,WZLOOQRWKRZHYHUEHUHSUHVHQWDWLYHLQDFRXQWU\ZKHUHDODUJH
VHJPHQWRIWKHSRWHQWLDOYRWHUVDUHQRWUHDFKDEOHE\WHOHSKRQH7KLVGRHVQRWQHFHVVDULO\
PHDQWKDWWKHSROOLQJVKRXOGQRWKDYHEHHQGRQHLQWKLVZD\7KHUHVXOWKRZHYHUVKRXOG
EHSUHVHQWHGDVUHIOHFWLQJWKHRSLQLRQRIDVHJPHQWRIWKHWDUJHWSRSXODWLRQZKRDUH
DFFHVVLEOHE\SKRQHDQGQRWQHFHVVDULO\UHSUHVHQWLQJWKHZKROHWDUJHWSRSXODWLRQ
,QKHDOWKUHVHDUFKWKHFOLQLFRUKRVSLWDOPD\SURYLGHWKHDFFHVVLEOHSRSXODWLRQ
7KLVKRZHYHUGRHVQRWQHFHVVDULO\UHSUHVHQWWKHFRPPXQLW\LIQRWHYHU\RQHJRHVWRWKH
FOLQLFRUKRVSLWDOIRUWKHFRQGLWLRQLQTXHVWLRQ7KLVGRHVQRWPHDQWKDWFOLQLFRUKRVSLWDO
VWXGLHVVKRXOGQRWEHGRQH7KH\SURYLGHXVHIXOLQIRUPDWLRQEXWWKHUHVXOWVVKRXOGQRW
EHSUHVHQWHGDVUHIOHFWLQJWKHUHVXOWVIRUDOOSHRSOHZKRKDYHWKHFRQGLWLRQ
4.6.2 Types of sampling

7KHVDPSOHVHOHFWHGIURPWKHDFFHVVLEOHSRSXODWLRQVKRXOGEHUHSUHVHQWDWLYHRIWKH
DFFHVVLEOHSRSXODWLRQ,WVKRXOGDFFXUDWHO\UHIOHFWWKHFKDUDFWHULVWLFVRIWKHSRSXODWLRQ
IURPZKLFKLWLVGUDZQ,WVKRXOGEHDPLQLDWXUL]HGUHSUHVHQWDWLRQRIWKHDFFHVVLEOH
SRSXODWLRQ
5DQGRPVDPSOLQJLVQRWKDSKD]DUGVDPSOLQJ,WLVVDPSOLQJGRQHLQDV\VWHPDWLF
ZD\WRHQVXUHDVIDUDVSRVVLEOHFRPSOHWHREMHFWLYLW\LQWKHVHOHFWLRQRIWKHVDPSOH
5DQGRPVDPSOLQJLVDZD\RIHQVXULQJWKDWDOOPHPEHUVRIWKHSRSXODWLRQKDYHDQHTXDO
FKDQFHRIEHLQJVHOHFWHG,WGRHVQRWJXDUDQWHHWKDWWKHVDPSOHZLOOQRWEHGLIIHUHQWLQ
FKDUDFWHULVWLFVIURPWKHDFFHVVLEOHSRSXODWLRQ5DWKHULWHOLPLQDWHVDSRVVLEOHUHDVRQ
WKDWWKH\VKRXOGEHGLIIHUHQW
$VGLVFXVVHGLQVHFWLRQUDQGRPDVVLJQPHQWLVLPSRUWDQWZKHQWZRLQWHUYHQWLRQV
RU PRUH DUH FRPSDUHG ,W PLQLPL]HV JURXS GLIIHUHQFHV GXH WR ELDVHG VHOHFWLRQ
5DQGRPL]DWLRQZDVFRPPRQO\GRQHPDQXDOO\XVLQJDWDEOHRIUDQGRPQXPEHUV1RZ
LWLVXVXDOO\GRQHXVLQJDFRPSXWHUSURJUDP
6WUDWLILHGUDQGRPVDPSOLQJLVDVSHFLDOW\SHRIVDPSOLQJWRHQVXUHWKDWDOOVXEJURXSV
LQWKHDFFHVVLEOHSRSXODWLRQDUHUHSUHVHQWHGLQWKHVDPSOH7KLVLVSDUWLFXODUO\LPSRUWDQW
LIFHUWDLQVXEJURXSVDUHSUHVHQWLQVPDOOQXPEHUVLQWKHSRSXODWLRQRUDUHLPSRUWDQW
WREHLQFOXGHG,QVWUDWLILHGUDQGRPVDPSOLQJNH\VXEJURXSVDUHGHILQHGIRUH[DPSOH
E\VH[VRFLDOFODVVLQFRPHJURXSVJHRJUDSKLFORFDWLRQVHWFDQGVDPSOHVDUHGUDZQ
DWUDQGRPIURPHDFKRIWKHVH³VWUDWD´7KHFRPSXWHUSURJUDPFDQEHDGMXVWHGWRGUDZ
GLVSURSRUWLRQDWHO\IURPRQHRUPRUHJURXSVWRHQVXUHWKHLUDGHTXDWHUHSUHVHQWDWLRQ
&OXVWHUVDPSOLQJLVDQRWKHUZD\RIUDQGRPVDPSOLQJ,WLVEDVHGILUVWRQWKHUDQGRP
VHOHFWLRQRIFHUWDLQVXEJURXSVIURPZKLFKWKHVDPSOHFDQEHWDNHQ)RUH[DPSOHLQD
FRPPXQLW\VXUYH\FHUWDLQVWUHHWVRUEORFNVDUHVHOHFWHGDWUDQGRPILUVW7KHQDUDQGRP
VDPSOHLVVHOHFWHGIURPHDFKUDQGRPO\VHOHFWHGFOXVWHU,QDKHDOWKVHUYLFHVVWXG\D
QXPEHURIGLVWULFWVDUHUDQGRPO\VHOHFWHG7KHQDUDQGRPVDPSOHRIKHDOWKVHUYLFHXQLWV
LVVHOHFWHGIURPHDFK
6\VWHPDWLFVDPSOLQJLVGRQHE\DVLPSOHSHULRGLFSURFHVVIRUH[DPSOHVHOHFWLQJ
HYHU\VHFRQGRUWKLUGSDWLHQW
&RQVHFXWLYHVDPSOLQJLQYROYHVWDNLQJHYHU\VXEMHFWZKRSUHVHQWVKHUVHOIKLPVHOI
RYHUDVSHFLILHGWLPHSHULRG7KHVHDUHQRWVWULFWO\UDQGRPWHFKQLTXHVEXWWKH\DYRLG
ELDVLQWKHVHOHFWLRQ
4.7 Sample size

7KHGHVLUHGVDPSOHVL]HLVQRZHDVLO\FDOFXODWHGZLWKWKHKHOSRIFRPSXWHUVWDWLVWLFDO
SURJUDPVEXWWKHSULQFLSOHVXQGHUO\LQJWKHFDOFXODWLRQDQGWKHOLPLWDWLRQVPXVWEH
FOHDUO\XQGHUVWRRGE\LQYHVWLJDWRUV
,WLVQRWQHFHVVDULO\WUXHWKDWWKHELJJHUWKHVDPSOHWKHEHWWHUWKHVWXG\%H\RQGD
FHUWDLQSRLQWDQLQFUHDVHLQVDPSOHVL]HZLOOQRWLPSURYHWKHVWXG\,QIDFWLWPD\GR
WKHRSSRVLWHLIWKHTXDOLW\RIWKHPHDVXUHPHQWRUGDWDFROOHFWLRQLVDGYHUVHO\DIIHFWHG
E\WKHODUJHVL]HRIWKHVWXG\,WLVDOVREHWWHUWRHQVXUHWKDWWKHVDPSOHLVUHSUHVHQWDWLYH
UDWKHUWKDQEHLQJYHU\ODUJH
7KHVWDWLVWLFDOFRQFHSWEHKLQGFDOFXODWLRQRIWKHGHVLUHGVDPSOHVL]HLVVLPSOH:KHQ
ZHVWXG\DUHSUHVHQWDWLYHVDPSOHZHDLPWRJHQHUDOL]HIURPWKHVDPSOHILQGLQJVWRWKH
SRSXODWLRQIURPZKLFKWKHVDPSOHZDVGUDZQ:HFDQQRWEHFRPSOHWHO\FHUWDLQDERXW
WKLV8QOHVVZHVWXG\WKHZKROHSRSXODWLRQWKHVDPSOLQJHUURUFDQQRWEHEURXJKWGRZQ
WR]HUR$QDO\WLFDOVWDWLVWLFVKHOSVXVWRGHILQHWKHGHJUHHRISUREDELOLW\WKDWDILQGLQJD
GLIIHUHQFHRUDUHODWLRQVKLSFDQEHJHQHUDOL]HGWRWKHSRSXODWLRQIURPZKLFKWKHVDPSOH
LVGUDZQ7KLVLVFDOOHGWKHVWDWLVWLFDOVLJQLILFDQFHRIWKHILQGLQJ7KHVL]HRIWKHVDPSOH
LVDQHVVHQWLDOHOHPHQWLQPDNLQJWKLVVWDWLVWLFDOSUREDELOLW\FDOFXODWLRQ7KHVPDOOHUWKH
VL]HRIWKHVDPSOHWKHOHVVOLNHO\WKDWWKHILQGLQJVFDQEHJHQHUDOL]HG)RUFDOFXODWLQJ
WKHGHVLUHGVDPSOHVL]HEHIRUHEHJLQQLQJWKHVWXG\ZHGRWKHH[HUFLVHLQUHYHUVH:H
GHFLGHEHIRUHKDQGRQDOHYHORISUREDELOLW\RUXQFHUWDLQW\WKDWZHDUHZLOOLQJWRDFFHSW
IRUWKHVWXG\DQGWKHQZHILQGWKHGHVLUHGVDPSOHVL]HWRSURYLGHWKDWOHYHORIVWDWLVWLFDO
SUREDELOLW\7UDGLWLRQDOO\PRVWVWXGLHVVHWWKLVOHYHORIVWDWLVWLFDOVLJQLILFDQFHDWWKDW
LVDFFHSWLQJDFKDQFHRIRIILQGLQJDQDVVRFLDWLRQWKDWLVQRWDFWXDOO\WKHUH,WPXVWEH
UHFRJQL]HGKRZHYHUWKDWWKLVYDOXHLVDUELWUDU\DQGRWKHUYDOXHVFDQDQGDUHVRPHWLPHV
XVHG,QJHQHUDOWKHLQYHVWLJDWRUVKRXOGDLPIRUDORZHUSUREDELOLW\RIHUURUZKHQLWLV
SDUWLFXODUO\LPSRUWDQWWRDYRLGPDNLQJDIDOVHSRVLWLYHVWDWHPHQWDERXWDILQGLQJ
:KHQWKHVWXG\LVGHVLJQHGWRILQGDGLIIHUHQFHRUDQDVVRFLDWLRQZHPD\QRWILQGD
GLIIHUHQFHRUDQDVVRFLDWLRQ,QWKLVFDVHZHVWLOOZDQWWRFDOFXODWHVWDWLVWLFDOSUREDELOLW\
WKDWZHPD\KDYHPLVVHGDGLIIHUHQFHRUDQDVVRFLDWLRQWKDWH[LVWVLQWKHSRSXODWLRQEXW
ZDVQRWIRXQGLQWKHVDPSOH7KLVVRFDOOHGVWDWLVWLFDOSRZHURIWKHVWXG\GHSHQGVDOVR
RQWKHVL]HRIWKHVDPSOH7KHODUJHUWKHVL]HRIWKHVDPSOHWKHKLJKHUWKHSRZHURIWKH
VWXG\)RUFDOFXODWLQJWKHVDPSOHVL]HEHIRUHWKHVWXG\EHJLQVWKHLQYHVWLJDWRUVKDYHWR
PDNHDGHFLVLRQRQWKHOHYHORIVWDWLVWLFDOSRZHUWKH\DUHZLOOLQJWRDFFHSWIRUWKHVWXG\
7UDGLWLRQDOO\PRVWVWXGLHVVHWVWDWLVWLFDOSRZHUDWZKLFKLVDFFHSWLQJDFKDQFH
RIPLVVLQJDGLIIHUHQFHRUDQDVVRFLDWLRQWKDWLVDFWXDOO\WKHUH,WPXVWEHUHFRJQL]HG
KRZHYHUWKDWWKLVYDOXHLVDUELWUDU\DQGRWKHUYDOXHVFDQDQGDUHVRPHWLPHVXVHG,Q
JHQHUDOWKHLQYHVWLJDWRUVKRXOGDLPDWDKLJKHUVWDWLVWLFDOSRZHUZKHQLWLVSDUWLFXODUO\
LPSRUWDQWWRDYRLGIDOVHQHJDWLYHHUURU
$OWKRXJKDVWDWLVWLFLDQPD\GRWKHQHFHVVDU\H[HUFLVHWRGHWHUPLQHWKHVDPSOH
VL]HVKHFDQRQO\GRLWZLWKJXLGDQFHIURPWKHLQYHVWLJDWRURQWKHOHYHORIXQFHUWDLQW\
WKDWLVFRQVLGHUHGDFFHSWDEOH,QDGGLWLRQFDOFXODWLRQRIWKHVWDWLVWLFDOVLJQLILFDQFHDQG
VWDWLVWLFDOSRZHUKDVWRWDNHLQWRFRQVLGHUDWLRQVRPHFKDUDFWHULVWLFVRIWKHGDWD7KHVH
FKDUDFWHULVWLFVZLOOWKXVDOVREHQHHGHGIRUFDOFXODWLQJWKHVDPSOHVL]H6LQFHWKHGDWD
DUHQRWDYDLODEOHEHIRUHWKHVWXG\EHJLQVWKHLQYHVWLJDWRUVZLOOKDYHWRPDNHVRPH
DVVXPSWLRQVDERXWWKHGDWDDQGSURYLGHWKHVHDVVXPSWLRQVWRWKHVWDWLVWLFLDQWREHDEOH
WRFDOFXODWHWKHGHVLUHGVDPSOHVL]H7KHSURFHGXUHIRUHVWLPDWLQJVDPSOHVL]HLVQRWDV
SUHFLVHDVLQYHVWLJDWRUVPD\EHOHGWRWKLQN2QHVXFKDVVXPSWLRQLVDERXWWKHSUHYDOHQFH
LQFLGHQFHRUIUHTXHQF\RIWKHFRQGLWLRQRUHYHQW,IWKHUDWHRIWKHHYHQWLVODUJHVWDWLVWLFDO
SRZHUZLOOEHKLJKZLWKDVPDOOHUQXPEHURIFDVHV,IWKHHYHQWLVUDUHDODUJHUVDPSOH
VL]HZLOOEHQHHGHG$OVRWKHODUJHUWKHYDULDWLRQLQWKHGDWDWKHODUJHUWKHVDPSOHVL]H
WKDWZLOOEHQHHGHGWRDFKLHYHDFHUWDLQOHYHORIVWDWLVWLFDOVLJQLILFDQFH)RUVDPSOHVL]H
WREHFDOFXODWHGZHWKXVQHHGWRPDNHDSULRUHVWLPDWHRIWKHIUHTXHQF\RIWKHFRQGLWLRQ
XQGHUVWXG\DQGWKHGHJUHHRIYDULDWLRQVLQWKHGDWD6RPHLQIRUPDWLRQPD\EHDYDLODEOH
IURPSUHYLRXVVWXGLHVWRJXLGHWKHHVWLPDWHV,IQRWLWLVXSWRWKHLQYHVWLJDWRUVWRFRPH
XSZLWKDWHQWDWLYHHVWLPDWHZKLFKWKHVWDWLVWLFLDQFDQXVH
7KHHIIHFWVL]HLQDVWXG\UHIHUVWRWKHDFWXDOVL]HRIWKHGLIIHUHQFHVREVHUYHGEHWZHHQ
JURXSVRUWKHVWUHQJWKRIUHODWLRQVKLSVEHWZHHQYDULDEOHV7KHOLNHOLKRRGWKDWDVWXG\ZLOO
EHDEOHWRGHWHFWDQDVVRFLDWLRQEHWZHHQDSUHGLFWRUDQGDQRXWFRPHYDULDEOHGHSHQGVRQ
WKHPDJQLWXGHRIWKHDVVRFLDWLRQZHGHFLGHWRORRNIRU/DUJHVDPSOHVL]HVDUHQHHGHG
WRGHWHFWVPDOOGLIIHUHQFHV7KHFKRLFHRIHIIHFWVL]HLVGLIILFXOWDQGDUELWUDU\EXWLWPXVW
EHVHWEHIRUHKDQGDQGPXVWPDNHDPHDQLQJIXOGLIIHUHQFH7KHUXOHLVWKDWWKHVPDOOHU
WKHGLIIHUHQFH\RXZLVKWRGHWHFWWKHODUJHUWKHVDPSOHVL]HQHHGVWREH,QGHVLJQLQJD
VWXG\WKHLQYHVWLJDWRUFKRRVHVWKHVL]HRIHIIHFWWKDWLVFRQVLGHUHGLPSRUWDQW
,QPDNLQJWKHILQDOHVWLPDWLRQRIWKHVDPSOHVL]HIDFWRUVVXFKDVGURSRXWVDWWULWLRQ
DQGORVVWRIROORZXSVKRXOGDOVREHDFFRXQWHGIRU,IWKHFDOFXODWHGVDPSOHVL]HSURYHV
WREHODUJHUWKDQFDQEHSUDFWLFDOO\REWDLQHGWKHLQYHVWLJDWRUVKDYHDQXPEHURIRSWLRQV
WRLQFUHDVHWKHHIIHFWVL]HWKH\ORRNIRUWRGHFUHDVHWKHSRZHURIWKHVWXG\WRPRGLI\
WKHGHVLJQRUWRJLYHXSWKHVWXG\
4.8 Measurement
$QLPSRUWDQWTXHVWLRQLQWKHUHVHDUFKGHVLJQLVWKHGHFLVLRQRQKRZPHDVXUHPHQWV
DUHPDGHWRHQVXUHUHOLDELOLW\DQGYDOLGLW\5HOLDELOLW\PHDQVWKDWWKHREVHUYHUUHSHDWLQJ
WKHWHVWRUVRPHRQHHOVHXVLQJWKHVDPHPHWKRGVKRXOGEHDEOHWRREWDLQWKHVDPH
ILQGLQJV9DOLGLW\PHDQVWKDWWKHPHDVXUHPHQWVKRXOGDFWXDOO\UHSUHVHQWZKDWLWLV
LQWHQGHGWRPHDVXUH
7RHQVXUHUHOLDELOLW\RUUHSURGXFLELOLW\RIWKHUHVXOWVWKHIROORZLQJVKRXOGEH
FRQVLGHUHG
0HDVXUHPHQWVPDGHVKRXOGQRWYDU\E\REVHUYHURUEHWZHHQREVHUYHUVLQWUDDQG
LQWHUREVHUYHUFRQVLVWHQF\
,QVWUXPHQWRUODERUDWRU\YDULDELOLW\VKRXOGEHWDNHQLQWRFRQVLGHUDWLRQ
6XEMHFW YDULDELOLW\ VKRXOG EH FRQVLGHUHG LI PHDVXUHPHQWV YDU\ DFFRUGLQJ WR WKH
WLPHWKH\DUHPDGHIRUH[DPSOHIDVWLQJRUDIWHUPHDOWLPHRIWKHGD\RUGD\RIWKH
PHQVWUXDOF\FOH
,QWUDREVHUYHU DQG LQWHUREVHUYHU RU UDWHU UHOLDELOLW\ DUH LPSRUWDQW LVVXHV LQ
PHDVXUHPHQW,QDVWXG\WRGRFXPHQWWKHPELRSV\VOLGHVZLWKVXVSHFWHG+RGJNLQV
GLVHDVHZHUHSUHVHQWHGWRWKUHHSDWKRORJLVWVRYHUDQPRQWKSHULRG&RSSOHVRQHWDO
7KHVSHFLPHQVZHUHXQODEHOOHGDQGRYHUWKH\HDURIWKHVWXG\ZHUHSUHVHQWHG
RQWZRRFFDVLRQVWRHDFKRIWKHWKUHHREVHUYHUV7KHWKUHHREVHUYHUVGLVDJUHHGZLWK
WKHPVHOYHV RQ VHYHQ HLJKW DQG QLQH RFFDVLRQV RXW RI WKH 2YHUDOO LQWHUUDWHU
DJUHHPHQWZDVFDOFXODWHGDWRUDFFRUGLQJWRWKHSDUWLFXODUGLDJQRVWLFIHDWXUH
GHVFULEHG
2EWDLQLQJWKHVDPHUHVXOWE\WKHVDPHDQGGLIIHUHQWUDWHUVHQVXUHVUHOLDELOLW\DQG
UHSURGXFLELOLW\EXWGRHVQRWPHDQYDOLGLW\7KHWHVWLWVHOIPD\QRWEHDFFXUDWHLQ
PHDVXULQJZKDWLWLVLQWHQGHGWRPHDVXUH7KLVLVSDUWLFXODUO\DSSDUHQWLQGLDJQRVWLFWHVWV
DVZLOOEHGLVFXVVHGLQPRUHGHWDLOLQ&KDSWHU7KHWHVWPD\EHVHQVLWLYHLQGHWHFWLQJ
SHRSOHZLWKWKHGLVHDVHEXWQRWYHU\VSHFLILFLQH[FOXGLQJSHRSOHZLWKRXWWKHFRQGLWLRQ
RUYLFHYHUVD7RWHVWIRUYDOLGLW\RIWKHPHDVXUHPHQWLWKDVWREHFRPSDUHGWRD³JROG
VWDQGDUG´,IIRUH[DPSOHZHDUHXVLQJDGLDJQRVWLFWHVWDVDQLQGLFDWRURIEUHDVWFDQFHU
LWVKRXOGEHFRPSDUHGWRWKHJROGVWDQGDUGRIDEUHDVWELRSV\
4.9 Planning qualitative research

7KHDERYHVHFWLRQVGHDOWZLWKSODQQLQJTXDQWLWDWLYHUHVHDUFK4XDOLWDWLYHUHVHDUFK
QHHGVRWKHUDSSURDFKHV8OLQHWDO
2QHZD\WRNHHSWKHGHVLJQIRFXVHGRQWKHUHVHDUFKSUREOHPLVWRGHYHORSD
FRQFHSWXDOIUDPHZRUN$FRQFHSWXDOIUDPHZRUNLVDVHWRIUHODWHGLGHDVEHKLQGWKH
UHVHDUFKGHVLJQ$FRQFHSWXDOIUDPHZRUNKHOSVWRRXWOLQHWKHUHVHDUFKTXHVWLRQVDQG
SURYLGHVDFRQWH[WIRUXQGHUVWDQGLQJWKHUHVHDUFK
7KUHHPDLQPHWKRGVDUHFRPPRQO\XVHGLQTXDOLWDWLYHUHVHDUFKREVHUYDWLRQLQ
GHSWKLQWHUYLHZVDQGJURXSGLVFXVVLRQ7KHLQYHVWLJDWRUKDVWRVHOHFWZKLFKPHWKRG
ZRXOGEHPRUHDSSURSULDWHWRDQVZHUWKHUHVHDUFKTXHVWLRQRUPD\XVHPRUHWKDQRQH
PHWKRG7KHUHVHDUFKHULQWKHVHGLIIHUHQWGHVLJQVSOD\VWKHUROHRIREVHUYHULQWHUYLHZHU
RUJURXSPRGHUDWRU
Observation
'HSHQGLQJRQWKHREMHFWLYHRIWKHVWXG\REVHUYDWLRQFDQEHPDGHIURPDQRXWVLGHU
RULQVLGHUSHUVSHFWLYHRUVRPHZKHUHLQEHWZHHQ2XWVLGHUREVHUYHUVPDLQWDLQDGLVWDQFH
,QVLGHUREVHUYHUVLQWHUDFW
$VDQH[DPSOHRIDQRXWVLGHUREVHUYDWLRQVWXG\WKHLQYHVWLJDWRUPD\REVHUYHWKH
TXDOLW\RIKHDOWKFDUHGHOLYHU\LQDFOLQLFKHDOWKFHQWUHRUDSKDUPDF\$VSHFLDOW\SHRI
REVHUYDWLRQVWXG\FDOOHG³WLPHDQGPRWLRQVWXG\´LVXVHGWRVWXG\KRZKHDOWKZRUNHUV
XVHWKHLUWLPH7KHUHVHDUFKHUREVHUYHVZKDWDKHDOWKZRUNHULVGRLQJRYHUDGHILQHG
VDPSOHRIWLPH6KHPD\XVHDEHHSHUWKDWJRHVRIIHYHU\QXPEHURIPLQXWHVDQGD
FKHFNOLVWWRUHFRUGDFWLYLWLHV
$VSHFLDOIRUPRIREVHUYDWLRQLVWKHVRFDOOHG³P\VWHU\FOLHQW´WHFKQLTXH,WLVXVHG
SDUWLFXODUO\LQFOLHQW±SURYLGHUVWXGLHVZKHUHWKHSUHVHQFHRIDQRXWVLGHREVHUYHUPLJKW
FKDQJHWKHSURYLGHU¶VFXVWRPDU\EHKDYLRXU7UDLQHGGDWDFROOHFWRUVSUHVHQWDVVLPXODWHG
FOLHQWV7KHGHFHSWLYHQDWXUHRIWKLVWHFKQLTXHUDLVHVHWKLFDOFRQFHUQV7KHGHFLVLRQWR
XVHWKHWHFKQLTXHVKRXOGEHPDGHRQO\DIWHUFDUHIXOUHIOHFWLRQRQWKHHWKLFDOLPSOLFDWLRQV
,QIRUPHGFRQVHQWPD\EHREWDLQHGIURPWKHKHDOWKVHUYLFHWRXVHWKHWHFKQLTXHDW
XQDQQRXQFHGWLPHVRYHUDSHULRGRIWLPHIRUH[DPSOHVHYHUDOPRQWKV
,QSDUWLFLSDQWREVHUYDWLRQWKHLQYHVWLJDWRULQWHUDFWV6KHPD\IRUH[DPSOHDVN
FOLHQWVDERXWWKHLUSHUFHSWLRQVRIWKHKHDOWKVHUYLFH
In-depth interviews
,QWHQVLYHRQHRQRQHLQWHUYLHZLQJLVDFODVVLFDOPHWKRGLQTXDOLWDWLYHUHVHDUFK
'LIIHUHQWIURPTXDQWLWDWLYHVWXGLHVEDVHGRQDVWUXFWXUHGTXHVWLRQQDLUHWKHLQGHSWK
LQWHUYLHZLVPRUHRIDVRFLDOHQFRXQWHUZLWKTXHVWLRQVIORZLQJIURPWKHDQVZHURIWKH
UHVSRQGHQWDVDIROORZXSWRWKHDQVZHURUWRSUREHIXUWKHULQWRWKHDQVZHU2SHQHQGHG
TXHVWLRQLQJLVDEDVLFWRROLQTXDOLWDWLYHUHVHDUFK7KHLQWHUYLHZPD\WDNHWKHIRUP
RIDQLQIRUPDOFRQYHUVDWLRQZLWKOLWWOHRUQRSUHSDUDWLRQDQGVHTXHQFLQJRITXHVWLRQV
$OWHUQDWLYHO\DWRSLFJXLGHRURXWOLQHPD\EHXVHGWRKHOSLQIRFXVLQJWKHLQWHUYLHZEXW
ZLWKRXWSUHVWUXFWXULQJWKHTXHVWLRQV$SUHGHWHUPLQHGVHWRIRSHQHQGHGTXHVWLRQVLV
KRZHYHUWKHPRVWVWDQGDUGL]HGDSSURDFKIRULQGHSWKLQWHUYLHZV
Focus groups
)RFXVJURXSGLVFXVVLRQVDUHWKHPHWKRGXVHGZKHQLQIRUPDWLRQDQGLQVLJKWVZLOO
EHEHWWHUJDLQHGIURPWKHLQWHUDFWLRQRIDJURXSWKDQIURPLQGHSWKLQWHUYLHZVZLWK
LQGLYLGXDOV7KHWZRPHWKRGVPD\FRPSOHPHQWHDFKRWKHU$IRFXVJURXSGLVFXVVLRQLV
QRWDJURXSLQWHUYLHZ,WLVEDVHGRQWKHH[FKDQJHRILQIRUPDWLRQLGHDVDQGYLHZVDPRQJ
WKHSDUWLFLSDQWVWKHPVHOYHV7KHUHVHDUFKHULVSOD\LQJWKHUROHRIDPRGHUDWRUDQGQRW
DQLQWHUYLHZHU,QUHFHQW\HDUVIRFXVJURXSPHWKRGRORJ\KDVEHHQLQFUHDVLQJO\XVHG
&HUWDLQJXLGHOLQHVQHHGWREHREVHUYHG
7KHJURXSVKRXOGEHUHODWLYHO\KRPRJHQHRXVIRUH[DPSOHLQDJHDQGVH[DQG
VRFLRFXOWXUDOEDFNJURXQG$QRQ\PLW\DPRQJSDUWLFLSDQWVPD\EHGHVLUDEOHLISHRSOH
IHHOPRUHFRPIRUWDEOHWRWDONIUHHO\ZLWKVWUDQJHUVWKDQZLWKSHRSOHWKH\NQRZDQGZLOO
PHHWDJDLQ
)RUPRVWSXUSRVHVJURXSVRIHLJKWWRWHQSDUWLFLSDQWVDUHDGHTXDWHIRUDJRRGDQG
PDQDJHDEOHGLVFXVVLRQ$VWRWKHQXPEHURIJURXSVLWLVJHQHUDOO\DGYLVHGWRKDYHDWOHDVW
WZRJURXSVIRUHDFKGHILQLQJGHPRJUDSKLFYDULDEOH,IIRUH[DPSOHVH[LVWKHYDULDEOH
WZRZRPHQDQGWZRPHQJURXSVZLOOEHQHHGHG
$WZRKRXUGLVFXVVLRQLVOLNHO\WRJHQHUDWHWRSDJHVRIWUDQVFULSW7KH
UROHRIWKHPRGHUDWRULVWRFUHDWHDFRPIRUWDEOHFOLPDWHIRURSHQH[FKDQJHVWLPXODWH
GLVFXVVLRQNHHSWKHGLVFXVVLRQIRFXVHGDQGHQFRXUDJHHYHU\RQHWRSDUWLFLSDWH7KH
PRGHUDWRUVKRXOGQRWDOORZRQHRUWZRYRFDOLQGLYLGXDOVWRGRPLQDWHWKHGLVFXVVLRQ
7KHUDSSRUWHXURUQRWHWDNHUVKRXOGEHUHFRUGLQJZKDWSHRSOHVD\EXWVKRXOGDOVREH
DZDUHRIERG\ODQJXDJH
4.10 A note on questionnaire design

$ TXHVWLRQQDLUH LV D GRFXPHQW GHVLJQHG IRU WKH SXUSRVH RI VHHNLQJ VSHFLILF
LQIRUPDWLRQIURPWKHUHVSRQGHQWV
7KHTXHVWLRQQDLUHPD\EHVHOIDGPLQLVWHUHGRUDGPLQLVWHUHGE\LQWHUYLHZHUV7KH
VHOIDGPLQLVWHUHGTXHVWLRQQDLUHDSSURDFKLVFKHDSOHVVVXVFHSWLEOHWRLQWHUYLHZHUELDV
DQGFDQEHDGPLQLVWHUHGE\PDLO$WWKHVDPHWLPHWKHUDWHRIQRQUHVSRQVHPD\EHKLJK
DQGPD\ELDVWKHUHVXOWV$OVRDQVZHUVPD\EHLQFRPSOHWH
7KHUHDUHWZRPDMRUTXHVWLRQIRUPDWVWKHRSHQHQGHGDQGFORVHGUHVSRQVHW\SHV
,QDFORVHGUHVSRQVHTXHVWLRQWKHUHVSRQGHQWLVSURYLGHGZLWKDOLVWRISUHGHWHUPLQHG
UHVSRQVHRSWLRQV2SHQHQGHGTXHVWLRQVHOLFLWPRUHGHWDLOHGUHVSRQVHVEXWWKHUHVSRQVHV
UHTXLUHPRUHHIIRUWWRHQFRGHIRUGDWDDQDO\VLV$TXHVWLRQQDLUHPD\LQFOXGHERWK
TXHVWLRQIRUPDWV
&ORVHGUHVSRQVHTXHVWLRQVPD\EHXVHGWRHOLFLWDWWLWXGHVRIWKHUHVSRQGHQWVWRD
FHUWDLQVWDWHPHQW7ZRIRUPDWVFDQEHFKRVHQ3ROJDUDQG7KRPDV,QWKH/LNHUW
W\SHIRUPDWWKHUHVSRQGHQWFKRRVHVIURPDPRQJVWURQJO\DJUHHDJUHHXQGHFLGHG
GLVDJUHHVWURQJO\GLVDJUHH,QWKHIRUFHGFKRLFHIRUPDWUHVSRQVHVDUHOLPLWHGWR
VWURQJO\DJUHHDJUHHGLVDJUHHDQGVWURQJO\GLVDJUHH7KLVIRUPDWGRHVQRWDOORZDQ
XQGHFLGHGDQVZHU
4XHVWLRQVVKRXOGEHZHOOZRUGHGWRDYRLGDQ\DPELJXLW\-DUJRQVKRXOGQRWEHXVHG
4XHVWLRQVVKRXOGQRWEHSKUDVHGLQDZD\WKDWLQIOXHQFHVWKHUHVSRQVHLQRQHGLUHFWLRQRU
DQRWKHU7KHTXHVWLRQQDLUHVKRXOGDOZD\VEHSUHWHVWHGLQDSLORWVWXG\EHIRUHWKHPDLQ
VXUYH\,QWHUYLHZHUVVKRXOGEHWUDLQHGWRPDNHVXUHWKDWWKHTXHVWLRQQDLUHLVDGPLQLVWHUHG
LQDXQLIRUPZD\
$TXHVWLRQQDLUHW\SLFDOO\LQFOXGHVWKHIROORZLQJFRPSRQHQWV
DQLQWURGXFWRU\VWDWHPHQWE\WKHLQWHUYLHZHUWRLQWURGXFHKHUVHOIKLPVHOIDQGH[SODLQ
WKHSXUSRVHRIWKHTXHVWLRQQDLUHWKHUHVSRQGHQWVVKRXOGDOVREHLQIRUPHGDERXWWKH
FRQILGHQWLDOLW\RIWKHLUUHVSRQVHV
GHPRJUDSKLFTXHVWLRQVWRFROOHFWUHOHYDQWLQIRUPDWLRQDERXWWKHEDFNJURXQGRIWKH
UHVSRQGHQW
IDFWXDOTXHVWLRQV
RSLQLRQTXHVWLRQVRSLQLRQTXHVWLRQVUHTXLUHUHIOHFWLRQLWLVJHQHUDOO\HDVLHUIRUWKH
UHVSRQGHQWWRDQVZHUIDFWXDOTXHVWLRQVSXWWLQJWKHIDFWXDOTXHVWLRQVILUVWVHUYHVDV
D³ZDUPXS´WRWKHRSLQLRQTXHVWLRQV
FORVLQJVWDWHPHQWE\WKHLQWHUYLHZHUWRWKDQNWKHUHVSRQGHQWVDQGZKHUHDSSURSULDWH
WRDVNLIVKHZDQWVWRSURYLGHDQ\DGGLWLRQDOFRPPHQW
$PHWKRGFRPPRQO\XVHGWRWHVWIRUUHOLDELOLW\LQUHVXOWVREWDLQHGE\TXHVWLRQQDLUHV
LVWRORRNIRULQWHUQDOFRQVLVWHQF\WKDWLVWKHH[WHQWWRZKLFKWKHUHVSRQVHVRQGLIIHUHQW
TXHVWLRQVFRUUHODWHZLWKHDFKRWKHU,IWKH\WHQGWREHKLJKO\FRUUHODWHGZLWKHDFKRWKHU
WKHQWKHWHVWLVVDLGWREHLQWHUQDOO\FRQVLVWHQW7KHFRPSXWHUSURJUDPPHFDQEHEXLOWXS
WRGHWHFWLQFRQVLVWHQF\
7KHUHLVDWHQGHQF\DPRQJLQYHVWLJDWRUVWRSXWWRRPDQ\TXHVWLRQV7KLVKDVEHHQ
HQFRXUDJHGE\WKHLQWURGXFWLRQRIFRPSXWHUDVVLVWHGDQDO\VLV,QIRUPDWLRQFROOHFWHGLQD
TXHVWLRQQDLUHVKRXOGEHEDVHGRQDQGOLPLWHGWRWKHREMHFWLYHVRIWKHVWXG\
4.11 A note on research in health economics

$OOPHWKRGVRIHFRQRPLFHYDOXDWLRQLQKHDOWKFDUHKDYHRQHSULQFLSOHLQFRPPRQ
WKH\H[DPLQHRQHRUPRUHSRVVLEOHLQWHUYHQWLRQVDQGFRPSDUHWKHFRVWVRILQSXWVRU
UHVRXUFHVQHFHVVDU\WRFDUU\RXWVXFKLQWHUYHQWLRQVZLWKWKHLUHIIHFWVRUHFRQRPLFDOO\
DVVHVVHGEHQHILWV-HIIHUVRQHWDO
,QHFRQRPLFHYDOXDWLRQWKHFRVWRIDQLOOQHVVJHQHUDOO\LQFOXGHV
GLUHFWFRVWVZKLFKDUHFRVWVERUQHE\WKHKHDOWKFDUHV\VWHPFRPPXQLW\DQGSDWLHQWV¶
IDPLOLHVLQDGGUHVVLQJWKHLOOQHVVIRUH[DPSOHGLDJQRVLVRUWUHDWPHQWFRVWV
LQGLUHFWFRVWVZKLFKPD\EHWDQJLEOHRULQWDQJLEOHLQGLUHFWWDQJLEOHFRVWVDUHPDLQO\
SURGXFWLYLW\ORVVHVFDXVHGE\WKHGLVHDVHFRQGLWLRQDQGERUQHE\WKHLQGLYLGXDO
IDPLO\VRFLHW\RUE\WKHHPSOR\HULQGLUHFWLQWDQJLEOHFRVWVLQFOXGHWKHFRVWVRI
SDLQJULHIDQGVXIIHULQJDQGWKHORVVRIOHLVXUHWLPH
,QHFRQRPLFHYDOXDWLRQUHVRXUFHVDUHHVWLPDWHGDVDOOLQSXWVLQWRKHDOWKVHUYLFH
SURGXFWLRQLQFOXGLQJWLPHJRRGVHTXLSPHQWEXLOGLQJVVSHFLDOL]HGNQRZOHGJHHWF
&RVWEHQHILWDQDO\VLVDQGFRVWHIIHFWLYHQHVVDQDO\VLVDUHUHODWHGDQDO\WLFDOPHWKRGV
WKDWFRPSDUHKHDOWKFDUHSUDFWLFHVRUWHFKQLTXHVLQWHUPVRIWKHLUUHODWLYHHFRQRPLF
HIILFLHQFLHVLQSURYLGLQJKHDOWKEHQHILWV,QDFRVWHIIHFWLYHQHVVDQDO\VLVWKHQHWPRQHWDU\
FRVWVRIDKHDOWKFDUHLQWHUYHQWLRQDUHFRPSDUHGZLWKVRPHPHDVXUHRIFOLQLFDORXWFRPHRU
HIIHFWLYHQHVVVXFKDVFDVHVRIGLVHDVHDYRLGHGFDVHVLGHQWLILHGLQVFUHHQLQJSURFHGXUHV
OLIH\HDUVJDLQHGRUGHDWKVDYRLGHG&RVWEHQHILWDQDO\VLVFRPSDUHVPRQHWDU\FRVWVWR
HVWLPDWHGPRQHWDU\EHQHILWVRIDQLQWHUYHQWLRQ
&RVWHIIHFWLYHQHVVDQDO\VLVLVIUHTXHQWO\QHVWHGZLWKLQDUDQGRPL]HGFRQWUROOHGWULDO
,WLVSDUWLFXODUO\YDOXDEOHZKHQWKHFRPSDUHGLQWHUYHQWLRQVKDYHZLGHO\GLIIHULQJFRVWVRU
UHVRXUFHFRQVHTXHQFHV&RPSHWLQJLQWHUYHQWLRQVLQWKHWULDOPD\VKRZOLWWOHGLIIHUHQFH
LQRXWFRPH7KHDGGLWLRQRIWKHHFRQRPLFSHUVSHFWLYHRIIHUVDIXUWKHUGLPHQVLRQRI
HYDOXDWLRQ3URVSHFWLYHHFRQRPLFGDWDFROOHFWLRQDORQJVLGHDWULDODOORZVWKHHYDOXDWLRQ
WREHEDVHGRQUHOLDEOHHVWLPDWHVRIHIIHFWLYHQHVV
4.12 Ethics in research design

4.12.1 Categories of health research
)URP DQ HWKLFDO VWDQGSRLQW IRXU FDWHJRULHV RI KHDOWK UHVHDUFK FDQ EH
GLVWLQJXLVKHG
5HVHDUFKLQYROYLQJKXPDQH[SHULPHQWDWLRQ7KLVLVWKHUHVHDUFKFDWHJRU\WKDWUDLVHV
PRVWHWKLFDOFRQFHUQV8QGHUWKLVFDWHJRU\WZRW\SHVRIPHGLFDOUHVHDUFKFDQEH
GLVWLQJXLVKHGDUHVHDUFKRIWKHUDSHXWLFRUGLDJQRVWLFQDWXUHWKDWLVFDUULHGRXWRQ
SDWLHQWVZKRPD\H[SHFWDSRWHQWLDOEHQHILWIURPWKHLUSDUWLFLSDWLRQDQGEUHVHDUFK
RIDSXUHO\VFLHQWLILFQDWXUHIRUZKLFKKXPDQVXEMHFWVYROXQWHHUWRDGYDQFHPHGLFDO
VFLHQFHEXWZLOOQRWGUDZDQ\WKHUDSHXWLFRUGLDJQRVWLFEHQHILW(WKLFDOVDIHJXDUGV
DUHPRVWQHHGHGLQWKLVFDWHJRU\
5HVHDUFKLQYROYLQJKXPDQVXEMHFWVEXWQRWH[SHULPHQWDWLRQ(SLGHPLRORJLFDODQG
ILHOGVWXGLHVDVZHOODVTXDOLWDWLYHUHVHDUFKIDOOXQGHUWKLVFDWHJRU\$OWKRXJKQR
H[SHULPHQWDWLRQLVLQYROYHGVXFKVWXGLHVFDQEHLQWUXVLYHRQWKHLQGLYLGXDO¶VSULYDF\
DQGHYHQRQFRPPXQLWLHV
5HVHDUFKLQYROYLQJH[SHULPHQWDWLRQRQDQLPDOV(WKLFVLQWKLVFDWHJRU\KDVEHHQ
UHFHLYLQJLQFUHDVLQJDWWHQWLRQUHFHQWO\
5HVHDUFKQRWLQYROYLQJKXPDQVXEMHFWVRUDQLPDOH[SHULPHQWDWLRQ7KLVFDWHJRU\
RIUHVHDUFKZRXOGVWLOOEHERXQGE\HWKLFDOSULQFLSOHVWKDWFRYHUUHVHDUFKLQJHQHUDO
PHGLFDODQGQRQPHGLFDO
4.12.2 Ethics in research design involving experimentation

on human subjects
$OOUHVHDUFKLQYROYLQJKXPDQVXEMHFWVVKRXOGEHFRQGXFWHGLQDFFRUGDQFHZLWKWKH
HWKLFDOSULQFLSOHVFRQWDLQHGLQWKHFXUUHQWYHUVLRQRIWKH:RUOG0HGLFDO$VVRFLDWLRQ
'HFODUDWLRQRI+HOVLQNL$QQH[$OOLQGLYLGXDOVLQYROYHGLQWKHFRQGXFWRIDQ\FOLQLFDO
WULDOPXVWEHIXOO\LQIRUPHGRIDQGFRPSO\ZLWKHWKLFDOSULQFLSOHVLQFOXGLQJEHQHILFHQFH
QRQPDOHILFHQFHDQGUHVSHFW
7KHSULQFLSOHRIEHQHILFHQFHLPSOLHVWKDW
DVFLHQWLILFDQGWHFKQLFDOO\VRXQGGHVLJQLVDQHWKLFDOUHTXLUHPHQWDGHVLJQWKDW
ZLOOQRWSURYLGHWKHDQVZHUWRWKHUHVHDUFKTXHVWLRQLVHWKLFDOO\XQDFFHSWDEOHDVWKH
SDWLHQWVZLOOEHVXEMHFWHGWRDQXQQHFHVVDU\SURFHVV
WKHVDPSOHVL]HLVDGHTXDWHWRSURYLGHVWDWLVWLFDOO\YDOLGUHVXOWVEXWLVQRWODUJHUWKDQ
LVQHFHVVDU\WRSURYLGHWKHDQVZHUV
7KHSULQFLSOHRIQRQPDOHILFHQFHLPSOLHVWKDW
DQ\SRWHQWLDOULVNVDUHSURSHUO\HYDOXDWHGDQGEDODQFHGZLWKSRWHQWLDOEHQHILWVDUH
PLQLPL]HGLQHYHU\ZD\SRVVLEOHLQFOXGLQJDGHTXDWHVFUHHQLQJIRUFRQWUDLQGLFDWLRQV
DQGDUHFDUHIXOO\PRQLWRUHG
ZKHUHDGYHUVHHIIHFWVDUHHQFRXQWHUHGDGHTXDWHWUHDWPHQWLVSURYLGHG
7KHSULQFLSOHRIUHVSHFWLPSOLHVWKDW
SDUWLFLSDQWV DUH IXOO\ LQIRUPHG DQG JLYH WKHLU IUHH FRQVHQW WR SDUWLFLSDWH LQ WKH
WULDO
UHVHDUFKWULDOVRQFKLOGUHQDQGSHUVRQVZLWKPHQWDOGLVDELOLW\DUHOLPLWHGWRGLVHDVH
FRQGLWLRQVVSHFLILFWRWKHPDQGWKHLQIRUPHGFRQVHQWRISDUHQWVRUDJXDUGLDQLV
REWDLQHG
FRQILGHQWLDOLW\LVDGKHUHGWR
&RQILGHQWLDOLW\LVDQHWKLFDOREOLJDWLRQLQWKHSUDFWLFHRIPHGLFLQH6LQFHLQUHVHDUFK
LQIRUPDWLRQLVOLNHO\WREHKDQGOHGE\RWKHUSHRSOHLQYROYHGLQWKHUHVHDUFKVWHSVVKRXOG
EHWDNHQWRHQVXUHWKHFRQILGHQWLDOLW\RIWKHUHFRUGVHLWKHUE\OLPLWLQJDFFHVVRUE\
UHSODFLQJSDWLHQWLGHQWLILFDWLRQZLWKFRGHQXPEHUV
$QXPEHURIHWKLFDOFRQVLGHUDWLRQVDSSO\ZKHQDQHZWKHUDS\LVEHLQJWHVWHGRQ
SDWLHQWVDFFRUGLQJWRWKHSULQFLSOHRI³GRQRKDUP´RUQRQPDOHILFHQFH
3UHFOLQLFDOVWXGLHVWKDWSURYLGHVXIILFLHQWGRFXPHQWDWLRQRIWKHSRWHQWLDOVDIHW\RI
WKHSKDUPDFHXWLFDOSURGXFWVKRXOGEHDYDLODEOH
,QIRUPDWLRQDERXWPDQXIDFWXULQJSURFHGXUHVVKRXOGHVWDEOLVKWKDWWKHSURGXFWLVRI
VXLWDEOHTXDOLW\
7KH GDWD DYDLODEOH VKRXOG EH DSSURSULDWH WR WKH SKDVH VL]H DQG GXUDWLRQ RI WKH
WULDO
'DWDIURPSUHYLRXVDQGRQJRLQJFOLQLFDOWULDOVVKRXOGEHFRPSLOHGEHIRUHWKHWULDO
7KHLQYHVWLJDWRUVVKRXOGEHZHOOTXDOLILHGDQGWKHWULDOVLWHDGHTXDWH
$OOSDUWLHVLQYROYHGLQDFOLQLFDOWULDOVKRXOGFRPSO\IXOO\ZLWKWKHH[LVWLQJQDWLRQDO
UHJXODWLRQVRUUHTXLUHPHQWV
4.12.3 Epidemiological, field and qualitative studies

7KLVUHVHDUFKLVEDVHGPRVWO\RQREVHUYDWLRQDQGJHQHUDOO\UHTXLUHVQRLQWHUYHQWLRQ
PRUHLQYDVLYHWKDQDVNLQJTXHVWLRQVDQGFDUU\LQJRXWURXWLQHPHGLFDOH[DPLQDWLRQVDQG
VRPHWLPHVODERUDWRU\WHVWVRU;UD\H[DPLQDWLRQV6XFKVWXGLHVGRQRWFDUU\SK\VLFDO
ULVNVIRUWKHUHVHDUFKVXEMHFWV+RZHYHUWKH\FDQEHLQWUXVLYH3V\FKRVRFLDOKDUP
PD\EHDVRUPRUHPHDQLQJIXOWRWKHSHUVRQWKDQSK\VLFDOKDUP(WKLFDOFRQVLGHUDWLRQV
LQFOXGHIUHHLQIRUPHGFRQVHQWFRQILGHQWLDOLW\DQGEHQHILFHQFH
7KHSULQFLSOHRIIUHHLQIRUPHGFRQVHQWLPSOLHVWKDWLQGLYLGXDOVXEMHFWVVKRXOG
XQGHUVWDQGDQGDJUHHWRWKHUHDVRQVIRUFROOHFWLQJWKHLQIRUPDWLRQ,QODUJHFRPPXQLW\
VXUYH\VWKHFRPPXQLW\PXVWDOVRDJUHHWRWKHVWXG\
7KHSULQFLSOHRIFRQILGHQWLDOLW\LPSOLHVWKDWLQIRUPDWLRQJDWKHULQJLQTXDOLWDWLYH
UHVHDUFKLVEDVHGRQPXWXDOWUXVW7KLVWUXVWZLOOEHVHULRXVO\EUHDFKHGE\DQ\SRVVLELOLW\
RIEUHDNRIFRQILGHQWLDOLW\,QIRUPDWLRQFROOHFWHGDERXWVXEMHFWVLQILHOGVWXGLHVLV
JHQHUDOO\FODVVLILHGDVOLQNHGRUXQOLQNHG&,2068QOLQNHGLQIRUPDWLRQLV
LQIRUPDWLRQZKLFKFDQQRWEHOLQNHGDVVRFLDWHGRUFRQQHFWHGZLWKWKHSHUVRQWRZKRPLW
UHIHUV&RQILGHQWLDOLW\KHUHLVQRWDWVWDNH/LQNHGLQIRUPDWLRQPD\VWLOOEHDQRQ\PRXV
LILWLVOLQNHGWRWKHSHUVRQE\DFRGHRURWKHUPHDQVDQGWKHLQYHVWLJDWRUFDQQRWNQRZ
WKHLGHQWLW\RIWKHSHUVRQ,QRWKHUFDVHVVWULFWDGKHUHQFHWRFRQILGHQWLDOLW\VKRXOGEH
PDLQWDLQHG
7KHSULQFLSOHRIEHQHILFHQFHLPSOLHVWKDW
7KHLQGLYLGXDOKDVDULJKWWREHLQIRUPHGRIDQ\KHDOWKFRQGLWLRQUHYHDOHGGXULQJ
WKHVWXG\DQGVKRXOGEHKHOSHGWRJHWWKHDSSURSULDWHFDUH
7KHFRPPXQLW\KDVDULJKWWREHLQIRUPHGDERXWWKHRXWFRPHRIWKHVWXG\DQGDQ\
SRWHQWLDOLPSOLFDWLRQV
7KHLQYHVWLJDWRUVKDYHWKHHWKLFDOREOLJDWLRQWRSOD\DQDGYRFDF\UROHWRLPSURYH
WKHKHDOWKFRQGLWLRQRIWKHFRPPXQLW\EDVHGRQWKHUHVXOWVRIWKHVWXG\
/RFDOSHUVRQQHOVKRXOGEHXWLOL]HGDVIDUDVSRVVLEOHDQGWKH\VKRXOGEHWUDLQHG
LQWKHUHTXLUHGVNLOOV$QHWKLFDOO\FRQGXFWHGHSLGHPLRORJLFDORUILHOGVWXG\VKRXOG
OHDYH VRPHWKLQJ EHKLQG LQ WKH FRPPXQLW\ LQ ZKLFK LW ZDV FRQGXFWHG 6RFDOOHG
³VDIDULUHVHDUFK´VKRXOGEHGLVFRXUDJHG
4.12.4 Ethics in research designs involving experimentation

on animals
7KHDQLPDOPRGHOFKRVHQPXVWEHUHOHYDQWWRWKHKXPDQ7KHLQIRUPDWLRQPXVWEH
DSSOLFDEOHWRWKHKXPDQ
7KHPLQLPXPQXPEHURIDQLPDOVVKRXOGEHXVHG([SHULPHQWVVKRXOGEHGHVLJQHG
ZLWKSURSHUFDOFXODWLRQRIWKHVL]HRIWKHDQLPDOVDPSOHQHHGHGWRDQVZHUWKHUHVHDUFK
TXHVWLRQ RU WHVW WKH UHVHDUFK K\SRWKHVLV 1R PRUH WKDQ WKH PLQLPDO QXPEHU RI
DQLPDOVVKRXOGEHXVHGEXWDVXIILFLHQWQXPEHURIDQLPDOVVKRXOGEHXVHGWRSURYLGHD
VFLHQWLILFDOO\YDOLGFRQFOXVLRQ

Browner WS, et al. Getting ready to estimate sample size: hypotheses and underlying
principles. In: Hulley SB, Cummings SR, eds. Designing clinical research: an epidemiologic
approach, 2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 51–62.
Byrne DW. Publishing your medical research paper. Baltimore, Lippincott Williams &
Wilkins, 1998: 5–44.
Carey SS. A beginner’s guide to scientific method, 2nd edition. New York, Wadsworth
Publishing Company, 1998.
Coppleson L, Factor R, Strums S, Graff P, Rappaport H. Observer disagreement in the
classification and histology of Hodgkin’s disease. Journal of the National Cancer Institute,
1970, 45: 731–740.
International guidelines for ethical review of epidemiological studies. Geneva, Council for
International Organizations of Medical Sciences, 1991.
International guiding principles for biomedical research involving animals. Geneva, Council
for International Organizations of Medical Sciences, 1985.
Hulley SB, Martin JN, Cummings SR. Planning the measurements: precision and accuracy.
In: Hulley SB, Cummings SR. eds. Designing clinical research: an epidemiologic approach,
2nd edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 37–49.
Devers KJ, Sofaer S, Rundall TG, eds. Qualitative methods in health services research:
a special supplement to HSR. Health Services Research, 1999, 34 (5) Part II: 1083–
1263.
Doll R, Hill AB. Mortality in relation to smoking: ten years’ observation of British doctors.
British Medical Journal, 1964, 1:1399–1414; 1460–1467.
Doll R, Peto R. Mortality in relation to smoking: 20 years’ observation on British doctors.
Doll R, Peto R, Wheatley K et al. Mortality in relation to smoking: 40 years’ observations

on male British doctors. British Medical Journal, 1994, 309: 901–911.
Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet 2002,
359: 57–61.
Grimes DA, Schulz KF. Descriptive studies: what they can and cannot do. Lancet, 2002,
359: 145–49.
Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet,
2002, 359: 248–52.
Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet, 2002, 359:
341–45.
Jefferson T, Demicheli V, Mugford M. Elementary economic evaluation in health care, 2nd
edition. London, British Medical Journal Books, 2000.
Neame R, Kluge E-H. The impact of informatics. Computerisation and health care: some
worries behind the promises. British Medical Journal, 1999, 319:1295.
O’Brien PMS, Pipkin FB. eds. Introduction to research methodology for specialists and
trainees. London, Royal College of Obstetricians and Gynaecologists Press, 1999.
Polgar S, Thomas SA. Introduction to research in the health sciences, 4th edition. London,
New York, Churchill Livingstone, 2000: 62; 63; 107–114.
Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet, 2002, 359:
431–34.
Schulz KF, Grimes DA. Generation of allocation sequences in randomized trials: chance
not choice. Lancet, 2002, 359: 515–519.
Schulz KF, Grimes DA. Allocation concealment in randomized trials: defending against
deciphering. Lancet, 2002, 359: 614–618.
Schulz KF, Grimes DA. Blinding in randomized trials: hiding who got what. Lancet, 2002,
359: 696–700.
Schulz KF, Grimes DA. Sample size slippages in randomized trials: exclusions and the
lost and wayward. Lancet, 2002, 359: 781–85.
Schulz KF, Grimes DA. Unequal group sizes in randomized trials: guarding against
guessing. Lancet, 2002, 359: 966–70.
Swinscow TDV, Campbell MJ. Statistics at square one. 10th edition. London, BMJ Books,
2002.
Ulin PR, Robinson ET, Tolley EE, McNeill ET. Qualitative methods: A field guide for applied
research in sexual and reproductive health. North Carolina, Family Health International,
2002.
Varkevisser C, Pathmanathan I, Brownlee. Designing and conducting health systems

research projects.Volume 1: Proposal development and field work.Volume 2: Data analysis
and report writing. Ottawa, International Development Research Centre, 1995.
Wingo PA, Higgins JA, Rubin GL, Zahniser SC. An epidemiologic approach to reproductive
health. Geneva, World Health Organization, 1994 (WHO/HRP/EPI/1994).
Health research methodology. A guide for training in research methods. 2nd edition.
Manila, World Health Organization Regional Office for the Western Pacific, 2001.
Chapter 5
Writing the research protocol
5.1 Introduction
$IWHUSURSHUDQGFRPSOHWHSODQQLQJRIWKHVWXG\WKHSODQVKRXOGEHZULWWHQGRZQ
7KHSURWRFROLVWKHGHWDLOHGSODQRIWKHVWXG\(YHU\UHVHDUFKVWXG\VKRXOGKDYHD
SURWRFRODQGWKHSURWRFROVKRXOGEHZULWWHQ
7KHZULWWHQSURWRFRO
IRUFHVWKHLQYHVWLJDWRUVWRFODULI\WKHLUWKRXJKWVDQGWRWKLQNDERXWDOODVSHFWVRIWKH
VWXG\
LV D QHFHVVDU\ JXLGH LI D WHDP QRW D VLQJOH LQYHVWLJDWRU LV ZRUNLQJ RQ WKH
UHVHDUFK
LVHVVHQWLDOLIWKHVWXG\LQYROYHVUHVHDUFKRQKXPDQVXEMHFWVRULVRQH[SHULPHQWDO
DQLPDOVLQRUGHUWRJHWWKHLQVWLWXWLRQ¶VHWKLFDODSSURYDO
LVDQHVVHQWLDOFRPSRQHQWRIDUHVHDUFKSURSRVDOVXEPLWWHGIRUIXQGLQJ
'XULQJWKHSURFHVVRIWKHGHYHORSPHQWRIWKHSURWRFROLQYHVWLJDWRUVFDQDQGVKRXOG
WU\WREHQHILWIURPWKHDGYLFHRIFROOHDJXHVDQGH[SHUWVLQUHILQLQJWKHLUSODQV%XWRQFH
DSURWRFROIRUWKHVWXG\KDVEHHQGHYHORSHGDQGDSSURYHGDQGWKHVWXG\KDVVWDUWHGDQG
SURJUHVVHGLWVKRXOGEHDGKHUHGWRVWULFWO\DQGVKRXOGQRWEHFKDQJHG7KLVLVSDUWLFXODUO\
LPSRUWDQWLQPXOWLFHQWUHVWXGLHV9LRODWLRQVRIWKHSURWRFROFDQGLVFUHGLWWKHZKROH
VWXG\,IWKHYLRODWLRQVDUHPLQRUDWOHDVWWKDWSDUWRIWKHVWXG\VKRXOGEHH[FOXGHGIURP
WKHDQDO\VLV
$QDGGLWLRQDOVWHSDIWHUZULWLQJWKHSURWRFROSDUWLFXODUO\LQODUJHVWXGLHVZLWK
WHDPVRILQYHVWLJDWRUVLVWRGHYHORSZKDWPD\EHFDOOHGWKHRSHUDWLRQVPDQXDOIRUWKH
VWXG\7KLVZLOOLQFOXGHGHWDLOHGLQVWUXFWLRQWRWKHLQYHVWLJDWRUVWRDVVXUHDXQLIRUPDQG
VWDQGDUGL]HGDSSURDFKWRFDUU\LQJRXWWKHVWXG\ZLWKJRRGTXDOLW\FRQWURO
$ZHOOWKRXJKWRXWDQGZHOOZULWWHQSURWRFROFDQEHMXGJHGDFFRUGLQJWRWKUHHPDLQ
FULWHULD
,VLWDGHTXDWHWRDQVZHUWKHUHVHDUFKTXHVWLRQVDQGDFKLHYHWKHVWXG\REMHFWLYH"
,VLWIHDVLEOHLQWKHSDUWLFXODUVHWXSIRUWKHVWXG\"
'RHVLWSURYLGHHQRXJKGHWDLOWKDWFDQDOORZDQRWKHULQYHVWLJDWRUWRGRWKHVWXG\DQG
DUULYHDWFRPSDUDEOHFRQFOXVLRQV"
7KHSURWRFROVKRXOGRXWOLQHWKHUDWLRQDOHIRUWKHVWXG\LWVREMHFWLYHWKHPHWKRGRORJ\
XVHGDQGKRZWKHGDWDZLOOEHPDQDJHGDQGDQDO\VHG,WVKRXOGKLJKOLJKWKRZHWKLFDO
LVVXHVKDYHEHHQFRQVLGHUHGDQGZKHUHDSSURSULDWHKRZJHQGHULVVXHVDUHEHLQJ
DGGUHVVHG
5.2 Format for the protocol

7KHUHVHDUFKSURWRFROLVJHQHUDOO\ZULWWHQDFFRUGLQJWRWKHIROORZLQJIRUPDW
3URMHFWWLWOH
3URMHFWVXPPDU\
3URMHFWGHVFULSWLRQ
í 5DWLRQDOH
í 2EMHFWLYHV
í 0HWKRGRORJ\
í 'DWDPDQDJHPHQWDQGDQDO\VLV

(WKLFDOFRQVLGHUDWLRQV
*HQGHULVVXHV
5HIHUHQFHV
Project title
7KHWLWOHVKRXOGEHGHVFULSWLYHDQGFRQFLVH,WPD\QHHGWREHUHYLVHGDIWHUFRPSOHWLRQ
RIWKHZULWLQJRIWKHSURWRFROWRUHIOHFWPRUHFORVHO\WKHVHQVHRIWKHVWXG\
Project summary
7KHVXPPDU\VKRXOGEHFRQFLVHDQGVKRXOGVXPPDUL]HDOOWKHHOHPHQWVRIWKH
SURWRFRO,WVKRXOGVWDQGRQLWVRZQDQGQRWUHIHUWKHUHDGHUWRSRLQWVLQWKHSURMHFW
GHVFULSWLRQ
Project description
Rationale
7KLVLVHTXLYDOHQWWRWKHLQWURGXFWLRQLQDUHVHDUFKSDSHU,WSXWVWKHSURSRVDOLQ
FRQWH[W,WVKRXOGDQVZHUWKHTXHVWLRQRIZK\DQGZKDWZK\WKHUHVHDUFKQHHGVWREH
GRQHDQGZKDWZLOOEHLWVUHOHYDQFH$EULHIGHVFULSWLRQRIWKHPRVWUHOHYDQWVWXGLHV
SXEOLVKHGRQWKHVXEMHFWVKRXOGEHSURYLGHGWRVXSSRUWWKHUDWLRQDOHIRUWKHVWXG\
Writing the research protocol 67
Objective(s)
6SHFLILFREMHFWLYHVDUHVWDWHPHQWVRIWKHUHVHDUFKTXHVWLRQV2EMHFWLYHVVKRXOGEH
VLPSOHQRWFRPSOH[VSHFLILFQRWYDJXHDQGVWDWHGLQDGYDQFHQRWDIWHUWKHUHVHDUFKLV
GRQH$IWHUVWDWHPHQWRIWKHSULPDU\REMHFWLYHVHFRQGDU\REMHFWLYHVPD\EHPHQWLRQHG
<RXQJLQYHVWLJDWRUVDUHDGYLVHGWRUHVLVWWKHWHPSWDWLRQWRSXWWRRPDQ\REMHFWLYHVRU
RYHUDPELWLRXVREMHFWLYHVWKDWFDQQRWEHDGHTXDWHO\DFKLHYHGE\WKHLPSOHPHQWDWLRQRI
WKHSURWRFRO
Methodology
7KHPHWKRGRORJ\VHFWLRQKDVWREHWKRXJKWRXWFDUHIXOO\DQGZULWWHQLQIXOOGHWDLO,W
LVWKHPRVWLPSRUWDQWSDUWRIWKHSURWRFRO,WVKRXOGLQFOXGHLQIRUPDWLRQRQWKHUHVHDUFK
GHVLJQWKHUHVHDUFKVXEMHFWVLQWHUYHQWLRQVLQWURGXFHGREVHUYDWLRQVWREHPDGHDQG
VDPSOHVL]H
5HVHDUFKGHVLJQ7KHFKRLFHRIWKHGHVLJQVKRXOGEHH[SODLQHGLQUHODWLRQWRWKH
VWXG\REMHFWLYHV
5HVHDUFKVXEMHFWVRUSDUWLFLSDQWV'HSHQGLQJRQWKHW\SHRIWKHVWXG\WKHIROORZLQJ
TXHVWLRQVVKRXOGEHDQVZHUHG
± :KDWDUHWKHFULWHULDIRULQFOXVLRQRUVHOHFWLRQ"
± :KDWDUHWKHFULWHULDIRUH[FOXVLRQ"
± ,QLQWHUYHQWLRQVWXGLHVKRZZLOOVXEMHFWVEHDOORFDWHGWRLQGH[DQG
FRPSDULVRQJURXSV"
± :KDWDUHWKHFULWHULDIRUGLVFRQWLQXDWLRQ"
,QWHUYHQWLRQV,IDQLQWHUYHQWLRQLVLQWURGXFHGDGHVFULSWLRQPXVWEHJLYHQRIWKH
GUXJVRUGHYLFHVWREHXVHGDQGZKHWKHUWKH\DUHDOUHDG\FRPPHUFLDOO\DYDLODEOH
RU LQ SKDVHV RI H[SHULPHQWDWLRQ )RU GUXJV DQG GHYLFHV WKDW DUH FRPPHUFLDOO\
DYDLODEOHWKHSURWRFROPXVWVWDWHWKHLUSURSULHWDU\QDPHVPDQXIDFWXUHUFKHPLFDO
FRPSRVLWLRQGRVHDQGIUHTXHQF\RIDGPLQLVWUDWLRQ)RUGUXJVDQGGHYLFHVWKDWDUH
VWLOO LQ WKH H[SHULPHQWDO VWDJH RU WKDW DUH FRPPHUFLDOO\ DYDLODEOH EXW DUH EHLQJ
XVHGIRUDGLIIHUHQWLQGLFDWLRQRULQDGLIIHUHQWPRGHRIDGPLQLVWUDWLRQDGGLWLRQDO
LQIRUPDWLRQVKRXOGEHSURYLGHGRQDYDLODEOHSUHFOLQLFDOLQYHVWLJDWLRQVLQDQLPDOV
DQGRUUHVXOWVRIVWXGLHVDOUHDG\FRQGXFWHGRQKXPDQV,QVXFKFDVHVWKHDSSURYDORI
WKHGUXJUHJXODWRU\DJHQF\LQWKHFRXQWU\LVJHQHUDOO\QHHGHGEHIRUHLPSOHPHQWLQJ
WKHVWXG\
2EVHUYDWLRQV ,QIRUPDWLRQ VKRXOG EH SURYLGHG RQ WKH REVHUYDWLRQV WR EH PDGH
KRZWKH\ZLOOEHPDGHDQGKRZIUHTXHQWO\ZLOOWKH\EHPDGH,IWKHREVHUYDWLRQ
LVPDGHE\DTXHVWLRQQDLUHWKLVVKRXOGEHDSSHQGHGWRWKHSURWRFRO/DERUDWRU\RU
RWKHUGLDJQRVWLFDQGLQYHVWLJDWLYHSURFHGXUHVVKRXOGEHGHVFULEHG)RUHVWDEOLVKHG
SURFHGXUHVUHIHUHQFHWRDSSURSULDWHSXEOLVKHGZRUNLVHQRXJK)RUQHZRUPRGLILHG
SURFHGXUHVDQDGHTXDWHGHVFULSWLRQLVQHHGHGZLWKDMXVWLILFDWLRQIRUWKHLUXVH
6DPSOHVL]H7KHSURWRFROVKRXOGSURYLGHLQIRUPDWLRQDQGMXVWLILFDWLRQDERXWVDPSOH
VL]H$ODUJHUVDPSOHVL]HWKDQQHHGHGWRWHVWWKHUHVHDUFKK\SRWKHVLVLQFUHDVHVWKH
FRVWDQGGXUDWLRQRIWKHVWXG\DQGZLOOEHXQHWKLFDOLILWH[SRVHVKXPDQVXEMHFWVWR
DQ\SRWHQWLDOXQQHFHVVDU\ULVNZLWKRXWDGGLWLRQDOEHQHILW$VPDOOHUVDPSOHVL]HWKDQ
QHHGHGFDQDOVREHXQHWKLFDOLILWH[SRVHVKXPDQVXEMHFWVWRULVNZLWKQREHQHILW
WRVFLHQWLILFNQRZOHGJH7KHEDVLV RQ ZKLFK VDPSOH VL]H LV FDOFXODWHGVKRXOG EH
H[SODLQHGLQWKHPHWKRGRORJ\VHFWLRQRIWKHSURWRFRO&DOFXODWLRQRIVDPSOHVL]HKDV
EHHQPDGHHDV\E\FRPSXWHUVRIWZDUHSURJUDPV%XWWKHSULQFLSOHVXQGHUO\LQJWKH
HVWLPDWLRQVKRXOGEHZHOOXQGHUVWRRG7KHVHKDYHEHHQH[SODLQHGLQ&KDSWHU
Data management and analysis

7KHSURWRFROVKRXOGSURYLGHLQIRUPDWLRQRQKRZWKHGDWDZLOOEHPDQDJHGLQFOXGLQJ
GDWDFRGLQJIRUFRPSXWHUDQDO\VLVPRQLWRULQJDQGYHULILFDWLRQ,QIRUPDWLRQVKRXOG
DOVREHSURYLGHGRQWKHDYDLODEOHFRPSXWHUIDFLOLW\7KHVWDWLVWLFDOPHWKRGVXVHGIRUWKH
DQDO\VLVRIGDWDVKRXOGEHFOHDUO\RXWOLQHG
Ethical considerations
$VRXWOLQHGLQ&KDSWHUVHFWLRQHWKLFDOFRQVLGHUDWLRQVDSSO\WRDOOW\SHVRI
KHDOWKUHVHDUFK7KHVHLQFOXGHUHVHDUFKLQYROYLQJKXPDQH[SHULPHQWDWLRQZKHWKHUWKH
UHVHDUFKLVRIWKHUDSHXWLFRUGLDJQRVWLFQDWXUHWKDWLVFDUULHGRXWRQSDWLHQWVZKRPD\
H[SHFWDSRWHQWLDOEHQHILWIURPWKHLUSDUWLFLSDWLRQRULVRIDSXUHO\VFLHQWLILFQDWXUH
IRUZKLFKKXPDQVXEMHFWVYROXQWHHUWRDGYDQFHPHGLFDOVFLHQFHEXWZLOOQRWGUDZDQ\
WKHUDSHXWLFRUGLDJQRVWLFEHQHILW7KHUHDUHDOVRHWKLFDOFRQVLGHUDWLRQVIRUUHVHDUFK
LQYROYLQJKXPDQVXEMHFWVEXWQRWH[SHULPHQWDWLRQ(SLGHPLRORJLFDOILHOGDQGTXDOLWDWLYH
VWXGLHVIDOOXQGHUWKLVFDWHJRU\$OWKRXJKQRH[SHULPHQWDWLRQLVLQYROYHGVXFKVWXGLHV
FDQEHDVLQWUXVLYHRQWKHLQGLYLGXDO¶VSULYDF\DQGHYHQRQFRPPXQLWLHV7KHHWKLFVRI
UHVHDUFKLQYROYLQJH[SHULPHQWDWLRQRQDQLPDOVKDVEHHQUHFHLYLQJSURSHUDQGLQFUHDVLQJ
DWWHQWLRQUHFHQWO\
$OOUHVHDUFKSURWRFROVLQWKHELRPHGLFDOILHOGSDUWLFXODUO\LILWLQYROYHVKXPDQ
VXEMHFWVPXVWLQFOXGHDVHFWLRQDGGUHVVLQJHWKLFDOFRQVLGHUDWLRQV7KLVLQFOXGHVWZR
FRPSRQHQWV7KHILUVWLVDZULWWHQDSSURYDORIWKHDSSURSULDWHHWKLFVUHYLHZFRPPLWWHH
WRJHWKHUZLWKDZULWWHQIRUPIRULQIRUPHGFRQVHQWZKHUHDSSURSULDWH7KHVHFRQGLV
DVSHFLDOVHFWLRQSUHIHUDEO\LQWKHIRUPDWRIDFKHFNOLVWWRDGGUHVVDOOSRVVLEOHHWKLFDO
FRQFHUQV6LPSO\JHWWLQJWKHHWKLFDODSSURYDOLVQRWHQRXJK
Approval by ethics review committees

)RUVWXGLHVLQKXPDQVRULQYROYLQJKXPDQELRORJLFDOPDWHULDOVWKHSURWRFROPXVW
EHDSSURYHGE\WKHORFDOLQVWLWXWLRQDORUHTXLYDOHQWHWKLFVFRPPLWWHHDQGRUQDWLRQDO
HWKLFVFRPPLWWHH
)RUDQLPDOVWXGLHVDSSURYDOLVUHTXLUHGIURPWKHDQLPDOZHOIDUHFRPPLWWHHRIWKH
LQVWLWXWHRULWVHTXLYDOHQW,IQRVXFKFRPPLWWHHH[LVWVDVWDWHPHQWVLJQHGE\WKHSULQFLSDO
LQYHVWLJDWRUVVKRXOGLQGLFDWHWKDWWKHUHVHDUFKZLOOEHFDUULHGRXWLQDFFRUGDQFHZLWK
WKH ,QWHUQDWLRQDO *XLGLQJ 3ULQFLSOHV IRU %LRPHGLFDO 5HVHDUFK LQYROYLQJ$QLPDOV
VHH
Informed decision-making
$FRQVHQWIRUPZKHUHDSSURSULDWHPXVWEHGHYHORSHGDQGDWWDFKHGWRWKHSURWRFRO
,WVKRXOGEHZULWWHQLQWKHSURVSHFWLYHVXEMHFWV¶PRWKHUWRQJXH7KHFRQVHQWIRUPKDV
WZRSDUWVDDVWDWHPHQWGHVFULELQJWKHVWXG\DQGWKHQDWXUHRIWKHVXEMHFW¶VLQYROYHPHQW
LQLWDQGEDFHUWLILFDWHRIFRQVHQWDWWHVWLQJWRWKHVXEMHFW¶VFRQVHQW%RWKSDUWVVKRXOG
EHZULWWHQLQVLPSOHODQJXDJHVRWKDWWKHVXEMHFWFDQHDVLO\XQGHUVWDQGWKHFRQWHQWV$V
PXFKDVSRVVLEOHWKHXVHRIPHGLFDOWHUPLQRORJ\LQZULWLQJXSWKHFRQVHQWIRUPVKRXOG
EHDYRLGHG6SHFLDOFDUHLVQHHGHGZKHQVXEMHFWVDUHLOOLWHUDWH
7KHVWDWHPHQWVKRXOGDVDSSURSULDWHH[SODLQZK\WKHVWXG\LVEHLQJGRQHDQGZK\
WKHVXEMHFWKDVEHHQDVNHGWRSDUWLFLSDWH,WVKRXOGGHVFULEHLQVHTXHQFHZKDWZLOO
KDSSHQLQWKHFRXUVHRIWKHVWXG\JLYLQJHQRXJKGHWDLOIRUWKHVXEMHFWWRJDLQDFOHDU
LGHDRIZKDWWRH[SHFW,WVKRXOGFODULI\ZKHWKHURUQRWWKHVWXG\SURFHGXUHVRIIHUDQ\
EHQHILWVWRWKHVXEMHFWRUWRRWKHUVDQGH[SODLQWKHQDWXUHOLNHOLKRRGDQGWUHDWPHQWRI
DQWLFLSDWHGGLVFRPIRUWRUDGYHUVHHIIHFWVLQFOXGLQJSV\FKRORJLFDODQGVRFLDOULVNVLI
DQ\:KHUHUHOHYDQWWKHVWDWHPHQWVKRXOGLQFOXGHDFRPSDULVRQZLWKULVNVSRVHGE\
VWDQGDUGWUHDWPHQWVRUGUXJV,IWKHULVNVDUHXQNQRZQRUDFRPSDUDWLYHULVNFDQQRWEH
JLYHQLWVKRXOGEHVRVWDWHG)LQDOO\WKHVWDWHPHQWVKRXOGLQGLFDWHWKDWWKHVXEMHFWKDV
WKHULJKWWRZLWKGUDZIURPWKHVWXG\DWDQ\WLPHZLWKRXWLQDQ\ZD\DIIHFWLQJKHUKLV
IXUWKHUPHGLFDOFDUH
Ethics checklist
7KHSURWRFROPXVWGHVFULEHWKHPHDVXUHVWKDWZLOOEHXQGHUWDNHQWRHQVXUHWKDW
WKHSURSRVHGUHVHDUFKLVFDUULHGRXWLQDFFRUGDQFHZLWKWKH:RUOG0HGLFDO$VVRFLDWLRQ
'HFODUDWLRQRI+HOVLQNLRQ(WKLFDO3ULQFLSOHVIRU0HGLFDO5HVHDUFK,QYROYLQJ+XPDQ
6XEMHFWV$QQH[
$FKHFNOLVWPXVWDGGUHVVHWKLFDOFRQFHUQVWKDWFRXOGEHUDLVHGDERXWWKHPHWKRGRORJ\
LQFOXGLQJWKHUHVHDUFKGHVLJQVHOHFWLRQRIVXEMHFWVWKHLQWHUYHQWLRQVLQWURGXFHGDQGWKH
REVHUYDWLRQVWREHPDGH
,VWKHUHVHDUFKGHVLJQDGHTXDWHWRSURYLGHDQVZHUVWRWKHUHVHDUFKTXHVWLRQ",WLV
XQHWKLFDOWRH[SRVHVXEMHFWVWRUHVHDUFKWKDWZLOOKDYHQRYDOXH
,V WKH PHWKRG RI VHOHFWLRQ RI UHVHDUFK VXEMHFWV MXVWLILHG" 7KH XVH RI YXOQHUDEOH
VXEMHFWV DV UHVHDUFK SDUWLFLSDQWV QHHGV VSHFLDO MXVWLILFDWLRQ 9XOQHUDEOH VXEMHFWV
LQFOXGHWKRVHLQSULVRQPLQRUVDQGSHUVRQVZLWKPHQWDOGLVDEOLW\3DUWLFXODUO\LQ
LQWHUQDWLRQDOUHVHDUFKLWLVLPSRUWDQWWRHQVXUHWKDWWKHSRSXODWLRQLQZKLFKWKHVWXG\
LVFRQGXFWHGZLOOEHQHILWIURPDQ\SRWHQWLDORXWFRPHRIWKHUHVHDUFK7KH\VKRXOG
QRWEHGRLQJLWWRWKHEHQHILWRIDQRWKHUSRSXODWLRQ-XVWLILFDWLRQLVQHHGHGIRUDQ\
LQGXFHPHQWILQDQFLDORURWKHUZLVHIRUSDUWLFLSDQWVWREHHQUROOHGLQWKHVWXG\
$UHLQWHUYHQWLRQVMXVWLILHGLQWHUPVRIULVNVEHQHILWVUDWLR"5LVNVDUHQRWOLPLWHGWR
SK\VLFDOKDUP3V\FKRORJLFDODQGVRFLDOULVNVPXVWDOVREHFRQVLGHUHG
)RUREVHUYDWLRQVPDGHKDYHPHDVXUHVEHHQWDNHQWRHQVXUHFRQILGHQWLDOLW\"
Gender issues
,WZDVRQO\UHFHQWO\WKDWDWWHQWLRQZDVGUDZQWRWKHLPSRUWDQFHRIDGGUHVVLQJJHQGHU
LVVXHVLQUHVHDUFKSURWRFROV7KH&RPPLVVLRQRQWKH6WDWXVRI:RPHQPDGHWKHDERYH
VWDWHPHQW7KLVZDVLQUHVSRQVHWRVHYHUDODUHDVRIFRQFHUQ(QVXUHZKHUHLQGLFDWHG
WKDWFOLQLFDOWULDOVRISKDUPDFHXWLFDOVPHGLFDOGHYLFHVDQGRWKHUPHGLFDOSURGXFWV
LQFOXGHZRPHQZLWKWKHLUIXOONQRZOHGJHDQGFRQVHQWDQGHQVXUHWKDWWKHUHVXOWLQJGDWD
LVDQDO\VHGIRUVH[DQGJHQGHUGLIIHUHQFHV
:RPHQZHUHRIWHQH[FOXGHGIURPFOLQLFDOWULDOVRQGLVHDVHFRQGLWLRQVWKDWDIIHFW
ERWKPHQDQGZRPHQRQWKHEDVLVRIELRORJLFDOYDULDELOLW\DQGRUYXOQHUDELOLW\
%XWZRPHQZHUHJLYHQWKHVDPHGUXJVZKLFKKDGQRWEHHQWHVWHGRQWKHPDVPHQ
LIWKHGUXJVSURYHGVDIHDQGHIIHFWLYHIRUPHQ
'UXJVDQGGHYLFHVLQWHQGHGIRUXVHE\ZRPHQRQO\ZHUHVRPHWLPHVWHVWHGRQWKHP
ZLWKRXWWKHLUSURSHULQIRUPHGFRQVHQWSDUWLFXODUO\LQSRRUUHVRXUFHVHWWLQJV
:KHQZRPHQZHUHLQFOXGHGZLWKPHQDVUHVHDUFKVXEMHFWVJHQGHUZDVQRWDOZD\V
WDNHQLQWRFRQVLGHUDWLRQZKHQUHVXOWVZHUHDQDO\VHG
,WLVZHOONQRZQWKDWJHQHWLFDQGKRUPRQDOIDFWRUVPRGLI\WKHSUHYDOHQFHEHKDYLRXU
DQGWUHDWPHQWRIGLVHDVHVRIERG\V\VWHPVLQPHQDQGZRPHQ%XWZKDWLVOHVVNQRZQLV
WKDWFXOWXUDOO\HYROYHGJHQGHUUHODWHGGLIIHUHQFHVLQOLIHVW\OHEHKDYLRXUDUHDOVRSRZHUIXO
GHWHUPLQDQWVRIZRPHQ¶VKHDOWKDQGDFFRXQWIRUPDMRUGLIIHUHQFHVLQWKHGLVHDVHEXUGHQ
EHWZHHQPDOHVDQGIHPDOHVSUREDEO\PRUHWKDQJHQHWLFRUKRUPRQDOIDFWRUV%RWK
ELRORJLFDODQGJHQGHUUHODWHGGLIIHUHQFHVFDQLQIOXHQFHWKHRXWFRPHRIWKHUHVHDUFKIRU
PHQDQGZRPHQ
References
7KHSURWRFROVKRXOGHQGZLWKUHOHYDQWUHIHUHQFHVRQWKHVXEMHFW

Commission on the Status of Women Forty-third session. Revised draft agreed conclusions
on women and health submitted by the Chairperson of the Commission. New York, United
Nations Economic and Social Council, 1999 (E/CN.6/1999/L.2/Rev.1).
Fathalla MF. Gender matters in health research. In: International Conference on Health
Research for Development, Bangkok 10-13 October 2000. Conference report. Geneva,
Global Forum for Health Research, 2001: 105–108.
Kendall MJ and Hawkins C. Planning and protocol writing. In: Hawkins C, Sorgi M, eds.
Research: How to plan, speak and write about it. Berlin, Springer-Verlag, 1985: 12–28.
UNDP/UNFPA/WHO/World Bank Special Programme of Research, development
and research training in human reproduction. Preparing a research project proposal.
Guidelines and forms. 3rd edition. Geneva, World Health Organization, 2000 (WHO/
HRP/PP/2000).
Chapter 6
Submitting a research proposal
6.1 Introduction
$UHVHDUFKSURSRVDOLVDGRFXPHQWZULWWHQIRUWKHSXUSRVHRIREWDLQLQJIXQGLQJIRU
DUHVHDUFKSURMHFW5HVHDUFKHUVVKRXOGIDPLOLDUL]HWKHPVHOYHVZLWKWKHSRWHQWLDOVRXUFHV
IRUIXQGLQJDQGWKHLUVSHFLILFUHTXLUHPHQWVDQGPHFKDQLVPV7KH\VKRXOGNQRZKRZ
WRVXEPLWDSURSRVDOWKDWZLOOKDYHDJRRGFKDQFHRIJHWWLQJIXQGHG*UDQWVPDQVKLSLV
WKHWHUPXVHGIRUWKHDELOLW\WRVHFXUHJUDQWVWRVXSSRUWUHVHDUFKSURMHFWV7KHUHVHDUFK
SURSRVDOLQFOXGHVDOOWKHFRPSRQHQWVRIWKHUHVHDUFKSURWRFRORXWOLQHGLQWKHSUHYLRXV
FKDSWHU,QDGGLWLRQWKHSURSRVDOKDVWRLQFOXGHDGGLWLRQDOLQIRUPDWLRQWRFRQYLQFH
WKHIXQGLQJDJHQF\WKDWWKHSURMHFWLVZRUWK\RIVXSSRUWDQGFDQEHVXFFHVVIXOO\
LPSOHPHQWHG
6.2 How to get your research project funded

6.2.1 Sources of funding
)XQGLQJIRUKHDOWKUHVHDUFKEDVLFDOO\FRPHVIURPHLWKHUSXEOLFVRXUFHVRUSULYDWH
VRXUFHV3XEOLFVRXUFHVLQFOXGHJRYHUQPHQWVDQGLQWHUJRYHUQPHQWDORUJDQL]DWLRQV
3ULYDWHVRXUFHVLQFOXGHWKHQRWIRUSURILWVHFWRUVXFKDVSKLODQWKURSLFIRXQGDWLRQVDQG
QRQJRYHUQPHQWDORUJDQL]DWLRQVDQGWKHIRUSURILWSULYDWHLQGXVWU\%HVLGHVWKHVHSULPDU\
VRXUFHVWKHUHDUHLQWHUPHGLDU\DJHQFLHVRUJDQL]DWLRQVZKLFKSOD\DUROHLQFKDQQHOOLQJ
IXQGLQJIURPWKHSULPDU\VRXUFHVWRWKHDFWRUVLQUHVHDUFK
*RYHUQPHQW IXQGLQJ LV SURYLGHG WKURXJK SXEOLFO\ IXQGHG QDWLRQDO UHVHDUFK
RUJDQL]DWLRQVVXFKDVQDWLRQDOUHVHDUFKFRXQFLOVLQVWLWXWHVRIKHDOWKDQGXQLYHUVLWLHV
6RPHPLQLVWULHVRIKHDOWKVHHWKHYDOXHRIKHDOWKUHVHDUFKIRUWKHLUZRUNDQGDOORFDWH
DEXGJHWIRULW
*RYHUQPHQWVLQGHYHORSHGFRXQWULHVPD\DOORFDWHIXQGVIRUUHVHDUFKWKURXJKWKHLU
ELODWHUDORIILFLDOGHYHORSPHQWDVVLVWDQFHWRGHYHORSLQJFRXQWULHV7ZRFRXQWULHV6ZHGHQ
DQG&DQDGDSURYLGHIXQGLQJIRUUHVHDUFKWKURXJKSXEOLFO\VXSSRUWHGVHPLDXWRQRPRXV
DJHQFLHV7KH6ZHGLVK$JHQF\IRU5HVHDUFKLQ'HYHORSLQJ&RXQWULHV6$5(&DQG
WKH,QWHUQDWLRQDO'HYHORSPHQW5HVHDUFK&HQWUH,'5&LQ&DQDGDSURYLGHDVSHFLDO
PHFKDQLVPIRUVXSSRUWLQJUHVHDUFKWRVROYHGHYHORSLQJFRXQWU\SUREOHPV
Submitting a research proposal 73
,QWHUJRYHUQPHQWDORUJDQL]DWLRQVVXFKDVWKH:RUOG+HDOWK2UJDQL]DWLRQVXSSRUW
UHVHDUFKWKURXJKSURYLVLRQRIIXQGLQJDVZHOODVWHFKQLFDOVXSSRUW6XSSRUWLVSURYLGHG
WKURXJKKHDGTXDUWHUV¶SURJUDPPHVDVZHOODVWKURXJKUHJLRQDORIILFHV6SHFLDOUHVHDUFK
SURJUDPPHVLQ:+2FRYHUWKHDUHDVRIUHSURGXFWLYHKHDOWKUHVHDUFKDQGWURSLFDOGLVHDVH
UHVHDUFK
7KHQRWIRUSURILWSULYDWHVHFWRULQFOXGHVVHYHUDOIRXQGDWLRQVODUJHDQGVPDOO
([DPSOHVLQFOXGHWKH:HOOFRPH7UXVWLQWKH8.DQGWKH5RFNHIHOOHU)RUGDQG%LOODQG
0HOLQGD*DWHV)RXQGDWLRQVLQWKH86$DPRQJRWKHUV
,Q WKH IRUSURILW SULYDWH VHFWRU SKDUPDFHXWLFDO FRPSDQLHV ODUJHO\ EDVHG LQ
LQGXVWULDOL]HGFRXQWULHVDUHLQYHVWLQJLQFUHDVLQJO\ODUJHVXPVRIPRQH\LQUHVHDUFKDQG
GHYHORSPHQW
$OD\HURILQWHUPHGLDU\VXSSRUWRIWHQVHUYHVDVDEULGJHEHWZHHQWKHIXQGHUVDQG
WKRVHFRQGXFWLQJUHVHDUFK$QLQFUHDVLQJQXPEHURILQWHUQDWLRQDOUHVHDUFKSURJUDPPHV
KDYHEHHQDFWLYHIRFXVLQJRQSDUWLFXODUDUHDVRIKHDOWKUHVHDUFK([DPSOHVLQFOXGHWKH
3RSXODWLRQ&RXQFLOKHDGTXDUWHUHGLQ1HZ<RUNDQGZLWKDQXPEHURIUHJLRQDORIILFHV
)DPLO\+HDOWK,QWHUQDWLRQDO)+,KHDGTXDUWHUHGLQ&KDSHO+LOO1RUWK&DUROLQDDQGWKH
3URJUDPIRU$SSURSULDWH7HFKQRORJ\LQ+HDOWK3$7+ZLWKKHDGTXDUWHUVLQ6HDWWOH
6.2.2 Will the project be funded?

)XQGLQJRUJDQL]DWLRQVUHFHLYHPDQ\PRUHSURSRVDOVWKDQZKDWWKH\FDQIXQG7KH
VHOHFWLRQSURFHVVLVYHU\FRPSHWLWLYH7KHIROORZLQJIDFWRUVDUHJHQHUDOO\WDNHQLQWR
FRQVLGHUDWLRQLQGHFLGLQJZKHWKHUWKHSURSRVDOLVWREHIXQGHG
LPSRUWDQFHDQGUHOHYDQFHRIWKHUHVHDUFKTXHVWLRQWRWKHGHFODUHGLQWHUHVWVRIWKH
DJHQF\VXFFHVVLQREWDLQLQJDJUDQWGHSHQGVRQPDWFKLQJWKHSURSRVDOZLWKWKH
LQWHUHVWVRIDJUDQWLQJDJHQF\
TXDOLW\RIWKHUHVHDUFKGHVLJQ
DELOLW\RIWKHLQYHVWLJDWRUVWRFDUU\RXWWKHSURMHFW
FDSDFLW\RIWKHUHVHDUFKIDFLOLW\WRFDUU\RXWWKHSURMHFW
DELOLW\RIWKHLQVWLWXWLRQWRKDQGOHWKHDGPLQLVWUDWLYHDQGILQDQFLDOSURFHGXUHV
VDWLVIDFWRU\HWKLFDOFRQVLGHUDWLRQV
UHDOLVWLFDQGMXVWLILDEOHEXGJHWZLWKLQWKHOLPLWVVHWE\WKHDJHQF\DQGQRUPDOO\
ZLWKQRH[SHFWDWLRQVIRUFRQWLQXHGIXQGLQJDIWHUWKHFRPSOHWLRQRIWKHSURMHFW
UHDVRQDEOHWLPHIUDPHIRUFRPSOHWLRQRIWKHSURMHFW
XQGHUVWDQGLQJRIDQWLFLSDWHGSUREOHPV
FODULW\DQGVW\OHRIWKHZULWWHQSURSRVDO
:ULWLQJZLWKHQWKXVLDVPLVDJRRGLGHDEXWRYHUVWDWHPHQWVVKRXOGEHDYRLGHG7KH
DSSOLFDQWVKRXOGEHUHDOLVWLFDERXWWKHOLPLWDWLRQVRIWKHVWXG\
6.2.3 How to submit a research proposal

)XQGLQJRUJDQL]DWLRQVXVHRQHRUPRUHRIWKHIROORZLQJPHFKDQLVPVWRVHOHFWDQG
IXQGUHVHDUFKSURMHFWVVROLFLWSURSRVDOVDGYHUWLVHDQGLQYLWHSURSRVDOVRUKDYHDQRSHQ
GRRUSROLF\
6ROLFLWLQJSURSRVDOV,QWKLVFDVHRQHRUPRUHUHVHDUFKLQVWLWXWLRQVDUHDSSURDFKHG
DQGDUHDVNHGIRUWKHLULQWHUHVWLQVXEPLWWLQJDUHVHDUFKSURSRVDOLQDFHUWDLQDUHDRI
LPSRUWDQFHWRWKHIXQGLQJDJHQF\8VXDOO\WKHLQVWLWXWLRQDSSURDFKHGLVDFHQWUHRI
H[FHOOHQFH
$GYHUWLVLQJDQLQYLWDWLRQIRUVXEPLWWLQJSURSRVDOVLQFHUWDLQDUHDVRILQWHUHVW+HUH
WKHSURFHVVLVFRPSHWLWLYHDQGQRUPDOO\WKHUHLVDWLPHOLPLWIRUVXEPLWWLQJSURSRVDOV
$SDUWRIJUDQWVPDQVKLSLVWREHUHDG\ZLWKJRRGLGHDVDQGWREHDEOHWRVSHHGLO\
FRPSLOHDQDWWUDFWLYHSURSRVDO7KHSURSRVDOVDUHWKHQLQGHSHQGHQWO\UHYLHZHGDQG
VFRUHGDQGDVPDOOQXPEHULVVHOHFWHGIRUIXQGLQJ6RPHIXQGLQJDJHQFLHVZLOODVN
ILUVWIRUDEULHIFRQFHSWRXWOLQHRIWKHSURSRVDODQGWKHQVKRUWOLVWWKHDSSOLFDWLRQV
DQGDVNIRUFRPSOHWHSURSRVDOVIURPWKHVKRUWOLVW
$QRSHQGRRUSROLF\IRUDQ\JRRGSURSRVDO0RVWIXQGLQJDJHQFLHVKRZHYHUKDYH
DUHDVRILQWHUHVWDQGDUHDVLQZKLFKWKH\DUHQRWLQWHUHVWHG*RRGDGYLFHLQWKLVDS
SURDFKLVQRWWRVHQGDIXOOSURSRVDO$EULHIRXWOLQHRIWKHSURMHFWZLWKWKHOHYHO
RIIXQGLQJUHTXHVWHGLVHQRXJKWRJHWDUHVSRQVHDERXWWKHSRWHQWLDOLQWHUHVWRIWKH
DJHQF\RURUJDQL]DWLRQLQFRQVLGHULQJLW,IWKHUHVSRQVHLVSRVLWLYHWKHIXOOSURSRVDO
FDQEHVHQW
)XQGLQJRUJDQL]DWLRQVKDYHWKHLURZQZHEVLWHV,QIRUPDWLRQDERXWWKHLULQWHUHVWV
DQGPHFKDQLVPVFDQEHHDVLO\DFFHVVHG
6.2.4 Response to comments of reviewers

5HVHDUFKSURSRVDOVDUHFRPPRQO\VXEMHFWHGWRSHHUUHYLHZ7KHUHYLHZHUVPD\
VXJJHVWWKDWWKHSURSRVDOFDQEHPDGHPRUHDFFHSWDEOHE\UHYLVLRQV7KHLQYHVWLJDWRUVGR
QRWQHHGWRPDNHDOOWKHFKDQJHVVXJJHVWHGDXWRPDWLFDOO\7KH\VKRXOGDGRSWUHYLVLRQV
WKDWZLOOVDWLVI\WKHUHYLHZHU¶VFULWLFLVPVZKHUHYHUSRVVLEOHDQGMXVWLI\DQ\GHFLVLRQQRW
WRGRVR,WLVJRRGWRLQGLFDWHLQDVHSDUDWHSDJHWKHFULWLFLVPPDGHDQGKRZWKHUHYLVHG
SURSRVDOUHVSRQGHGWRWKHP
6.3 Components of a research proposal

$UHVHDUFKSURSRVDOFRPPRQO\IROORZVWKHIROORZLQJIRUPDWZKLFKLQFOXGHVWKH
FRPSRQHQWVRIWKHUHVHDUFKSURWRFROZLWKVRPHDGGLWLRQDOLQIRUPDWLRQ6RPHIXQGLQJ
DJHQFLHVKDYHWKHLURZQIRUPDWVIRUVWDQGDUGL]LQJDSSOLFDWLRQVDQGVWUHDPOLQLQJWKH
UHYLHZSURFHVV
7LWOHSDJH
3URMHFWVXPPDU\
3URMHFWGHVFULSWLRQ
(WKLFDOFRQVLGHUDWLRQV
*HQGHULVVXHV
7LPHWDEOH
3UREOHPVDQWLFLSDWHG
%XGJHW
5HIHUHQFHV
&XUULFXOXPYLWDHRIWKHLQYHVWLJDWRUV
Title page
7KLVSDJHVKRXOGSURYLGHLQIRUPDWLRQRQ
3URMHFWWLWOH
3ULQFLSDOLQYHVWLJDWRUV
,QVWLWXWLRQ
'XUDWLRQRIWKHSURMHFW
)XQGLQJUHTXHVWHG
5HVHDUFKJUDQWVDUHQRUPDOO\JLYHQWRLQVWLWXWLRQVQRWWRLQGLYLGXDOV7KHQDPHRIWKH
LQVWLWXWLRQVKRXOGEHJLYHQLQWKHWLWOHSDJH,IWKHLQVWLWXWLRQLVQRWNQRZQWRWKHDJHQF\
DEULHILQIRUPDWLRQDERXWWKHLQVWLWXWLRQPD\EHJLYHQDVDQDQQH[RUPD\EHUHTXHVWHG
E\WKHDJHQF\7KHQDPHRIWKHILQDQFLDORIILFHUZKRZLOOEHLQFKDUJHRIDGPLQLVWHULQJ
WKHJUDQWVKRXOGEHJLYHQLQDGGLWLRQWRWKHQDPHVRIWKHLQYHVWLJDWRUV
7KHGXUDWLRQRIWKHSURMHFWPXVWEHVSHFLILHG0RVWDJHQFLHVZLOOQRWFRPPLWVXSSRUW
EH\RQGWKUHH\HDUV7KHIXQGLQJUHTXHVWHGVKRXOGEHVSHFLILHG,QDPXOWL\HDUSURMHFW
WKHDPRXQWUHTXHVWHGIRUHDFK\HDUVKRXOGEHRXWOLQHG
Project summary
7KHSURMHFWVXPPDU\VKRXOGEHFDUHIXOO\ZULWWHQ,WZLOOEHWKHILUVWDQGPD\EH
WKHRQO\SDUWUHDGE\WKHUHYLHZHUV,WVKRXOGUHYHDOSHUVXDVLYHO\WKHLPSRUWDQFHDQG
WKHVWUHQJWKVRIWKHSURMHFW
Project description
7KLVVKRXOGIROORZWKHOLQHVRIWKHSURWRFRODVDOUHDG\GLVFXVVHGLQWKHFKDSWHURQ
ZULWLQJWKHSURWRFRO7KHUDWLRQDOHVKRXOGQRWRQO\H[SODLQZK\WKHSURMHFWLVLPSRUWDQW
WRGREXWVKRXOGDOVRLQGLFDWHLWVUHOHYDQFHWRWKHSDUWLFXODUOLQHVRILQWHUHVWRIWKH
IXQGLQJDJHQF\3UHYLRXVZRUNE\WKHLQYHVWLJDWRUVRQWKHUHVHDUFKWRSLFZLOOLQGLFDWH
WKHFRPSHWHQFHRIWKHLQYHVWLJDWRUVWRFDUU\RXWWKHZRUN3LORWVWXGLHVLIDOUHDG\GRQH
DUHLPSRUWDQWWRGHPRQVWUDWHWKHIHDVLELOLW\RIWKHUHVHDUFK
Ethical considerations
$SSURYDOIURPWKHORFDOHWKLFVUHYLHZFRPPLWWHHGRHVQRWUHOLHYHWKHGRQRUDJHQF\
IURPWKHHWKLFDOUHVSRQVLELOLW\IRUWKHSURMHFW$OVRDSSURYDOE\DGRQRUDJHQF\GRHVQRW
UHOLHYHWKHUHVHDUFKLQVWLWXWLRQIURPHWKLFDOUHVSRQVLELOLW\IRUWKHSURMHFW(WKLFDOLVVXHV
DQGFRQFHUQVVKRXOGEHDGGUHVVHGIXOO\LQWKHUHVHDUFKSURSRVDODVRXWOLQHGLQWKHFKDSWHU
RQZULWLQJWKHUHVHDUFKSURWRFRO
Gender issues
0RVWIXQGLQJRUJDQL]DWLRQVDUHQRZLQFUHDVLQJO\FRQVFLRXVDERXWJHQGHULVVXHV
7KHVHVKRXOGEHDGGUHVVHGLQWKHSURSRVDODVRXWOLQHGLQWKHSUHYLRXVFKDSWHURQZULWLQJ
WKHUHVHDUFKSURWRFRO
Timetable
7KHLQYHVWLJDWRUVVKRXOGFRPPLWWKHPVHOYHVWRDWLPHWDEOH7KLVPD\LQFOXGH
DSUHSDUDWRU\SKDVHWRWUDLQUHVHDUFKZRUNHUVWRSURFXUHHTXLSPHQWVXSSOLHVRUWR
FRPSOHWHDSLORWSKDVH7KHWLPHWDEOHVKRXOGWKHQHVWLPDWHWKHGXUDWLRQIRUFROOHFWLRQ
RIGDWDILQDODQDO\VLVRIGDWDDQGZULWLQJXSWKHUHSRUW,QSURMHFWSURSRVDOVRIDORQJ
GXUDWLRQPRUHWKDQRQH\HDUWKHWLPHWDEOHVKRXOGVHWPLOHVWRQHVWREHUHDFKHG7KHVH
DUHWDNHQLQWRFRQVLGHUDWLRQZKHQSURJUHVVUHSRUWVDUHUHYLHZHGE\WKHIXQGLQJDJHQF\
)XQGLQJLVRIWHQUHOHDVHGRQWKHEDVLVRIWKHVHSURJUHVVUHSRUWV
Problems anticipated
7KHLQYHVWLJDWRUVVKRXOGGHPRQVWUDWHWKHLUDZDUHQHVVRIREVWDFOHVDQGGLIILFXOWLHV
ZKLFKPD\LQWHUIHUHZLWKWKHVXFFHVVIXOFRPSOHWLRQRIWKHSURMHFWZLWKLQWKHWLPHIUDPH
DQGFRVWSURSRVHG7KH\VKRXOGH[SODLQKRZWKHVHREVWDFOHVDQGGLIILFXOWLHVZRXOGEH
GHDOWZLWK$QLQYHVWLJDWRUZKRGRHVQRWDQWLFLSDWHDQ\SUREOHPSUREDEO\KDVQRWWKRXJKW
RXWWKHGHWDLOVRIWKHSURMHFWFDUHIXOO\
Budget
7KHEXGJHWUHTXHVWVKRXOGEHLWHPL]HGDQGHDFKLWHPVKRXOGEHMXVWLILHG
Budget itemization
7KHIROORZLQJDUHH[DPSOHVRIFDWHJRULHVRIH[SHQVHV
3HUVRQQHOQDPHVSRVLWLRQVSHUFHQWDJHRIWLPHVSHQWRQWKHSURMHFWVDODU\IULQJH
EHQHILWV
(TXLSPHQW
6XSSOLHV
3DWLHQWFDUHFRVWV
7UDYHO
'DWDSURFHVVLQJ
&RPPXQLFDWLRQV
6HFUHWDULDOH[SHQVHV
3XEOLFDWLRQGLVVHPLQDWLRQRILQIRUPDWLRQDERXWWKHRXWFRPHRIWKHSURMHFW
Budget justification
$OOLWHPVLQWKHEXGJHWQHHGWREHMXVWLILHGDQGDUHFORVHO\VFUXWLQL]HGLQWKH
IROORZLQJZD\
$UHDOOSHUVRQQHOQHHGHGIRUWKHDPRXQWRIWLPHVWDWHG"
$UHFULWLFDOSHUVRQQHOGHYRWLQJHQRXJKWLPHWRWKHSURMHFW"
0DMRUSLHFHVRIHTXLSPHQWDUHGLIILFXOWWRMXVWLI\LQDVPDOOSURMHFWDQH[FHSWLRQ
PD\ EH PDGH IRU D GHYHORSLQJ FRXQWU\ LQVWLWXWLRQ DV SDUW RI UHVHDUFK FDSDELOLW\
VWUHQJWKHQLQJ
7KHEXGJHWVKRXOGQRWLQFOXGHDQ\XQGXHLQGXFHPHQWIRUVXEMHFWSDUWLFLSDWLRQ
,IWKHGXUDWLRQRIWKHSURMHFWLVPRUHWKDQRQH\HDUDGHWDLOHGEXGJHWLVQHHGHGIRUDW
OHDVWWKHILUVW\HDU%XGJHWUHTXHVWIRUWKHVXEVHTXHQW\HDUVVKRXOGEHRXWOLQHG$JHQFLHV
ZRXOGQRUPDOO\DSSURYHWKHEXGJHWIRUWKHIXOOGXUDWLRQRIWKHSURMHFWEXWIXQGVZLOOEH
UHOHDVHGRQD\HDUO\EDVLVVXEMHFWWRWKHVXEPLVVLRQRIDFFHSWDEOHSURJUHVVDQGILQDQFLDO
UHSRUWV
$JHQFLHVQRUPDOO\ZLOODOORZVRPHIOH[LELOLW\LQWKHXVHRIWKHEXGJHWSURYLGHGWKH
WRWDOEXGJHWLVQRWH[FHHGHG)RUVKLIWVEHWZHHQEXGJHWLWHPVKRZHYHULWLVH[SHFWHG
WKDWWKHDJHQF\¶VDSSURYDOEHVRXJKWEHIRUHKDQG
$QXQUHDOLVWLFEXGJHWLVOLNHO\WROHDGWRUHMHFWLRQRIWKHSURSRVDO7KHEXGJHWPD\
EHXQUHDOLVWLFLQRQHRIWZRZD\V,WPD\DVNIRUPRUHWKDQLVQHHGHGWRXQGHUWDNHWKH
SURMHFWRULWPD\DVNIRUPXFKOHVVWKDQLVUHDOLVWLFDOO\QHHGHGWRXQGHUWDNHWKHSURMHFW
VXFFHVVIXOO\7KHLQYHVWLJDWRUVPD\ZDQWWROLPLWWKHEXGJHWWRWKHIXQGLQJFHLOLQJRIWKH
DJHQF\EXWNHHSWKHODUJHSURMHFWDVLWLV,QVWHDGWKH\VKRXOGOLPLWWKHSURMHFWREMHFWLYHV
WRZKDWFDQUHDOLVWLFDOO\EHDFKLHYHGZLWKWKHUHTXHVWHGIXQGV
References
$QXPEHURIUHFHQWUHIHUHQFHVRQWKHVXEMHFWVKRXOGEHFLWHGLQVXSSRUWRIWKH
SURSRVDO
Curriculum vitae (CVs) of the investigator(s)

7KHDELOLW\RIWKHLQYHVWLJDWRUVWRFDUU\RXWWKHSURMHFWLVDQLPSRUWDQWFRQVLGHUDWLRQ
%LRJUDSKLFDOVNHWFKHVRIWKHLQYHVWLJDWRUVRU&9VVKRXOGEHDWWDFKHG7KHWUDFNUHFRUGRI
WKHLQYHVWLJDWRUVLVLPSRUWDQW3UHOLPLQDU\VWXGLHVRURWKHUZRUNGRQHE\WKHLQYHVWLJDWRUV
RQWKHVXEMHFWVKRXOGEHLQFOXGHG

Cummings SR, Holly EA, Hulley SB. Writing and funding a research proposal. In: Hulley
SB, Cummings SR. eds. Designing clinical research: an epidemiologic approach, 2nd
edition. Philadelphia, Lippincott Williams & Wilkins, 2001: 285–298.
Wingo PA, Higgins JA, Rubin GL, Zahniser SC. An epidemiologic approach to reproductive
health. Geneva. World Health Organization, 1994: 15–67 (WHO/HRP/EPI/1994).
Health research methodology: A guide for training in research methods. 2nd edition. Manila,
World Health Organization Regional office for the Western Pacific, 2001: 147–161.
UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and
Research Training in Human Reproduction. Preparing a research project proposal.
Guidelines and forms. 3rd edition. Geneva, World Health Organization, 2000 (WHO/
HRP/PP/2000).
Wyatt KM, Dimmock PW. Applying for a grant. In: O’Brien PMS, Pipkin FB. Introduction to
research methodology for specialists and trainees. London, Royal College of Obstetricians
and Gynaecologists Press, 1999: 201–209.
Chapter 7
Implementing the research project
7.1 Introduction
+RZVKRXOGUHVHDUFKEHGRQH"7KHDQVZHUWRWKLVTXHVWLRQFDQEHJLYHQLQRQHZRUG
ZHOO:KDWHYHUWKHUHDVRQIRUWKHUHVHDUFKDQGZKDWHYHUWKHNLQGRIUHVHDUFKLWVKRXOG
EHGRQHZHOODQGVKRXOGFRQIRUPWRHVWDEOLVKHGVWDQGDUGVRIVFLHQWLILFPHWKRGRORJ\,W
KDVEHHQVDLGWKDWWKHUHLVRQO\RQHW\SHRIUHVHDUFKJRRGUHVHDUFK%DGUHVHDUFKGRHV
QRWGHVHUYHWKHQDPHRIUHVHDUFK
,WLVQRWHQRXJKWKDWWKHUHVHDUFKTXHVWLRQKDVEHHQZHOOFRQFHLYHGWKHDSSURSULDWH
UHVHDUFKGHVLJQVHOHFWHGDQGDGHWDLOHGSURWRFROZHOOWKRXJKWRXWDQGZULWWHQ$OOWKHVH
SURYLGHDJRRGDQDWRP\IRUWKHUHVHDUFK3K\VLRORJ\PDWWHUVHYHQPRUH7KHUHVHDUFK
VKRXOGEHLPSOHPHQWHGZLWKVFLHQWLILFULJRXU
7.2 Scientific rigour

7KH(QJOLVKZRUG³ULJRXUÓLWHUDOO\PHDQV³VWULFWQHVV´,QVFLHQWLILFUHVHDUFKWKH
WHUPULJRXULVXVHGWRLPSO\WKDW
WKHVWXG\SURWRFROLVEHLQJDGKHUHGWR
WKHUHVHDUFKLVFRQGXFWHGLQDFFRUGDQFHZLWKHVWDEOLVKHGHWKLFDOVWDQGDUGV
PHWLFXORXVDQGGHWDLOHGUHFRUGVRIDOOREVHUYDWLRQVDUHPDLQWDLQHG
PHWKRGVRIPHDVXUHPHQWDUHXVHGLQDQREMHFWLYHZD\WRSURYLGHYDOLGDQGUHOLDEOH
UHVXOWV
GDWDDUHDQDO\VHGDQGLQWHUSUHWHGXVLQJDSSURSULDWHVWDWLVWLFDOPHWKRGVWRDVVHVVWKH
YDOLGLW\RIWKHUHVXOWVDQGWKHLUJHQHUDOL]DELOLW\
WKHUHVHDUFKHUVFRQWLQXHWREHZHOOYHUVHGZLWKWKHOLWHUDWXUHRQWKHVXEMHFWGXULQJ
WKHVWXG\
UHVXOWVDUHSUHVHQWHGLQVXFKDZD\WKDWRWKHULQYHVWLJDWRUVFDQUHDQDO\VHWKHGDWD
XVLQJWKHVDPHSURFHVVHVDQGPHWKRGVDQGUHDFKWKHVDPHFRQFOXVLRQVDQGRWKHU
LQYHVWLJDWRUVFDQUHSOLFDWHWKHVWXG\WRFRQILUPRUUHIXWHWKHILQGLQJV
7.3 Pre-testing the protocol

,WLVDOZD\VZLVHWRSUHWHVWWKHSURWRFRODIWHUGHYHORSLQJLW7KLVLVSDUWLFXODUO\
LPSRUWDQW LQ ODUJH DQG H[SHQVLYH VWXGLHV:KDW DSSHDUV WR EH D VWUDLJKWIRUZDUG
DQG SUREOHPIUHH SURWRFRO PD\ SURYH WR KDYH ORJLVWLF DQG SUDFWLFDO SUREOHPV LQ
LPSOHPHQWDWLRQ7KHSUHWHVWLVVRPHWLPHVFDOOHGDSLORWVWXG\%DVHGRQWKHRXWFRPHRI
WKHSLORWVWXG\WKHSURWRFROPD\EHPRGLILHGEHIRUHWKHVWXG\SURSHULVLPSOHPHQWHG
7KHSLORWVWXG\FDQKHOSLQGHWHUPLQLQJZKHWKHUWKHUHTXLUHGQXPEHUDVZHOODV
FRPSRVLWLRQRIVWXG\VXEMHFWVZLOOEHUHFUXLWHGZLWKLQWKHWLPHIUDPHRIWKHVWXG\7KH
VL]HRIWKHVDPSOHPD\QHHGWREHPRGLILHGRUDOWHUQDWLYHDSSURDFKHVRIUHFUXLWPHQW
PD\EHH[SORUHG
7KHSLORWVWXG\FDQKHOSLQWHVWLQJWKHPHWKRGVRIPHDVXUHPHQW,IWKHVWXG\UHOLHVRQ
KRZUHFRUGVKDYHEHHQNHSWWKHVHUHFRUGVPD\EHFKHFNHGIRUDFFXUDF\DQGFRPSOHWLRQ
EHIRUHWKHVWXG\LVVWDUWHG,IDTXHVWLRQQDLUHKDVEHHQGHVLJQHGWKLVZLOOQHHGWREHSUH
WHVWHGWRFKHFNWKDWWKHTXHVWLRQVDUHFOHDUZLWKRXWDQ\DPELJXLW\DQGWKDWWKHDQVZHUV
ZLOOEHFRQVLVWHQW0RGLILFDWLRQVPD\KDYHWREHPDGHIRUWKHILQDOLQVWUXPHQW,IWKH
PHWKRGRORJ\LQYROYHVDFOLQLFDORUODERUDWRU\PHDVXUHPHQWWKLVKDVWREHWHVWHGIRU
LQWHUUDWHUDQGLQWUDUDWHUUHOLDELOLW\LHIRUFRQVLVWHQF\LQUHVXOWVREWDLQHGE\GLIIHUHQW
ZRUNHUVDQGE\WKHVDPHZRUNHUDWGLIIHUHQWWLPHV
7KHSLORWVWXG\FDQDOVRKHOSLQWHVWLQJWKHV\VWHPIRUGDWDPDQDJHPHQW(QWHULQJ
DQGHGLWLQJWKHGDWDIURPWKHSLORWVWXG\ZLOOVKRZZKHWKHUWKHV\VWHPLVZRUNLQJZHOO
7KLVLQFOXGHVGHVLJQLQJWKHIRUPVIRUUHFRUGLQJPHDVXUHPHQWVFKRRVLQJDFRPSXWHU
GHYHORSLQJSURJUDPPHVIRUGDWDHQWU\PDQDJHPHQWDQGDQDO\VLVDQGSODQQLQJGXPP\
WDEXODWLRQVWRDVVXUHWKDWWKHDSSURSULDWHYDULDEOHVDUHFROOHFWHG
7.4 Monitoring of the study

7KHVWXG\VKRXOGEHPRQLWRUHG,QODUJHFOLQLFDOWULDOVDPRQLWRUPD\EHDSSRLQWHG
ZLWKWKHUHVSRQVLELOLW\RIUHSRUWLQJRQWKHSURJUHVVRIWKHWULDODQGIRUYHULILFDWLRQRI
GDWD7KHUHDUHWZRFRPSRQHQWVWRPRQLWRULQJGDWDPDQDJHPHQWUHFRUGNHHSLQJDQG
GDWDKDQGOLQJDQGGDWDTXDOLW\TXDOLW\DVVXUDQFHDQGTXDOLW\FRQWURO
Record-keeping and handling of data

$OOVWHSVLQYROYHGLQGDWDPDQDJHPHQWVKRXOGEHGRFXPHQWHGLQRUGHUWRDOORZ
VWHSE\VWHSUHWURVSHFWLYHDVVHVVPHQWRIWKHTXDOLW\RIWKHGDWDDQGWKHSHUIRUPDQFH
RIWKHFOLQLFDOWULDO³WKHDXGLWSDSHUWUDLOFRQFHSW´$EDVLFDVSHFWRIWKHLQWHJULW\RI
GDWDLVWKHVDIHJXDUGLQJRI³EOLQGLQJ´ZLWKUHJDUGWRDVVLJQPHQWRIVXEMHFWVWRGLIIHUHQW
WUHDWPHQWV6XEMHFWILOHVDQGRWKHUVXSSRUWLQJGDWDPXVWEHNHSWIRUDSHULRGRIWLPHDV
UHTXLUHGE\ORFDOUHJXODWLRQV
Implementing the research project 81
$FRPPRQSUREOHPLQUHVHDUFKLVWKHWHQGHQF\RILQYHVWLJDWRUVWRFROOHFWPDQ\
GDWDPXFKPRUHWKDQWKH\FDQDQDO\VHRUSXEOLVK7KLVFDQUHVXOWLQDQH[FHVVLYHO\ODUJH
GDWDEDVHDQGLQFUHDVHWKHFKDQFHRILQDFFXUDF\/LPLWLQJWKHGDWDWREHFROOHFWHGWRWKH
HVVHQWLDOGDWDIRUWKHVWXG\DQGHOLPLQDWLQJUHGXQGDQFLHVZLOOHQKDQFHWKHDFFXUDF\RI
WKHVWXG\$JHQHUDODGYLFHWRLQYHVWLJDWRUVLVWREHSDUVLPRQLRXVQRWWRH[SDQGPRUH
WKDQLVQHFHVVDU\
Quality assurance and quality control

$V\VWHPIRUTXDOLW\DVVXUDQFHPXVWEHLPSOHPHQWHGWRHQVXUHWKDWWKHVWXG\LV
SHUIRUPHGDQGWKHGDWDDUHJHQHUDWHGUHFRUGHGDQGUHSRUWHGLQFRPSOLDQFHZLWKWKH
SURWRFROJRRGFOLQLFDOSUDFWLFHDQGQDWLRQDOUHJXODWLRQV,QFOLQLFDOWULDOVDOOVLWHVDQG
DOOGDWDDQGGRFXPHQWVPXVWEHDYDLODEOHIRUYHULILFDWLRQ$OOREVHUYDWLRQVDQGILQGLQJV
VKRXOGEHYHULILDEOHLQRUGHUWRHQVXUHWKHFUHGLELOLW\RIGDWDDQGWRHQVXUHWKDWWKH
FRQFOXVLRQVSUHVHQWHGDUHGHULYHGFRUUHFWO\IURPWKHUDZGDWD4XDOLW\DVVXUDQFHLV
FDUULHGRXWZLWKWKHIROORZLQJREMHFWLYHVWRHQVXUHWKDWQRGDWDDUHPLVVLQJDQGWRHQVXUH
WKDWGDWDDUHSUHFLVHDQGDFFXUDWH
0LVVLQJGDWDZLOOLQWURGXFHDSUREOHPLQWKHDQDO\VLVRIUHVXOWVZKHWKHUWKHGDWD
DUHPLVVLQJEHFDXVHWKHPHDVXUHPHQWZDVQRWPDGHRUZDVQRWUHFRUGHG$VSHFLDO
W\SHRIPLVVLQJGDWDLVORVVWRIROORZXS/RVVWRIROORZXSZLOOGHFUHDVHWKHQXPEHURI
VXEMHFWV*HQHUDOO\ZKHQVDPSOHVL]HLVHVWLPDWHGDSURYLVLRQLVPDGHIRUDQHVWLPDWHG
SHUFHQWDJHRIORVVWRIROORZXS%XWWKLVGRHVQRWFRPSOHWHO\VROYHWKHSUREOHP/RVVWR
IROORZXSPD\LQWURGXFHDELDVLQWKHVWXG\DQGGLVFUHGLWLWVFRQFOXVLRQV7KHVXEMHFWV
ORVWWRIROORZXSPD\EHGLIIHUHQWIURPWKHVXEMHFWVZKRFRQWLQXHGLQWKHVWXG\)RU
H[DPSOHVXEMHFWVZKRGHYHORSVHULRXVVLGHHIIHFWVFRPSOLFDWLRQVRUHYHQGLHPD\EH
GLVSURSRUWLRQDWHO\UHSUHVHQWHGLQWKHORVVWRIROORZXS
0RQLWRULQJGXULQJWKHVWXG\FDQKHOSLQUHGXFLQJWKHSUREOHPRIPLVVLQJGDWD
$FRPSXWHUSURJUDPFDQKHOSGXULQJGDWDHQWU\WRHQVXUHWKDWDOOGDWDDUHHQWHUHG7KH
FRPSXWHUSURJUDPZLOOIODJPLVVLQJDQGRXWRIUDQJHYDOXHV
,QDFFXUDWHDQGLPSUHFLVHGDWDDUHDZRUVHSUREOHPWKDQPLVVLQJGDWDEHFDXVHWKH\
PD\QRWEHGLVFRYHUHGDIWHUWKHIDFW2QO\DV\VWHPDWLFTXDOLW\FRQWUROSURJUDPPHZLOO
DYRLGWKHSUREOHP
5HOLDELOLW\RIPHDVXUHPHQWVLVDQLPSRUWDQWFRPSRQHQWRITXDOLW\DVVXUDQFH7RWHVW
IRULQWUDREVHUYHUUHOLDELOLW\DFRPPRQZD\LVWRGRWKHPHDVXUHPHQWVWZLFHWHVW±UHWHVW
UHOLDELOLW\7KHUHVXOWVREWDLQHGIURPWKHILUVWWHVWDUHWKHQFRUUHODWHGZLWKWKHVHFRQGWHVW
7RWHVWIRULQWHUREVHUYHUUHOLDELOLW\DFRPPRQZD\LVWRKDYHWKHVDPHPHDVXUHPHQWV
GRQHE\WZRREVHUYHUV7KHUHVXOWVREWDLQHGIURPWKHILUVWWHVWDUHWKHQFRUUHODWHGZLWK
WKHVHFRQGWHVW
7RHQVXUHWKHTXDOLW\FRQWURORIODERUDWRU\PHDVXUHPHQWVEOLQGHGGXSOLFDWHVRU
VWDQGDUGSRROVFDQEHXVHG,QPXOWLFHQWUHVWXGLHVLQYROYLQJODERUDWRU\PHDVXUHPHQWV
DFRPPRQSUDFWLFHLVWRKDYHDUHIHUHQFHODERUDWRU\7KLVUHIHUHQFHODERUDWRU\ZLOO
VWDQGDUGL]HWKHWHVWWREHXVHGDQGZLOOSHULRGLFDOO\VHQGWKHVDPHVDPSOHWRWKHGLIIHUHQW
FHQWUHVDQGSURYLGHWKHPZLWKIHHGEDFNRQKRZWKHLUUHVXOWVFRPSDUHZLWKHDFKRWKHU
DQGZLWKUHVXOWVDVGHWHUPLQHGLQWKHUHIHUHQFHODERUDWRU\7KLVPHFKDQLVPRITXDOLW\
FRQWUROLVHVVHQWLDOEHIRUHDGHFLVLRQLVPDGHWRSRROWKHUHVXOWVIURPWKHGLIIHUHQWFHQWUHV
WRJHWKHUIRUDQDO\VLV
7.5 Periodic tabulations and reports

3HULRGLFWDEXODWLRQRIWKHGDWDLVXVHIXOLQWKHPRQLWRULQJSURFHVV3HULRGLFIUHTXHQF\
GLVWULEXWLRQWDEOHVZLOOUHYHDODEHUUDQWYDOXHV3HULRGLFDOO\ORRNLQJDWWKHGDWDVKRXOG
QHYHUPHDQEUHDNLQJWKHFRGHIRUEOLQGHGVWXGLHV
7.6 Validation of results in qualitative research

7KHUHVHDUFKHUGRLQJTXDOLWDWLYHUHVHDUFKPD\XVHWZRRUPRUHPHWKRGVREVHUYDWLRQ
LQWHUYLHZVIRFXVJURXSGLVFXVVLRQVWRDQVZHUWKHVDPHTXHVWLRQRUPD\XVHPRUHWKDQ
RQHVRXUFHIRUGDWDFROOHFWLRQ7KHREMHFWLYHLVWRHQKDQFHWKHYDOLGLW\DQGUHOLDELOLW\RI
WKHUHVXOWVE\FRPSDULQJWKHGDWDREWDLQHGIURPGLIIHUHQWPHWKRGVRUGLIIHUHQWVRXUFHV
7KLVSURFHVVLQTXDOLWDWLYHUHVHDUFKLVVRPHWLPHVUHIHUUHGWRDV³WULDQJXODWLRQ´7KH
LGHDRIWULDQJXODWLRQRULJLQDWHGIURPDFUDIWXVHGE\ODQGVXUYH\RUVZKRLQFUHDVHWKH
YDOLGLW\RIDPDSE\LQFRUSRUDWLQJPHDVXUHVIURPGLIIHUHQWDQJOHV0XOWLSOHDQGGLYHUVH
REVHUYDWLRQVFDQHQULFKWKHGHVFULSWLRQRIDSKHQRPHQRQ7KHUHVHDUFKHUVPD\DOVR
FURVVFKHFNLQWHULPUHVHDUFKILQGLQJVZLWKWKHUHVSRQGHQWV7KLVLVFDOOHG³UHVSRQGHQW
YDOLGDWLRQ´
7.7 Good clinical practice

5HVXOWVRIFOLQLFDOWULDOVRQQRYHOSKDUPDFHXWLFDOSURGXFWVKDYHWREHVXEPLWWHGWR
GUXJUHJXODWRU\DXWKRULWLHVEHIRUHWKHSURGXFWVFDQEHDSSURYHGIRUJHQHUDOXVH7KH
GUXJUHJXODWRU\DXWKRULW\ZLOOQRWRQO\ORRNLQWRWKHUHVXOWV,WZLOODOVRFRQVLGHUWKH
SURFHVVE\ZKLFKWKHVHUHVXOWVZHUHREWDLQHGDQGKRZWKHUHVHDUFKZDVFDUULHGRXW
7KHUHVHDUFKVKRXOGKDYHEHHQFRQGXFWHGDFFRUGLQJWRJRRGFOLQLFDOSUDFWLFH*&3
7KHGUXJUHJXODWRU\DXWKRULW\ZLOOGLVFDUGDQ\UHVXOWVRIUHVHDUFKWKDWGLGQRWFRQIRUP
WRWKHJXLGHOLQHVIRU*&3
*&3LVDVWDQGDUGIRUFOLQLFDOVWXGLHVZKLFKHQFRPSDVVHVWKHGHVLJQFRQGXFW
PRQLWRULQJWHUPLQDWLRQDXGLWDQDO\VHVUHSRUWLQJDQGGRFXPHQWDWLRQRIWKHVWXGLHVDQG
ZKLFKHQVXUHVWKDWWKHVWXGLHVDUHVFLHQWLILFDOO\DQGHWKLFDOO\VRXQGDQGWKDWWKHFOLQLFDO
SURSHUWLHVRIWKHSKDUPDFHXWLFDOSURGXFWXQGHULQYHVWLJDWLRQDUHSURSHUO\GRFXPHQWHG$
:RUOG+HDOWK2UJDQL]DWLRQWHFKQLFDOUHSRUWSURYLGHVJXLGHOLQHVIRUJRRGFOLQLFDOSUDFWLFH
IRUWULDOVRQSKDUPDFHXWLFDOSURGXFWVDQGLVWKHEDVLVIRUVRPHRIWKHPDWHULDOLQWKLV
FKDSWHU:+2
$XGLWLVDQLPSRUWDQWFRPSRQHQWRI*&3$QDXGLWLVDV\VWHPDWLFH[DPLQDWLRQ
FDUULHGRXWLQGHSHQGHQWO\RIWKRVHGLUHFWO\LQYROYHGLQWKHFOLQLFDOWULDO,WVREMHFWLYH
LVWRGHWHUPLQHZKHWKHUWKHFRQGXFWRIDWULDOFRPSOLHVZLWKWKHDJUHHGSURWRFRODQG
ZKHWKHUWKHGDWDUHSRUWHGDUHFRQVLVWHQWZLWKWKHUHFRUGVRQVLWH)RUH[DPSOHLWPD\
FKHFNZKHWKHUGDWDUHSRUWHGRUUHFRUGHGLQWKHFDVHUHSRUWIRUPVDUHFRQVRQDQWZLWK
WKRVHIRXQGLQKRVSLWDOILOHVDQGRWKHURULJLQDOUHFRUGV7KHDXGLWRUPD\XVHVWDWLVWLFDOO\
FRQWUROOHGVDPSOLQJWRYHULI\GDWDREWDLQHGLQDWULDO
7.8 Research on new pharmaceutical products

&OLQLFDOWULDOVRISKDUPDFHXWLFDOSURGXFWVVKRXOGEHGRQHLQDVWHSZLVHIDVKLRQ
3URJUHVVWRWKHQH[WSKDVHVKRXOGIROORZWKHVXFFHVVIXOFRPSOHWLRQRIWKHSUHYLRXVSKDVH
7KHQXPEHURIVXEMHFWVLQWKHWULDOLVLQFUHDVHGIURPRQHSKDVHWRWKHQH[WDVVDIHW\DQG
HIILFDF\RIWKHSURGXFWEHFRPHVEHWWHUHVWDEOLVKHG$QLPDOWR[LFRORJ\VWXGLHVDUHXVXDOO\
UHTXLUHGDQGVSHFLILFWR[LFRORJ\VWXGLHVVKRXOGEHFRPSOHWHGEHIRUHPRYLQJIURPRQH
SKDVHWRWKHQH[W
&OLQLFDOWULDOVDUHJHQHUDOO\FODVVLILHGLQWRSKDVHV,WR,9,WLVQRWSRVVLEOHWRGUDZ
GLVWLQFWOLQHVEHWZHHQWKHSKDVHVDQGGLYHUJLQJRSLQLRQVDERXWGHWDLOVDQGPHWKRGRORJ\
H[LVW$EULHIGHVFULSWLRQRIWKHLQGLYLGXDOSKDVHVEDVHGRQWKHLUSXUSRVHVDVUHODWHGWR
FOLQLFDOGHYHORSPHQWRISKDUPDFHXWLFDOSURGXFWVLVJLYHQEHORZ
3KDVH,FOLQLFDOWULDOV7KHVHDUHWKHILUVWWULDOVRIDQHZDFWLYHLQJUHGLHQWRUQHZ
IRUPXODWLRQLQKXPDQVRIWHQFDUULHGRXWLQKHDOWK\YROXQWHHUV7KHLUSXUSRVHLVWR
HVWDEOLVKDSUHOLPLQDU\HYDOXDWLRQRIWKHVDIHW\DQGWKHSKDUPDFRNLQHWLFDQGZKHUH
SRVVLEOHSKDUPDFRG\QDPLFSURILOHRIWKHDFWLYHLQJUHGLHQWLQKXPDQV
3KDVH,,FOLQLFDOWULDOV7KHVHWULDOVDUHSHUIRUPHGLQDOLPLWHGQXPEHURIVXEMHFWV
DQGDUHRIWHQRIDFRPSDUDWLYHHJSODFHERFRQWUROOHGGHVLJQ7KHLUSXUSRVHLV
WRGHPRQVWUDWHWKHUDSHXWLFDFWLYLW\DQGWRDVVHVVWKHVKRUWWHUPVDIHW\RIWKHDFWLYH
LQJUHGLHQW LQ SDWLHQWV VXIIHULQJ IURP D GLVHDVH RU FRQGLWLRQ IRU ZKLFK WKH DFWLYH
LQJUHGLHQWLVLQWHQGHG7KLVSKDVHDOVRDLPVDWWKHGHWHUPLQDWLRQRIDSSURSULDWHGRVH
UDQJHV RU UHJLPHQV DQG LI SRVVLEOH FODULILFDWLRQ RI GRVH±UHVSRQVH UHODWLRQVKLSV
LQRUGHUWRSURYLGHDQRSWLPDOEDFNJURXQGIRUWKHGHVLJQRIH[SDQGHGWKHUDSHXWLF
WULDOV
3KDVH,,,FOLQLFDOWULDOV3KDVH,,,WULDOVLQFOXGHODUJHUDQGSRVVLEO\YDULHGSDWLHQW

JURXSVZLWKWKHSXUSRVHRIGHWHUPLQLQJWKHVKRUWWHUPDQGORQJWHUPVDIHW\HIILFDF\
EDODQFHRIIRUPXODWLRQVRIWKHDFWLYHLQJUHGLHQWDQGRIDVVHVVLQJLWVRYHUDOODQG
UHODWLYHWKHUDSHXWLFYDOXH7KHSDWWHUQDQGSURILOHRIDQ\IUHTXHQWDGYHUVHUHDFWLRQV
PXVW EH LQYHVWLJDWHG DQG VSHFLDO IHDWXUHV RI WKH SURGXFW PXVW EH H[SORUHG HJ
FOLQLFDOO\UHOHYDQWGUXJLQWHUDFWLRQVIDFWRUVOHDGLQJWRGLIIHUHQFHVLQHIIHFWVXFKDV
DJH7KHVHWULDOVVKRXOGSUHIHUDEO\EHRIDUDQGRPL]HGGRXEOHEOLQGGHVLJQEXW
RWKHUGHVLJQVPD\EHDFFHSWDEOH*HQHUDOO\WKHFRQGLWLRQVXQGHUZKLFKWKHVHWULDOV
DUHFDUULHGRXWVKRXOGEHDVFORVHDVSRVVLEOHWRQRUPDOFRQGLWLRQVRIXVH
3KDVH ,9 FOLQLFDO WULDOV 3KDVH ,9 WULDOV DUH VWXGLHV SHUIRUPHG DIWHU PDUNHWLQJ
RI WKH SKDUPDFHXWLFDO SURGXFW 7KH\ DUH FDUULHG RXW RQ WKH EDVLV RI WKH SURGXFW
FKDUDFWHULVWLFVIRUZKLFKWKHPDUNHWLQJDXWKRUL]DWLRQZDVJUDQWHGDQGDUHQRUPDOO\
LQWKHIRUPRISRVWPDUNHWLQJVXUYHLOODQFHRUDVVHVVPHQWRIWKHUDSHXWLFYDOXHRU
WUHDWPHQWVWUDWHJLHV$OWKRXJKPHWKRGVPD\GLIIHUWKHVHVWXGLHVVKRXOGXVHWKHVDPH
VFLHQWLILFDQGHWKLFDOVWDQGDUGVDVDSSOLHGLQSUHPDUNHWLQJVWXGLHV$IWHUDSURGXFW
KDVEHHQSODFHGRQWKHPDUNHWFOLQLFDOWULDOVGHVLJQHGWRH[SORUHQHZLQGLFDWLRQV
QHZPHWKRGVRIDGPLQLVWUDWLRQQHZFRPELQDWLRQVHWFDUHQRUPDOO\FRQVLGHUHGDV
WULDOVRQQHZSKDUPDFHXWLFDOSURGXFWV
7.9 Termination of the study

$VWXG\RQDQHZSKDUPDFHXWLFDOSURGXFWVKRXOGEHFORVHO\PRQLWRUHG7KHVWXG\
VKRXOGVWRSLIDXQDQWLFLSDWHGSRWHQWLDOO\VHULRXVVLGHHIIHFWVDUHHQFRXQWHUHGRUEWKH
FRPSDUDWLYHVWXG\VKRZVFOHDUO\EHIRUHWKHVWXG\LVFRPSOHWHGWKDWRQHGUXJLVFOHDUO\
VXSHULRUWRWKHRWKHU
7.10 Changes in the protocol

7KHVWXG\VKRXOGEHFDUULHGRXWLQDFFRUGDQFHZLWKWKHZULWWHQSURWRFRO$Q\
VXEVHTXHQWFKDQJHPXVWEHDJUHHGXSRQDQGGRFXPHQWHG)RUODUJHVWXGLHVVWDQGDUG
RSHUDWLQJSURFHGXUHVLQWKHIRUPRIGHWDLOHGZULWWHQLQVWUXFWLRQVVKRXOGEHGHYHORSHG
DQGIROORZHG
7KHSURWRFROVKRXOGEHDGKHUHGWR8QDXWKRUL]HGFKDQJHVLQWKHSURWRFRODUHWHUPHG
YLRODWLRQV9LRODWLRQVRIWKHSURWRFROLIGLVFRYHUHGODWHGLVFUHGLWWKHVWXG\,IGLVFRYHUHG
EHIRUHWKHDQDO\VLVWKHGDWDVKRXOGEHGLVFDUGHGIURPWKHDQDO\VLV0LQRUFKDQJHVFDQEH
PDGHLQWKHSURWRFROLIWKLVGRHVQRWDIIHFWWKHFKDUDFWHULVWLFVRIWKHGDWD2WKHUZLVHWKH
GDWDEHIRUHDQGDIWHUWKHFKDQJHFDQQRWEHSRROHGWRJHWKHU,IPDMRUFKDQJHVKDYHWREH
PDGHLQWKHSURWRFROGDWDEHIRUHDQGDIWHUWKHFKDQJHVKRXOGEHDQDO\VHGVHSDUDWHO\
7.11 Ethical issues in the implementation of the study

7.11.1 Ethical principles
$QHWKLFDOO\DFFHSWDEOHGHVLJQLVRQO\DVJRRGDVWKHFDUU\LQJRXWRIWKHGHVLJQ7KH
HWKLFDOSULQFLSOHRIQRQPDOHILFHQFHRU³GRQRKDUP´LPSOLHVWKDWGXULQJLPSOHPHQWDWLRQ
RIFOLQLFDOWULDOVD³FXWRIISRLQW´VKRXOGEHGHILQHGVRWKDWLIWKHSURSRVHGWUHDWPHQW
SURYHVULVN\RULQIHULRUWRWKHDOWHUQDWLYHLWVKRXOGEHVWRSSHG7KHHWKLFDOSULQFLSOHRI
UHVSHFWLPSOLHVGXULQJLPSOHPHQWDWLRQWKDWSDWLHQWVVKRXOGEHDEOHWRZLWKGUDZWKHLU
FRQVHQWDWDQ\WLPHZLWKRXWORVLQJDQ\EHQHILW
7.11.2 Experimentation on animals

(WKLFDODSSURYDOLVQHHGHGIRUDQLPDOUHVHDUFKIURPWKHDSSURSULDWHORFDODQGQDWLRQDO
DXWKRULWLHV2QO\LQYHVWLJDWRUVDQGSHUVRQQHOZKRKDYHWKHDSSURSULDWHTXDOLILFDWLRQVDQG
H[SHULHQFHVKRXOGFDUU\RXWUHVHDUFKRQDQLPDOV([SHULPHQWDOZRUNRQDQLPDOVVKRXOG
RQO\EHGRQHLQTXDOLILHGDQGFHUWLILHGIDFLOLWLHV5HVHDUFKDQLPDOVVKRXOGEHSURSHUO\
FDUHGIRUDVUHJDUGVKRXVLQJHQYLURQPHQWDOFRQGLWLRQVQXWULWLRQDQGYHWHULQDU\FDUH
1RUPDOO\WKHFDUHRIDQLPDOVVKRXOGEHXQGHUWKHVXSHUYLVLRQRIYHWHULQDULDQVKDYLQJ
H[SHULHQFHLQODERUDWRU\DQLPDOVFLHQFH7KHDYRLGDQFHRUPLQLPL]DWLRQRIGLVFRPIRUW
GLVWUHVVRUSDLQWRWKHDQLPDOLVDQHWKLFDOLPSHUDWLYH3URFHGXUHVZLWKDQLPDOVWKDW
PD\FDXVHPRUHWKDQPRPHQWDU\RUPLQLPDOSDLQRUGLVWUHVVVKRXOGEHSHUIRUPHGZLWK
DSSURSULDWHVHGDWLRQDQDOJHVLDRUDQDHVWKHVLDLQDFFRUGDQFHZLWKDFFHSWHGYHWHULQDU\
SUDFWLFH$WWKHHQGRIRUZKHQDSSURSULDWHGXULQJDQH[SHULPHQWDQLPDOVWKDWZRXOG
RWKHUZLVHVXIIHUVHYHUHRUFKURQLFSDLQGLVWUHVVGLVFRPIRUWRUGLVDEOHPHQWWKDWFDQQRW
EHUHOLHYHGVKRXOGEHSDLQOHVVO\NLOOHG
7.11.3 Scientific honesty

'DWDVKRXOGEHFDUHIXOO\DQGDFFXUDWHO\FROOHFWHGZLWKRXWDQ\VXEMHFWLYHELDVRQ
WKHSDUWRIWKHLQYHVWLJDWRUV$VGLVFXVVHGLQ&KDSWHUDPHWKRGRORJ\WKDWLVUHOHYDQW
LQWKLVUHJDUGLVWKHGRXEOHEOLQGFRQWUROOHGFOLQLFDOWULDOZKHUHWKHLQYHVWLJDWRUVDUHQRW
DZDUHRIWKHW\SHRIPHGLFLQHWKHVXEMHFWLVJLYHQ,QD³WULSOHEOLQGHG´GHVLJQSDWLHQWV
FOLQLFLDQVDQGVWDWLVWLFLDQVRUSHUVRQVPHDVXULQJWKHRXWFRPHDUHXQDZDUHRIZKLFK
JURXSLVVXEMHFWWRZKLFKLQWHUYHQWLRQ$QRWKHUUHVHDUFKPHWKRGRORJ\LVUDQGRPL]DWLRQ
ZKHUHE\LWLVQRWXSWRWKHLQYHVWLJDWRUWRDVVLJQSDUWLFXODUWUHDWPHQWVWRGLIIHUHQWVXEMHFWV
7KHGHFLVLRQLVPDGHE\UDQGRPDOORFDWLRQ
'HOLEHUDWHVFLHQWLILFIUDXGLVHWKLFDOO\XQIRUJLYDEOH)UDXGLQYROYHVGHOLEHUDWH
GHFHSWLRQDQGPD\WDNHWKHIRUPRIIDEULFDWLQJGDWDLQYHQWLQJSDWLHQWVRUPDQLSXODWLQJ
GDWDWRSURYLGHDGHVLUHGDQVZHU7KHSUHVVXUHWR³SXEOLVKRUSHULVK´LQDFDGHPLF
LQVWLWXWLRQVPD\EHDIDFWRUDVZHOODVWKHSUDFWLFHRIGUXJFRPSDQLHVRISD\LQJDIHHWR
WKHLQYHVWLJDWRUIRUHYHU\SDWLHQWSDUWLFLSDWLQJLQDFOLQLFDOWULDO/RFDOUHVHDUFKHWKLFV
FRPPLWWHHVVKRXOGKDYHWKHDXWKRULW\WRDXGLWWKHLPSOHPHQWDWLRQRIWKHUHVHDUFKDQG
WRFRQWDFWUHVHDUFKVXEMHFWV
7.11.4 Fiscal honesty

5HVHDUFKSURJUDPPHVDQGSURMHFWVDUHFRPPRQO\VXSSRUWHGE\JRYHUQPHQWSULYDWH
RULQWHUQDWLRQDOIXQGV7KHUHVHDUFKIXQGVKDYHWREHXVHGWRPHHWWKHH[SHQVHVDVDJUHHG
XSRQLQWKHUHVHDUFKSURSRVDO([SHQGLWXUHKDVWREHGRFXPHQWHG$FFXUDWHSHULRGLFDQG
ILQDOILQDQFLDOUHSRUWVDUHUHTXLUHGDQGVKRXOGEHVXEPLWWHG

Hulley SB, Cummings SR. Implementing the study: Pre-testing, quality control, and protocol
revisions. In: Hulley SB, Cumming SR, eds. Designing clinical research: an epidemiologic
Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva,
World Health Organization, 1995: 97–137 (WHO Technical Report Series, No. 850).
Chapter 8
Describing and analysing research
results
8.1 Introduction
'DWDDFFXPXODWHGGXULQJWKHUHVHDUFKFDQEHYROXPLQRXVDQGZLOOQHHGWREH
VXPPDUL]HGDQGSUHVHQWHGLQDFOHDUDFFXUDWHIRUPDW)RUWKLVWRROVRIGHVFULSWLYH
VWDWLVWLFVDUHXVHGLQFOXGLQJWDEXODWLRQFDOFXODWLRQVILJXUHVDQGFRUUHODWLRQ
$IWHUWKHLQYHVWLJDWRUVKDYHVXPPDUL]HGDQGGHVFULEHGWKHUHVXOWVWKHQH[WVWHS
LVWRDQDO\VHWKHUHVXOWV,QWKHDQDO\VLVWKH\QHHGWRTXHVWLRQZKHWKHUWKHHVWLPDWHV
PDGHLQWKHVWXG\FDQEHJHQHUDOL]HGEH\RQGWKHUHODWLYHO\VPDOOQXPEHURIWKHVDPSOH
VWXGLHG7KH\QHHGDOVRWRTXHVWLRQZKHWKHUWKHGLIIHUHQFHVRUDVVRFLDWLRQVIRXQGFDQ
EHH[SODLQHGE\FKDQFHDQGVRPD\QRWEHUHDO,QIHUHQWLDOVWDWLVWLFVSURYLGHWKHWRROVWR
KHOSLQDQVZHULQJWKHVHTXHVWLRQV
7KLVFKDSWHUHPSKDVL]HVWKHXQGHUO\LQJFRQFHSWVLQGHVFULELQJDQGDQDO\VLQJ
UHVHDUFKUHVXOWV7RNHHSWKHFODULW\RIWKHPHVVDJHWHFKQLFDOGHWDLODQGPDWKHPDWLFDO
FDOFXODWLRQVDUHQRWDGGUHVVHG)RUWKHVHWKHUHDGHUFDQFRQVXOWWKHOLVWRIUHIHUHQFHVDQG
DGGLWLRQDOVRXUFHVIRUWKHFKDSWHU
8.2 Descriptive statistics

7KHUHVXOWVRIWKHVWXG\PXVWEHFOHDUO\VXPPDUL]HGWRDOORZWKHLUSURSHUDQDO\VLV
DQGLQWHUSUHWDWLRQ'HVFULSWLYHVWDWLVWLFVKHOSVXVWRPDNHVHQVHRIDODUJHYROXPHRIGDWD
,WVILUVWXVHLVFUHGLWHGWR-RKQ*UDXQWDVWRUHNHHSHULQ/RQGRQLQWKHPLGWKFHQWXU\
:HDYHU%H\RQGWKHERULQJEXVLQHVVRIWKHVWRUHDQGERRNNHHSLQJKHGHYHORSHG
DQRXWVLGHLQWHUHVWLQDUHDVRIPDWKHPDWLFV+HH[HUFLVHGKLVWDOHQWLQUHYLHZLQJDZHHNO\
FKXUFKSXEOLFDWLRQLVVXHGE\WKHORFDOSDULVKFOHUNVWKDWOLVWHGWKHQXPEHUVRIELUWKV
FKULVWHQLQJVDQGGHDWKVLQHDFKSDULVK7KHVHVRFDOOHG³ELOOVRIPRUWDOLW\´DOVROLVWHG
WKHFDXVHVRIGHDWKWKXVSURYLGLQJ*UDXQWZLWKDPDVVLYHEXWXQRUJDQL]HGPDVVRI
LQIRUPDWLRQDERXWWKHRQJRLQJGUDPDRIELUWKDQGGHDWKRFFXUULQJDOODURXQGKLP
*UDXQWPDGHDELJHIIRUWWRRUJDQL]HWKHGDWDLQDZD\WKDWZDVSUREDEO\LQVSLUHGE\KLV
WHFKQLTXHVIRUWUDFNLQJKLVVKRSLQYHQWRU\+HGHYLVHGWDEOHVWKDWFRXOGEHHDVLO\XSGDWHG
+HWRRNJUHDWSDLQVWRUHGXFHVHYHUDOFRQIXVHGYROXPHVRILQIRUPDWLRQLQWRWDEOHVDQG
VXFFLQFWSDUDJUDSKV+HZDVDEOHWRFRPSDUHFKDQJHVLQPRUWDOLW\WDEOHVRYHUWKH\HDUV
*UDXQWSXEOLVKHGWKHVXPPDU\RIKLVZRUNHQWLWOHG³1DWXUDODQGSROLWLFDOREVHUYDWLRQV
PDGHXSRQWKHELOOVRIPRUWDOLW\´LQ+LVERRNLPPHGLDWHO\DWWUDFWHGWKHDWWHQWLRQ
RIJRYHUQPHQWOHDGHUVDQGSURPLQHQWSULYDWHFLWL]HQV7KHVWRU\JRHVWKDW.LQJ&KDUOHV
,,ZDVVRLPSUHVVHGZLWK*UDXQW¶VZRUNWKDWKHSURSRVHGKLVQDPHIRUPHPEHUVKLSRI
WKHQHZO\FUHDWHGSUHVWLJLRXV5R\DO6RFLHW\DIRUXPLQZKLFKWKHQDWLRQ¶VPRVWEULOOLDQW
VFLHQWLVWVFRXOGJDWKHUWRJHWKHUDQGH[FKDQJHLGHDV*UDQW¶VWUDGHDVDVKRSNHHSHU
SURYRNHGREMHFWLRQVIURPWKHPHPEHUVEXWWKH\ZHUHRYHUUXOHGE\WKHNLQJ
7KH IROORZLQJ WRROV FDQ EH XVHG LQ GHVFULELQJ DQG VXPPDUL]LQJ WKH UHVXOWV
WDEXODWLRQFDOFXODWLRQVJUDSKVILJXUHVDQGFRUUHODWLRQ
8.3 Tabulation
$ILUVWVWHSLQVXPPDUL]LQJWKHGDWDLVFRPPRQO\WRJURXSWKHPLQVXPPDU\
WDEOHV7KHSODQIRUWKHWDEOHVVKRXOGEHGHYHORSHGLQWKHUHVHDUFKGHVLJQSKDVH7KH
WHUP³GXPP\WDEOHV´LVXVHGWRGHVFULEHWDEOHVWKDWDUHQRW\HWILOOHGZLWKGDWD'XULQJ
WKHLPSOHPHQWDWLRQSKDVHRIWKHUHVHDUFKWKHVHGXPP\WDEOHVPD\EHILOOHGZLWKWKH
DYDLODEOHGDWDWRVHHKRZWKHUHVXOWVDUHVKDSLQJXS
Frequency distribution tables

$IUHTXHQF\GLVWULEXWLRQWDEOHJLYHVWKHIUHTXHQF\ZLWKZKLFKDSDUWLFXODUYDOXH
DSSHDUVLQWKHGDWD,QGHVLJQLQJWKHIUHTXHQF\GLVWULEXWLRQWDEOHIRUQXPHULFDOGDWD
VXLWDEOHFODVVERXQGDULHVDUHQHHGHG7KHQXPEHURIFODVVHVLVLPSRUWDQW,IWKHFODVVHV
DUHWRRVPDOOWKHWDEOHZLOOEHXQZLHOG\,IWKH\DUHWRRODUJHLQIRUPDWLRQPD\EHORVW
E\EHLQJWRRVXPPDUL]HG,ILQGRXEWFODVVHVDUHEHWWHULQLWLDOO\FKRVHQWREHVPDOOUDWKHU
WKDQODUJH6PDOORQHVFDQEHHDVLO\DPDOJDPDWHGWRIRUPODUJHURQHVLIQHHGHG&ODVVHV
PXVWDOVREHPXWXDOO\H[FOXVLYH)RUH[DPSOHLIZHWDEXODWHGDWDDERXWWKHGLDVWROLF
EORRGSUHVVXUHZHPD\PDNHWKHFODVVHVDVWRDQGWRQRWWRDQG
WR
Cross-tabulation tables
)UHTXHQF\GLVWULEXWLRQWDEOHVPD\GHVFULEHRQHYDULDEOHDWDWLPHIRUH[DPSOHDJH
GLVWULEXWLRQ'HSHQGLQJRQWKHREMHFWLYHVRIWKHVWXG\WKHUHLVRIWHQWKHQHHGWRH[DPLQH
WKHUHODWLRQVKLSEHWZHHQVHYHUDORIWKHYDULDEOHVDWRQFHIRUEHWWHUGHVFULSWLRQRIWKHGDWD
RULQRUGHUWRORRNIRUGLIIHUHQFHVRUUHOHYDQWDVVRFLDWLRQV
&URVVWDEXODWLRQ WDEOHV PD\ EH GHVFULSWLYH RU DQDO\WLFDO 'HVFULSWLYH FURVV
WDEXODWLRQVPD\EHXVHGWRGHVFULEHWKHVDPSOH$QH[DPSOHLVDFRPSRVLWHWDEOH
GHVFULELQJWKHEDFNJURXQGRIVXEMHFWVVXFKDVDJHVH[SURIHVVLRQHWF$QDO\WLFDO
Describing and analysing research results 89
FURVVWDEXODWLRQVPD\EHXVHGWRGHWHUPLQHGLIIHUHQFHVEHWZHHQJURXSV$QH[DPSOHLV
DWDEOHFRPSDULQJORZELUWKZHLJKWEDELHVOHVVWKDQJDQGQRUPDOELUWKZHLJKW
EDELHVLQZRPHQZKRUHFHLYHGDQGZKRGLGQRWUHFHLYHSUHQDWDOFDUH7KHDFFHSWHG
FRQYHQWLRQLQDQDO\WLFDOFURVVWDEXODWLRQVLVWRSXWWKHFDWHJRULHVRIWKHGHSHQGHQW
YDULDEOHELUWKZHLJKWDVFROXPQKHDGLQJVDQGWKHLQGHSHQGHQWYDULDEOHSUHQDWDOFDUH
DVURZKHDGLQJV7KHWRWDOVDUHDOVRSXWIRUWKHFROXPQVDQGIRUWKHURZV,ISHUFHQWDJHV
DUHXVHGWKH\VKRXOGDGGXSWRDWRWDORI
$QDO\WLFDOFURVVWDEXODWLRQVPD\IRFXVRQH[SORULQJDVVRFLDWLRQVRUUHODWLRQVKLSV
EHWZHHQYDULDEOHV$QH[DPSOHLVWKHUHODWLRQVKLSEHWZHHQWKHDJHRIWKHPRWKHUV
DQGWKHGXUDWLRQRIEUHDVWIHHGLQJ&ROXPQVPD\KDYHWKUHHFDWHJRULHVIRUGXUDWLRQRI
EUHDVWIHHGLQJ±PRQWKVPRQWKVDQGPRQWKVRUPRUH$JHLVSXWLQURZVRI
DJHJURXSVIRUH[DPSOHOHVVWKDQ±±DQGRUPRUH
7KHQHHGIRUFURVVWDEXODWLRQVLVGLFWDWHGE\WKHREMHFWLYHVRIWKHVWXG\3RVVLEOH
FRQFOXVLRQVDUHDQWLFLSDWHGGXULQJWKHUHVHDUFKGHVLJQ'XPP\FURVVWDEXODWLRQVWKDW
ZLOODOORZWKHFRQFOXVLRQVWREHPDGHDUHGHYHORSHGDQGOHIWHPSW\WREHILOOHGZKHQ
WKHGDWDDUHDYDLODEOH
8.4 Calculations
1XPHULFDOGDWDFDQEHVXPPDUL]HGE\FDOFXODWLQJWKHLUFHQWUDOWHQGHQF\DQG
YDULDELOLW\E\FDOFXODWLQJSHUFHQWDJHDQGSURSRUWLRQVDQGE\FDOFXODWLQJUDWLRVDQG
UDWHV&RPSXWHUVRIWZDUHSURJUDPPHVKDYHIDFLOLWDWHGWKHVHFDOFXODWLRQV
Central tendency
7KHPRVWFRPPRQO\XVHGPHDVXUHRIFHQWUDOWHQGHQF\LVWKHDULWKPHWLFPHDQ
/HVVIDPLOLDUEXWDOVRXVHIXOPHDVXUHPHQWVRIFHQWUDOWHQGHQF\DUHWKHPHGLDQDQGWKH
PRGH
7KHPHDQDOVRFDOOHGDULWKPHWLFPHDQLVGHULYHGE\VXPPLQJXSWKHLQGLYLGXDO
YDOXHVDQGGLYLGLQJE\WKHWRWDOQXPEHURIPHDVXUHPHQWV
7KHPHGLDQRIDGLVWULEXWLRQLVDPLGSRLQWDWZKLFKRQHKDOIRIWKHREVHUYDWLRQVIDOO
EHORZDQGRQHKDOIIDOODERYHWKHYDOXH
7KHPRGHLVWKHPRVWIUHTXHQWPHDVXUHPHQWLQDGLVWULEXWLRQ
,IWKHGDWDIDOOLQD³QRUPDO´HYHQO\VSUHDGDURXQGWKHPHDQGLVWULEXWLRQWKHPHDQ
PHGLDQDQGPRGHFRLQFLGH,Q³VNHZHG´GLVWULEXWLRQVGDWDQRWHYHQO\VSUHDGWKH\YDU\
DQGPD\DOOEHPHDQLQJIXOLQWKHSUHVHQWDWLRQRIWKHGDWD
Variability
,QDGGLWLRQWRNQRZLQJWKHPHDQYDOXHRIDVHULHVRIPHDVXUHPHQWVLWLVLPSRUWDQW
WRKDYHVRPHLGHDDERXWWKHLUYDULDWLRQDURXQGWKHPHDQ7KHUHDUHWKUHHZD\VWR
SUHVHQWWKHYDULDELOLW\RIGDWDDURXQGWKHPHDQWKHUDQJHWKHVWDQGDUGGHYLDWLRQDQG
WKHSHUFHQWLOHV
7KHUDQJHJLYHVWKHYDOXHVDWWKHWRSDQGDWWKHERWWRPEXWGRHVQRWJLYHPXFK
LQGLFDWLRQRIWKHVSUHDGRIREVHUYDWLRQVDURXQGWKHPHDQ7KLVVSUHDGLVSURYLGHGE\WKH
VWDQGDUGGHYLDWLRQ
7KHVWDQGDUGGHYLDWLRQ6'LVFDOFXODWHGIURPDIRUPXODWKDWVXPVWKHVTXDUHVRI
GLIIHUHQFHVEHWZHHQWKHJURXSPHDQDQGHDFKLQGLYLGXDOYDOXH7KLVVXPWRWDOLVWHUPHG
WKHYDULDQFH7KHVTXDUHURRWRIWKHYDULDQFHSURYLGHVWKHVWDQGDUGGHYLDWLRQ7KHJUHDWHU
WKHGLIIHUHQFHVEHWZHHQWKHYDOXHVWKHPRUHVSUHDGWKHGLVWULEXWLRQDQGWKHODUJHUWKH
VWDQGDUGGHYLDWLRQ0DWKHPDWLFLDQVKDYHFDOFXODWHGWKDWLIWKHREVHUYDWLRQVIROORZD
³QRUPDO´GLVWULEXWLRQYDOXHVHYHQO\VSUHDGDURXQGWKHPHDQDUDQJHFRYHUHGE\RQH
VWDQGDUGGHYLDWLRQDERYHDQGEHORZWKHPHDQZLOOLQFOXGHDERXWRIWKHREVHUYDWLRQV
$UDQJHRI6'ZLOOFRYHUDERXWRIREVHUYDWLRQV$UDQJHRI6'ZLOOFRYHU
DERXWRIWKHREVHUYDWLRQV&DOFXODWLQJWKHPHDQDQGWKHVWDQGDUGGHYLDWLRQJLYHV
XVDJRRGVXPPDU\RIWKHGDWD
3HUFHQWLOHVSURYLGHDQRWKHUZD\RIORRNLQJDWYDULDWLRQVLQGLVWULEXWLRQV-XVWDVWKH
PHGLDQLVWKHWKSHUFHQWLOHRIDFROOHFWLRQRIGDWDWKHWKRUWKSHUFHQWLOHFDQEH
GHWHUPLQHGDQGLQGLFDWHVWKDWDSDUWLFXODUPHDVXUHPHQWLVODUJHUWKDQRURIDOO
WKHRWKHUYDOXHV7KHLQWHUTXDUWLOHUDQJHLVWKHGLVWDQFHEHWZHHQWKHVFRUHVUHSUHVHQWLQJ
WKHWKDQGWKSHUFHQWLOHUDQNVLQDGLVWULEXWLRQ2QHDGYDQWDJHRISHUFHQWLOHVLV
WKDWWKH\FDQEHDSSOLHGWRGDWDZLWKVNHZHGQRWQRUPDOGLVWULEXWLRQWKDWLVGDWDQRW
GLVWULEXWHGHYHQO\DURXQGWKHPHDQ
Percentages, proportions, ratios and rates

$SHUFHQWDJHLVWKHQXPEHURIXQLWVZLWKDFHUWDLQFKDUDFWHULVWLFGLYLGHGE\WKH
WRWDOQXPEHURIXQLWVLQWKHVDPSOHDQGPXOWLSOLHGE\8VXDOO\PLVVLQJGDWDDUHQRW
LQFOXGHGLQWKHFDOFXODWLRQRISHUFHQWDJHV&DXWLRQVKRXOGEHH[HUFLVHGZKHQGHVFULELQJ
SHUFHQWDJHVEDVHGRQVPDOOQXPEHUV,QVXFKFDVHVDVPDOOGLIIHUHQFHPD\DSSHDUDVD
ELJGLIIHUHQFHLQSHUFHQWDJHV
$SURSRUWLRQLVDQXPHULFDOH[SUHVVLRQWKDWFRPSDUHVRQHSDUWRIWKHVWXG\XQLWVWR
WKHZKROH$SURSRUWLRQFDQEHH[SUHVVHGDVDIUDFWLRQIRUH[DPSOHDSURSRUWLRQRI
RUDGHFLPDOIRUH[DPSOH
$UDWLRLVDQXPHULFDOH[SUHVVLRQRIWKHUHODWLRQVKLSEHWZHHQRQHVHWRIIUHTXHQFLHV
DQGDQRWKHU$QH[DPSOHLVWKHUDWLRRIPDOHVWRIHPDOHVLQDVDPSOH
$UDWHLVDQXPHULFDOH[SUHVVLRQRIWKHIUHTXHQF\RIDFRQGLWLRQLQDJLYHQSRSXODWLRQ
PHDVXUHGLQDVSHFLILHGSHULRGRIWLPH7ZRUDWHVFRPPRQO\XVHGLQKHDOWKVFLHQFHVDUH
LQFLGHQFHUDWHDQGSUHYDOHQFHUDWH,QFLGHQFHUDWHUHODWHVWKHQXPEHURIQHZFDVHVRID
FRQGLWLRQLQDSRSXODWLRQZLWKLQDWLPHSHULRG3UHYDOHQFHUDWHUHODWHVWKHWRWDOQXPEHU
RIFDVHVZLWKDFRQGLWLRQLQDSRSXODWLRQDWDJLYHQWLPH
$QLOOXVWUDWLRQRIWKHGLIIHUHQFHEHWZHHQUDWHVDQGUDWLRVLVWKHPHDVXUHPHQWRI
PDWHUQDOPRUWDOLW\,IZHUHODWHWKHQXPEHURIZRPHQZKRGLHEHFDXVHRISUHJQDQF\
DQGFKLOGELUWKWRWKHQXPEHURIZRPHQZKRKDYHOLYHELUWKVZHDUHFDOFXODWLQJDUDWLR
,IZHUHODWHWKHPWRDOOZRPHQLQWKHFKLOGEHDULQJSHULRGRYHUDFHUWDLQWLPHZHDUH
FDOFXODWLQJDUDWH
8.5 Graphs/figures
)LJXUHVLPSURYHWKHUHDGDELOLW\RIWKHUHVXOWV$&KLQHVHVDJHRQFHVDLGWKDWDSLFWXUH
LVZRUWKPRUHWKDQDWKRXVDQGZRUGV)LJXUHVLQFOXGHEDUFKDUWVSLHFKDUWVKLVWRJUDPV
OLQHJUDSKVDQGPDSV7KH\DUHJHQHUDOO\XVHIXOIRUWKHSUHVHQWDWLRQRIGDWD$KLVWRJUDP
UHVHPEOHVDEDUJUDSKEXWWKHEDUVDUHGUDZQWRWRXFKHDFKRWKHUUHIOHFWLQJWKHXQGHUO\LQJ
FRQWLQXLW\RIWKHGDWD
$FRPPRQILUVWVWHSLQORRNLQJDWDQGVXPPDUL]LQJGDWDLVWRSORWWKHPLQDIUHTXHQF\
GLVWULEXWLRQFXUYH(DFKYDULDEOHLVSORWWHGDJDLQVWWKHIUHTXHQF\ZLWKZKLFKLWLVIRXQG
7KHVKDSHRIWKLVGLVWULEXWLRQFXUYHWHOOVDORWDERXWWKHGDWDDQGKDVLPSOLFDWLRQVIRU
VXEVHTXHQWDQDO\VLV
:KHQWKHIUHTXHQF\GLVWULEXWLRQLVDEHOOVKDSHGFXUYHLWLVGHVFULEHGDVQRUPDORU
*DXVVLDQGLVWULEXWLRQ*DXVVD*HUPDQPDWKHPDWLFLDQZKROLYHGLQWKHHDUO\QLQHWHHQWK
FHQWXU\SURSRVHGWKH³ODZRIHUURUV´ZKLFKVWDWHVWKDWUHSHDWHGPHDVXUHPHQWVPDGH
RQWKHVDPHSK\VLFDOREMHFWIDOOLQDSUHGLFWDEOHSDWWHUQRUGLVWULEXWLRQ*DXVV¶VRULJLQDO
ODZZDVLQWHQGHGIRUPHDVXUHPHQWRQWKHVDPHREMHFW,WKDVEHHQODWHUDSSOLHGWRWKH
JURXSLQJRIPHDVXUHPHQWVPDGHRQGLIIHUHQWREMHFWV
:KHQWKHIUHTXHQF\GLVWULEXWLRQFXUYHLVDV\PPHWULFDOLWLVGHVFULEHGDVVNHZHG
GLVWULEXWLRQ,QDVNHZHGGLVWULEXWLRQWKHFXUYHVDUHDV\PPHWULFDOZLWKRQHVLGHRIWKH
FXUYHH[WHQGLQJLQDQHORQJDWHGIDVKLRQ
/HVVFRPPRQO\WKHIUHTXHQF\GLVWULEXWLRQFXUYHPD\VKRZPRUHWKDQRQHSHDN
8.6 Correlation
,QWKHFRQWH[WRIFRUUHODWLRQGDWDDUHFODVVLILHGDVHLWKHULQGHSHQGHQWRUGHSHQGHQW
YDULDEOHV,QGHSHQGHQWRULQSXWYDULDEOHVRUGLQDULO\KDYHYDOXHVWKDWDUHDXWRQRPRXVRI
WKHGHSHQGHQWRURXWFRPHYDULDEOHV%HFDXVHLQGHSHQGHQWYDULDEOHVSUHFHGHGHSHQGHQW
YDULDEOHVWKH\RIWHQDUHFDOOHGSUHGLFWRUV'HSHQGHQWDOVRFDOOHGRXWSXWRURXWFRPH
YDULDEOHVKDYHUHVSRQVHVWKDWDUHFRQWLQJHQWRQLQGHSHQGHQWYDULDEOHV,QGHSHQGHQW
YDULDEOHVDUHDQWHFHGHQWVGHSHQGHQWYDULDEOHVDUHFRQVHTXHQWV,QHSLGHPLRORJ\
LQGHSHQGHQWYDULDEOHVDUHRIWHQFDOOHGULVNIDFWRUVRUH[SRVXUHYDULDEOHV
Scatter diagram
:KHQDQLQYHVWLJDWRUKDVFROOHFWHGWZRVHWVRIREVHUYDWLRQVDQGZDQWVWRVHHZKHWKHU
WKHUHLVDUHODWLRQEHWZHHQWKHPLWLVEHVWWRFRQVWUXFWDVFDWWHUGLDJUDPILUVW7KHYHUWLFDO
VFDOHUHSUHVHQWVRQHVHWRIPHDVXUHPHQWVDQGWKHKRUL]RQWDOVFDOHWKHRWKHU7KHGRWVLQD
VFDWWHUGLDJUDPJHQHUDOO\OLHQHLWKHULQDVLQJOHVWUDLJKWOLQHQRUHTXLGLVWDQWRQHLWKHUVLGH
RIDFHQWUDOOLQH7KH\RIWHQOLHLQDURXJKO\HOOLSWLFDODUHD7KHVFDWWHUGLDJUDPJLYHVDQ
LQGLFDWLRQZKHWKHUDFRUUHODWLRQPD\H[LVWDQGLWVGLUHFWLRQ
8VXDOO\LQGHSHQGHQWYDULDEOHVDUHJUDSKHGRQWKH [D[LVKRUL]RQWDOD[LVDQG
GHSHQGHQWYDULDEOHVDUHJUDSKHGRQWKH\D[LVYHUWLFDOD[LV
Correlation coefficient
:KHQWKHUHODWLRQVKLSEHWZHHQWZRYDULDEOHVFDQEHH[SUHVVHGJUDSKLFDOO\E\
DVWUDLJKWOLQHFRUUHODWLRQFDQEHH[SUHVVHGDVWKHFRUUHODWLRQFRHIILFLHQW&RUUHODWLRQ
PD\EHSRVLWLYHRUQHJDWLYH:KHQRQHYDULDEOHLQFUHDVHVDVWKHRWKHULQFUHDVHVWKH
FRUUHODWLRQLVSRVLWLYHZKHQRQHGHFUHDVHVDVWKHRWKHULQFUHDVHVLWLVQHJDWLYH7KH
FRUUHODWLRQFRHIILFLHQWULVPHDVXUHGRQDVFDOHWKDWYDULHVIURPWKURXJKWR±
&RPSOHWHFRUUHODWLRQEHWZHHQWZRYDULDEOHVLVH[SUHVVHGDV,WVKRXOGEHFOHDUWKDW
FRUUHODWLRQPHDQVDVVRFLDWLRQEXWGRHVQRWQHFHVVDULO\PHDQFDXVDWLRQ7KLVFRQFOXVLRQ
LVOHIWWRWKHLQWHUSUHWDWLRQRIWKHUHVXOWV
Regression equation
&RUUHODWLRQEHWZHHQWZRYDULDEOHVPHDQVWKDWZKHQRQHRIWKHPFKDQJHVE\DFHUWDLQ
DPRXQWWKHRWKHUFKDQJHVRQWKHDYHUDJHE\DFHUWDLQDPRXQW7KHUHODWLRQVKLSFDQEH
GHVFULEHGE\DVLPSOHHTXDWLRQFDOOHGWKHUHJUHVVLRQHTXDWLRQ7KHUHJUHVVLRQHTXDWLRQ
FDQEHXVHGWRFRQVWUXFWDUHJUHVVLRQOLQHRQDVFDWWHUGLDJUDP$VWKHOLQHPXVWEH
VWUDLJKWLWZLOOSUREDEO\SDVVWKURXJKIHZLIDQ\RIWKHGRWV7KHUHJUHVVLRQFRHIILFLHQW
LVWKHWHUPXVHGWRVLJQLI\WKHDPRXQWE\ZKLFKDFKDQJHLQRQHYDULDEOHLQGHSHQGHQW
YDULDEOHPXVWEHPXOWLSOLHGWRJLYHWKHFRUUHVSRQGLQJDYHUDJHFKDQJHLQDQRWKHUYDULDEOH
GHSHQGHQWYDULDEOH,WUHSUHVHQWVWKHGHJUHHWRZKLFKWKHUHJUHVVLRQOLQHVORSHVXSZDUGV
RUGRZQZDUGV
8.7 Inferential statistics

8.7.1 Analysis
$IWHUVXPPDUL]LQJDQGGHVFULELQJWKHUHVXOWVLQYHVWLJDWRUVPRYHWRWKHQH[WVWHSRI
DQDO\VLQJWKHUHVXOWV7KHLQYHVWLJDWRUVVKRXOGTXHVWLRQZKHWKHUWKHILQGLQJVLQWKHVWXG\
FRXOGEHJHQHUDOL]HGEH\RQGWKHUHODWLYHO\VPDOOQXPEHURIWKHVDPSOHVWXGLHG7KLVLV
UHIHUUHGWRDVH[WHUQDOYDOLGLW\RUJHQHUDOL]DELOLW\
6WDWLVWLFVKHOSVXVLQPDNLQJLQIHUHQFHVDQGDUHWKHUHIRUHFDOOHGLQIHUHQWLDOVWDWLVWLFV
$QLQIHUHQFHLVDJHQHUDOL]DWLRQPDGHDERXWDSRSXODWLRQIURPWKHVWXG\RIDVXEVHWRU
VDPSOHRIWKDWSRSXODWLRQ,QVWDWLVWLFVWKHWHUPSRSXODWLRQKDVDGLIIHUHQWPHDQLQJIURP
WKHJHQHUDOXVDJHRIWKHZRUG,WQHHGVQRWWRUHIHURQO\WRSHRSOHRUDQLPDWHFUHDWXUHV
6LQFHDSRSXODWLRQFRPPRQO\FRQWDLQVWRRPDQ\LQGLYLGXDOVWRVWXG\FRQYHQLHQWO\
DQLQYHVWLJDWLRQLVRIWHQUHVWULFWHGWRRQHRUPRUHVDPSOHVGUDZQIURPLW,WVKRXOGEH
HPSKDVL]HGWKDWLIWKHVWXG\VDPSOHLVQRWUHSUHVHQWDWLYHRIWKHSRSXODWLRQWKHLQIHUHQFH
ZHPDNHIURPWKHUHVXOWZLOOEHPLVOHDGLQJ$QDO\WLFDOVWDWLVWLFVZLOOEHRIQRKHOSLI
WKHVDPSOHLVQRWUHSUHVHQWDWLYH$QDO\WLFDOVWDWLVWLFVFDQQRWFRUUHFWRXUPLVWDNHVLQ
GHVLJQLQJWKHVWXG\
%XWHYHQZLWKSURSHUO\VHOHFWHGVDPSOHVUHVXOWVIURPDVLQJOHVDPSOHDUHVWLOOVXEMHFW
WRVRPHGHJUHHRIXQFHUWDLQW\RUFKDQFH7KLVVDPSOLQJHUURUFDQQRWEHHOLPLQDWHG
FRPSOHWHO\EXWLWVSUREDEOHPDJQLWXGHFDQEHFDOFXODWHG
6WDWLVWLFVLVPRUHDERXWFRPPRQVHQVHWKDQDERXWPDWKHPDWLFV*HQHUDOL]DWLRQ
IURPWKHILQGLQJIURPWKHVDPSOHWRWKHSRSXODWLRQIURPZKLFKWKHVDPSOHZDVGUDZQ
GHSHQGVPDLQO\RQWKHWZRIDFWRUVWKHVL]HRIWKHVDPSOHDQGWKHYDULDELOLW\LQWKH
UHVXOWV1DWXUDOO\LIZHKDYHH[DPLQHGRIWKHFRPPXQLW\WKHQWKHUHVXOWZLOO
UHSUHVHQWWKHILQGLQJLQWKHZKROHFRPPXQLW\7KHVPDOOHUWKHVDPSOHGUDZQWKHOHVV
OLNHO\LWVILQGLQJVFDQEHJHQHUDOL]HG$OVRPDUNHGYDULDWLRQEHWZHHQVXEMHFWVLQWKH
PHDVXUHPHQWVREWDLQHGPHDQVWKDWGLIIHUHQWUHVXOWVDUHPRUHOLNHO\WREHREWDLQHGIURP
GLIIHUHQWVDPSOHV,IWKHUHVXOWVIDOOZLWKLQDZLGHUDQJHLHWKHYDULDELOLW\LVKLJKWKHQ
DVPDOOVDPSOHZLOOEHOHVVOLNHO\WRUHSUHVHQWWKHUHVXOWLQWKHZKROHSRSXODWLRQ:KDW
DQDO\WLFDOVWDWLVWLFVGRHVLVWRWUDQVODWHWKLVFRPPRQVHQVHLQWRTXDQWLWDWLYHWHUPVE\
SXWWLQJDILJXUHRQWKHSUREDELOLW\7KLVLVLOOXVWUDWHGE\WKHFRQFHSWRIVWDQGDUGHUURU
8.7.2 Standard error

7KHVWDQGDUGHUURU6(LVDVWDWLVWLFDOPHDVXUHDERXWWKHSUREDELOLW\WKDWWKHILQGLQJ
LQWKHVDPSOHZLOOUHIOHFWWKHILQGLQJLQWKHSRSXODWLRQ7KHVWDQGDUGHUURUGHSHQGVRQWZR
IDFWRUVWKHVL]HRIWKHVDPSOHDQGWKHYDULDWLRQVRIPHDVXUHPHQWVLQWKHVDPSOHLQGLFDWHG
E\WKHVWDQGDUGGHYLDWLRQ)RUH[DPSOHWKHVWDQGDUGHUURURIDPHDQLVFDOFXODWHGDVWKH
VWDQGDUGGHYLDWLRQGLYLGHGE\WKHVTXDUHURRWRIWKHQXPEHURIREVHUYDWLRQV
%\LWVHOIWKHVWDQGDUGHUURUPD\KDYHDOLPLWHGPHDQLQJEXWLWFDQEHXVHGWR
SURGXFHDFRQILGHQFHLQWHUYDOZKLFKKDVDXVHIXOLQWHUSUHWDWLRQ,QVLPSOHWHUPVLWKDV
EHHQFDOFXODWHGWKDWWKHVDPSOHPHDQSOXVRUPLQXVWLPHVLWVVWDQGDUGHUURUJLYHVWKH
FRQILGHQFHLQWHUYDOPHDQLQJWKDWWKHUHLVRQO\DFKDQFHWKDWWKLVLQWHUYDOGRHV
QRWLQFOXGHWKHPHDQRIWKHSRSXODWLRQ$FRQILGHQFHLQWHUYDOLVWKXVDUDQJHRIYDOXHV
ZKLFKLQFOXGHVWKHSRSXODWLRQSDUDPHWHUDWDVSHFLILHGOHYHORISUREDELOLW\
7KHVWDQGDUGHUURU6(FDQEHFDOFXODWHGQRWRQO\RQDPHDQEXWDOVRRQWKH
GLIIHUHQFHEHWZHHQWZRPHDQVRQDSHUFHQWDJHRQDGLIIHUHQFHEHWZHHQWZRSHUFHQWDJHV
DQGRQDFRUUHODWLRQFRHIILFLHQW
7KHVWDQGDUGHUURUVKRXOGEHFOHDUO\GLIIHUHQWLDWHGIURPWKHVWDQGDUGGHYLDWLRQ7KH
VWDQGDUGGHYLDWLRQLVDPHDVXUHRIWKHYDULDELOLW\LQWKHVDPSOHVWXGLHG7KHVWDQGDUGHUURU
LVDPHDVXUHRIWKHXQFHUWDLQW\LQDVDPSOHVWDWLVWLF7KHVWDQGDUGHUURUZKLFKGHSHQGV
RQERWKWKHVWDQGDUGGHYLDWLRQDQGWKHVDPSOHVL]HLVDUHFRJQLWLRQWKDWDVDPSOHLV
XQOLNHO\WRGHWHUPLQHWKHSRSXODWLRQYDOXHH[DFWO\,QPDQ\SXEOLFDWLRQVWKHVLJQLV
XVHGWRMRLQWKH6'RU6(WRDQREVHUYHGPHDQ7KLVPD\EHFRQIXVLQJDVWRZKHWKHULW
UHIHUVWRWKH6'RU6(7KHSUHVHQWSROLF\RIPDQ\VFLHQWLILFMRXUQDOVLVWRUHPRYHWKH
VLJQVDQGWRLQGLFDWHFOHDUO\EHWZHHQEUDFNHWVZKHWKHUWKH6'RU6(LVEHLQJTXRWHG
HJWKHPHDQZDVNJ6'NJ
8.7.3 Testing the research hypothesis

7KHIRUPXODWLRQRIWKHUHVHDUFKK\SRWKHVLVKDVEHHQGLVFXVVHGLQ&KDSWHU
5HVHDUFKHUVPD\IHHOVWURQJO\WKDWWKHLUK\SRWKHVLVLVWUXH7KLVKRZHYHUVKRXOGQRW
LQIOXHQFHWKHYLJRXUZLWKZKLFKWKHK\SRWKHVLVVKRXOGEHWHVWHG6LU3HWHU0HGDZDULQ
KLVERRN³$GYLFHWRD\RXQJVFLHQWLVW´VDLG³,FDQQRWJLYHDQ\VFLHQWLVWRIDQ\DJHEHWWHU
DGYLFHWKDQWKLVWKHLQWHQVLW\RIWKHFRQYLFWLRQWKDWDK\SRWKHVLVLVWUXHKDVQREHDULQJ
RQZKHWKHULWLVWUXHRUQRW´0HGDZDU6FLHQWLVWVVKRXOGDYRLGIDOOLQJLQORYH
ZLWKWKHLUSHWK\SRWKHVHV7KHLPSRUWDQWTXHVWLRQLVZKHWKHUWKHK\SRWKHVLVFDQVWDQG
XSWRFULWLFDOHYDOXDWLRQ
,QVFLHQWLILFPHWKRGRORJ\WKHUHVHDUFKK\SRWKHVLVLVWKHUHIRUHQRWWHVWHGGLUHFWO\
,QVWHDGZHVWDUWZLWKDQDVVXPSWLRQWKDWWKHUHLVQRGLIIHUHQFHRUDVVRFLDWLRQEHWZHHQ
WKHYDULDEOHVFRPSDUHG7KLVLVFDOOHGWKHQXOOK\SRWKHVLV+7KHQXOOK\SRWKHVLVLV
WKXVWKHFRQWUDU\WRWKHUHVHDUFKK\SRWKHVLVDOVRWHUPHGDOWHUQDWLYHK\SRWKHVLV
,QVFLHQWLILFPHWKRGRORJ\HYHQLIDGLIIHUHQFHRUDQDVVRFLDWLRQLVIRXQGLWVKRXOG
EHDVVXPHGWKDWLWLVGXHWRFKDQFHXQWLOLWLVSURYHQE\VWDWLVWLFDODQDO\VLVWKDWLWLV
XQOLNHO\WREHH[SODLQHGE\FKDQFH7KHUHVHDUFKK\SRWKHVLVLVDFFHSWHGE\H[FOXVLRQLI
WKHVWDWLVWLFDOWHVWUHMHFWVWKHQXOOK\SRWKHVLV
8VLQJWKHQXOOK\SRWKHVLVLQVFLHQWLILFZRUNKDVEHHQOLNHQHGWRWKHMXGLFLDOSURFHVV
RIDVVXPLQJLQQRFHQFHXQWLOJXLOWLVSURYHG%URZQHUHWDO,QVRPHZD\VWKH
LQYHVWLJDWRU¶VSUREOHPLVVLPLODUWRWKDWIDFHGE\DMXGJHWU\LQJDGHIHQGDQW7KHDEVROXWH
WUXWKDERXWZKHWKHUWKHGHIHQGDQWFRPPLWWHGWKHFULPHFDQQRWEHGHWHUPLQHG,QVWHDG
WKHMXGJHEHJLQVE\SUHVXPLQJLQQRFHQFHWKHGHIHQGDQWGLGQRWFRPPLWWKHFULPH7KH
MXGJHPXVWGHFLGHZKHWKHUWKHUHLVVXIILFLHQWHYLGHQFHWRUHMHFWWKHSUHVXPHGLQQRFHQFH
RIWKHGHIHQGDQWWKHVWDQGDUGLQOHJDOODQJXDJHLVNQRZQDV³EH\RQGUHDVRQDEOHGRXEW´
$MXGJHFDQHUUKRZHYHUE\FRQYLFWLQJDGHIHQGDQWZKRLVLQQRFHQWRUE\IDLOLQJWR
FRQYLFWRQHZKRLVDFWXDOO\JXLOW\$ORQJWKHVDPHUHDVRQLQJWZRNLQGVRIPLVWDNHVFDQ
EHPDGHLQWKHWHVWLQJRIWKHQXOOK\SRWKHVLVLQUHVHDUFKPHWKRGRORJ\DQGGHWHUPLQLQJ
VWDWLVWLFDOO\ZKHWKHUWKHILQGLQJFRXOGEHGXHWRFKDQFH7KHILUVWLVZKHQZHUHMHFWWKH
QXOOK\SRWKHVLVDQGLWLVWUXH7KLVLVVLPLODUWRWKHPLVWDNHLQWKHMXGLFLDOSURFHVVRI
UHMHFWLQJWKHLQQRFHQFHDQGFRQYLFWLQJDQLQQRFHQWGHIHQGDQW,QVWDWLVWLFDOODQJXDJH
WKLVLVFDOOHGDW\SH,HUURU)DLOLQJWRUHMHFWWKHQXOOK\SRWKHVLVZKHQLWLVQRWWUXHLV
FDOOHGDW\SH,,HUURU7KLVZRXOGEHVLPLODULQWKHMXGLFLDOSURFHVVRIIDLOLQJWRFRQYLFWD
GHIHQGDQWZKRLVDFWXDOO\JXLOW\7KHVWDWLVWLFDOWHVWVXVHGWRDVVHVVZKHWKHUWKHILQGLQJV
FDQEHH[SODLQHGE\FKDQFHDUHLQDVHQVHVLPLODUWRWKHMXGLFLDOSURFHVVRIDVVHVVLQJ
SURRIEH\RQGUHDVRQDEOHGRXEW
7KHSUREDELOLW\RIFRPPLWWLQJDW\SH,HUURUUHMHFWLQJWKHQXOOK\SRWKHVLVZKHQ
LWLVDFWXDOO\WUXHRUSURYLQJDQDVVRFLDWLRQZKHQQRQHH[LVWVLVFDOOHGDOSKD$QRWKHU
QDPHIRUDOSKDLVWKHOHYHORIVWDWLVWLFDOVLJQLILFDQFH7KHSUREDELOLW\RIPDNLQJDW\SH,,
HUURUIDLOLQJWRUHMHFWWKHQXOOK\SRWKHVLVZKHQLWLVDFWXDOO\IDOVHRUIDLOLQJWRSURYHDQ
DVVRFLDWLRQZKHQLWDFWXDOO\H[LVWVLVFDOOHGEHWD7KHTXDQWLW\EHWDLVFDOOHGSRZHU
6WDWLVWLFDOSRZHURIDVWXG\LVWKXVWKHSUREDELOLW\RIREVHUYLQJDQHIIHFWRIDVSHFLILHG
HIIHFWVL]HLIRQHH[LVWV
8.8 What statistical tests tell us

8.8.1 Probability
$OEHUW(LQVWHLQVDLG³$VIDUDVWKHODZVRIPDWKHPDWLFVUHIHUWRUHDOLW\WKH\DUHQRW
FHUWDLQDQGDVIDUDVWKH\DUHFHUWDLQWKH\GRQRWUHIHUWRUHDOLW\´7KHUHLVQRFHUWDLQW\
LQVFLHQFH7KHUHDUHSUREDELOLWLHV:KDWLVFHUWDLQDERXWVFLHQFHLVWKHXQFHUWDLQW\,Q
VFLHQWLILFPHWKRGRORJ\ZHWU\WRPLQLPL]HWKHSUREDELOLW\RIILQGLQJDQDVVRFLDWLRQZKHQ
QRDVVRFLDWLRQDFWXDOO\H[LVWVDQGWRPLQLPL]HWKHSUREDELOLW\RIPLVVLQJDQDVVRFLDWLRQ
ZKHQDQDVVRFLDWLRQDFWXDOO\H[LVWV:HFDQQRWHOLPLQDWHWKLVSUREDELOLW\RIHUURUEXW
DQDO\WLFDOVWDWLVWLFVFDQJLYHXVDQHVWLPDWHRILWVPDJQLWXGH7KHSUREDELOLW\RIPDNLQJ
DQHUURUGHSHQGVRQWKHVL]HRIWKHVDPSOHVWXGLHGLQRUGHUWRWHVWWKHQXOOK\SRWKHVLV7KH
ODUJHUWKHVL]HRIWKHVDPSOHWKHOHVVOLNHO\ZLOOEHWKHSUREDELOLW\RIPDNLQJDQHUURU
7KLVLVZK\GHWHUPLQDWLRQRIVDPSOHVL]HLVDQHVVHQWLDOFRPSRQHQWRIUHVHDUFKGHVLJQ
8.8.2 Statistical significance

$VWDWLVWLFDOVLJQLILFDQFHWHVWHVWLPDWHVWKHOLNHOLKRRGWKDWDQREVHUYHGVWXG\UHVXOW
IRUH[DPSOHDGLIIHUHQFHEHWZHHQWZRJURXSVRUDQDVVRFLDWLRQFDQEHGXHWRFKDQFHDQG
WKHUHIRUHQRLQIHUHQFHFDQEHPDGHIURPLW
7HVWVRIVWDWLVWLFDOVLJQLILFDQFHDUHEDVHGRQFRPPRQORJLFDQGFRPPRQVHQVH7KDWD
GLIIHUHQFHLVOLNHO\WREHUHDODQGQRWGXHWRFKDQFHLVEDVHGODUJHO\RQWKUHHFULWHULD7KH
ILUVWLVWKHPDJQLWXGHRIWKHGLIIHUHQFHREVHUYHG,WLVUHDVRQDEOHWRH[SHFWWKDWWKHODUJHU
WKHGLIIHUHQFHWKHPRUHOLNHO\WKDWLWLVQRWGXHWRFKDQFH7KHVHFRQGLVWKHGHJUHHRI
YDULDWLRQVLQWKHYDOXHVREWDLQHGLQWKHVWXG\,IWKHYDOXHVIDOOZLWKLQWRRZLGHDUDQJH
GLIIHUHQFHVLQPHDQVZRXOGEHPRUHOLNHO\WREHGXHWRFKDQFHYDULDWLRQV7KHWKLUGYHU\
LPSRUWDQWFULWHULRQLVWKHVL]HRIVDPSOHVWXGLHG7KHODUJHUWKHVL]HRIWKHVDPSOHWKH
PRUHOLNHO\WKDWWKHUHVXOWGUDZQIURPLWZLOOUHIOHFWWKHUHVXOWVLQWKHSRSXODWLRQ:KDW
VWDWLVWLFLDQVGRLVWRWXUQWKLVVLPSOHORJLFWKURXJKPDWKHPDWLFVLQWRDTXDQWLWDWLYH
IRUPXODWRGHVFULEHWKHOHYHORISUREDELOLW\
:KHQWKHGDWDDUHDQDO\VHGZHVHWDQDUELWUDU\YDOXHIRUZKDWZHFDQDFFHSW
DVDOSKDRUOHYHORIVWDWLVWLFDOVLJQLILFDQFHLHWKHSUREDELOLW\RIFRPPLWWLQJDW\SH
,HUURUUHMHFWLQJWKHQXOOK\SRWKHVLVZKHQLWLVDFWXDOO\WUXHRUSURYLQJDQDVVRFLDWLRQ
ZKHQQRQHH[LVWV7KHVWDWLVWLFDOWHVWVWKHQGHWHUPLQHWKH3YDOXH3LVWKHSUREDELOLW\
WKDWDGLIIHUHQFHRUDQDVVRFLDWLRQDVODUJHDVWKHRQHREVHUYHGFRXOGKDYHRFFXUUHG
E\FKDQFHDORQH7KHQXOOK\SRWKHVLVLVUHMHFWHGLIWKH3YDOXHLVOHVVWKDQDOSKDWKH
SUHGHWHUPLQHGOHYHORIVWDWLVWLFDOVLJQLILFDQFH3UREDELOLW\RU3LVXVXDOO\H[SUHVVHGDVD
SHUFHQWDJH$UHVXOWLVFRPPRQO\FRQVLGHUHGWREHXQOLNHO\WREHGXHWRFKDQFHRUWREH
VWDWLVWLFDOO\VLJQLILFDQWLIWKH3YDOXHLVOHVVWKDQ3OHVVWKDQDQGLVVDLGWREH
KLJKO\VLJQLILFDQWLI3LVOHVVWKDQ7KHUHLVQRWKLQJPDJLFDODERXWWKHVHOHYHOVRI
SUREDELOLW\7KH\DUHDUELWUDU\FXWRIISRLQWVDWUDGLWLRQWKDWEHJDQLQWKHVZLWKDQ
LQIOXHQWLDOVWDWLVWLFLDQQDPHG)LVKHU,WLVLPSRUWDQWWRNHHSLQPLQGWKDWWKHVL]HRI3RU
WKHOLNHOLKRRGWKDWDILQGLQJLVDFKDQFHILQGLQJGHSHQGVRQWZRYDOXHVWKHPDJQLWXGH
RIWKHGLIIHUHQFHDQGWKHVL]HRIWKHVDPSOHVWXGLHG
8.8.3 Confidence intervals

6WDWLVWLFDOVLJQLILFDQFHRIWKHUHVXOWIRUH[DPSOHDGLIIHUHQFHIRXQGLQDSDUWLFXODU
VWXG\JLYHVXVDQLQGLFDWLRQWKDWWKHGLIIHUHQFHZDVXQOLNHO\WREHH[SODLQHGE\FKDQFH
%XWLWGRHVQRWJLYHXVDQLQGLFDWLRQRIWKHPDJQLWXGHRIWKDWGLIIHUHQFHLQWKHSRSXODWLRQ
IURPZKLFKWKHVDPSOHZDVVWXGLHG)RUWKLVWKHFRQFHSWRIFRQILGHQFHLQWHUYDOVKDVEHHQ
GHYHORSHG'LIIHUHQWIURPDWHVWRIVWDWLVWLFDOVLJQLILFDQFHDFRQILGHQFHLQWHUYDO&,
DOORZVXVWRHVWLPDWHZKHWKHUWKHVWUHQJWKRIWKHHYLGHQFHLVVWURQJRUZHDNDQGZKHWKHU
WKHVWXG\LVGHILQLWLYHRUZKHWKHURWKHUVWXGLHVZLOOEHQHHGHG,IWKHFRQILGHQFHLQWHUYDO
LVQDUURZWKHVWUHQJWKRIHYLGHQFHZLOOEHVWURQJ:LGH&,VLQGLFDWHJUHDWHUXQFHUWDLQW\
DERXWWKHWUXHYDOXHRIDUHVXOW$VWDWLVWLFLDQFDQFDOFXODWH&,VRQWKHUHVXOWRIMXVWDERXW
DQ\VWDWLVWLFDOWHVW
:HFDQWDNHDQH[DPSOHZKHUHDQLQYHVWLJDWRUIRXQGWKDWWKHKDHPRJORELQ+E
OHYHODSSHDUHGWREHGLIIHUHQWLQPDOHVDQGIHPDOHV,QPDOHVWKHPHDQ+EOHYHOZDV
,QIHPDOHVWKHPHDQ+EOHYHOZDV$VWDWLVWLFDOVLJQLILFDQFHWHVWEDVHGRQ
D3YDOXHZLOOWHOOXVDERXWKRZOLNHO\WKLVGLIIHUHQFHLVWREHUHDORUWREHDFKDQFH
ILQGLQJ%XWWKHVWDWLVWLFDOWHVWGRHVQRWWHOOXVDERXWWKHUDQJHRIWKHGLIIHUHQFHWKDWFDQ
EHH[SHFWHGRQWKHEDVLVRIWKHGDWDEHWZHHQPHDQ+EOHYHOVRIPDOHVDQGIHPDOHVLQ
WKHZKROHSRSXODWLRQLIRWKHUVDPSOHVZHUHWDNHQDQGVWXGLHG7KHGLIIHUHQFHEHWZHHQ
WKHWZRPHDQVLQWKLVSDUWLFXODUVWXG\LV%XWFRQILGHQFHLQWHUYDOVFRXOGEHIRU
H[DPSOHWR
:KHQFRQILGHQFHLQWHUYDO&,UHSRUWLQJLVXVHGDSRLQWHVWLPDWHRIWKHUHVXOWLV
JLYHQWRJHWKHUZLWKDUDQJHRIYDOXHVWKDWDUHFRQVLVWHQWZLWKWKHGDWDDQGZLWKLQZKLFK
RQHFDQH[SHFWWKHWUXHYDOXHLQWKHSRSXODWLRQWROLH7KH&,WKXVSURYLGHVDUDQJHRI
SRVVLELOLWLHVIRUWKHSRSXODWLRQYDOXH7KLVLVLQFRQWUDVWWRVWDWLVWLFDOVLJQLILFDQFHZKLFK
RQO\LQGLFDWHVZKHWKHURUQRWWKHILQGLQJFDQEHH[SODLQHGE\FKDQFH
$VLQVWDWLVWLFDOWHVWVWKHLQYHVWLJDWRUVPXVWVHOHFWWKHGHJUHHRIFRQILGHQFHRU
FHUWDLQW\WKH\DFFHSWWREHDVVRFLDWHGZLWKDFRQILGHQFHLQWHUYDOWKRXJKLVWKHPRVW
FRPPRQFKRLFHMXVWDVDOHYHORIVWDWLVWLFDOVLJQLILFDQFHLVZLGHO\XVHG
,QJHQHUDOZKHQD&,FRQWDLQVD]HURGLIIHUHQFHLWPHDQVWKDWRQHLVXQDEOH
WRUHMHFWWKHQXOOK\SRWKHVLVDWWKHOHYHO,ILQWKHH[DPSOHDERYHWKH&,IRUWKH
GLIIHUHQFHLQ+EOHYHOEHWZHHQPDOHVDQGIHPDOHLV±WRZHFDQQRWUHMHFWWKHQXOO
K\SRWKHVLVWKDWWKHUHLVQRGLIIHUHQFHEHFDXVHWKHFRQILGHQFHLQWHUYDOLQFOXGHV:HGR
QRWXVHGDVKZKHQSXWWLQJWKH&,,WPD\EHFRQIXVLQJEHFDXVHWKH&,PD\EHPLQXV±
:HDOVRGRQRWXVHEHFDXVHWKHLQWHUYDOVDUHFRPPRQO\QRWHTXDO
7KH&,LVDOVRXVHIXOLQDQDO\VLQJFRUUHODWLRQ7KHFRUUHODWLRQFRHIILFLHQWU
DVGLVFXVVHGLQVHFWLRQLVPHDVXUHGRQDVFDOHWKDWYDULHVIURPWKURXJKWR
±&RPSOHWHFRUUHODWLRQEHWZHHQWZRYDULDEOHVLVH[SUHVVHGDV$VWDWLVWLFDOWHVWRI
VLJQLILFDQFHZLOOWHOOXVWKHSUREDELOLW\WKDWDGHJUHHRIFRUUHODWLRQIRXQGLQWKHVWXG\LV
OLNHO\RUQRWWREHGXHWRFKDQFH%XWLWGRHVQRWWHOOXVRQWKHEDVLVRIWKHGDWDDERXW
WKHUDQJHRIFRUUHODWLRQFRHIILFLHQWVWKDWPD\EHH[SHFWHGLIDODUJHQXPEHURIRWKHU
VLPLODUVWXGLHVLVGRQHRQWKHVDPHSRSXODWLRQ&RQILGHQFHLQWHUYDOVSURYLGHWKLVUDQJH
$JDLQLIWKLVUDQJHLQFOXGHVZHFDQQRWUHMHFWWKHQXOOK\SRWKHVLVWKDWDFWXDOO\WKHUH
LVQRUHDOFRUUHODWLRQ
7KHWZRH[WUHPHVRI&,DUHVRPHWLPHVSUHVHQWHGDVFRQILGHQFHOLPLWV+RZHYHUWKH
ZRUG³OLPLWV´VXJJHVWVWKDWWKHUHLVQRJRLQJEH\RQGDQGPD\EHPLVXQGHUVWRRGEHFDXVH
RIFRXUVHWKHSRSXODWLRQYDOXHZLOOQRWDOZD\VOLHZLWKLQWKHFRQILGHQFHLQWHUYDO,IZH
KDYHDFFHSWHGDFHUWDLQW\OHYHORIWKHQWKHUHLVVWLOODFKDQFHWKDWWKHUDQJHZLOO
JREH\RQGWKHFRQILGHQFHLQWHUYDO
8.8.4 Statistical power

$VWXG\GHVLJQHGWRILQGDGLIIHUHQFHRUDQDVVRFLDWLRQPD\ILQGQRVXFKGLIIHUHQFHRU
DVVRFLDWLRQ$OWHUQDWLYHO\LWPD\ILQGVXFKDGLIIHUHQFHEXWDSSOLFDWLRQRIWKHVWDWLVWLFDO
WHVWVKRZVWKDWWKHQXOOK\SRWKHVLVFDQQRWEHUHMHFWHG7KXVDQ\GLIIHUHQFHRUDVVRFLDWLRQ
IRXQGLQWKHVWXG\PD\EHGXHWRFKDQFHDQGQRLQIHUHQFHFDQEHPDGHIURPLW:HFDQQRW
DFFHSWWKLVFRQFOXVLRQZLWKRXWTXHVWLRQLQJZKHWKHUWKHVWXG\KDGWKHVWDWLVWLFDOSRZHU
WRLGHQWLI\DQHIIHFWLILWZDVWKHUH&DOFXODWLRQRIWKHVWDWLVWLFDOSRZHUKHOSVXVWRNQRZ
KRZOLNHO\D³PLVV´LVWRRFFXUDWDJLYHQHIIHFWVL]H
3RZHULVDQLPSRUWDQWFRQFHSWLQWKHLQWHUSUHWDWLRQRIQXOOUHVXOWV)RUH[DPSOH
LIFRPSDULVRQRIWZRWUHDWPHQWVGRHVQRWVKRZWKDWRQHLVVXSHULRUWRWKHRWKHUWKLV
PD\EHGXHWRODFNRISRZHULQWKHVWXG\$SRVVLEOHUHDVRQFRXOGEHDVPDOOVL]HRIWKH
VDPSOH
$VGLVFXVVHGLQ&KDSWHUVHFWLRQWKHVWDWLVWLFDOSRZHUIRUDJLYHQHIIHFWVL]H
LVGHILQHGVWDWLVWLFDOO\DVPLQXVSUREDELOLW\RIDPLVVLHW\SH,,HUURURUEHWD,WLV
FRPPRQO\EXWDUELWUDULO\VHWDW7KLVPHDQVWKDWZHDFFHSWDFKDQFHWKDWD
ILQGLQJRUDGLIIHUHQFHZLOOEHPLVVHG7KHVFLHQWLILFWUDGLWLRQLVWRDFFHSWDORZHUOHYHO
RIFHUWDLQW\IRUQRWPLVVLQJDILQGLQJZKHQLWLVWUXHWKDQIRUDFFHSWLQJDILQGLQJZKHQ
LWLVQRWWUXH7KLVFDQEHVHHQDVDQDQDORJ\WRWKHMXGLFLDOWUDGLWLRQWKDWFRQYLFWLQJDQ
LQQRFHQWGHIHQGDQWLVDZRUVHHUURUWKDQDTXLWWLQJDJXLOW\GHIHQGDQWDQGUHTXLUHVPRUH
FHUWDLQW\
8.9 Selection of statistical test

7KHUHDUHDODUJHQXPEHURIVWDWLVWLFDOWHVWVIRUDQDO\VLQJVFLHQWLILFGDWD6WDQGDUG
WH[WERRNVFDQEHFRQVXOWHGDERXWWKHW\SHRIVWDWLVWLFDOWHVWDQGWKHLUDSSOLFDWLRQVDQG
PHWKRGRORJ\7KHFRPSXWHUKDVIDFLOLWDWHGVWDWLVWLFDOZRUNWRDJUHDWGHJUHH$QXPEHU
RIVRIWZDUHSDFNDJHVDUHDYDLODEOHFRPPHUFLDODQGQRQFRPPHUFLDO0LFURVRIW([FHO
LVDSURJUDPFRPPRQO\LQFOXGHGLQFRPSXWHUVRIWZDUHSDFNDJHV(SL,QIRLVDVRIWZDUH
SURJUDPDYDLODEOHIUHHIURPWKH&HQWHUVIRU'LVHDVH&RQWURODQG3UHYHQWLRQ$WODQWD
86$ ZHE VLWH KWWSZZZFGFJRY ,W ZDV GHYHORSHG LQ FROODERUDWLRQ ZLWK WKH
:RUOG+HDOWK2UJDQL]DWLRQDVDZRUGSURFHVVLQJGDWDEDVHDQGVWDWLVWLFVV\VWHPIRU
HSLGHPLRORJ\WREHXVHGRQ,%0FRPSDWLEOHPLFURFRPSXWHUV7KHFRPPHUFLDOVWDWLVWLFDO
VRIWZDUHSDFNDJH6366SURYLGHVDJRRGEDODQFHRISRZHUIOH[LELOLW\DQGHDVHRIXVH
$QRWKHUFRPPRQO\XVHGSDFNDJHLV6$67KHUHDUHDOVRRWKHUSDFNDJHV
2QHGLVDGYDQWDJHRIFRPSXWHUL]DWLRQLVWKDWLWPD\JLYHLQYHVWLJDWRUVDEOLQGWUXVW
LQVWDWLVWLFVDVDQDFFXUDWHDQGSUHFLVHVFLHQFH6WDWLVWLFVLVEDVHGRQSUREDELOLWLHVDQG
QRWRQFHUWDLQWLHV6WDWLVWLFDOFDOFXODWLRQVDUHEDVHGWRDFHUWDLQH[WHQWRQDVVXPSWLRQV
$FRPSOH[VWDWLVWLFDOWHVWGRHVQRWQHFHVVDULO\PHDQDPRUHUREXVWWHVW$FRPSOH[WHVW
PD\KDYHWREHEDVHGRQPRUHDVVXPSWLRQVDQGWKHUHVXOWLQJHVWLPDWHVPD\EHOHVV
UDWKHUWKDQPRUHUREXVW
)RUODUJHVWXGLHVWKHDGYLFHDQGKHOSRIDSURIHVVLRQDOVWDWLVWLFLDQVKRXOGEHVRXJKW
IURPWKHEHJLQQLQJ%XWLWLVWKHLQYHVWLJDWRUZKRNQRZVWKHW\SHRIGDWDDQGWKHTXHVWLRQV
WREHDQVZHUHGDQGZKRPXVWIXOO\JUDVSWKHFRQFHSWVEHKLQGVWDWLVWLFDOFDOFXODWLRQV
DQGWKHPHDQLQJDQGOLPLWDWLRQVRIWKHH[HUFLVH,QYHVWLJDWRUVVKRXOGDOVRIDPLOLDUL]H
WKHPVHOYHVZLWKWHUPVXVHGE\VWDWLVWLFLDQVWREHDEOHWRFRPPXQLFDWHZHOOZLWKWKHP
7KH\VKRXOGDOVRXQGHUVWDQGWKHIDFWRUVWDNHQLQWRFRQVLGHUDWLRQE\VWDWLVWLFLDQVZKHQ
WKH\GHFLGHRQWKHDSSURSULDWHWHVWWREHXVHGDQGWKHFRPPRQORJLFEHKLQGWKHWHVWV
,QJHQHUDOWKHW\SHRIVWDWLVWLFDOWHVWWREHXVHGGHSHQGVRQW\SHRIGDWDWREHDQDO\VHG
KRZWKHGDWDDUHGLVWULEXWHGW\SHRIVDPSOHDQGWKHTXHVWLRQWREHDQVZHUHG
Type of data
6WDWLVWLFLDQVXVHFHUWDLQWHUPVLQGHVFULELQJWKHSURSHUWLHVRIWKHGDWDWREHDQDO\VHG
7KHW\SHRIGDWDLQIOXHQFHVWKHFKRLFHRIWKHVWDWLVWLFDOWHVWWREHXVHG
)RUWKHSXUSRVHVRIGDWDGHVFULSWLRQDQGVWDWLVWLFDODQDO\VLVGDWDDUHORRNHGDW
DVYDULDEOHV'DWDDUHFODVVLILHGDVHLWKHUQXPHULFDORUFDWHJRULFDO'DWDDUHFODVVLILHG
DVQXPHULFDOLIWKH\DUHH[SUHVVHGLQQXPEHUV1XPHULFDOGDWDPD\EHGLVFUHWHRU
FRQWLQXRXV&RQWLQXRXVYDULDEOHVDUHWKRVHZKLFKDUHPHDVXUHGRQDFRQWLQXRXVVFDOH
7KH\DUHQXPEHUVWKDWFDQEHDGGHGVXEWUDFWHGPXOWLSOLHGDQGGLYLGHG
&DWHJRULFDOYDULDEOHVDUHRQHVZKHUHHDFKLQGLYLGXDOLVRQHRIDQXPEHURIPXWXDOO\
H[FOXVLYHFODVVHV&DWHJRULFDOGDWDPD\EHQRPLQDORURUGLQDO,QQRPLQDOGDWDWKH
FDWHJRULHVFDQQRWEHRUGHUHGRQHDERYHDQRWKHU$QH[DPSOHRIFDWHJRULFDOQRPLQDO
YDULDEOHLVVH[PDOHRUIHPDOHRUPDULWDOVWDWXVPDUULHGQRWPDUULHGGLYRUFHG,Q
RUGLQDOGDWDWKHYDULDEOHVFDQEHRUGHUHGRQHDERYHDQRWKHU$QH[DPSOHRIRUGLQDO
FDWHJRULFDOGDWDLVWKHJUDGLQJRISDLQPLOGPRGHUDWHVHYHUHRUWKHVWDJLQJRIWXPRXUV
ILUVWVWDJHVHFRQGVWDJHWKLUGVWDJHIRXUWKVWDJH
$FRQWLQXRXVYDULDEOHPD\EHJURXSHGLQWRRUGHUHGFDWHJRULFDOYDULDEOHVIRU
H[DPSOHLQDJHJURXSV,QJURXSLQJFRQWLQXRXVYDULDEOHVFDUHVKRXOGEHWDNHQWKDWJURXSV
GRQRWRYHUODSIRUH[DPSOHDJHJURXSVRI±\HDUV±\HDUVHWF
7KHW\SHRIVWDWLVWLFDOWHVWDSSOLHGGHSHQGVRQZKHWKHUGHDOLQJZLWKQXPHULFDORU
FDWHJRULFDOGDWD
Distribution of the data

7KHGLVWULEXWLRQRIWKHGDWDLVLPSRUWDQWIRUWKHVWDWLVWLFLDQV'DWDIDOOLQDQRUPDO
GLVWULEXWLRQZKHQWKH\DUHVSUHDGHYHQO\DURXQGWKHPHDQDQGWKHIUHTXHQF\GLVWULEXWLRQ
FXUYHLVEHOOVKDSHGRU*DXVVLDQ)RUVXFKGDWDZKLFKDUHPRUHFRPPRQVWDWLVWLFLDQV
DSSO\ZKDWWKH\FDOOSDUDPHWULFWHVWVVWDWLVWLFV:KHQWKHGLVWULEXWLRQFXUYHLVVNHZHG
VWDWLVWLFLDQV XVH RWKHU W\SHV RI WHVWV FDOOHG QRQSDUDPHWULF RU GLVWULEXWLRQ IUHH
VWDWLVWLFV
Type of sample
7HVWVDOVRGLIIHUZKHQWKHGDWDZHUHREWDLQHGIURPLQGHSHQGHQWVXEMHFWVRUIURP
UHODWHGVDPSOHVVXFKDVWKRVHLQYROYLQJUHSHDWHGPHDVXUHPHQWVRIWKHVDPHVXEMHFWV7HVWV
IRUDQDO\VLVRISDLUHGDQGXQSDLUHGREVHUYDWLRQVDUHGLIIHUHQW%\SDLUHGREVHUYDWLRQV
ZHPHDQUHSHDWHGPHDVXUHPHQWVPDGHRQWKHVDPHVXEMHFWRUREVHUYDWLRQVPDGHRQ
VXEMHFWVDQGPDWFKHGFRQWUROV8QSDLUHGREVHUYDWLRQVDUHPDGHRQLQGHSHQGHQWVXEMHFWV
$GLIIHUHQWW\SHRIWHVWPD\DOVREHQHHGHGLIWKHVDPSOHVL]HLVVPDOO
Questions to be answered
6WDWLVWLFLDQVFDQRQO\ORRNIRUDQVZHUVWRTXHVWLRQVZKLFKWKHLQYHVWLJDWRUVSXWWR
WKHP7KH\PD\EHDVNHGWRORRNDWGLIIHUHQFHVEHWZHHQJURXSVRUIRUDQDVVRFLDWLRQ
6HOHFWLRQRIWKHDSSURSULDWHVWDWLVWLFDOWHVWIRUGLIIHUHQFHVEHWZHHQJURXSVZLOOGHSHQGRQ
ZKHWKHULQYHVWLJDWRUVDUHORRNLQJIRUDGLIIHUHQFHEHWZHHQWZRJURXSVRUDUHFRPSDULQJ
PRUHWKDQWZRJURXSV
,ILQYHVWLJDWRUVDUHORRNLQJIRUUHODWLRQVKLSDVVRFLDWLRQDQGFRUUHODWLRQVHOHFWLRQ
RIWKHVWDWLVWLFDOWHVWZLOOGHSHQGRQZKHWKHUWKH\DUHORRNLQJIRUDQDVVRFLDWLRQEHWZHHQ
RQO\WZRYDULDEOHVRUDUHLQWHUHVWHGLQPXOWLSOHYDULDEOHV8QLYDULDWHDQDO\VLVLVDVHW
RIPDWKHPDWLFDOWRROVWRDVVHVVWKHUHODWLRQVKLSEHWZHHQRQHLQGHSHQGHQWYDULDEOHDQG
RQHGHSHQGHQWYDULDEOH0XOWLYDULDWHDQDO\VLVDVVHVVHVWKHLQGHSHQGHQWFRQWULEXWLRQRI
PXOWLSOHLQGHSHQGHQWYDULDEOHVRQDGHSHQGHQWYDULDEOHDQGLGHQWLILHVWKRVHLQGHSHQGHQW
YDULDEOHVPRVWVLJQLILFDQWLQH[SODLQLQJWKHYDULDWLRQRIWKHGHSHQGHQWYDULDEOH,WDOVR
SHUPLWVFOLQLFDOUHVHDUFKHUVWRDGMXVWIRUGLIIHUHQFHVLQSDWLHQWFKDUDFWHULVWLFVZKLFKPD\
LQIOXHQFHWKHRXWFRPHRIWKHVWXG\/RJLVWLFUHJUHVVLRQLVDPHWKRGFRPPRQO\XVHGE\
VWDWLVWLFLDQVLQPXOWLYDULDWHDQDO\VLV
,ILQYHVWLJDWRUVDUHORRNLQJIRUDQHIIHFWRIRQHYDULDEOHRQDQRWKHUWKH\QHHGWR
GHFLGHRQZKHWKHUWKH\DUHORRNLQJWRWKHHIIHFWLQRQHH[SHFWHGGLUHFWLRQRQO\RUZLWKRXW
UHIHUHQFHWRDQH[SHFWHGGLUHFWLRQ7KHDOWHUQDWLYHK\SRWKHVLVRXWOLQLQJDUHODWLRQVKLS
PD\EHGLUHFWLRQDORUQRQGLUHFWLRQDO)RUH[DPSOHDUHODWLRQVKLSEHWZHHQVPRNLQJDQG
FDUGLRYDVFXODUGLVHDVHFDQRQO\EHGLUHFWLRQDO,WLVQRWH[SHFWHGLQWKHK\SRWKHVLVWKDWLW
PD\GHFUHDVHFDUGLRYDVFXODUGLVHDVH+RZHYHUWKHUHODWLRQVKLSEHWZHHQRUDOKRUPRQDO
FRQWUDFHSWLYHVDQGFHUWDLQGLVHDVHFRQGLWLRQVIRUH[DPSOHFDQEHQRQGLUHFWLRQDO7KH
GLVHDVHFRQGLWLRQVPD\LQFUHDVHRUGHFUHDVHDVDUHVXOWRIRUDOKRUPRQDOFRQWUDFHSWLYH
XVH7RWHVWDQRQGLUHFWLRQDOK\SRWKHVLVWKHVWDWLVWLFLDQZLOOQHHGWRXVHDWZRWDLOHG
WHVW8VXDOO\DODUJHUVDPSOHVL]HLVQHHGHGIRUDWZRWDLOHGWHVWFRPSDUHGZLWKDRQH
WDLOHGWHVW
8.10 Examples of some common statistical tests

7KHIROORZLQJWZRH[DPSOHVLOOXVWUDWHWKHFRQFHSWVEHKLQGWKHFDOFXODWLRQVPDGHLQ
VWDWLVWLFDOWHVWVDQGWKHORJLFRQZKLFKWKH\DUHEDVHG
The t test
7KHWWHVWLVXVHGIRUQXPHULFDOGDWDWRGHWHUPLQHZKHWKHUDQREVHUYHGGLIIHUHQFH
EHWZHHQWKHPHDQVRIWZRJURXSVFDQEHFRQVLGHUHGVWDWLVWLFDOO\VLJQLILFDQWLHXQOLNHO\
WREHGXHWRFKDQFH,WLVWKHSUHIHUUHGWHVWZKHQWKHQXPEHURIREVHUYDWLRQVLVIHZHUWKDQ
DQGFHUWDLQO\ZKHQWKH\DPRXQWWRRQO\RUOHVV$QH[DPSOHZRXOGEHDVWXG\RI
KHLJKWLQWZRJURXSVRIZRPHQRQHJURXSRIZRPHQGHOLYHUHGQRUPDOO\DQGWKHRWKHU
JURXSRIGHOLYHUHGE\&DHVDUHDQVHFWLRQ$GLIIHUHQFHLQWKHDYHUDJHKHLJKWLVIRXQG
EHWZHHQWKHWZRJURXSVDQGZHZDQWWRNQRZZKHWKHUWKHGLIIHUHQFHLVVLJQLILFDQWRULV
PRUHOLNHO\WREHGXHWRFKDQFH
7KHEDVLVRIWKHWWHVWLVWKHORJLFWKDWZKHQWKHGLIIHUHQFHEHWZHHQWKHWZRPHDQV
LVODUJHWKHYDULDELOLW\DPRQJGDWDLVVPDOODQGWKHVDPSOHVL]HLVUHDVRQDEO\ODUJHWKH
OLNHOLKRRGLVLQFUHDVHGWKDWWKHGLIIHUHQFHLVQRWDFKDQFHILQGLQJ$WYDOXHLVFDOFXODWHG
RQWKHEDVLVRIWKHGLIIHUHQFHEHWZHHQWKHWZRPHDQVDQGWKHYDULDELOLW\DPRQJWKHGDWD
XVLQJDVSHFLDOIRUPXOD
$VSHFLDOVWDWLVWLFDOWDEOHKDVEHHQGHYHORSHGWRSURYLGHDWKHRUHWLFDOWYDOXH
FRUUHVSRQGLQJRQRQHVLGHWRWKHVLJQLILFDQFHOHYHODQGRQWKHRWKHUVLGHWRWKHVL]H
RIWKHVDPSOHVWXGLHG7KHVLJQLILFDQFHOHYHO3YDOXHRUWKHSUREDELOLW\RIILQGLQJWKH
GLIIHUHQFHE\FKDQFHZKHQWKHUHLVQRUHDOGLIIHUHQFHLVVHWE\WKHLQYHVWLJDWRU$3YDOXH
RILVFRPPRQO\XVHG7KHVDPSOHVL]HXVHGE\VWDWLVWLFLDQVLVFDOOHG³GHJUHHVRI
IUHHGRP´)RUWKHWWHVWWKHQXPEHURIGHJUHHVRIIUHHGRPLVFDOFXODWHGDVWKHVXPRIWKH
WZRVDPSOHVL]HVPLQXV7KHFRQFHSWRIGHJUHHVRIIUHHGRPLVEDVHGRQWKHQRWLRQWKDW
VLQFHWKHWRWDORIYDOXHVLQHDFKVHWRIPHDVXUHPHQWVLVIL[HGWKHQDOOWKHPHDVXUHPHQWV
PLQXVRQHDUHIUHHWRKDYHDQ\YDOXH7KHODVWPHDVXUHPHQWKRZHYHUFDQRQO\KDYH
RQHYDOXHWKHYDOXHQHHGHGWREULQJWKHWRWDOWRWKHIL[HGWRWDOYDOXHRIWKHVXPRIDOO
PHDVXUHPHQWV
7KHFDOFXODWHGWYDOXHLVWKHQFRPSDUHGZLWKWKHWYDOXHDVREWDLQHGIURPWKHWDEOH
,IWKHFDOFXODWHGWYDOXHLVODUJHUWKDQWKHWDEOHWYDOXHZHFDQUHMHFWWKHQXOOK\SRWKHVLV
DWWKHOHYHORIVWDWLVWLFDOVLJQLILFDQFHWKDWZHFKRVH
7KHWWHVWZDVGHYHORSHGLQE\WKH%ULWLVKPDWKHPDWLFLDQ*RVVHWZKRZRUNHG
QRWIRUDQ\RIWKHSUHVWLJLRXVUHVHDUFKLQVWLWXWLRQVEXWIRUWKH*XLQQHVVEUHZHU\7KH
EUHZHU\HPSOR\HG*RVVHWWWRZRUNRXWVWDWLVWLFDOVDPSOLQJWHFKQLTXHVWKDWZRXOGLPSURYH
WKHTXDOLW\DQGUHSURGXFLELOLW\RILWVEHHUPDNLQJSURFHGXUHV*RVVHWWSXEOLVKHGKLVZRUN
XQGHUWKHQDPHRI³6WXGHQW´7KHWHVWLVVRPHWLPHVUHIHUUHGWRDVWKH6WXGHQWWHVW
Chi-square test (Ȥ2)

7KH&KLVTXDUHWHVWLVXVHGIRUFDWHJRULFDOGDWDWRILQGRXWZKHWKHUREVHUYHG
GLIIHUHQFHVEHWZHHQSURSRUWLRQVRIHYHQWVLQJURXSVPD\EHFRQVLGHUHGVWDWLVWLFDOO\
VLJQLILFDQW)RUH[DPSOHDVWXG\ORRNVDWDFOLQLFDOWULDOFRPSDULQJDQHZGUXJDJDLQVW
DVWDQGDUGGUXJ,QVRPHSDWLHQWVWKHGUXJVUHVXOWHGLQPDUNHGLPSURYHPHQW,QRWKHUV
WKH\UHVXOWHGLQVRPHLPSURYHPHQW,QDWKLUGJURXSWKHUHZDVQRLPSURYHPHQW7KH
SHUIRUPDQFHRIWKHWZRWHVWHGGUXJVZDVGLIIHUHQW&DQWKLVILQGLQJEHH[SODLQHGE\
FKDQFH"7KHORJLFLVWKDWLIWKHGLIIHUHQFHVZHUHODUJHDQGLIWKHVL]HRIWKHVDPSOHZDV
UHDVRQDEOHWKHOLNHOLKRRGWKDWWKHILQGLQJVDUHGXHWRFKDQFHZRXOGEHOHVV
,QFRPSOLDQFHZLWKWKHQXOOK\SRWKHVLVZHDVVXPHWKHUHLVQRGLIIHUHQFHDQG
FDOFXODWHWKHH[SHFWHGIUHTXHQF\IRUHDFKFHOOPDUNHGLPSURYHPHQWVRPHLPSURYHPHQW
DQGQRLPSURYHPHQWLIWKHUHZDVQRGLIIHUHQFHDPRQJWKHJURXSV7KHQZHFDOFXODWH
KRZGLIIHUHQWDUHWKHREVHUYHGUHVXOWVIURPWKHH[SHFWHGUHVXOWVLIWKHUHZDVQRGLIIHUHQFH
)URPWKLVXVLQJDVSHFLDOIRUPXODD&KLVTXDUHYDOXHLVWKHQFDOFXODWHG%HFDXVH
WKHGLIIHUHQFHVEHWZHHQWKHREVHUYHGDQGH[SHFWHGYDOXHVFDQEHPLQXVRUSOXVWKH
GLIIHUHQFHVKDYHWREHVTXDUHGEHIRUHVXPPLQJWKHPXSKHQFHWKHQDPHRIWKHWHVW
6WDWLVWLFLDQVKDYHGHYHORSHGDVSHFLDOVWDWLVWLFDOWDEOHWRILQGWKHWKHRUHWLFDO&KL
VTXDUHYDOXHFRUUHVSRQGLQJWRZKDW3YDOXHLVDFFHSWHGE\WKHLQYHVWLJDWRUXVXDOO\WDNHQ
DVDQGWRWKHVL]HRIWKHVDPSOHVWXGLHG
,IWKHFDOFXODWHG&KLVTXDUHYDOXHLVODUJHUWKDQWKHK\SRWKHWLFDOYDOXHREWDLQHGIURP
WKHWDEOHWKHQXOOK\SRWKHVLVFDQEHUHMHFWHGDWWKHVSHFLILHGOHYHORISUREDELOLW\
8.11 Description and analysis of results of qualitative

research
'HVFULSWLRQDQGDQDO\VLVRIUHVXOWVRITXDOLWDWLYHUHVHDUFKGLIIHUVIURPTXDQWLWDWLYH
GDWD3RSHHWDO4XDOLWDWLYHVWXGLHVDUHJHQHUDOO\QRWGHVLJQHGWREHUHSUHVHQWDWLYH
LQWHUPVRIVWDWLVWLFDOJHQHUDOL]DELOLW\7KH\GRQRWJDLQPXFKIURPDODUJHUVDPSOHVL]H
7KHWHUP³WUDQVIHUDELOLW\´RUH[WHUQDOYDOLGLW\GHVFULEHVWKHUDQJHDQGOLPLWDWLRQVIRU
DSSOLFDWLRQRIWKHVWXG\ILQGLQJVEH\RQGWKHFRQWH[WLQZKLFKWKHVWXG\ZDVGRQH
:KLOHTXDQWLWDWLYHDQDO\WLFDOUHVHDUFKVWDUWVZLWKWKHGHYHORSPHQWRIDUHVHDUFK
K\SRWKHVLVDQGWKHQWHVWVLWLQTXDOLWDWLYHUHVHDUFKK\SRWKHVHVDUHRIWHQJHQHUDWHGIURP
WKHDQDO\VLVRIGDWD
8QOLNHTXDQWLWDWLYHVWXGLHVTXDOLWDWLYHVWXGLHVGHDOZLWKWH[WXDOPDWHULDO'XULQJ
GDWDFROOHFWLRQWKHLQYHVWLJDWRUPD\EHWDNLQJQRWHVXVLQJDQDOUHDG\SUHSDUHGRXWOLQHRU
FKHFNOLVWRUXVLQJDXGLRWDSHV$XGLRWDSHVVKRXOGEHWUDQVFULEHGDVVRRQDVSRVVLEOHDIWHU
WKHLQWHUYLHZRUGLVFXVVLRQJURXS7UDQVFULSWVDQGQRWHVDUHWKHUDZGDWDRITXDOLWDWLYH
UHVHDUFK7KH\SURYLGHDGHVFULSWLYHUHFRUGRIWKHUHVHDUFKEXWWKH\QHHGWREHDQDO\VHG
DQGLQWHUSUHWHGDQRIWHQWLPHFRQVXPLQJDQGGHPDQGLQJWDVN$QDO\VLVRITXDOLWDWLYH
GDWDRIIHUVGLIIHUHQWFKDOOHQJHVIURPTXDQWLWDWLYHGDWD7KHGDWDRIWHQFRQVLVWRIDPDVV
RIQDUUDWLYHWH[W
Data immersion
7KHILUVWVWHSLQWKHDQDO\VLVRITXDOLWDWLYHGDWDLVIRUWKHLQYHVWLJDWRUWRIDPLOLDUL]H
KHUVHOIKLPVHOI FRPSOHWHO\ ZLWK WKH GDWD D SURFHVV FRPPRQO\ GHVFULEHG DV GDWD
LPPHUVLRQ7KLVPHDQVWKDWWKHUHVHDUFKHUVKRXOGUHDGDQGUHUHDGWKHQRWHVDQG
WUDQVFULSWVWREHFRPSOHWHO\IDPLOLDUZLWKWKHFRQWHQW7KLVVWHSGRHVQRWKDYHWRZDLW
WLOODOOWKHGDWDLVLQ,WPD\SURJUHVVDVWKHGDWDDUHEHLQJFROOHFWHG,WPD\HYHQKHOS
LQUHVKDSLQJWKHRQJRLQJGDWDFROOHFWLRQDQGIXUWKHUUHILQHPHQWRIWKHPHWKRGRORJ\
)DPLOLDUL]DWLRQZLWKWKHUDZGDWDKHOSVWKHLQYHVWLJDWRUVWRLGHQWLI\WKHLVVXHVWKHPHV
DQGFRQFHSWVIRUZKLFKGDWDQHHGWREHH[DPLQHGDQGDQDO\VHG
Coding of the data

7KHQH[WVWHSLVFRGLQJ,QDTXDQWLWDWLYHTXHVWLRQQDLUHFRGLQJLVGRQHLQQXPEHUV
,QTXDOLWDWLYHDQDO\VLVZRUGVSDUWVRIZRUGVRUFRPELQDWLRQRIZRUGVDUHXVHGWRIODJ
GDWDZKLFKFDQODWHUEHUHWULHYHGDQGSXWWRJHWKHU&RGHVDUHFDOOHGODEHOV3LWIDOOVLQ
FRGLQJVKRXOGEHDYRLGHG&RGLQJWRRPXFKFDQFRQFHDOLPSRUWDQWXQLI\LQJFRQFHSWV
&RGLQJWRROLWWOHPD\IRUFHWKHUHVHDUFKHUWRIRUFHQHZILQGLQJVLQWRH[LVWLQJFRGHVLQWR
ZKLFKWKH\GRQRWSHUIHFWO\ILW
0RGHUQFRPSXWHUVRIWZDUHFDQJUHDWO\HQKDQFHTXDOLWDWLYHDQDO\VLVWKURXJKEDVLF
GDWDPDQLSXODWLYHSURFHGXUHV7KHW\SHRIVRIWZDUHQHHGHGGHSHQGVRQWKHFRPSOH[LW\
RIWKHVWXG\)RUVRPHVWXGLHVDQDO\VLVFDQEHGRQHXVLQJDZRUGSURFHVVRUZLWKVHDUFK
FRS\DQGSDVWHWRROVDVZHOODVVSOLWVFUHHQIXQFWLRQV0RUHFRPSOH[VWXGLHVQHHG
VRIWZDUHVSHFLILFDOO\GHVLJQHGIRUTXDOLWDWLYHGDWDDQDO\VLV
)RUH[DPSOHLQVWHDGRIW\SLQJHYHU\FRGHLQWRFRPSXWHUVWRUHGWH[WWKHVSHFLDO
VRIWZDUHFDQNHHSDUHFRUGRIFRGHVFUHDWHGDQGDOORZVWKHLQYHVWLJDWRUWRVHOHFWIURP
DOUHDG\FUHDWHGFRGHVIURPGURSGRZQPHQXV$SDUWIURPIDFLOLWDWLQJWKHFRGLQJWKLV
DYRLGVPLVWDNHVLQW\SLQJWKHFRGHHDFKWLPHDQGKHOSVWRDVVHPEOHWH[WVHJPHQWVIRU
IXUWKHUDQDO\VLV,WPD\DOVRHQDEOHUHYLVLQJDXWRPDWLFDOO\DSDUWLFXODUFRGLQJODEHODFURVV
DOOSUHYLRXVO\FRGHGWH[W2QHFKDQJHLQWKHPDVWHUOLVWFKDQJHVDOORFFXUUHQFHVRIWKH
FRGH
$QRWKHUIXQFWLRQWKDWFDQEHSURYLGHGE\WKHVSHFLDOVRIWZDUHSURJUDPLVWKH
FRQVWUXFWLRQRIHOHFWURQLFLQGH[HVDQGFURVVLQGH[HV$QHOHFWURQLFLQGH[LVDZRUGOLVW
FRPSULVHGRIDOOVXEVWDQWLYHZRUGVLQWKHWH[WDQGWKHLUORFDWLRQVLQWHUPVRIVSHFLILF
WH[WOLQHQXPEHURUZRUGSRVLWLRQLQDOLQH2QFHWH[WVKDYHEHHQLQGH[HGLWLVHDV\
WRVHDUFKDQGILQGVSHFLILFZRUGVRUFRPELQDWLRQVRIZRUGVDQGWRPRYHWRWKHLUQH[W
RFFXUUHQFH
7KHVRIWZDUHSURJUDPPD\DOVRFRQVWUXFWK\SHUOLQNVLQWKHWH[WDOORZLQJFURVV
UHIHUHQFLQJRUOLQNLQJDSLHFHRIWH[WLQRQHILOHZLWKDQRWKHULQWKHVDPHRUGLIIHUHQWILOH
+\SHUOLQNVKHOSWRFDSWXUHWKHFRQFHSWXDOOLQNVREVHUYHGEHWZHHQVHFWLRQVRIWKHGDWD
ZKLOHSUHVHUYLQJWKHFRQWLQXLW\RIWKHQDUUDWLYH+\SHUOLQNVPD\DOVREHXVHIXOZKHQ
GLIIHUHQWIRFXVJURXSGLVFXVVLRQVKDYHEHHQFRQGXFWHG+\SHUOLQNVDOVRFDQUHODWHFRGHV
DQGWKHLUUHODWHGVHJPHQWVWRRQHDQRWKHU
'LIIHUHQWVRIWZDUHSDFNDJHVDUHDYDLODEOH7KH&HQWHUVIRU'LVHDVH&RQWURODQG
3UHYHQWLRQ&'&$WODQWD86$KDVGHYHORSHGSDFNDJHVZKLFKDUHIUHHDQGDYDLODEOH
RQOLQHIURPLWVZHEVLWHKWWSZZZFGFJRY&RPPHUFLDOVRIWZDUHLVDOVRDYDLODEOH
Coding sort
7KHQH[WVWHSDIWHUFRGLQJLVWRFRQGXFWD³FRGLQJVRUWÉ\FROOHFWLQJVLPLODUO\
FRGHGEORFNVRIWH[WLQQHZGDWDILOHV&RGLQJVRUWVFDQEHGRQHPDQXDOO\XVLQJ
KLJKOLJKWLQJDQGFXWDQGSDVWHWHFKQLTXHVZLWKVLPSOHZRUGSURFHVVLQJVRIWZDUHRU
FDQEHGRQHZLWKTXDOLWDWLYHGDWDDQDO\VLVVRIWZDUH$IWHUH[WUDFWLQJDQGFRPELQLQJDOO
WKHLQIRUPDWLRQRQDWKHPHLQDFRGLQJVRUWWKHLQYHVWLJDWRUZLOOEHUHDG\IRUDFORVH
H[DPLQDWLRQRIWKHGDWD
3XWWLQJTXDOLWDWLYHGDWDLQWDEOHVDQGILJXUHVLVRIWHQFDOOHG³GDWDUHGXFWLRQ´$
WDEOHWKDWFRQWDLQVZRUGVQRWQXPEHUVDVLQTXDQWLWDWLYHUHVHDUFKLVFDOOHGD³PDWUL[´$
PDWUL[HQDEOHVWKHUHVHDUFKHUWRDVVHPEOHDORWRIUHODWHGVHJPHQWVRIWH[WLQRQHSODFH
WRUHGXFHDFRPSOLFDWHGGDWDVHWWRDPDQDJHDEOHVL]H6RPHVRIWZDUHSDFNDJHVPDNH
LWHDV\WRGHYHORSVXFKPDWULFHV7KH\FDQDOVREHGHYHORSHGPDQXDOO\6RPHWLPHV
TXDOLWDWLYHGDWDFDQEHFDWHJRUL]HGFRXQWHGDQGGLVSOD\HGLQWDEOHV$QVZHUVWRRSHQ
HQGHGTXHVWLRQVLQTXHVWLRQQDLUHVFDQRIWHQEHFDWHJRUL]HGDQGVXPPDUL]HGLQDWDEOH
)RUTXDOLWDWLYHGDWDDGLDJUDPLVRIWHQDILJXUHZLWKER[HVRUFLUFOHVFRQWDLQLQJYDULDEOHV
DQGDUURZVLQGLFDWLQJWKHUHODWLRQVKLSEHWZHHQWKHYDULDEOHV)ORZFKDUWVDUHVSHFLDO
W\SHVRIGLDJUDPVWKDWH[SUHVVWKHORJLFDOVHTXHQFHRIDFWLRQVRUGHFLVLRQV

Briscoe MH. A researcher’s guide to scientific and medical illustrations. New York,
Springer-Verlag, 1990.
Browner WS et al. Getting ready to estimate sample size: hypotheses and underlying
principles. In: Hulley SB, Cummings SR, eds. Designing clinical research: an epidemiologic
Gardner MJ, Altman DG. Statistics with confidence: confidence intervals and statistical
guidelines. London, BMJ Books, 1997.
Gehlbach SH. Interpreting the medical literature. 3rd edition. New York, McGraw-Hill Inc.,
1993: 138.
Hill AB. Principles of medical statistics, 9th edition. New York, Oxford University Press,
1971.
Malterad K. Qualitative research: standards, challenges, and guidelines. Lancet, 2001,
358: 483–88.
Medawar PB. Advice to a young scientist. New York, Basic Books, 1979: 39.
Pope C, Ziebland S, Mays V. Qualitative research in health care: Analysing qualitative
data. British Medical Journal, 2000, 320:114–116.
Swinscow TDV, Campbell MJ. Statistics at square one. 10th edition. London, BMJ Books,
2002.
Weaver JH. Conquering statistics: numbers without the crunch. Cambridge, Massachusetts,
Perseus Publishing, 2000: 5–12.
Chapter 9
Interpreting research results
9.1 Introduction
5HVHDUFKHUVVKRXOGGHVFULEHWKHLUUHVXOWVFOHDUO\DQGLQDZD\WKDWRWKHUUHVHDUFKHUV
FDQFRPSDUHWKHPZLWKWKHLURZQUHVXOWV7KH\VKRXOGDOVRDQDO\VHWKHUHVXOWVXVLQJ
DSSURSULDWHVWDWLVWLFDOPHWKRGVWRWU\WRGHWHUPLQHWKHSUREDELOLW\WKDWWKH\PD\KDYH
EHHQFKDQFHILQGLQJVDQGPD\QRWEHUHSOLFDEOHLQODUJHUVWXGLHV%XWWKLVLVQRWHQRXJK
5HVXOWVQHHGWREHLQWHUSUHWHGLQDQREMHFWLYHDQGFULWLFDOZD\EHIRUHDVVHVVLQJWKHLU
LPSOLFDWLRQVDQGEHIRUHGUDZLQJFRQFOXVLRQV,QWHUSUHWDWLRQRIUHVHDUFKUHVXOWVLVQRWMXVWD
FRQFHUQIRUUHVHDUFKHUV+HDOWKSURIHVVLRQDOVUHDGLQJRUKHDULQJUHVHDUFKUHVXOWVVKRXOG
EHDEOHWKHPVHOYHVWRLQWHUSUHWWKHPFRUUHFWO\DQGWRDVVHVVWKHLULPSOLFDWLRQVIRUWKHLU
ZRUN3ROLF\PDNHUVVKRXOGDOVREHDZDUHRIWKHSRVVLEOHSLWIDOOVLQLQWHUSUHWLQJUHVHDUFK
UHVXOWVDQGVKRXOGEHFDXWLRXVLQGUDZLQJFRQFOXVLRQVIRUSROLF\GHFLVLRQV
9.2 Interpreting descriptive statistics

7KHPHDQRUDYHUDJHLVRQO\PHDQLQJIXOLIWKHGDWDIDOOLQWRDQRUPDOGLVWULEXWLRQ
FXUYHWKDWLVWKH\DUHHYHQO\GLVWULEXWHGDURXQGWKHPHDQ7KHPHDQRUDYHUDJHE\
LWVHOIKDVDOLPLWHGYDOXH7KHUHLVDQDQHFGRWHDERXWDPDQKDYLQJRQHIRRWRQLFHDQG
WKHRWKHULQERLOLQJZDWHUVWDWLVWLFDOO\VSHDNLQJRQDYHUDJHKHLVSUHWW\FRPIRUWDEOH
7KHUDQJHRIWKHGDWDDQGWKHLUGLVWULEXWLRQH[SUHVVHGLQWKHVWDQGDUGGHYLDWLRQPXVW
EHNQRZQ,WLVVRPHWLPHVPRUHLPSRUWDQWWRNQRZWKHQXPEHURUSHUFHQWDJHRIVXEMHFWV
RUYDOXHVWKDWDUHDEQRUPDOWKDQWRNQRZWKHPHDQ
'HVFULSWLYHVWDWLVWLFVFDQQRWEHXVHGWRGHILQHGLVHDVH7KHDYHUDJHVKRXOGQRWEH
WDNHQWRLQGLFDWHWKH³QRUPDO´7KHVWDQGDUGGHYLDWLRQVKRXOGQRWEHXVHGDVDGHILQLWLRQ
RI³QRUPDOÚDQJH7RDOORZDFXWRIISRLQWLQDVWDWLVWLFDOGLVWULEXWLRQWRGHILQHDGLVHDVH
LVZURQJ7KLVLVSDUWLFXODUO\LPSRUWDQWLQODERUDWRU\GDWDZKHUHWKHUDQJHRIQRUPDOLV
RIWHQEDVHGRQPHDVXUHPHQWVLQDODUJHQXPEHURIKHDOWK\SHRSOH7KHVWDQGDUGGHYLDWLRQ
LVEDVHGRQWKHYDOXHVLQRIWKHDSSDUHQWO\QRUPDOKHDOWK\SHRSOH2XWO\LQJYDOXHV
DUHFRQVLGHUHGDEQRUPDOWKRXJKWKH\GRQRWLQGLFDWHGLVHDVH:LWKWKHPRGHUQWHQGHQF\
RIXVLQJDODUJHEDWWHU\RIODERUDWRU\WHVWVIRUHDFKSDWLHQWWKHOLNHOLKRRGRIVRFDOOHG
DEQRUPDOYDOXHVEHFRPHVKLJK)RUH[DPSOHZKHQRIHDFKRIELRFKHPLFDO
GHWHUPLQDWLRQVLQKHDOWK\SHRSOHDUHURXWLQHO\FODVVLILHGDVGHYLDQWWKHOLNHOLKRRGWKDW
Interpreting research results 107
DQ\QRQGLVHDVHGLQGLYLGXDOZLOOKDYHDOOGHWHUPLQDWLRQVUHSRUWHGDVQRUPDOZLOOEH
RQO\*HKOEDFK*UDSKVPD\GLVWRUWWKHYLVXDOLPSUHVVLRQRIUHODWLRQVKLSV
LIWKHVFDOHRQWKH[DQG\D[HVLVSXWLQGLIIHUHQWZD\V$QDVVRFLDWLRQRUFRUUHODWLRQ
GRHVQRWPHDQFDXVDWLRQ$QDVVRFLDWLRQRUFRUUHODWLRQQHHGVH[SODQDWLRQ%HFDXVHRI
WKHLPSRUWDQFHRIWKLVTXHVWLRQLWZLOOEHGHDOWZLWKLQGHWDLOLQDQRWKHUVHFWLRQLQWKLV
FKDSWHU
9.3 Interpreting “statistical significance”

$OEHUW(LQVWHLQVDLG³1RWHYHU\WKLQJWKDWFDQEHFRXQWHGFRXQWVDQGQRWHYHU\WKLQJ
WKDWFRXQWVFDQEHFRXQWHG´$VWDWLVWLFDOO\VLJQLILFDQWILQGLQJVLPSO\PHDQVWKDWLWLV
SUREDEO\FDXVHGE\VRPHWKLQJRWKHUWKDQFKDQFH6LJQLILFDQWGRHVQRWPHDQLPSRUWDQW
7RDOORZSURSHULQWHUSUHWDWLRQH[DFW3YDOXHVVKRXOGEHSURYLGHGDVZHOODVWKH
VWDWLVWLFDOWHVWXVHG7KHWHUP³RUSKDQHG´3YDOXHVLVXVHGWRGHVFULEH3YDOXHVSUHVHQWHG
ZLWKRXWLQGLFDWLRQRIWKHVWDWLVWLFDOWHVWXVHG
6WDWLVWLFDOWHVWVQHHGWREHNHSWLQSURSHUSHUVSHFWLYH7KHVL]HRIWKH3YDOXHVKRXOG
QRWEHWDNHQDVDQLQGLFDWLRQRIWKHLPSRUWDQFHRIWKHUHVXOW7KHLPSRUWDQFHRIWKHUHVXOW
GHSHQGVRQWKHUHVXOWLWVHOIDQGLWVLPSOLFDWLRQ5HVXOWVPD\EHVWDWLVWLFDOO\VLJQLILFDQW
EXWRIOLWWOHRUQRLPSRUWDQFH$WWDFKLQJDIDQF\3YDOXHWRWULYLDOREVHUYDWLRQVGRHV
OLWWOHWRHQKDQFHWKHLULPSRUWDQFH$VWDWLVWLFDOO\VLJQLILFDQWRUHYHQDKLJKO\VLJQLILFDQW
GLIIHUHQFHGRHVQRWQHFHVVDULO\PHDQDFOLQLFDOO\LPSRUWDQWILQGLQJ$GLIIHUHQFHLVD
GLIIHUHQFHRQO\LILWPDNHVDGLIIHUHQFH
'LIIHUHQFHVPD\QRWEHVWDWLVWLFDOO\VLJQLILFDQWEXWPD\VWLOOEHLPSRUWDQW7KH
GLIIHUHQFHVPD\EHUHDOEXWEHFDXVHRIWKHVPDOOVL]HRIWKHVDPSOHWKH\DUHQRW
VWDWLVWLFDOO\VLJQLILFDQW$3YDOXHLQWKHQRQVLJQLILFDQWUDQJHWHOOV\RXWKDWHLWKHUWKHUH
LVQRGLIIHUHQFHRUWKDWWKHQXPEHURIVXEMHFWVLVQRWODUJHHQRXJKWRVKRZWKHGLIIHUHQFH
$VGLVFXVVHGLQ&KDSWHUWKHVWXG\PD\QRWKDYHKDGWKHSRZHUWRVKRZDQHIIHFWRI
WKDWVL]H
9.4 Bias
$OOVWXGLHVDUHSRWHQWLDOO\VXEMHFWWRELDVOLWHUDOO\GHILQHGDVV\VWHPDWLFGHYLDWLRQ
IURPWKHWUXWK%LDVLVDV\VWHPDWLFHUURULQFRQWUDVWWRDUDQGRPHUURUGXHWRFKDQFH
7KHHIIHFWRIELDVLVFDOOHG³OLNHLVQRORQJHUFRPSDUHGZLWKOLNH´%LDVKDVDGLUHFWLRQ
,WHLWKHULQFUHDVHVRUGHFUHDVHVWKHHVWLPDWHEXWFDQQRWGRERWK7KLVLVLQFRQWUDVWWR
FKDQFHILQGLQJVWKDWFDQKDYHDQ\HIIHFWRQWKHHVWLPDWH
,IWKHVWXG\VDPSOHLVQRWUHSUHVHQWDWLYHRIWKHSRSXODWLRQWKHLQIHUHQFHZHPDNH
IURPWKHUHVXOWPD\EHPLVOHDGLQJ$QDO\WLFDOVWDWLVWLFVZLOOEHRIQRKHOSLIWKHVDPSOH
LVQRWUHSUHVHQWDWLYH$QDO\WLFDOVWDWLVWLFVFDQQRWFRUUHFWRXUPLVWDNHVLQGHVLJQLQJWKH
VWXG\(YHU\DWWHPSWVKRXOGEHPDGHLQWKHGHVLJQRIWKHVWXG\WRHQVXUHWKDWWKHVDPSOH
LVUHSUHVHQWDWLYH%LDVFDQQRWEHDGGUHVVHGRUFRUUHFWHGE\VWDWLVWLFV7KHPDLQSURWHFWLRQ
LVWRWKLQNRIWKHSRVVLELOLW\RIWKHELDVDQGGHVLJQLWRXW8VLQJVRSKLVWLFDWHGFRPSXWHU
SURJUDPVGRHVQRWJXDUDQWHHWKHYDOLGLW\RIWKHVWXG\,QFRPSXWHUMDUJRQWKH\VD\
³JDUEDJHLQJDUEDJHRXW´,I\RXIHHGWKHFRPSXWHUZLWKWKHZURQJLQIRUPDWLRQ\RX
ZLOOJHWDZURQJRXWFRPH,IWKHSRVVLELOLW\RIELDVFDQQRWEHDYRLGHGFRPSOHWHO\LQWKH
SODQQLQJRIWKHVWXG\WKHLQYHVWLJDWRUVPXVWSRLQWWKLVRXWZKHQWKH\SUHVHQWWKHILQGLQJV
RIWKHVWXG\%LDVFDQRFFXUZKHQJURXSVEHLQJFRPSDUHGGLIIHUV\VWHPDWLFDOO\LQDZD\
WKDWLVUHODWHGWRWKHRXWFRPH0DLQW\SHVRIELDVFDQRFFXUDWWZROHYHOVDWWKHOHYHO
RIVHOHFWLRQRIVXEMHFWVVHOHFWLRQELDVDQGDWWKHOHYHORIFROOHFWLQJWKHLQIRUPDWLRQ
LQIRUPDWLRQRUPHDVXUHPHQWELDV
6HOHFWLRQELDVLVDV\VWHPDWLFGLIIHUHQFHEHWZHHQVXEMHFWVVHOHFWHGIRUDVWXG\DQG
WKRVHZKRDUHQRWVHOHFWHG/RVVWRIROORZXSFDQFDXVHDVHOHFWLRQELDV$WWULWLRQLV
WKHWHUPXVHGIRUUHGXFWLRQLQWKHQXPEHURIVXEMHFWVZKRUHPDLQLQDVWXG\$WWULWLRQ
ELDVRFFXUVZKHQWKHVXEMHFWVZKRGURSRXWRIDVWXG\DUHV\VWHPDWLFDOO\GLIIHUHQWIURP
WKRVHZKRFRPSOHWHWKHVWXG\)RUH[DPSOHWKRVHZKRGHYHORSFRPSOLFDWLRQVRUVLGH
HIIHFWVPD\EHPRUHOLNHO\WRGURSRXWRIWKHVWXG\5HVSRQVHELDVLVDVSHFLILFW\SH
RIVHOHFWLRQELDVLQZKLFKUHVSRQGHQWVGLIIHUV\VWHPDWLFDOO\IURPQRQUHVSRQGHQWVWRD
TXHVWLRQQDLUH
0HDVXUHPHQWRULQIRUPDWLRQELDVRFFXUVZKHQWKHPHWKRGVRIPHDVXUHPHQWRU
REWDLQLQJLQIRUPDWLRQDUHFRQVLVWHQWO\GLVVLPLODULQGLIIHUHQWJURXSVRISDWLHQWV2QH
W\SHLVUHFDOOELDV,WLVHQFRXQWHUHGIRUH[DPSOHZKHQSHRSOHZLWKDFHUWDLQFRQGLWLRQ
DUHPRUHOLNHO\WRUHPHPEHUH[SRVXUHWRWKHYDULDEOHXQGHUVWXG\WKDQSHRSOHZLWKRXW
WKHFRQGLWLRQ$QH[DPSOHLVLIDVWXG\WULHVWRFRPSDUHWKHIUHTXHQF\RISDVWRUDO
FRQWUDFHSWLYHXVHDPRQJZRPHQDGPLWWHGWRKRVSLWDOEHFDXVHRIWKURPERSKOHELWLV
DQGDJURXSRIZRPHQDGPLWWHGIRURWKHUUHDVRQV,WLVHQWLUHO\SRVVLEOHWKDWZRPHQ
ZLWKWKURPERSKOHELWLVLIDZDUHRIWKHUHSRUWHGDVVRFLDWLRQEHWZHHQRHVWURJHQVDQG
WKURPERWLFHYHQWVPLJKWUHSRUWXVHRIRUDOFRQWUDFHSWLYHVPRUHFRPSOHWHO\WKDQZRPHQ
ZLWKRXWWKURPERSKOHELWLV$VSHFLDOW\SHRILQIRUPDWLRQELDVLVVXUYHLOODQFHRUGLDJQRVWLF
VXVSLFLRQELDVHQFRXQWHUHGZKHQSDWLHQWVZLWKDULVNIDFWRUPD\EHWHVWHGIRUWKHRXWFRPH
PRUHIUHTXHQWO\DQGFDUHIXOO\WKDQWKRVHZLWKRXWWKHULVNIDFWRU)RUH[DPSOHZRPHQ
XVLQJKRUPRQDOFRQWUDFHSWLYHVPD\EHVFUHHQHGPRUHIUHTXHQWO\DQGPRUHFDUHIXOO\
IRUQHRSODVLDRIWKHXWHULQHFHUYL[WKDQRWKHUZRPHQOHDGLQJWRWKHGLDJQRVLVRIPRUH
FDVHV
9.5 Confounding
,QVLPSOHWHUPVFRQIRXQGHUVDUHDOORIWKH³RWKHUWKLQJV´WKDWFRXOGH[SODLQWKH
UHVXOWRIWKHUHVHDUFK$FDUHIXOLQYHVWLJDWRUVKRXOGORRNIRUDOOSRVVLEOHH[SODQDWLRQVRI
WKHUHVXOWVEHIRUHPDNLQJDFRQFOXVLRQ,QJRRGVFLHQWLILFWKLQNLQJRQHVKRXOGQRWWU\WR
DVVXPHRQHLQWHUSUHWDWLRQRIWKHUHVXOWVZKHQRWKHULQWHUSUHWDWLRQVDUHDOVRSRVVLEOH
)RUH[DPSOHDVWXG\PD\ILQGWKDWWKHULVNRIOXQJFDQFHULVPRUHLQPDQXDOZRUNHUV
$JRRGLQYHVWLJDWRUZLOOQRWDVVXPHWKDWPDQXDOZRUNSUHGLVSRVHVWROXQJFDQFHUEHIRUH
ORRNLQJIRURWKHUSRVVLEOHH[SODQDWLRQV7KHUHVXOWPD\IRUH[DPSOHEHGXHWRDIDFWWKDW
PDQXDOZRUNHUVDUHPRUHOLNHO\WRVPRNHDQGLWLVVPRNLQJQRWPDQXDOZRUNZKLFKLV
DVVRFLDWHGZLWKOXQJFDQFHU
$QRWKHUH[DPSOHLVZKHQDQDVVRFLDWLRQLVUHSRUWHGEHWZHHQKHUSHVYLUXVLQIHFWLRQ
DQGFHUYLFDOFDQFHU%RWKKHUSHVYLUXVDQGDQXPEHURIRWKHULQIHFWLRXVDJHQWVZKLFK
PD\SRVVLEO\FDXVHFHUYLFDOFDQFHUDUHWUDQVPLWWHGE\VH[XDOFRQWDFW7KHUHLVVWURQJ
HYLGHQFHWKDWKXPDQSDSLOORPDYLUXVLQIHFWLRQOHDGVWRFHUYLFDOFDQFHU,WFRXOGEHWKDW
WKHKLJKHUSUHYDOHQFHRIKHUSHVYLUXVLQIHFWLRQLQZRPHQZLWKFHUYLFDOFDQFHULVRQO\D
FRQVHTXHQFHRIJUHDWHUVH[XDODFWLYLW\DQGVRLVLQGLUHFWO\UHODWHGWRDWUXHFDXVHZKLFK
LVDOVRWUDQVPLWWHGVH[XDOO\
7KHUHDUHWKUHHZD\VWRGHDOZLWKFRQIRXQGLQJWRWKLQNRILWLQSODQQLQJDQGGHVLJQLQJ
WKHVWXG\WRPHDVXUHUHFRUGWKHSUHVHQFHRIWKHFRQIRXQGHUGXULQJLPSOHPHQWDWLRQRI
WKHVWXG\DQGWRDOORZIRULWLQWKHDQDO\VLV
7KHFDVHPL[RUSDWLHQWPL[ZKLFKUHIHUVWREDVHOLQHGLIIHUHQFHVDPRQJUHVHDUFK
VXEMHFWVFDQEHDFRQIRXQGLQJIDFWRU0DWFKLQJLVDQLPSRUWDQWWHFKQLTXHIRUFUHDWLQJ
DFRQWUROJURXSE\SDLULQJVXEMHFWVEDVHGRQRQHRUPRUHFRQIRXQGLQJIDFWRUV$Q
DOWHUQDWLYHLVWRXVHWKHFRQWUROWDEOHPHWKRGLQZKLFKVWUDWLILFDWLRQLVGRQHDIWHUZDUGV
5DWKHUWKDQDUUDQJLQJVXEMHFWVE\JURXSVDVWKHVWXG\LVGHVLJQHGUHVXOWVDUHFDOFXODWHG
ZLWKLQVSHFLILHGVXEGLYLVLRQV:KHQPRUHWKDQDIHZFRQIRXQGLQJYDULDEOHVDUHSUHVHQW
WKHVWDWLVWLFDOWHFKQLTXHRIPXOWLYDULDWHDQDO\VLVLVXVHG
$VDQH[DPSOHRIDQDO\VLVIRUFRQIRXQGLQJIDFWRUVZHPD\ORRNDWDVWXG\RIWKH
UHODWLRQVKLSEHWZHHQWKHZRUNLQJVWDWXVRIPRWKHUVDQGWKHGXUDWLRQRIEUHDVWIHDGLQJ
7KHVWXG\PD\VKRZWKDWZRPHQZKRDUHHPSOR\HGIXOOWLPHDUHOHVVOLNHO\WREUHDVWIHHG
IRUDORQJGXUDWLRQWKDQZRPHQZKRDUHHPSOR\HGSDUWWLPHDQGZRPHQZKRDUHQRW
HPSOR\HG+RZHYHUWKHOHYHORIHGXFDWLRQRIWKHPRWKHUPD\EHDFRQIRXQGLQJYDULDEOH
VLQFHLWFDQDIIHFWWKHRXWFRPHGXUDWLRQRIEUHDVWIHHGLQJDQGLWPD\FRUUHODWHZLWKWKH
ZRUNLQJVWDWXV%HIRUHEODPLQJZRUNIRUWKHVKRUWHUGXUDWLRQRIEUHDVWIHHGLQJWKHUH
LVDQHHGWRFRQVLGHUWKHFRQIRXQGLQJIDFWRURIHGXFDWLRQ6WUDWLILFDWLRQPD\EHXVHG
$FURVVWDEXODWLRQWDEOHPD\EHFRQVWUXFWHGIRUPRWKHUVDWGLIIHUHQWHGXFDWLRQDOOHYHOV
IRUH[DPSOHWKRVHZKRKDGQRVFKRROLQJOHVVWKDQ\HDUVRIVFKRROLQJ±\HDUVDQG
\HDUVRUPRUH)RUHDFKWDEOHZHORRNDWGXUDWLRQRIEUHDVWIHHGLQJLQPRWKHUVZKR
DUHHPSOR\HGIXOOWLPHHPSOR\HGSDUWWLPHDQGQRWHPSOR\HG$QDOWHUQDWLYHZD\RI
FRQVLGHULQJWKLVFRQIRXQGLQJIDFWRULVPDWFKLQJDWWKHGHVLJQDQGLPSOHPHQWDWLRQSKDVH
)RUHDFKHPSOR\HGPRWKHUZLWKOHVVWKDQ\HDUVRIVFKRROLQJZHZRXOGFKRRVHDQRQ
HPSOR\HGPRWKHUZLWKDVLPLODUHGXFDWLRQDOOHYHO
&UXGHUDWHVDUHWKHWHUPVXVHGZKHQUHVXOWVKDYHQRWEHHQDGMXVWHGIRUFRQIRXQGLQJ
IDFWRUV$GMXVWHGUDWHVDUHWKHWHUPVXVHGZKHQUHVXOWVKDYHXQGHUJRQHVWDWLVWLFDO
WUDQVIRUPDWLRQWRSHUPLWIDLUFRPSDULVRQEHWZHHQJURXSVGLIIHULQJLQVRPHFKDUDFWHULVWLF
WKDWPD\DIIHFWULVNRIGLVHDVH
9.6 Making the case for causation

7KHDVVRFLDWLRQRIWZRYDULDEOHVGRHVQRWQHFHVVDULO\PHDQFDXVDWLRQDQGVKRXOG
QRWEHLQWHUSUHWHGDVDFDXVDOUHODWLRQVKLS+LVWRULFDOO\VFLHQWLVWVKDGWRVWUXJJOHZLWK
WKLVLVVXHLQWKHHDUO\GD\VZKHQPLFURELRORJLVWVEHJDQWRGLVFRYHUDQGUHSRUWRQWKH
DVVRFLDWLRQRIFHUWDLQPLFURRUJDQLVPVZLWKVRPHGLVHDVHFRQGLWLRQV,Q.RFK
VWLSXODWHGWKDWIRUDQLQIHFWLRXVDJHQWWREHFRQVLGHUHGWKHFDXVHRIDGLVHDVHWKH
IROORZLQJFULWHULDPXVWEHHVWDEOLVKHG
WKHRUJDQLVPPXVWEHSUHVHQWLQHYHU\FDVHRIWKHGLVHDVH
WKHRUJDQLVPPXVWEHLVRODWHGDQGJURZQLQSXUHFXOWXUH
WKHRUJDQLVPPXVWFDXVHDVSHFLILFGLVHDVHZKHQLQRFXODWHGLQWRDQDQLPDODQG
WKHRUJDQLVPPXVWWKHQEHUHFRYHUHGIURPWKHDQLPDODQGLGHQWLILHG
$IDOVHDSSHDUDQFHRIDVVRFLDWLRQFDQRFFXUWKURXJKWKUHHPHFKDQLVPVFKDQFHELDV
RUFRQIRXQGLQJ%XWHYHQDIWHUH[FOXGLQJWRWKHEHVWRIRXUHIIRUWWKHSRVVLELOLWLHVRI
FKDQFHELDVDQGFRQIRXQGLQJYDULDEOHVRWKHUFULWHULDDUHQHHGHGWRWXUQDQDVVRFLDWLRQ
LQWRFDXVDWLRQ6LU$XVWLQ%UDGIRUG+LOOSURSRVHGDVHWRIIHDWXUHVWKDWVKRXOGEHVRXJKW
ZKHQGHFLGLQJZKHWKHUDUHODWLRQVKLSLVFDXVDORUMXVWDQDVVRFLDWLRQ+LOO7KH\
DUHVWLOOYDOLGDQGDUHUHIHUUHGWRDVWKH%UDGIRUG+LOOFULWHULD
VWUHQJWKRIWKHDVVRFLDWLRQ
FRQVLVWHQF\RIWKHREVHUYHGHYLGHQFH
VSHFLILFLW\RIWKHUHODWLRQVKLS
WHPSRUDOLW\RIWKHUHODWLRQVKLS
ELRORJLFDOJUDGLHQWRIWKHGRVH±UHVSRQVH
ELRORJLFDOSODXVLELOLW\
FRKHUHQFHRIWKHHYLGHQFH
H[SHULPHQWDOFRQILUPDWLRQ
UHDVRQLQJE\DQDORJ\
6WUHQJWKRIWKHDVVRFLDWLRQ$VWURQJDVVRFLDWLRQEHWZHHQDSXUSRUWHGFDXVHDQGHIIHFW
DVH[SUHVVHGIRUH[DPSOHE\DODUJHUHODWLYHRUDEVROXWHULVNLVEHWWHUHYLGHQFHIRUD
FDXVDOUHODWLRQVKLSWKDQDZHDNDVVRFLDWLRQ
&RQVLVWHQF\RIWKHREVHUYHGHYLGHQFH:KHQVHYHUDOVWXGLHVFRQGXFWHGDWGLIIHUHQW
WLPHVLQGLIIHUHQWVHWWLQJVDQGZLWKGLIIHUHQWNLQGVRISDWLHQWVDOOFRPHWRWKHVDPH
FRQFOXVLRQHYLGHQFHIRUDFDXVDOUHODWLRQVKLSLVVWUHQJWKHQHG
6SHFLILFLW\ RI WKH UHODWLRQVKLS 6SHFLILFLW\ RQH FDXVH RQH HIIHFW LV PRUH RIWHQ
IRXQGIRUDFXWHGLVHDVHV%XWIRURWKHUGLVHDVHVWKHUHDUHRIWHQPDQ\FDXVHVIRUWKH
VDPHHIIHFWDQGPDQ\HIIHFWVPD\DULVHIURPWKHVDPHFDXVH$QH[DPSOHLVWKH
DVVRFLDWLRQRIVPRNLQJDQGOXQJFDQFHU6PRNLQJFDXVHVRWKHUGLVHDVHVDQGOXQJ
FDQFHUKDVRWKHUFDXVHV6WURQJVSHFLILFLW\LVHYLGHQFHIRUFDXVHEXWWKHDEVHQFHRI
VSHFLILFLW\LVRQO\ZHDNHYLGHQFHDJDLQVWDFDXVHDQGHIIHFWUHODWLRQVKLS
7HPSRUDOLW\RIWKHUHODWLRQVKLS&DXVHVVKRXOGREYLRXVO\SUHFHGHHIIHFWV7KLVVHOI
HYLGHQWSULQFLSOHPD\KRZHYHUEHRYHUORRNHGZKHQLQWHUSUHWLQJFURVVVHFWLRQDORU
FDVHFRQWUROVWXGLHVLQZKLFKERWKWKHFDXVHDQGHIIHFWDUHPHDVXUHGDWWKHVDPH
SRLQWLQWLPH
%LRORJLFDOJUDGLHQWRIWKHGRVH±UHVSRQVH$GRVH±UHVSRQVHUHODWLRQVKLSLVSUHVHQW
ZKHQYDU\LQJDPRXQWVRIWKHSXUSRUWHGFDXVHDUHUHODWHGWRYDU\LQJDPRXQWVRIWKH
HIIHFW$QH[DPSOHRIDGRVH±UHVSRQVHFXUYHLVZKHQOXQJFDQFHUUDWHVDUHSORWWHG
DJDLQVWQXPEHURIFLJDUHWWHVVPRNHG
%LRORJLFDOSODXVLELOLW\:KHQWKHDVVHUWLRQRIFDXVHDQGHIIHFWLVFRQVLVWHQWZLWKRXU
NQRZOHGJHRIWKHPHFKDQLVPVRIGLVHDVHDVWKH\DUHFXUUHQWO\XQGHUVWRRGSODXVLELOLW\
LVRIWHQJLYHQFRQVLGHUDEOHZHLJKWZKHQDVVHVVLQJFDXVDWLRQ,WLVLPSRUWDQWKRZHYHU
WRUHPHPEHUWKDWZKDWLVFRQVLGHUHGELRORJLFDOO\SODXVLEOHGHSHQGVRQWKHVWDWHRI
PHGLFDONQRZOHGJHDWWKHWLPH
&RKHUHQFHRIWKHHYLGHQFH$IDFWRULVDOVRPRUHOLNHO\WREHDFDXVHRIGLVHDVHLI
LWVUHPRYDOUHVXOWVLQDGHFUHDVHGULVNRIGLVHDVH)RUH[DPSOHLISHRSOHJLYHXS
VPRNLQJGRHVWKLVGHFUHDVHWKHOLNHOLKRRGRIOXQJFDQFHU"
([SHULPHQWDO FRQILUPDWLRQ$ FDXVDO DVVRFLDWLRQ LV PRUH OLNHO\ LI VXSSRUWHG E\
H[SHULPHQWDWLRQLQDQLPDOV
5HDVRQLQJE\DQDORJ\7KHDUJXPHQWRIDQDORJ\IRUDFDXVHDQGHIIHFWUHODWLRQVKLS
LVVWUHQJWKHQHGLIWKHUHDUHH[DPSOHVRIZHOOHVWDEOLVKHGFDXVHVDQGHIIHFWVWKDWDUH
DQDORJRXVWRWKHRQHVLQTXHVWLRQ
9.7 Interpreting end points to measure the outcome

7KHXVHRIRQHHQGSRLQWPD\LJQRUHWKHSRVVLEOHHIIHFWRQRWKHUYDULDEOHVWKDW
PD\KDYHDFOLQLFDOLPSDFW)RUH[DPSOHRQHVWXG\UHSRUWHGDUHGXFWLRQLQKHDUW
DWWDFNIRUSK\VLFLDQVZKRWRRNORZGRVHDVSLULQ%XWWKHUHZDVDWUHQGWRZDUGLQFUHDVHG
KDHPRUUKDJLFVWURNHDPRQJWUHDWHGVXEMHFWVDQGDQXQGLPLQLVKHGRYHUDOOGHDWKUDWHIURP
FDUGLRYDVFXODUFDXVHV7KHDVSLULQDSSHDUVWREHSHUIRUPLQJWKHUROHRISODWHOHWLQKLELWLRQ
TXLWHZHOOEXWVHOHFWLQJRQO\RQHHQGSRLQWZRXOGKDYHPDVNHGLWVSRVVLEOHRWKHUHIIHFWV
6WHHULQJ&RPPLWWHHRIWKH3K\VLFLDQV¶+HDOWK6WXG\5HVHDUFK*URXS
,WLVDOVRLPSRUWDQWWRFRQVLGHUZKHQDQHQGSRLQWRURXWFRPHRFFXUVLQUHODWLRQWR
WKHLQWHUYHQWLRQ2XWFRPHVWKDWRFFXUORQJDIWHUVXEMHFWVVWRSWDNLQJDGUXJRUEHIRUH
EHQHILWVRIDQLQWHUYHQWLRQFDQORJLFDOO\EHH[SHFWHGFDQFRPSOLFDWHWKHLQWHUSUHWDWLRQ
6XUURJDWHHQGSRLQWVDUHVRPHWLPHVXVHGWRGHWHUPLQHDQRXWFRPHDQGFDXWLRQ
VKRXOGEHH[HUFLVHGLQH[WUDSRODWLQJIURPWKHUHVXOW$VXUURJDWHHQGSRLQWFDQEH
GHILQHGDVDYDULDEOHWKDWLVUHODWLYHO\HDVLO\PHDVXUHGDQGWKDWSUHGLFWVDUDUHRUGLVWDQW
RXWFRPHEXWZKLFKLVQRWLWVHOIDGLUHFWPHDVXUHRIHLWKHUKDUPRUFOLQLFDOEHQHILW7KH
WZRPDLQDGYDQWDJHVRIWKHXVHRIHQGSRLQWVDUHWKDWWKH\FDQFRQVLGHUDEO\UHGXFHWKH
VDPSOHVL]HGXUDWLRQDQGWKHUHIRUHFRVWRIVWXGLHV7KH\FDQDOVRDOORZWUHDWPHQWVWREH
DVVHVVHGLQVLWXDWLRQVZKHQWKHXVHRISULPDU\RXWFRPHVZRXOGEHH[FHVVLYHO\LQYDVLYH
RUXQHWKLFDO)RUDVXUURJDWHHQGSRLQWWREHDJRRGPHDVXUHRIWKHRXWFRPHLWPXVWKDYH
DJRRGSRVLWLYHSUHGLFWRUYDOXHDQGDJRRGQHJDWLYHSUHGLFWRUYDOXHLHLWVKRXOGEH
ERWKVHQVLWLYHDQGVSHFLILF,WLVQRWHQRXJKIRUWKHHQGSRLQWWREHELRORJLFDOO\SODXVLEOH
WRGUDZFOLQLFDOFRQFOXVLRQV7KHHQGSRLQWVKRXOGDOVREHDPHQDEOHWRTXDOLW\FRQWURO
PRQLWRULQJ([DPSOHVRIWKHXVHRIVXUURJDWHHQGSRLQWVLQFOXGHWKHXVHRIOLSLGSURILOH
DVDVXUURJDWHIRUWKHGHYHORSPHQWRIFDUGLRYDVFXODUGLVHDVHDQGWKHXVHRIWKH&'FHOO
FRXQWWRSUHGLFWVXUYLYDOLQ+,9LQIHFWLRQ
9.8 Interpreting studies of risk factors

6WXGLHVRIULVNIDFWRUVDUHYHU\LPSRUWDQW LQ WKH SUHYHQWLRQ RI GLVHDVH7KH\
RIWHQDWWUDFWSXEOLFDQGPHGLDDWWHQWLRQ8QOHVVLQWHUSUHWHGSURSHUO\WKH\FDQOHDGWR
PLVLQIRUPDWLRQ6WXGLHVRIULVNIDFWRUVFDQQRWEHLQWHUSUHWHGZLWKRXWSURSHUXQGHUVWDQGLQJ
RIWKHIROORZLQJFRQFHSWVEDVLFULVNUHODWLYHULVNFRQILGHQFHLQWHUYDOVDWWULEXWDEOHULVN
DQGEDODQFLQJULVNVDQGEHQHILWV
Basic risk
%DVLFULVNVWDWHPHQWVH[SUHVVWKHOLNHOLKRRGWKDWDSDUWLFXODUHYHQWZLOORFFXUZLWKLQ
DSDUWLFXODUSRSXODWLRQ)RUH[DPSOHWKH86:RPHQ¶V+HDOWK,QLWLDWLYH:+,6WXG\
UHSRUWHGLQ-XO\WKDWSRVWPHQRSDXVDOZRPHQXVLQJKRUPRQHUHSODFHPHQWWKHUDS\
+57KDGDQLQFLGHQFHRIFRORUHFWDOFDQFHURISHUZRPHQSHU\HDU7KLV
EDVLFULVNKRZHYHUGRHVQRWPHDQPXFKXQOHVVZHNQRZKRZPDQ\ZRPHQZRXOGKDYH
GHYHORSHGWKHVDPHGLVHDVHFRQGLWLRQZLWKRXWKDYLQJXVHG+57:LWKRXWWKLVLQIRUPDWLRQ
ZHFDQQRWLQWHUSUHWWKHILQGLQJ,WPD\LQGLFDWHDULVNEXWLWPD\DOVRLQGLFDWHDSURWHFWLYH
HIIHFW,QWKHSODFHERFRQWUROOHGJURXSIROORZHGXSLQWKHVDPHVWXG\WKHLQFLGHQFHZDV
7KLVPHDQVWKDW+57ZDVDFWXDOO\SURWHFWLYHDJDLQVWFRORUHFWDOFDQFHU:ULWLQJJURXS
IRUWKHZRPHQ¶VKHDOWKLQLWLDWLYHLQYHVWLJDWRUV
Relative risk
5HODWLYHULVNLVWKHUDWLRRIWKHLQFLGHQFHRIRXWFRPHLQWKHH[SRVHGJURXSWRWKH
LQFLGHQFHRIWKHRXWFRPHLQWKHXQH[SRVHGJURXS
7KHRGGVUDWLRDWHUPXVHGLQFDVHFRQWUROVWXGLHVPHDVXUHVWKHRGGVRIKDYLQJWKH
ULVNIDFWRUDPRQJSHRSOHZLWKWKHGLVHDVHGLYLGHGE\WKHRGGVRIKDYLQJWKHULVNIDFWRU
DPRQJSHRSOHZLWKRXWWKHGLVHDVH
Confidence interval
7KHVWDWLVWLFDOFRQFHSWRIFRQILGHQFHLQWHUYDOKDVEHHQGLVFXVVHGLQ&KDSWHU
$VWXG\WKDWUHSRUWVWKHUHODWLYHULVNRUWKHRGGVUDWLRZLWKRXWUHSRUWLQJWKHFRQILGHQFH
LQWHUYDOFDQQRWEHDGHTXDWHO\LQWHUSUHWHG&RQILGHQFHLQWHUYDOVVKRXOGDOZD\VEH
SUHVHQWHGIRUWKHUHODWLYHULVNDQGRGGVUDWLR7KHLPSRUWDQWIHDWXUHWRORRNIRULQ
DVVHVVLQJWKHFRQILGHQFHLQWHUYDOLVZKHWKHUWKHERXQGDULHVLQFOXGHXQLW\$UHODWLYHULVN
RURGGVUDWLRRIPHDQVWKHUHLVQRDVVRFLDWLRQEHWZHHQWKHULVNIDFWRUDQGWKHGLVHDVH$
UHODWLYHULVNPD\EHPXFKKLJKHUWKDQEXWLIWKHFRQILGHQFHLQWHUYDORYHUODSV
LWFDQEHFRQFOXGHGWKDWWKHLQFUHDVHLQULVNLVQRWVWDWLVWLFDOO\VLJQLILFDQWDQGFRXOG
KDYHEHHQDFKDQFHILQGLQJ
Attributable risk
7KHLPSRUWDQFHRIDULVNIDFWRUFDQQRWEHLQWHUSUHWHGRQWKHEDVLVRIWKHPDJQLWXGHRI
WKHUHODWLYHULVNZLWKRXWUHODWLQJLWWRWKHSUHYDOHQFHRIWKHSDUWLFXODUGLVHDVHFRQGLWLRQ
7KHWHUPDWWULEXWDEOHULVNLVDQHVWLPDWHWRTXDQWLI\WKHFRQWULEXWLRQZKLFKWKHSDUWLFXODU
ULVNIDFWRUPDNHVLQSURGXFLQJWKHGLVHDVHZLWKLQDSRSXODWLRQ7KHIROORZLQJWZR
H[DPSOHVLOOXVWUDWHWKHLPSRUWDQFHRIFDOFXODWLQJWKHDWWULEXWDEOHULVN
7KHUHODWLYHULVNRIOXQJFDQFHUGXHWRVPRNLQJLVPXFKJUHDWHUWKDQLVWKHUHODWLYH
ULVNRIP\RFDUGLDOLQIDUFWLRQDPRQJVPRNHUV+RZHYHUKHDUWGLVHDVHLVPXFKPRUH
FRPPRQWKDQOXQJFDQFHU6RHYHQWKRXJKWKHULVNDVVRFLDWHGZLWKKHDUWGLVHDVHDQG
VPRNLQJLVVPDOOLWVLPSRUWDQFHWRWKHJHQHUDOKHDOWKLVPDJQLILHGE\LWVUHODWLYHO\KLJKHU
LQFLGHQFH
:RPHQWDNLQJRUDOFRQWUDFHSWLYHSLOOVDUHPRUHOLNHO\WRKDYHDIDWDOKHDUWDWWDFN
WKDQZRPHQQRWWDNLQJWKHSLOO+RZHYHUZRPHQRIUHSURGXFWLYHDJHSLOOXVHUVKDYH
DORZLQFLGHQFHRIP\RFDUGLDOGLVHDVH7KLVLQFUHDVHGUHODWLYHULVNWUDQVODWHVLQWRDQ
DWWULEXWDEOHULVNRIRQO\YHU\IHZGHDWKVSHUXVHUVSHU\HDU
Balancing risks and benefits

'HFLVLRQVFDQQRWEHPDGHRQULVNVDORQHLIWKHUHDUHEHQHILWVDVZHOO7KLVDSSOLHV
IRUH[DPSOHWRWKHFDVHRIRUDOFRQWUDFHSWLYHVZKLFKKDYHKHDOWKULVNVEXWDOVRKHDOWK
EHQHILWVZKLFKRXWZHLJKWKHSRWHQWLDOULVNV
9.9 Interpreting studies of diagnostic tests

7KHWHUPGLDJQRVWLFWHVWLVXVHGEURDGO\WRGHVFULEHWKHYDOXHRIDV\PSWRPRU
FROOHFWLRQRIV\PSWRPVVLJQVRUVSHFLDOLQYHVWLJDWLRQLQWKHGLDJQRVLVRIDFOLQLFDO
FRQGLWLRQRUKHDOWKVLWXDWLRQ,QRUGHUWRDVVHVVWKHGLDJQRVWLFZRUWKRIWHVWVWKH\PXVW
EHFRPSDUHGWRWKHJROGVWDQGDUGLHWKHEHVWWHVWFXUUHQWO\DYDLODEOH2WKHUZLVHWKHUHLV
QRZD\WRPDNHVXUHWKDWWKHWHVWLVGLDJQRVLQJWKHFRQGLWLRQLQTXHVWLRQ3URFODPDWLRQV
RIKLJKO\VWDWLVWLFDOO\VLJQLILFDQWDVVRFLDWLRQVEHWZHHQWKHWHVWDQGWKHGLDJQRVLVDUHQRW
VXIILFLHQW,WLVHVVHQWLDOWRSURYLGHLQIRUPDWLRQRQWKHH[WHQWWRZKLFKGLDJQRVWLFWHVWV
PLVFODVVLI\VXEMHFWVLHPDNHDGLDJQRVLVRIDGLVHDVHZKHQLWLVQRWSUHVHQWRUPLVV
WKHGLDJQRVLVZKHQDGLVHDVHLVSUHVHQW)RUWKLVWKHFRQFHSWVRIVHQVLWLYLW\VSHFLILFLW\
SUHGLFWLYHYDOXHDQGHIILFLHQF\DUHXVHG
Sensitivity
6HQVLWLYLW\LVWKHDELOLW\RIDWHVWWRVLQJOHRXWSHRSOHZKRKDYHWKHGLVHDVH/RZ
VHQVLWLYLW\ZLOOPHDQWKDWWKHUHZLOOEHPDQ\IDOVHQHJDWLYHV
Specificity
6SHFLILFLW\LVWKHDELOLW\RIDWHVWWRODEHOSHRSOHZKRGRQRWKDYHWKHGLVHDVHDV
QHJDWLYH/RZVSHFLILFLW\PHDQVWKHUHZLOOEHPDQ\IDOVHSRVLWLYHV
Predictive value
7KHSUHGLFWLYHYDOXHRIDWHVWJLYHVWKHIUHTXHQF\ZLWKZKLFKDSRVLWLYHWHVWDFWXDOO\
VLJQLILHVGLVHDVH,WLVPRUHDSSURSULDWHO\ODEHOOHGSRVLWLYHSUHGLFWLYHYDOXH7KHQHJDWLYH
SUHGLFWLYHYDOXHLVOHVVRIWHQXVHG
Efficiency
(IILFLHQF\LVDQRYHUDOOHVWLPDWHRIDWHVW¶VDELOLW\WRFODVVLI\SDWLHQWVFRUUHFWO\,W
LVHVWLPDWHGE\DGGLQJWKHQXPEHUVRIWKHWZRFRUUHFWFODVVLILFDWLRQVWUXHSRVLWLYHDQG
WUXHQHJDWLYHDQGGLYLGLQJE\WKHWRWDOQXPEHURISDWLHQWVDVVHVVHG
Balancing sensitivity and specificity

'LDJQRVWLFWHVWVFDQQRWEHH[SHFWHGWREHSHUIHFW,QFUHDVLQJWKHVHQVLWLYLW\RIDWHVW
RIWHQUHVXOWVLQGHFUHDVHGVSHFLILFLW\DQGYLFHYHUVD7KHYDOXHRIDWHVWFDQQRWEHPDGH
RQWKHEDVLVRIVHQVLWLYLW\DQGVSHFLILFLW\DORQHRURQWKHEDVLVRIRYHUDOOHIILFLHQF\
0XFKGHSHQGVRQWKHSUHYDOHQFHRIWKHGLVHDVHFRQGLWLRQ7KHSUHGLFWLYHYDOXHLVDWWKH
PHUF\RISUHYDOHQFH(YHQDVPDOOSHUFHQWDJHRIIDOVHSRVLWLYHVFDQEHFRPHPDJQLILHG
ZKHQDGLVHDVHLVUDUH
&KRLFHVEHWZHHQVHQVLWLYLW\DQGVSHFLILFLW\PXVWEHPDGH7KHGHFLVLRQLVQRW
VWDWLVWLFDOLWLVFOLQLFDODQGHFRQRPLFDO:KHQWKHFRQVHTXHQFHVRIPLVVLQJDGLVHDVHDUH
FUXFLDOVHQVLWLYLW\LVSDUDPRXQW%XWLIWKHEXUGHQRIFUHDWLQJIDOVHSRVLWLYHVRXWZHLJKV
WKHDGYDQWDJHVRIFDSWXULQJDOOFDVHVRIDGLVHDVHLQFUHDVLQJVSHFLILFLW\VKRXOGEHWKH
JRDO
:LWKWKHHFRQRPLFDVSHFWVRIKHDOWKFDUHGUDZLQJLQFUHDVLQJDWWHQWLRQFRVWVDUH
EHFRPLQJDFRQFHUQLQWKHHYDOXDWLRQRIVFUHHQLQJSURFHGXUHV7KHIROORZLQJH[DPSOHRI
PDQGDWRU\SUHPDULWDOVHURORJLFDOWHVWLQJRI+,9LQIHFWLRQLOOXVWUDWHVWKHSRLQW$WHVWXVHG
PD\KDYHDVHQVLWLYLW\RIDQGDVSHFLILFLW\RI7KLVVRXQGVOLNHDQLPSUHVVLYH
SHUIRUPDQFH%XWLQDFRPPXQLW\ZKHUH+,9SUHYDOHQFHLVORZHYHQWKHORZUDWHRI
IDOVHSRVLWLYHVZLOOPHDQWKDWDODUJHQXPEHURISHRSOHZLOOEHXQQHFHVVDULO\DODUPHG
,WDOVRPHDQVWKDWDYHU\ODUJHQXPEHURISHRSOHZLOOQHHGWREHWHVWHGLQRUGHUWRGHWHFW
RQHVLQJOHWUXHSRVLWLYHFDVH$QHVWLPDWHZLOOQHHGWREHPDGHRIWKHFRVWRIGLDJQRVLQJ
RQHVLQJOHFDVH
0DQ\GLDJQRVWLFWHVWV\LHOGFRQWLQXRXVUHVXOWVIRUH[DPSOHVHUXPOHYHOVRISURVWDWH
VSHFLILFDQWLJHQ36$DVDVFUHHQLQJWHVWIRUSURVWDWHFDQFHU:LWKVXFKWHVWVDGHFLVLRQ
PXVWEHPDGHDVWRZKDWYDOXHZLOOFRQVWLWXWHDSRVLWLYHWHVWDYDOXHFDOOHGWKH³FXW
RIISRLQW´7KLVGHFLVLRQUHTXLUHVWUDGLQJDQLQFUHDVHLQVSHFLILFLW\IRUDGHFUHDVHLQ
VHQVLWLYLW\RUYLFHYHUVD5HFHLYHURSHUDWRUFKDUDFWHULVWLF52&FXUYHVDUHXVHIXO
IRUYLVXDOL]LQJDQGVHOHFWLQJWKHPRVWDSSURSULDWHFXWRIISRLQWIRUVFUHHQLQJWHVWV
7KHWHUPLQRORJ\FRPHVIURPLWVILUVWXVHLQWKHILHOGRIHOHFWURQLFV52&FXUYHVDUH
DJUDSKLFZD\RISRUWUD\LQJWKHWUDGHRIIVLQYROYHGEHWZHHQLPSURYLQJHLWKHUDWHVW¶V
VHQVLWLYLW\RULWVVSHFLILFLW\ZKHQGLIIHUHQWFXWRIIYDOXHVDUHVHOHFWHG)RUHDFKFXWRII
SRLQWVWDWLVWLFLDQVSORWWKHVHQVLWLYLW\RQWKHYHUWLFDOD[LVDQGWKHYDOXHWKDWLVPLQXV
VSHFLILFLW\IDOVHSRVLWLYHVRQWKHKRUL]RQWDOD[LV1HZPDQHWDO
9.10 Interpreting studies that report the results of

interventions
5HVXOWVEDVHGRQXQFRQWUROOHGVWXGLHVGRQRWPHDQPXFK,QPDQ\FDVHVLWLV
SRVVLEOHWKDWQRWUHDWPHQWFRXOGKDYHDFKLHYHGFRPSDUDEOHUHVXOWV
5HVXOWVRIFRQWUROOHGVWXGLHVEDVHGRQFRPSDULVRQRIDWUHDWPHQWZLWKDSODFHER
GRQRWPHDQPXFKLIWKHUHDUHRWKHUDYDLODEOHWUHDWPHQWV5HVXOWVVKRXOGEHEDVHGRQ
FRPSDUDWRUGUXJVFXUUHQWO\DYDLODEOH
7KHSUHIHUHQFHRIRQHGUXJRYHUDQRWKHUVKRXOGQRWEHEDVHGRQRQHDVSHFWRQO\RI
LWVSHUIRUPDQFH,WVKRXOGJLYHHTXDOFRQVLGHUDWLRQWRWKHIRXUHOHPHQWVRIWKHDFURQ\P
³67(3´VDIHW\WROHUDELOLW\HIILFDF\SULFH
$VWXG\PD\LQGLFDWHWKDWDQHZGUXJKDVUHVXOWHGLQPRUHLPSURYHPHQWWKDQWKH
FXUUHQWO\DYDLODEOHDQGXVHGGUXJ$VWDWLVWLFDOWHVWVKRZVWKDWWKLVGLIIHUHQFHEHWZHHQWKH
WZRGUXJVLVVWDWLVWLFDOO\VLJQLILFDQW:KDWWKHVWDWLVWLFDOWHVWVD\VLVWKDWWKHGLIIHUHQFH
LQWKHUHVXOWLVXQOLNHO\WRKDYHKDSSHQHGE\FKDQFHDQGWKDWWKHSUREDELOLW\RILWVEHLQJ
DFKDQFHILQGLQJLVOHVVWKDQ7KH3YDOXHFDQWHOOXVKRZUHPRWHWKHSRVVLELOLW\WKDW
WKHGLIIHUHQFHFDQEHIRXQGE\FKDQFH7KLVKRZHYHUGRHVQRWPHDQWKDWWKHUHVXOWLV
FOLQLFDOO\VLJQLILFDQW7KH3YDOXHGRHVQRWWHOOXVDQ\WKLQJDERXWWKHPDJQLWXGHRIWKH
GLIIHUHQFHEHWZHHQWKHWZRWUHDWPHQWVDQGKRZWKHSRLQWRIHVWLPDWHRIWKHGLIIHUHQFH
ZLOOEHFKDQJHGLIRWKHUVDPSOHVIURPWKHVDPHSRSXODWLRQDUHVWXGLHG)RUWKLVZHQHHG
WRNQRZWKHFRQILGHQFHLQWHUYDOVIRUWKHGLIIHUHQFHEHWZHHQWKHSHUIRUPDQFHRIWKHWZR
GUXJV&RQILGHQFHLQWHUYDOVZLOOVKRZWKHOLNHO\UDQJHRIWKHPDJQLWXGHRIWKHGLIIHUHQFH
LQWKHSHUIRUPDQFHRIWKHWZRGUXJV
(YHQLIDGUXJLVSURYHQWREHVXSHULRUWRDQRWKHUWKHTXHVWLRQVWLOOUHPDLQVDERXW
ZKDWWKLVPHDQVWRWKHLQGLYLGXDOSDWLHQWRULQGLYLGXDOFOLQLFLDQ2QHKDVWRFDOFXODWH
WKHQXPEHUQHHGHGWRWUHDWLQRUGHUWRDFKLHYHWKHWKHUDSHXWLFDGYDQWDJHRIWKHQHZ
LQWHUYHQWLRQ,IIRUH[DPSOHRQHLQWHUYHQWLRQUHGXFHVWKHDEVROXWHULVNRIG\LQJE\VD\
LWPHDQVWKDWWKHQXPEHUQHHGHGWRWUHDWZLWKWKHQHZLQWHUYHQWLRQWRDYRLGRQHGHDWK
ZLOOEH7KH³QXPEHUQHHGHGWRWUHDW´KDVLPSRUWDQWFRVWLPSOLFDWLRQVZKHQWKHUHVXOW
RIWKHLQWHUYHQWLRQLVLQWHUSUHWHG
9.11 Interpreting results of qualitative research

4XDOLWDWLYHUHVHDUFKPHWKRGVLQYROYHWKHLQWHUSUHWDWLRQRIWH[WXDOPDWHULDOGHULYHG
IURPWDONRUREVHUYDWLRQ
,QLQWHUSUHWLQJTXDOLWDWLYHILQGLQJVWKHLQYHVWLJDWRUVVKRXOGFDUHIXOO\ORRNLQWRWKHLU
FUHGLELOLW\GHSHQGDELOLW\FRQILUPDELOLW\DQGWUDQVIHUDELOLW\
&UHGLELOLW\PHDQVLQWHUSUHWLQJWKHTXDOLWDWLYHGDWDLQDZD\WKDWRIIHUVH[SODQDWLRQV
WKDWDUHFRQVLVWHQWZLWKWKHGDWDFROOHFWHG1HJDWLYHILQGLQJVVKRXOGEHDGHTXDWHO\
SUHVHQWHGDQGDGGUHVVHGDQGDOWHUQDWLYHH[SODQDWLRQVFRQVLGHUHG$VLQTXDQWLWDWLYH
UHVHDUFKWKHLQYHVWLJDWRUVVKRXOGORRNIRUFRQIRXQGLQJYDULDEOHV)RUH[DPSOHDVWXG\
PD\UHYHDOWKDWKRPHVVSUD\HGIRUPDODULDFRQWUROKDGDKLJKHULQFLGHQFHRIPDODULD
ZKHQVSUD\HGLQWKHDIWHUQRRQ,WFRXOGEHWKDWVSUD\HUVXVHGPRVWRIWKHVSUD\LQWKH
PRUQLQJVRWKDWWKHORDGWRFDUU\LQWKHDIWHUQRRQZRXOGEHOLJKWHU7RHQVXUHFUHGLELOLW\
RIWKHLQWHUSUHWDWLRQWKHLQYHVWLJDWRUVKRXOGDFWDVWKH³GHYLO¶VDGYRFDWH´FRQVLGHULQJ
DOOSRWHQWLDOO\FRPSHWLQJH[SODQDWLRQVRIWKHUHVXOWV
3RVVLEOHVRXUFHVIRUELDVVKRXOGEHFKHFNHGIRUH[DPSOHREVHUYHUELDVRUWKH
LQIOXHQFHRIWKHUHVHDUFKHURQWKHUHVHDUFKVLWXDWLRQ$UHVHDUFKHU¶VEDFNJURXQGDQG
SRVLWLRQZLOODIIHFWWKHSURFHVVRITXDOLWDWLYHUHVHDUFK7KHLQYHVWLJDWRUDOZD\VHQWHUVD
ILHOGRIUHVHDUFKZLWKFHUWDLQRSLQLRQVDERXWZKDWLWLVDOODERXW,QTXDOLWDWLYHUHVHDUFK
WKLVSRWHQWLDOELDVFDQQRWEHHOLPLQDWHGEXWLWVKRXOGEHH[SRVHGLQDSURFHVVWHUPHG
³UHIOH[LYLW\´5HIOH[LYLW\VWDUWVE\LGHQWLI\LQJSUHFRQFHSWLRQVEURXJKWLQWRWKHSURMHFWE\
WKHUHVHDUFKHUUHSUHVHQWLQJSUHYLRXVSHUVRQDODQGSURIHVVLRQDOH[SHULHQFHVSUHVWXG\
EHOLHIVDQGTXDOLILFDWLRQVIRUH[SORUDWLRQRIWKHILHOG'XULQJDOOVWHSVRIWKHUHVHDUFK
SURFHVVWKHHIIHFWRIWKHUHVHDUFKHUVKRXOGEHDVVHVVHGDQGODWHURQVKDUHG$GHTXDWH
DFFRXQWVRIWKHVHHIIHFWVVKRXOGEHFRQVLGHUHGLQWKHOLPLWDWLRQVDQGVWUHQJWKVRIWKH
VWXG\DQGWUDQVIHUDELOLW\RIILQGLQJV
'HSHQGDELOLW\PHDQVWKDWGDWDFDQEHUHSOLFDWHG7KHUHSOLFDWLRQLVQRWQHFHVVDULO\
RIWKHUHVXOWVEXWRIWKHSURFHVVXVHGWRREWDLQWKHUHVXOWV2WKHULQYHVWLJDWRUVVKRXOGEH
DEOHWRUHSOLFDWHWKHVWXG\
&RQILUPDELOLW\PHDQVWKDWRWKHUUHVHDUFKHUVFDQKDYHDFFHVVWRWKHGDWDDQGFDQ
GRWKHLURZQDQDO\VLV7KHFRQFHSWRI³DXGLWWUDLO´HQDEOHVRWKHUVRQWKHEDVLVRIWKH
FROOHFWHGGDWDWRUHYLHZWKHDQDO\VLVGHFLVLRQVDQGYHULI\WKHLQWHUSUHWDWLRQV
7UDQVIHUDELOLW\PHDQVWKHXVHRIWKHILQGLQJVWRPDNHLQIHUHQFHVWRRWKHUSRSXODWLRQV
7KLVPD\QRWEHSRVVLEOHEHFDXVHTXDOLWDWLYHUHVHDUFKLVRIWHQFRQWH[WVSHFLILF4XDOLWDWLYH
UHVHDUFKHPSKDVL]HVGHSWKPRUHWKDQEUHDGWKDQGLQVLJKWUDWKHUWKDQJHQHUDOL]DWLRQ,Q
VXFKFDVHVKRZHYHUWKHUHDUHOHVVRQVOHDUQWWKDWPD\KHOSLQXQGHUVWDQGLQJWKHVLWXDWLRQ
LQRWKHUSRSXODWLRQV

Altman DG, et al. The revised CONSORT statement for reporting randomized trials:
explanation and elaboration. Annals of Internal Medicine, 2001, 134: 663–694.
Bossuyut PM, et al. Towards complete and accurate reporting of studies of diagnostic
accuracy: the STARD initiative. British Medical Journal, 2003, 326: 41–44.
Newman B, Browner WS, Cummings SR. Designing studies of medical tests. In: Hulley SB,
Cumming SR, eds. Designing clinical research: an eidemiologic approach, 2nd edition.
Philadelphia, Lippincott Williams & Wilkins, 2001: 175–192.
Wilkins, 1998.
Devers KJ, Sofaer S, Rundall TG, eds. Qualitative methods in health services research:
A special supplement to HSR. Health Services Research 1999, 34 (5) Part II: 1083–
1263.
Doll R, Hill AB, Mortality in relation to smoking: ten years’ observation of British doctors.
British Medical Journal, 1964, 1:1399–1460.
Einstein A. http://www.memorable quotations.com/einstein.htm (accessed 30/04/2004).
Gehlbach SH. Interpreting the medical literature, 3rd edition. New York, McGraw-Hill
Inc., 1993.
Greenhalgh T. How to read a paper: the basics of evidence-based medicine. London,
BMJ Books, 1997.
Hill BA. The environment and disease: association or causation? Proceedings of the
Royal Society of Medicine, 1965, 58: 295–300.
Huff D. How to lie with statistics. London, Penguin Books, 1991.
358: 483–88.
Schulz KF, Grimes DA. Uses and abuses of screening tests. Lancet, 2002, 359: 881–
884.
Steering Committee of the Physicians’ Health Study Research Group: Final report on
the aspirin component of the ongoing physicians’ health study. New England Journal of
Medicine, 1989, 321:129.
Writing group for the Women’s Health Initiative investigators. Risks and benefits of
estrogen plus progestin in healthy postmenopausal women: principal results from the
Women’s Health Initiative randomized controlled trial. Journal of the American Medical
Association, 2002, 288: 312–333.
Chapter 10
Communicating research
,I\RXKDYHDQDSSOHDQG,KDYHDQDSSOHDQGLIZHH[FKDQJHWKHVHDSSOHVWKHQ\RX
DQG,ZLOOVWLOOHDFKKDYHRQHDSSOH%XWLI\RXKDYHDQLGHDDQG,KDYHDQLGHDDQG
ZHH[FKDQJHWKHVHLGHDVWKHQHDFKRIXVZLOOKDYHWZRLGHDV
*HRUJH%HUQDUG6KDZ
10.1 Introduction
5HVHDUFKLVQRWFRPSOHWHXQWLOLWLVZULWWHQXSDQGLWVUHVXOWVVKDUHGQRWRQO\ZLWK
RWKHUVFLHQWLVWVZKRPD\EXLOGXSRQLWWRIXUWKHUDGYDQFHWKHVFLHQFHEXWDOVRZLWKWKRVH
ZKRPD\EHQHILWIURPLWZKRPD\XVHLWDQGZKRKDYHDVWDNHLQLW(W\PRORJLFDOO\WKH
/DWLQ³FRPPXQLRÚHODWHVWRSDUWLFLSDWLRQDQGVKDULQJ&RPPXQLFDWLRQDQGVKDULQJDUH
WZRZRUGVVKDULQJWKHVDPHFRQFHSW
,WLVDQHWKLFDOGXW\WRFRPPXQLFDWHUHVHDUFKUHVXOWV(GLWRUVRIVFLHQWLILFMRXUQDOV
VKRXOGFRQVLGHUVHULRXVO\IRUSXEOLFDWLRQDQ\FDUHIXOO\GRQHVWXG\RIDQLPSRUWDQW
TXHVWLRQUHOHYDQWWRWKHLUUHDGHUVZKHWKHUWKHUHVXOWVDUHQHJDWLYHRUSRVLWLYH)DLOXUH
WRVXEPLWRUSXEOLVKVWXGLHVZLWKQHJDWLYHILQGLQJVFRQWULEXWHVWRSXEOLFDWLRQELDV
3KDUPDFHXWLFDOFRPSDQLHVKDYHRFFDVLRQDOO\EHHQKHOGJXLOW\RIVXSSUHVVLQJUHVHDUFK
UHVXOWVWKDWVKRZWKDWWKHLUSURGXFWVPD\QRWEHDVVDIHDVWKH\FODLP
5HVHDUFKHUVQRUPDOO\FRPPXQLFDWHWKHLUUHVXOWVWRRWKHUVFLHQWLVWVE\SXEOLVKLQJ
LQSHHUUHYLHZHGMRXUQDOVDQGSUHVHQWDWLRQLQVFLHQWLILFPHHWLQJV7KHLQWHUQHWLV
UHYROXWLRQL]LQJWKHGLVVHPLQDWLRQRIVFLHQWLILFLQIRUPDWLRQLQZD\VQHYHUWKRXJKW
SRVVLEOHEHIRUH,IWKHUHVHDUFKZDVIXQGHGUHVHDUFKHUVKDYHDQREOLJDWLRQWRVXEPLW
SHULRGLFUHSRUWVWRWKHIXQGLQJDJHQF\
7KHSULPDU\DLPRIKHDOWKUHVHDUFKLVWRLPSURYHKHDOWK7RDFKLHYHWKLVDLPUHVXOWV
RIUHVHDUFKVKRXOGQRWEHFRPPXQLFDWHGWRRWKHUVFLHQWLVWVRQO\7KHLQIRUPDWLRQKDVWR
UHDFKWKHKHDOWKSURIHVVLRQDOV5HVHDUFKZLWKSUDFWLFDOLPSOLFDWLRQVVKRXOGEHVFUXWLQL]HG
V\QWKHVL]HGDQGSUHVHQWHGLQWKHIRUPRIHYLGHQFHEDVHGUHYLHZVDQGJXLGHOLQHVDERXW
EHVWSUDFWLFHV7KHUHLVDJURZLQJDZDUHQHVVRIDJDSEHWZHHQFOLQLFDOSUDFWLFHDQGWKH
ILQGLQJVRIUHVHDUFK
,IUHVHDUFKLVWRLQIRUPSXEOLFSROLF\LWVKRXOGEHSURSHUO\FRPPXQLFDWHGWR
SROLF\PDNHUV6HQGLQJDUHSRUWLVQRWHQRXJK7KHUHVHDUFKVKRXOGEHSUHVHQWHGDQG
GLVFXVVHG
7KHUHLVDQHHGWRFRPPXQLFDWHVFLHQWLILFLQIRUPDWLRQWRSDWLHQWV3DWLHQWVQHHG
WRSDUWLFLSDWHLQPDNLQJLQIRUPHGGHFLVLRQVDQGFKRLFHVDERXWWKHLUWUHDWPHQWRSWLRQV
+HDOWKSURIHVVLRQDOVVKRXOGDOZD\VNHHSLQPLQGWKDWWKH\GRQRWWUHDWGLVHDVHVWKH\WUHDW
SDWLHQWVZKRKDYHWKHLUSUHIHUHQFHVYDOXHVDQGULJKWV$QLQIRUPHGSDWLHQWLVDOVRPRUH
OLNHO\WRIROORZSUHVFULEHGWUHDWPHQWZKLFKLVRIWHQDPEXODWRU\DQGVHOIDGPLQLVWHUHG
3DFNDJHVRISUHVFULSWLRQGUXJVQRUPDOO\LQFOXGHDQLQVHUWIRUSDWLHQWLQIRUPDWLRQ7KH
PDWHULDOLQWKLVLQVHUWLVFORVHO\VFUXWLQL]HGIRUDFFXUDF\E\WKHGUXJUHJXODWRU\DJHQF\
+HDOWKOLIHVW\OHEHKDYLRXULVDSRZHUIXOGHWHUPLQDQWRIKHDOWK)RUFHUWDLQKHDOWK
FRQGLWLRQVLWFDQEHPRUHLPSRUWDQWWKDQWKHSURYLVLRQRIKHDOWKFDUH(PSRZHULQJ
SHRSOHZLWKYDOLGVFLHQWLILFLQIRUPDWLRQLVPRUHOLNHO\WRLQGXFHDKHDOWK\OLIHVW\OH
(GXFDWLQJSDWLHQWVDERXWWKHHIIHFWLYHQHVVRILQWHUYHQWLRQVLVVRPHWLPHVDGYRFDWHGDVD
ZD\RIFKDQJLQJWKHEHKDYLRXURIKHDOWKSURIHVVLRQDOVZKRPD\EHUHOXFWDQWWRFKDQJH
WKHLUWUDGLWLRQDOZD\VRIWUHDWPHQWDQGWRDGRSWPRUHQRYHODSSURDFKHV3KDUPDFHXWLFDO
FRPSDQLHVDUHQRZH[SORLWLQJWKLVSDWLHQWFHQWUHGDSSURDFKE\WDUJHWLQJSDWLHQWVIRU
WKHLUPHVVDJHVLQSXEOLFPHGLD
&RPPXQLWLHVWKDWKDYHSDUWLFLSDWHGLQUHVHDUFKDUHHQWLWOHGWRNQRZDERXWWKH
RXWFRPHRIWKHUHVHDUFKDQGLWVLPSOLFDWLRQVIRUWKHP+HDOWKUHVHDUFKHUVQHHGWRHQJDJH
WKHSXEOLFLQZKDWWKH\DUHGRLQJDQGZKDWWKH\KRSHWRDFKLHYH)RURQHWKLQJVFLHQFH
QHHGVDIDYRXUDEOHSXEOLFHQYLURQPHQW)RUDQRWKHUWKLQJWKHUHLVDJURZLQJQHHGWR
HQVXUHDQGPDLQWDLQSXEOLFWUXVWLQVFLHQFH5HVHDUFKFDQRQO\WKULYHLQDIDYRXUDEOH
VFLHQWLILFHQYLURQPHQW&KDLUPDQ0DRRQFHVDLGZKHQWDONLQJRIUHYROXWLRQDULHV³WKH
ILVKQHHGDVHDWRVZLPLQ´6FLHQFHDOVRQHHGVDVHDWRVZLPLQ,WFDQRQO\WKULYHLID
FXOWXUHIRUUHVHDUFKLVSUHVHQWLQWKHVRFLHW\:LWKRXWDVWURQJDSSUHFLDWLRQRIVFLHQFHLQ
VRFLHW\WKHLQWURGXFWLRQRIWHFKQRORJ\GULYHQVROXWLRQVWRHYHU\GD\SUREOHPVZLOOEH
PRUHGLIILFXOWWKDQLWVKRXOGEH6FLHQFHVKRXOGEHFRPHPRUHFRPIRUWDEO\HQPHVKHGLQ
VRFLHW\¶VFROOHFWLYHFRQVFLRXVQHVV,QWKLVIDYRXUDEOHHQYLURQPHQWSHRSOHYROXQWHHUDV
UHVHDUFKVXEMHFWVZKHQWKH\NQRZWKDWWKHVFLHQWLILFEHQHILWZLOODFFUXHWRRWKHUVQRWWR
WKHPVHOYHV$GLVWLQFWLRQVKRXOGEHGUDZQEHWZHHQWKHSXEOLFXQGHUVWDQGLQJRIVFLHQFH
DQGWKHSXEOLFDSSUHFLDWLRQRIVFLHQFH,WGRHVQRWDFWXDOO\PDWWHUZKHWKHUWKHSXEOLFFDQ
GLVWLQJXLVKDSURWRQIURPDSURWHLQLQRUGHUWRDSSUHFLDWHVFLHQFH
7KLVFKDSWHUSURYLGHVJHQHUDOJXLGDQFHWRUHVHDUFKHUVRQFRPPXQLFDWLQJWKHLU
UHVXOWVWRRWKHUVFLHQWLVWVWRWKHIXQGLQJDJHQFLHVWRKHDOWKSURIHVVLRQDOVWRSROLF\
PDNHUVWRSDWLHQWVDQGWRWKHSXEOLFDWODUJH
10.2 Communicating to scientists

10.2.1 Publication in scientific journals
6FLHQWLVWVDOZD\VDLPWRSXEOLVKWKHLUUHVHDUFKILQGLQJVLQVFLHQWLILFMRXUQDOVWKDW
DUHSHHUUHYLHZHGWKDWDUHLQGH[HGDQGWKDWKDYHDKLJKLPSDFWIDFWRU3HHUUHYLHZHG
Communicating research 121
MRXUQDOVDUHMRXUQDOVLQZKLFKWKHDUWLFOHVDUHYHWWHGE\LQGHSHQGHQWUHIHUHHVIRUTXDOLW\
DQGLQWHUHVWDQGDUHWKHUHIRUHPRUHKLJKO\UHJDUGHGE\UHVHDUFKHUV$UWLFOHVSXEOLVKHG
LQMRXUQDOVWKDWDUHLQGH[HGE\LQGH[LQJVHUYLFHVVXFKDVWKH,QGH[0HGLFXVDUH
UHWULHYDEOHDQGDFFHVVLEOHWRRWKHUUHVHDUFKHUVHQVXULQJZLGHUGLVVHPLQDWLRQWRWKH
VFLHQWLILFFRPPXQLW\-RXUQDOVDUHUDQNHGE\WKHLULPSDFWIDFWRUDWHUPXVHGWRLQGLFDWH
KRZPDQ\WLPHVRQDYHUDJHMRXUQDOVSDSHUVDUHFLWHG7KLVFRQFHSWDQGLWVVKRUWFRPLQJV
DUHGLVFXVVHGLQPRUHGHWDLOLQ&KDSWHURQDVVHVVPHQWDQGHYDOXDWLRQRIUHVHDUFK
,WVKRXOGEHUHDOL]HGWKDWPXFKLPSRUWDQWUHVHDUFKLVFRQGXFWHGWKDWGRHVQRWPDNH
LWLQWRPDMRULQWHUQDWLRQDOMRXUQDOV-RXUQDOVFDQRQO\SXEOLVKDIUDFWLRQRIDOOSDSHUV
VXEPLWWHGWRWKHP7KHUHPD\DOVREHDELDVWRZDUGVSXEOLFDWLRQVIURPLQVWLWXWLRQVLQ
LQGXVWULDOL]HGFRXQWULHV7KHWRROVRIWKHLQIRUPDWLRQDJHKROGFRQVLGHUDEOHSURPLVHIRU
GHYHORSLQJFRXQWU\UHVHDUFKHUVHQDEOLQJWKHPWRGLVVHPLQDWHWKHUHVXOWVRIWKHLUUHVHDUFK
PRUHZLGHO\
7KHUHLVJURZLQJXQGHUVWDQGLQJRILQWHOOHFWXDOSURSHUW\ULJKWVE\DFDGHPLFVDQG
WKHLULQVWLWXWLRQVDQGDQLQFUHDVLQJNQRZOHGJHRIKRZWRGROLFHQVLQJGHDOV$GLVWLQFWLRQ
LVGUDZQEHWZHHQZKDWLVSDWHQWDEOHDQGZKDWLVQRW3XEOLFDWLRQRIVFLHQWLILFILQGLQJV
SXWVWKHILQGLQJVLQWKHSXEOLFGRPDLQDQGMHRSDUGL]HVDQ\SDWHQWDSSOLFDWLRQ,IWKHUHLV
QRSDWHQWSURWHFWLRQLQGXVWU\ZLOOQRWEHLQWHUHVWHGLQWKHGLVFRYHU\3XEOLFDWLRQVIURP
PDMRUXQLYHUVLW\FHQWUHVDUHQRZVFUHHQHGIRUSDWHQWDEOHGLVFRYHULHVEHIRUHSURFHHGLQJ
ZLWKSXEOLFDWLRQ0DQ\XQLYHUVLWLHVQRZHPSOR\SDWHQWODZ\HUV
&KDSWHUSURYLGHVGHWDLOHGJXLGHOLQHVRQKRZWRZULWHDVFLHQWLILFSDSHUDQG
&KDSWHURQKRZWRJHWLWSXEOLVKHG
10.2.2 Presentations in scientific meetings

3UHVHQWDWLRQRISDSHUVLQVFLHQWLILFPHHWLQJVLVDQRWKHULPSRUWDQWYHQXHIRUVFLHQWLILF
FRPPXQLFDWLRQ)RUPDQ\\HDUVLWZDVWKHPDMRUYHQXHRIFRPPXQLFDWLRQDPRQJ
VFLHQWLVWV5HVHDUFKHUVVKRXOGWUDLQWKHPVHOYHVLQWKHDUWRIVFLHQWLILFSUHVHQWDWLRQ
7KHUHDUHERWKDGYDQWDJHVDQGGLVDGYDQWDJHWRSUHVHQWLQJSDSHUVLQVFLHQWLILFPHHWLQJV
FRPSDUHGZLWKSXEOLVKLQJ$PRQJWKHDGYDQWDJHVDUHWKDWWKHLQIRUPDWLRQSUHVHQWHG
LVXSWRGDWHWKHUHLVXVXDOO\DORQJWLPHODJEHIRUHDSDSHULVSXEOLVKHGLQDUHSXWDEOH
MRXUQDODQGWKDWSUHVHQWDWLRQVDOORZGLVFXVVLRQDQGTXHVWLRQVWRWKHDXWKRUVSURYLGH
DQRSSRUWXQLW\IRUPHHWLQJRWKHUUHVHDUFKHUVLQWHUHVWHGLQWKHVDPHWRSLFDQGSURPRWH
QHWZRUNLQJLQUHVHDUFK$PRQJWKHGLVDGYDQWDJHVDUHWKDWVFLHQWLILFSUHVHQWDWLRQVDUH
QRWVXEMHFWHGWRWKHVDPHOHYHORISHHUUHYLHZDQGDUHQRWUHWULHYDEOHLQWKHOLWHUDWXUH
$SDSHUSUHVHQWHGDWDVFLHQWLILFPHHWLQJFDQEHVXEPLWWHGVXEVHTXHQWO\IRUSXEOLFDWLRQ
SURYLGHGWKDWWKHFRQIHUHQFHSDSHUVDVDZKROHKDYHQRWDOUHDG\EHHQSXEOLVKHGLQ
DMRXUQDO+RZHYHUSDSHUVSUHVHQWHGDWVFLHQWLILFPHHWLQJVXVXDOO\QHHGVXEVWDQWLDO
UHZRUNLQJEHIRUHIXOOSXEOLFDWLRQ
10.2.3 The age of paperless papers

7KHGUHDPWKDWWKHUHVXOWVRIWKHZRUOG¶VELRPHGLFDOUHVHDUFKFDQEHGLVVHPLQDWHG
IUHHO\DQGZLGHO\WRDOOPD\QRWEHIDUDZD\7KH:RUOG:LGH:HEDOORZVWKHGLVWULEXWLRQ
RILQIRUPDWLRQDWRQO\DIUDFWLRQRIWKHFRVWRIGLVWULEXWLRQRQSDSHU7KHLQWHUQHWZDV
RULJLQDOO\FUHDWHGDVDSODFHIRUVFLHQWLVWVWRGRVFLHQFH8QWLOMXVWDIHZ\HDUVDJR
UHVHDUFKHUVZHUHWKHPDLQLQKDELWDQWVRIF\EHUVSDFH7KHLQWHUQHWLVQRZFKDQJLQJWKH
SURFHVVRIUHVHDUFKSXEOLFDWLRQXVKHULQJLQDQHZDJHRISDSHUOHVVSDSHUV
7KHWLPHEHWZHHQWKHGD\DQDUWLFOHLVVXEPLWWHGWRDWUDGLWLRQDOMRXUQDOWRWKHGD\
LWUHDFKHVDVXEVFULEHU¶VKDQGVFDQDPRXQWWRPRQWKVRISHHUUHYLHZHGLWLQJSURRI
DSSURYDODQGVLPSOHTXHXLQJIRUVSDFH7RE\SDVVSDSHUDOWRJHWKHUVRPHMRXUQDOVKDYH
DOUHDG\DGRSWHGWKHRQOLQHV\VWHPIRUPDQXVFULSWVXEPLVVLRQWUDFNLQJDQGSHHUUHYLHZ
2WKHUMRXUQDOVZLOOVRRQIROORZ5HVHDUFKHUVVXEPLWWKHLUDUWLFOHVE\HPDLOLQVWDQWO\
YHULI\LQJWKDWLWKDVEHHQUHFHLYHGDQGHGLWRUVVHQGWKHPE\HPDLOIRUSHHUUHYLHZ
ZLWKRXWWKHGHOD\VLQYROYHGLQPDLOLQJ5HYLHZHU¶VFRPPHQWVDUHVHQWE\HPDLOWRWKH
DXWKRUVDQGUHTXHVWHGUHYLVLRQVDUHVHQWEDFNE\HPDLO7KURXJKDWUDFNLQJV\VWHP
XVLQJWKHLQWHUQHWDXWKRUVFDQFKHFNRQWKHSDSHU¶VVWDWXV7XUQDURXQGWLPHVFDQEHPXFK
VKRUWHUDVDUHVXOWZHHNVUDWKHUWKDQPRQWKV
6RPHMRXUQDOVSRVWHDUO\RQOLQHSDSHUVRQWKHLUZHEVLWHVDKHDGRISULQWSXEOLFDWLRQ
7KHYHUVLRQRIDQDUWLFOHSXEOLVKHGHDUO\RQOLQHLVWKHGHILQLWLYHYHUVLRQZKLFKZLOOEH
LGHQWLFDOLQFRQWHQWWRWKDWSXEOLVKHGLQWKHSULQWMRXUQDO:KHQWKHILQDODUWLFOHLVDVVLJQHG
WRDQLVVXHRIWKHMRXUQDOWKHHDUO\RQOLQHYHUVLRQLVUHPRYHG
(OHFWURQLFMRXUQDOVDUHVXSSOHPHQWLQJDQGLQVRPHFDVHVUHSODFLQJSDSHUMRXUQDOV
6XEVFULSWLRQSULFHVIRUHOHFWURQLFMRXUQDOVDUHDIUDFWLRQRIWKRVHIRUSDSHUSXEOLFDWLRQV
DQGDUHVRPHWLPHVIUHH$VRIWKHHQGRIWKHUHZHUHHOHFWURQLFMRXUQDOV
PRUHWKDQLQWKH\HDUEHIRUHDQGLQFOXGLQJWKHILHOGVRIPDWKVSK\VLFVFKHPLVWU\
ELRORJ\PHGLFLQHDQGWKHVRFLDOVFLHQFHV7KHQXPEHUKDVVLQFHEHHQLQFUHDVLQJ
,WLVWRRHDUO\WRSUHGLFWWKHGHDWKRIWKHELRPHGLFDOMRXUQDODVZHNQRZLW%XWZHDUH
FHUWDLQO\H[SHULHQFLQJDGUDPDWLFPHWDPRUSKRVLVRIWKHWRROVRIVFLHQWLILFFRPPXQLFDWLRQ
7KH:RUOG:LGH:HEPDNHVLWLQHYLWDEOHWKDWQHZV\VWHPVIRUGLVVHPLQDWLQJUHVHDUFK
ZLOOSDUWO\UHSODFHRUVXSSOHPHQWWUDGLWLRQDOMRXUQDOV
3XEOLVKLQJSHHUUHYLHZHGRULJLQDOUHVHDUFKKDVDGGLWLRQDOFRVWVHYHQRQWKHLQWHUQHW
&XUUHQWO\VXEVFULEHUVPHHWWKHFRVWV$QHZPRGHOLVQRZEHLQJH[SHULPHQWHGZLWK
ZKHUHE\DXWKRUVRUWKHLULQVWLWXWLRQVRUIXQGHUVSD\WKHFRVWVRISHHUUHYLHZDQG
HOHFWURQLFGLVVHPLQDWLRQRIWKHLUDUWLFOHV([SHULPHQWVZLWKWKH³DXWKRUSD\´PRGHO
DUHDOUHDG\XQGHUZD\%LR0HG&HQWUDOKWWSELRPHGFHQWUDOFRPLVDQLQGHSHQGHQW
FRPPHUFLDOSXEOLVKHUFRPPLWWHGWRSURYLGLQJIUHHDQGLPPHGLDWHRQOLQHDFFHVVWRWKH
IXOOWH[WRISHHUUHYLHZHGELRPHGLFDOUHVHDUFK$XWKRUVUHWDLQFRS\ULJKW%LR0HG&HQWUDO
KDVPRUHWKDQSHHUUHYLHZHGMRXUQDOVVSDQQLQJWKHILHOGVRIELRORJ\DQGPHGLFLQH
DQGSURYLGHVIUHHWHFKQLFDOVXSSRUWDQGKRVWLQJIRUJURXSVRIUHVHDUFKHUVZDQWLQJWR
UXQRQOLQHRSHQDFFHVVSHHUUHYLHZHGMRXUQDOVXQGHUWKHLURZQHGLWRULDOFRQWURO7KH
FRPSDQ\UHFHLYHVQRVXSSRUWIURPJRYHUQPHQWVRUIURPVFLHQWLILFVRFLHWLHV,QVWHDG
RIFKDUJLQJXVHUV%LR0HG&HQWUDOFRYHUVWKHFRVWVRISHHUUHYLHZDQGSXEOLFDWLRQE\
FKDUJLQJDXWKRUVIRUSURFHVVLQJPDQXVFULSWV7KHFKDUJH86SHUSXEOLVKHGDUWLFOH
LQFDQEHSDLGGLUHFWO\E\DXWKRUVXVXDOO\IURPWKHLUUHVHDUFKIXQGVRUYLDWKHLU
LQVWLWXWHVWKURXJK%LR0HG&HQWUDO¶VPHPEHUVKLSVFKHPH,Q%LR0HG&HQWUDOKDG
LQVWLWXWLRQDOPHPEHUVIURPFRXQWULHV7KHFKDUJHLVZDLYHGIRUDXWKRUVIURP
GHYHORSLQJFRXQWULHVDQGRWKHUVZKRDUHXQDEOHWRSD\:LGHVSUHDGDGRSWLRQRID86
FKDUJHSHUSXEOLVKHGDUWLFOHZRXOGUHSUHVHQWDWHQIROGVDYLQJIRUVFLHQFHDQGVRFLHW\
,WKDVEHHQHVWLPDWHGWKDWWKHVFLHQWLILFFRPPXQLW\FXUUHQWO\SD\VDERXW86SHU
SXEOLVKHGDUWLFOHEDVHGRQSXEOLVKHUV¶JURVVUHYHQXHVIURPMRXUQDOVXEVFULSWLRQV,WKDV
EHHQHVWLPDWHGWKDWEHWZHHQDQGWKHJOREDOPHGLFDOSXEOLVKLQJVHFWRUJUHZ
E\DQHVWLPDWHGWDNLQJLWVUHYHQXHWR86ELOOLRQ
7KH 3XEOLF /LEUDU\ RI 6FLHQFH 3/R6 KWWS??ZZZSORVRUJ D QRQSURILW
RUJDQL]DWLRQRIVFLHQWLVWVDQGSK\VLFLDQVLVDQRWKHULQLWLDWLYHFRPPLWWHGWRPDNLQJWKH
ZRUOG¶VVFLHQWLILFDQGPHGLFDOOLWHUDWXUHDIUHHO\DYDLODEOHSXEOLFUHVRXUFH,WLVEHLQJ
IXQGHGGXULQJLWVILUVWIRXU\HDUVE\D86PLOOLRQJUDQWIURPWKH*RUGRQDQG%HWW\
0RRUH)RXQGDWLRQ7KH,QWHUQHWDQGHOHFWURQLFSXEOLVKLQJHQDEOHWKHFUHDWLRQRISXEOLF
OLEUDULHVRIVFLHQFHFRQWDLQLQJWKHIXOOWH[WDQGGDWDRIDQ\SXEOLVKHGUHVHDUFKDUWLFOH
DYDLODEOHIUHHRIFKDUJHWRDQ\RQHDQ\ZKHUHLQWKHZRUOG7RUHDOL]HWKLVSRWHQWLDODQHZ
EXVLQHVVPRGHOIRUVFLHQWLILFSXEOLVKLQJLVUHTXLUHGWKDWWUHDWVWKHFRVWVRISXEOLFDWLRQ
DVWKHILQDOLQWHJUDOVWHSRIWKHIXQGLQJRIDUHVHDUFKSURMHFW7RGHPRQVWUDWHWKDWWKLV
SXEOLVKLQJPRGHOZLOOEHVXFFHVVIXOIRUWKHSXEOLFDWLRQRIWKHYHU\EHVWUHVHDUFK3/R6
SODQVWRSXEOLVKLWVRZQSHHUUHYLHZHGMRXUQDOV3/R6%LRORJ\ODXQFKHGLWVILUVWLVVXHRQ
2FWREHULQSULQWDQGRQOLQH3/R60HGLFLQHZLOOIROORZLQ3/R6%LRORJ\
SODQVWRPHHWLWVFRVWVE\FKDUJLQJDXWKRUVIRUHDFKSXEOLVKHGSDSHU,IDFFHSWHG
IRUSXEOLFDWLRQWKHDUWLFOHZLOOEHPDGHLPPHGLDWHO\DQGIUHHO\DYDLODEOHRQOLQH
10.3 Communicating to funding agencies

5HVHDUFKHUVQHHGWRUHSRUWUHJXODUO\WRWKHIXQGLQJDJHQF\RQWKHSURJUHVVRIWKHLU
UHVHDUFK0RVWDJHQFLHVUHTXLUHD\HDUO\SURJUHVVUHSRUW$IHZUHTXLUHVL[PRQWKO\
UHSRUWV1RUPDOO\LQPXOWL\HDUIXQGLQJRIDSURMHFWIXQGLQJIRUWKHQH[WSHULRGLV
FRQWLQJHQWRQWKHUHFHLSWRIDVDWLVIDFWRU\SURJUHVVUHSRUWDVZHOODVDILQDQFLDOUHSRUW
RQWKHH[SHQGLWXUHGXULQJWKHSHULRGFRYHUHGE\WKHUHSRUW
7KHSURJUHVVUHSRUWVKRXOGSURYLGHLQIRUPDWLRQWRVDWLVI\WKHDJHQF\DERXWWKH
SURJUHVVRIWKHSURMHFW$Q\SUREOHPVHQFRXQWHUHGVKRXOGEHSUHVHQWHG7KHSODQIRU
WKHQH[WSHULRGVKRXOGEHFOHDUO\RXWOLQHG$Q\SDSHUVVXEPLWWHGDFFHSWHGRUSXEOLVKHG
VKRXOGEHPHQWLRQHG7KHILQDQFLDOUHSRUWVKRXOGEHLWHPL]HG,IWKHUHVHDUFKGLGQRWJR
RQVFKHGXOHWKHLQYHVWLJDWRUVPD\UHTXHVWDQRFRVWH[WHQVLRQRIWKHJUDQW$WWKHHQG
RIWKHJUDQWDPRUHGHWDLOHGILQDOUHSRUWLVH[SHFWHG$ILQDOILQDQFLDOUHSRUWLVQHHGHG
WRFORVHWKHERRNVRQWKHJUDQW
10.4 Communicating to health professionals

5HVHDUFKHUVKDYHDFROOHFWLYHUHVSRQVLELOLW\WRHQVXUHWKDWKHDOWKFDUHSURYLGHUV
KDYHDFFHVVWRVFLHQWLILFHYLGHQFHWDLORUHGWRWKHLUQHHGV5HOLDQFHRQSDVVLYHGLIIXVLRQ
RILQIRUPDWLRQWRNHHSWKHNQRZOHGJHRIKHDOWKSURIHVVLRQDOVXSWRGDWHLVQRWHQRXJK
$OWKRXJKWKHVNLOOVIRUVHDUFKLQJIRUHYLGHQFHDQGFULWLFDOO\DSSUDLVLQJLWQHHGWR
EHPDVWHUHGPRVWKHDOWKSURIHVVLRQDOVFDQQRWNHHSXSZLWKWKHVWULGHVRIVFLHQWLILF
NQRZOHGJH$ERXWWZRPLOOLRQDUWLFOHVRQPHGLFDOLVVXHVDUHSXEOLVKHGHYHU\\HDU$Q
HGLWRULDOLQWKH%ULWLVK0HGLFDO-RXUQDOFDOFXODWHGLQWKDWIRUGRFWRUVWRNHHSXSWR
GDWHZLWKWKHH[SORVLRQRIVFLHQWLILFLQIRUPDWLRQLQWKHLUVSHFLDOW\WKH\QHHGWRUHDGDERXW
DUWLFOHVDGD\HYHU\GD\RIWKH\HDU0RVWUHVXOWVIURPUHVHDUFKDSSHDUILUVWLQSHHU
UHYLHZHGMRXUQDOV7KHVPDOOQXPEHURIVWXGLHVZLWKSUDFWLFDOLPSOLFDWLRQVIRUKHDOWK
SURIHVVLRQDOVLVVSUHDGWKLQO\WKURXJKDYDVWQXPEHURISXEOLFDWLRQV7KHHYLGHQFHIURP
WKHVHVWXGLHVQHHGVWREHV\QWKHVL]HG
5HVHDUFKHUVFDQDQGVKRXOGKHOSLQFRPPXQLFDWLQJQHZLQIRUPDWLRQWRKHDOWK
SURIHVVLRQDOVLQDPDQQHUWKDWLVWDLORUHGWRWKHLUQHHGV7KHGHYHORSPHQWDQGSXEOLFDWLRQ
RIHYLGHQFHEDVHGUHYLHZVDQGFOLQLFDOSUDFWLFHJXLGHOLQHVDUHH[DPSOHVRIKRZWKLV
FRPPXQLFDWLRQFDQEHDFKLHYHG
Evidence-based reviews
7KHUHDUHQRZDQLQFUHDVLQJQXPEHURIMRXUQDOVDQGDEVWUDFWLQJVHUYLFHVWKDW
UHYLHZLPSRUWDQWSDSHUVULJRURXVO\DQGSUHVHQWWKHUHVXOWVLQDZD\WKDWEXV\KHDOWK
SURIHVVLRQDOVFDQHDVLO\JUDVS$QH[DPSOHLV(YLGHQFHEDVHGPHGLFLQHSXEOLVKHG
WKURXJKDFROODERUDWLRQEHWZHHQWKH$PHULFDQ&ROOHJHRI3K\VLFLDQVDQGWKH%0-%ULWLVK
0HGLFDO-RXUQDO3XEOLVKLQJ*URXS,WLQFOXGHVDEVWUDFWVDQGFRPPHQWDULHVIURPPRVW
VSHFLDOWLHVZLWKSUHIHUHQFHJLYHQWRVWXGLHVWKDWFRYHUFRQGLWLRQVWKDWDUHFRPPRQO\
HQFRXQWHUHGLQSUDFWLFH,WDOVRSXEOLVKHVV\VWHPDWLFUHYLHZVDQGHGLWRULDOVRIJHQHUDO
LQWHUHVW$VWKHHGLWRUVSXWLWWKHMRXUQDOZLOOSXEOLVKWKHJROGWKDWLQWHOOHFWXDOO\LQWHQVH
SURFHVVHVZLOOPLQHIURPWKHRUHRIDERXWRIWKHZRUOG¶VWRSMRXUQDOV7KHMRXUQDOLV
DYDLODEOHRQOLQHKWWSHEPEPMMRXUQDOVFRPZLWKIUHHDFFHVVIRUSURIHVVLRQDOVIURP
ORZLQFRPHDQGORZPLGGOHLQFRPHFRXQWULHV
6\VWHPDWLFUHYLHZVRIUHVHDUFKVXFKDVWKHZRUNGRQHE\WKH&RFKUDQH&ROODERUDWLRQ
KDYHDOVREHFRPHDXVHIXOUHVRXUFHDVGHVFULEHGLQ&KDSWHU
Clinical practice guidelines

7KHPHGLFDOOLWHUDWXUHFDQEHELDVHGWRZDUGVLQQRYDWLRQV%XWLQQRYDWLRQVQHHGWR
EHFULWLFDOO\DVVHVVHG7KHFKDOOHQJHLVWRSURPRWHWKHDGRSWLRQRIWKRVHLQQRYDWLRQV
WKDWKDYHEHHQSURYHQWREHEHQHILFLDOWRGHOD\WKHVSUHDGRILQQRYDWLRQVQRW\HW
VKRZQWREHHIIHFWLYHDQGWRSUHYHQWWKHXSWDNHRILQHIIHFWLYHRUSRWHQWLDOO\KDUPIXO
LQQRYDWLRQV7KHUHDUHGDQJHUVLQXQFULWLFDODFFHSWDQFHRIPHGLFDOLQQRYDWLRQVE\KHDOWK
SURIHVVLRQDOV
6\VWHPDWLFUHYLHZVRIHYLGHQFHZLOOQRWDOZD\VOHDGWRFOHDUDQGXQDPELJXRXV
UHFRPPHQGDWLRQV5LJRURXVO\GHYHORSHGJXLGHOLQHVFDQWUDQVODWHFRPSOLFDWHGUHVHDUFK
ILQGLQJVLQWRDFWLRQDEOHUHFRPPHQGDWLRQVIRUFOLQLFDOSUDFWLFH(YLGHQFHEDVHGFOLQLFDO
SUDFWLFHJXLGHOLQHVFDQGHFUHDVHWKHXVHRILQDSSURSULDWHKHDOWKFDUHDQGFDQSURPRWH
WKHLQWURGXFWLRQRIQHZNQRZOHGJHDERXWEHVWSUDFWLFHV$JURZLQJQXPEHURIJXLGHOLQHV
DUHEHLQJGHYHORSHGDIWHUH[KDXVWLYHUHYLHZVRIHYLGHQFHE\DPXOWLWXGHRISURIHVVLRQDO
RUJDQL]DWLRQV
7REHXVHIXOJXLGHOLQHVVKRXOGEDODQFHWKHVWUHQJWKVDQGOLPLWDWLRQVRIDOOUHOHYDQW
UHVHDUFKHYLGHQFHZLWKWKHSUDFWLFDOUHDOLWLHVRIWKHKHDOWKFDUHDQGFOLQLFDOVHWWLQJV
7KH\ VKRXOG DOVR DFNQRZOHGJH WKH XQFHUWDLQW\$XWKRULWDWLYH PHGLFLQH LV JLYLQJ
ZD\WRHYLGHQFHEDVHGPHGLFLQH8QFHUWDLQW\ PDNHV LW GLIILFXOW WR PDNH GHILQLWH
UHFRPPHQGDWLRQVEDVHGRQHYLGHQFHLQDOOVLWXDWLRQV%DVHGRQWKHDYDLODEOHOHYHORI
HYLGHQFHUHFRPPHQGDWLRQVRQPDQDJHPHQWRULQWHUYHQWLRQVDUHQRZFRPPRQO\JUDGHG
DFFRUGLQJWRWKHIROORZLQJFDWHJRULHV$&2*
$ 7KHUHLVJRRGHYLGHQFHWRVXSSRUWWKHUHFRPPHQGDWLRQ
% 7KHUHLVIDLUHYLGHQFHWRVXSSRUWWKHUHFRPPHQGDWLRQ
& 7KHUHLVLQVXIILFLHQWHYLGHQFHWRVXSSRUWWKHUHFRPPHQGDWLRQKRZHYHU
WKHUHFRPPHQGDWLRQPD\EHPDGHRQRWKHUJURXQGV
' 7KHUHLVIDLUHYLGHQFHDJDLQVWWKHUHFRPPHQGDWLRQ
( 7KHUHLVJRRGHYLGHQFHDJDLQVWWKHUHFRPPHQGDWLRQ
10.5 Communicating to policy-makers

+HDOWKSROLF\PDNHUVQHHGDGHTXDWHDQGVFLHQWLILFDOO\YDOLGDWHGLQIRUPDWLRQWR
PDNHHYLGHQFHEDVHGSROLF\:KHUHWKHUHVHDUFKKDVSROLF\LPSOLFDWLRQVUHVHDUFKHUV
KDYHWKHUHVSRQVLELOLW\WRFRPPXQLFDWHWKHUHVXOWVWRWKHFRQFHUQHGSROLF\PDNHUV
0HUHO\SXEOLVKLQJWKHVWXG\RUVHQGLQJDFRS\RIWKHUHSRUWRIWKHVWXG\LVQRWHQRXJK
,WLVPXFKEHWWHUZKHUHSRVVLEOHWRKDYHDIDFHWRIDFHSUHVHQWDWLRQZLWKDPSOHWLPH
IRUGLVFXVVLRQ*UDQWPDNLQJERGLHVXVXDOO\DSSURYHDQDOORFDWLRQLQWKHEXGJHWIRU
GLVVHPLQDWLRQRIWKHUHVHDUFKUHVXOWV7KLVPD\LQFOXGHZKHUHDSSURSULDWHDPHHWLQJ
ZLWKKHDOWKPDQDJHUVDQGSROLF\PDNHUVWRLQIRUPDQGGLVFXVVWKHUHVXOWVZLWKWKHP
)RUUHVHDUFKZLWKSROLF\LPSOLFDWLRQVFRPPXQLFDWLRQVKRXOGQRWEHOHIWXQWLOWKH
FRPSOHWLRQRIWKHUHVHDUFK,WVKRXOGLGHDOO\VWDUWGXULQJWKHVWDJHRISODQQLQJWKHUHVHDUFK
WRHQVXUHWKDWUHVHDUFKTXHVWLRQVDUHIUDPHGDSSURSULDWHO\DQGWHVWHGLQUHOHYDQWFRQWH[WV
XVLQJLQWHUYHQWLRQVWKDWFDQEHUHSOLFDWHGLQSUDFWLFH:KHUHSRVVLEOHWKRVHZKRDUHPRVW
OLNHO\WRXVHWKHUHVXOWVRIUHVHDUFKVKRXOGDOVREHLQYROYHGLQWKHLPSOHPHQWDWLRQRIWKH
UHVHDUFKSURMHFW
7KHIROORZLQJDUHVRPHJXLGHOLQHVIRULQYHVWLJDWRUVZKHQPDNLQJDSUHVHQWDWLRQRI
WKHLUUHVXOWVWRSROLF\PDNHUV
.QRZ\RXUDXGLHQFHDQGWDLORUWKHSUHVHQWDWLRQWRWKHSDUWLFXODUDXGLHQFH7KHDXGL
HQFHPD\EHSK\VLFLDQVRQO\RUPD\LQFOXGHQXUVHVFRPPXQLW\OHDGHUVDQGGRQRU
DJHQFLHV,IQHFHVVDU\PRUHWKDQRQHSUHVHQWDWLRQVKRXOGEHPDGH
$YRLGWHFKQLFDOMDUJRQ,WZLOOQRWLPSUHVV,WZLOOVLPSO\FRQIXVHDQGGLVWUDFW
'R QRW RYHUORDG WKH SUHVHQWDWLRQ ZLWK VWDWLVWLFDO GDWD ,QFOXGH RQO\ WKH GDWD WKDW
MXVWLI\DQGH[SODLQWKHFRQFOXVLRQVDQGUHFRPPHQGDWLRQV
)ROORZWKHVDPHVWHSVDVLQDVFLHQWLILFSUHVHQWDWLRQZLWKHPSKDVLVRQWKHFRQFOX
VLRQVDQGUHFRPPHQGDWLRQV5HFRPPHQGDWLRQVDUHPRUHOLNHO\WREHLPSOHPHQWHG
LIWKH\DUHGLUHFWHGWRWKRVHZKRVKRXOGDQGFDQLPSOHPHQWWKHPDQGLIDWWHQWLRQLV
JLYHQWRWKHIHDVLELOLW\RIWKHLULPSOHPHQWDWLRQ6SHFLILFUHFRPPHQGDWLRQVDUHEHWWHU
WKDQJHQHUDOUHFRPPHQGDWLRQV$SODQRIDFWLRQLVHYHQEHWWHU3ROLF\PDNHUVRIWHQ
SUHIHUWREHJLYHQRSWLRQVDERXWZKDWFDQEHGRQHZLWKDQRXWOLQHRIWKHDGYDQWDJHV
DQGGLVDGYDQWDJHVRIHDFKRSWLRQ7KH\SUHIHUQRWWREHWROGZKDWWRGREXWWREH
JLYHQWKHLQIRUPDWLRQXSRQZKLFKWKH\FDQPDNHDSSURSULDWHGHFLVLRQV
9LVXDODLGVSURSHUO\VHOHFWHGDQGGHVLJQHGDUHXVHIXOLQKLJKOLJKWLQJWKHLPSRUWDQW
SRLQWVLQWKHSUHVHQWDWLRQLQFOXGLQJWKHPDLQFRQFOXVLRQVDQGUHFRPPHQGDWLRQV
$OORZDGHTXDWHWLPHIRUGLVFXVVLRQ
%HSUHSDUHGWRDFFHSWFRPPHQWVFULWLFLVPVDQGVXJJHVWLRQV%XWEHDOVRSUHSDUHG
WRGHIHQG\RXUUHVXOWV
+DYH DQ LQIRUPDWLYH H[HFXWLYH VXPPDU\ RI WKH VWXG\ DQG PDNH LW DYDLODEOH IRU
GLVWULEXWLRQLQWKHPHHWLQJ$FRS\RIWKHYLVXDODLGVPD\EHJLYHQDWWKHHQGRUDW
WKHEHJLQQLQJRIWKHSUHVHQWDWLRQ,WLVDOZD\VEHWWHUWKDWSDUWLFLSDQWVLQWKHPHHWLQJ
WDNHVRPHWKLQJZLWKWKHP7KHIXOOUHSRUWLVOHVVOLNHO\WREHUHDGWKDQDQH[HFXWLYH
VXPPDU\
+DYHDUHFRUGRIWKHPHHWLQJDQGDQRWHRIDQ\DJUHHPHQWVPDGH7KLVVKRXOGEH
SUHSDUHGVKRUWO\DIWHUWKHPHHWLQJEHIRUHWKHPHHWLQJLVIRUJRWWHQ7KHUHFRUGRU
PLQXWHVVKRXOGEHFLUFXODWHGWRWKRVHZKRDWWHQGHGWKHPHHWLQJDQGDOVRWRWKRVH
ZKRZHUHH[SHFWHGWRDWWHQGEXWFRXOGQRW
10.6 Communicating to patients

7KHKHDOWKUHVHDUFKFRPPXQLW\KDVDQREOLJDWLRQWRHQVXUHWKDWSDWLHQWVKDYHDFFHVV
WRDSSURSULDWHVFLHQWLILFLQIRUPDWLRQ7KHUHKDVEHHQDQH[SORVLRQRIKHDOWKLQIRUPDWLRQ
RQWKHLQWHUQHW0RUHWKDQPHGLFDOZHEVLWHVRIYDU\LQJTXDOLW\H[LVWDQG
WKHLUQXPEHULVJURZLQJUDSLGO\.LOH\DQG*UDKDP7KHLQWHUQHWUHYROXWLRQLQ
KHDOWKFDUHLVODUJHO\GULYHQE\DPDVVLYHFRQVXPHUGHPDQGIRURQOLQHKHDOWKUHVRXUFHV
7KHUHLVDJURZLQJERG\RIKHDOWKLQIRUPDWLRQGLUHFWHGDWSDWLHQWVZKLFKLVERWK
VFLHQWLILFDOO\VRXQGDQGLQWHOOLJLEOH,QWKH861DWLRQDO/LEUDU\RI0HGLFLQHKWWS
ZZZQOPQLKJRYODXQFKHGDFRQVXPHUKHDOWKSDJHFDOOHG0('/,1(SOXVGHVLJQHGWR
GLUHFWFRQVXPHUVWRUHVRXUFHVFRQWDLQLQJLQIRUPDWLRQWKDWZLOODVVLVWLQUHVHDUFKLQJWKHLU
KHDOWKTXHVWLRQV7KHSDJHVDUHGHVLJQHGIRUHGXFDWLRQDOXVHRQO\DQGDUHQRWLQWHQGHG
WRUHSODFHDGYLFHIURPDKHDOWKSURIHVVLRQDO7KHSDJHVSURYLGHDFDUHIXOO\VHOHFWHGOLVW
RIUHVRXUFHVQRWDFRPSUHKHQVLYHFDWDORJXH
&DUHVKRXOGEHWDNHQLQFRPPXQLFDWLQJUHVHDUFKILQGLQJVWRSDWLHQWV3HRSOHQHHG
WREHHPSRZHUHGZLWKVFLHQWLILFDOO\YDOLGDQGLQWHOOLJLEOHLQIRUPDWLRQ,QIRUPDWLRQ
SDUWLFXODUO\RQKHDOWKULVNVRUEHQHILWVRIGLIIHUHQWLQWHUYHQWLRQVFDQEHFRQIXVLQJLI
QRWDGHTXDWHO\SUHVHQWHGDQGH[SODLQHG&RQIXVLRQFDQOHDGWRSDWLHQWVPDNLQJZURQJ
GHFLVLRQV)RUH[DPSOHZRPHQDJHGRYHU\HDUVROGPD\EHWROGWKDWPDPPRJUDSK\
VFUHHQLQJUHGXFHVWKHLUULVNRIG\LQJIURPEUHDVWFDQFHUE\)HZSDWLHQWVZRXOG
XQGHUVWDQGWKDWWKLVLPSUHVVLYHILJXUHPHDQVDQDEVROXWHULVNUHGXFWLRQRIRQO\RQHLQ
RIZRPHQZKRGRQRWXQGHUJRPDPPRJUDSK\DERXWIRXUZLOOGLHIURPEUHDVW
FDQFHUZLWKLQWHQ\HDUVZKHUHDVRXWRIZRPHQZKRGRWKUHHZLOOGLH*LJHUHQ]HU
DQG(GZDUGV
10.7 Communicating to the community

,IWKHUHVHDUFKZDVDFRPPXQLW\EDVHGVWXG\WKHFRPPXQLW\KDVDULJKWWRNQRZ
WKHRXWFRPHRIWKHVWXG\,WLVWKHGXW\DQGUHVSRQVLELOLW\RIWKHLQYHVWLJDWRUVWRGR
WKLVDQGWRVHOHFWWKHDSSURSULDWHIRUPDQGZD\RIGRLQJLW,WLVDGYLVDEOHWRVKDUHWKH
LQIRUPDWLRQZLWKWKHFRPPXQLW\EHIRUHSXWWLQJLWLQWRWKHSXEOLFGRPDLQ,WZRXOGDOVREH
XVHIXOWRFKHFNZKHWKHUWKH\DJUHHZLWKWKHILQGLQJVDQGFRQFOXVLRQVDQGZKHWKHUWKHUH
DUHDGGLWLRQDOTXHVWLRQVWKDWQHHGHGWREHDGGUHVVHG7KHIHDVLELOLW\RIDQ\DFWLRQDEOH
UHFRPPHQGDWLRQVFDQDOVREHGLVFXVVHG
10.8 Communicating to the public

7KHSXEOLFLVHQWLWOHGWRDFFXUDWHVFLHQWLILFLQIRUPDWLRQRQLVVXHVWKDWFDQLQIOXHQFH
LQGLYLGXDOEHKDYLRXURUSXEOLFSROLF\&RPPXQLFDWLQJVFLHQWLILFKHDOWKLQIRUPDWLRQWR
WKHSXEOLFFDQEHGRQHE\SRSXODUVFLHQWLILFSXEOLFDWLRQVWDUJHWHGDWDOD\DXGLHQFHE\
XVLQJWKHFKDQQHOVRISXEOLFPHGLDDQGLQFUHDVLQJO\QRZE\XVLQJWKHLQWHUQHW
6FLHQWLVWVQHHGWRHQJDJHWKHSXEOLFLQZKDWWKH\DUHGRLQJ7KLVLQYROYHVPRUHWKDQ
MXVWPDNLQJVFLHQWLILFLQIRUPDWLRQIUHHO\DYDLODEOH7KHUROHRIVFLHQWLVWVLVQRORQJHU
WRSUHDFKHQOLJKWHQPHQWWRWKHLJQRUDQWPDVVHV2QFHUWDLQLVVXHVWKHUROHRIVFLHQWLVWV
LVWRSUHVHQWWKHFDVHREMHFWLYHO\WRDQHQOLJKWHQHGFLWL]HQMXU\WRDOORZWKHPWRPDNH
DQLQIRUPHGMXGJHPHQW6FLHQWLVWVPXVWDFFHSWWKDWWKH\DUHQRPRUHTXDOLILHGWKDQWKH
JHQHUDOSXEOLFWRPDNHYDOXHMXGJHPHQWVDVWRWKHXVHVWRZKLFKVFLHQFHVKDOOEHSXW7KH
XQFHUWDLQW\LQKHUHQWLQWKHVFLHQWLILFSURFHVVPXVWEHDGHTXDWHO\H[SRVHG7KHDUURJDQFH
RIVFLHQFHPXVWJLYHZD\WRDVFLHQWLILFFXOWXUHRIVRFLDOUHVSRQVLELOLW\
6FLHQWLVWVLQDUJXLQJWKHFDVHIRUDFDGHPLFIUHHGRPVWDWHWKDWVFLHQWLILFSURJUHVV
VKRXOGQRWEHVWRSSHGEHFDXVHRIWKHSRVVLELOLW\RIDEXVH7KHSXEOLFKRZHYHUKDV
DULJKWWREHFRQFHUQHG2QHVKRXOGQHYHUXQGHUHVWLPDWHWKHDELOLW\RIKXPDQEHLQJV
IRULUUDWLRQDOEHKDYLRXU7KHDWRPLFERPEDQGRWKHUVFLHQWLILFDOO\GHYHORSHGZHDSRQV
RIPDVVGHVWUXFWLRQDUHVWLOOLQWKHPHPRU\RIWKHSXEOLF7KHREMHFWLYHRIVFLHQFHLV
WRZRUNIRUDEHWWHUZRUOG6FLHQFHVKRXOGQRWEHXVHGIRUSXUSRVHVLQWHQGHGWRKDUP
KXPDQEHLQJVRUWKHHQYLURQPHQW6FLHQWLVWVKRXOGFRQVLGHUWKHHWKLFDOLPSOLFDWLRQVRI
WKHLUZRUN
7KHWDVNRIHGXFDWLQJWKHSXEOLFLVDFKLHYDEOHDVHYLGHQFHGE\DUHFHQWUHIHUHQGXPLQ
6ZLW]HUODQGRQJHQHWLFHQJLQHHULQJ9RWHUVZHUHGLYLGHGRQWKHLVVXH$IWHU6ZLW]HUODQG¶V
VFLHQWLVWVRSHQHGWKHLUODERUDWRULHVDQGFRPPXQLFDWHGZLWKWKHSXEOLFWKHUHVXOWZDVD
WZRWKLUGPDMRULW\DJDLQVWDWRWDOEDQRQJHQHWLFPRGLILFDWLRQRISODQWVDQGDQLPDOVDQG
WKHLUUHOHDVHLQWRWKHHQYLURQPHQW
10.9 Communicating to the public media

6FLHQWLVWVVKRXOGEHFDUHIXOLQFRPPXQLFDWLQJVFLHQWLILFGDWDWRWKHSXEOLFPHGLD
7KHPHGLDLQLWVSUHVHQWDWLRQRIVFLHQFHDLPVILUVWWRHQJDJHDQGHQWHUWDLQDQGRQO\
VHFRQGWRLQIRUP6FLHQWLVWVVKRXOGUHVLVWWKHWHPSWDWLRQWRFRPPXQLFDWHMXVWIRUWKH
VDNHRISXEOLFLW\6FLHQWLVWVVKRXOGKHOSWKHSXEOLFPHGLDWRSUHSDUHDQGSUHVHQWDFFXUDWH
UHSRUWVRIVFLHQWLILFGDWDRILQWHUHVWWRWKHSXEOLF
7KHUHDUHHWKLFDOFRQVLGHUDWLRQVLQFRPPXQLFDWLQJWKHUHVXOWVRIVFLHQWLILFUHVHDUFK
WRWKHSXEOLFPHGLD0HGLDUHSRUWVRIVFLHQWLILFUHVHDUFKEHIRUHWKHZRUNKDVEHHQSHHU
UHYLHZHGDQGIXOO\SXEOLVKHGPD\OHDGWRWKHGLVVHPLQDWLRQRILQDFFXUDWHRUSUHPDWXUH
FRQFOXVLRQV9HU\OLWWOHPHGLFDOUHVHDUFKKDVVXFKXUJHQWLPSOLFDWLRQVIRUSXEOLFKHDOWK
WKDWLWVKRXOGEHUHOHDVHGEHIRUHIXOOSXEOLFDWLRQLQDVFLHQWLILFMRXUQDO,QVXFKDVLWXDWLRQ
WKHGHFLVLRQVKRXOGEHPDGHQRWE\WKHUHVHDUFKHUVEXWE\WKHDSSURSULDWHSXEOLFKHDOWK
DXWKRULW\,PSURSHUO\FRPPXQLFDWHGVFLHQWLILFLQIRUPDWLRQFDQUHVXOWLQXQMXVWLILHG
SXEOLFDODUP5HVHDUFKHUVZKRSUHVHQWWKHLUZRUNDWDVFLHQWLILFPHHWLQJPD\GLVFXVV
WKHLUSUHVHQWDWLRQVZLWKPHGLDUHSRUWHUVEXWWKH\VKRXOGQRWJREH\RQGZKDWWKH\KDYH
SUHVHQWHG

Reading the medical literature. Applying evidence to practice. Washington, DC, American
College of Obstetricians and Gynaecologists, 1998.
Byrne DW. Publishing your medical research paper. Baltimore, Williams & Wilkins, 1998:
210–217.
Delamothe T, Smith R. PubMed Central: creating an Aladdin’s cave of ideas (editorial).
Delamothe T, Godlee F, Smith R. Scientific literature’s open sesame? British Medical
Journal, 2003, 326: 945–946.
Davidoff F, Haynes B, Sackett D, Smith R.. Evidence based medicine (editorial). British
Medical Journal, 1995, 310: 1085–1086.
Eysenbach G, Sa ER, Diepgen TL. Shopping around the Internet today and tomorrow:
towards the millenium of cybermedicine. British Medical Journal, 1999, 319: 1294.
Gigerenzen G, Edward A. Simple tools for understanding risks: from innumeracy to insight.
Grimes DA. Communicating research: working with the media. In: O’Brien PMS, Pipkin
FB, eds. Introduction to research methodology for specialists and trainees. London, Royal
College of Obstetricians and Gynaecologists Press, 1999: 210–217.
Kiley R, Graham E. The patient’s Internet handbook. London, Royal Society of Medicine
Press Ltd., 2002.
Lock S. Foreword. In: Hawkins C, Sorgi M, eds. Research: How to plan, speak and write
about it. Berlin, Springer-Verlag, 1985: vii.
Long M. The future of electronic publishing. In: Hall GM, ed. How to write a paper, 2nd
edition. London, BMJ Books, 1998: 132–138.
Shiffman RN et al. Standardized reporting of clinical practice guidelines: a proposal from
the Conference on Guideline Standardization. Annals of Internal Medicine, 2003, 139:
493–498.
Smith R. Closing the digital divide (editorial). British Medical Journal, 2003, 326: 328.
Smith R. Do patients need to read research? British Medical Journal, 2003, 326: 1304.
Tamber PS, Fiona F, Newmark P. Open access to peer-reviewed research: making it
happen. Lancet, 2003, 362: 1575–77.
Chapter 11
Writing a scientific paper
11.1 Introduction
:ULWLQJDVFLHQWLILFSDSHULVWKHPRVWFRPPRQZD\RIFRPPXQLFDWLQJWKHUHVXOWV
RIUHVHDUFKWRRWKHUVFLHQWLVWVDQGWRKHDOWKSURIHVVLRQDOV,WJRHVZLWKRXWVD\LQJWKDW
DXWKRUVVKRXOGDWDOOWLPHVKDYHLQPLQGREMHFWLYLW\FODULW\DQGKRQHVW\LQUHSRUWLQJWKHLU
UHVHDUFK7KHIRUPDWIRUZULWLQJDVFLHQWLILFSDSHUIRUSXEOLFDWLRQLQELRPHGLFDOMRXUQDOV
KDVEHHQVWDQGDUGL]HGWRSURYLGHDV\VWHPDWLFDQGRUJDQL]HGZD\WRSUHVHQWWKHGDWD7KH
WH[WRIREVHUYDWLRQDODQGH[SHULPHQWDODUWLFOHVLVXVXDOO\EXWQRWQHFHVVDULO\GLYLGHG
LQWRVHFWLRQVZLWKWKHKHDGLQJV,QWURGXFWLRQ0HWKRGV5HVXOWVDQG'LVFXVVLRQ/RQJ
DUWLFOHVPD\QHHGVXEKHDGLQJVLQVRPHVHFWLRQVHVSHFLDOO\WKH5HVXOWVDQG'LVFXVVLRQ
VHFWLRQVWRFODULI\WKHLUFRQWHQWV-RXUQDOVJHQHUDOO\SURYLGHLQHDFKLVVXHDQGRQWKHLU
ZHEVLWHVGHWDLOHGLQVWUXFWLRQVWRWKHDXWKRUVRQWKHUHTXLUHGIRUPDWIRUVXEPLWWLQJ
SDSHUV
7KHSURFHVVRIZULWLQJXSWKHUHVHDUFKVKRXOGEHJLQGXULQJWKHUHVHDUFKSODQQLQJ
DQGFRQWLQXHZKLOHWKHUHVHDUFKLVEHLQJLPSOHPHQWHG:KHQWKHUHVXOWVRIWKHUHVHDUFK
DUHDQDO\VHGDILUVWGUDIWRIWKHZULWWHQSDSHUFDQEHSURGXFHG5HYLVLRQRIWKLVGUDIWLV
DQLPSRUWDQWSDUWRIWKHSURFHVV,WVKRXOGLQFOXGHUHYLVLRQIRUWKHFRQWHQWDQGUHYLVLRQ
RIWKHVW\OH
1RWDOOVFLHQWLILFFRPPXQLFDWLRQVILWLQWRWKHFODVVLFDOIRUPDWIRUSUHVHQWDWLRQRI
UHVHDUFK7ZRVXFKH[DPSOHVDUHDFDVHUHSRUWDQGDVFLHQWLILFUHYLHZ7KHUHDUHVSHFLDO
FRQVLGHUDWLRQVLQZULWLQJDSDSHUGHVFULELQJWKHUHVXOWVRITXDOLWDWLYHUHVHDUFKDQGDOVR
LQZULWLQJDWKHVLVRUGLVVHUWDWLRQ
7KH,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUVLVVXHVDVHWRIXQLIRUP
UHTXLUHPHQWVIRUVXEPLWWLQJPDQXVFULSWVWRELRPHGLFDOMRXUQDOV7KHVHUHTXLUHPHQWVDUH
UHYLVHGSHULRGLFDOO\WKHODWHVWYHUVLRQEHLQJGDWHG1RYHPEHU7KHUHTXLUHPHQWV
ZHUHWDNHQLQWRFRQVLGHUDWLRQLQGHYHORSLQJWKHJXLGHOLQHVLQWKLVFKDSWHUDQGDOVRLQ
&KDSWHURQSXEOLVKLQJDVFLHQWLILFSDSHU)RUPRUHGHWDLOVWKHUHDGHUPD\FRQVXOWWKH
UHIHUHQFHVDQGDGGLWLRQDOVRXUFHVSURYLGHGIRUWKHFKDSWHU
Writing a scientific paper 131
11.2 Selecting a title for the paper

$JRRGWLWOHVKRXOGDGHTXDWHO\GHVFULEHWKHFRQWHQWVRIWKHSDSHULQWKHIHZHVW
SRVVLEOHZRUGV,WVKRXOGQRWEHWRRORQJRUWRRVKRUWJHQHUDOO\LWVKRXOGFRQVLVWRI
±ZRUGV6RPHMRXUQDOVEXWQRWDOODOORZVXEWLWOHV7KHWLWOHVKRXOGQRWLQFOXGH
DQ\XQQHFHVVDU\ZRUGVQRUZDVWHVSDFHZLWKSKUDVHVVXFKDV³2EVHUYDWLRQVRQ´RU³$
VWXG\RI´,WVKRXOGQRWFRQWDLQDEEUHYLDWLRQV
0DQ\MRXUQDOVUHTXLUHDUXQQLQJWLWOHVKRUWWLWOHWREHSULQWHGDWWKHWRSRUERWWRP
RIHYHU\SDJHRIWKHDUWLFOHZKHQLWLVSXEOLVKHG8VXDOO\WKLVLVEHWZHHQDQG
FKDUDFWHUV
11.3 Writing the abstract and key words

$QDEVWUDFWVKRXOGEHLQFOXGHGDWWKHEHJLQQLQJRIWKHSDSHU7KHDEVWUDFWFDQ
SHUVXDGHRUSXWRIIUHDGHUV7KHDEVWUDFWLVWKHSDUWRIWKHSDSHUWKDWZLOOEHLQFOXGHGLQ
PRVWHOHFWURQLFGDWDEDVHVDYDLODEOHIRUUHWULHYDO7KHDEVWUDFWVKRXOGVWDWHWKHSXUSRVHV
RIWKHVWXG\RULQYHVWLJDWLRQEDVLFSURFHGXUHVVHOHFWLRQRIVWXG\VXEMHFWVRUODERUDWRU\
DQLPDOVREVHUYDWLRQDODQGDQDO\WLFDOPHWKRGVPDLQILQGLQJVJLYLQJVSHFLILFGDWD
DQGWKHLUVWDWLVWLFDOVLJQLILFDQFHLISRVVLEOHDQGWKHSULQFLSDOFRQFOXVLRQV,WVKRXOG
HPSKDVL]HWKHQHZDQGLPSRUWDQWDVSHFWVRIWKHVWXG\RUREVHUYDWLRQV
$JRRGDEVWUDFWVKRXOGEHDPLQLDWXUHYHUVLRQRIWKHSDSHUSURYLGHDEULHIVXPPDU\
RIHDFKRIWKHPDLQVHFWLRQVRIWKHSDSHUDQGIROORZWKHVWUXFWXUHRIWKHSDSHU0DQ\
MRXUQDOVUHTXLUHDVWUXFWXUHGDEVWUDFWZKLFKLQFOXGHVVXEWLWOHVVXFKDVREMHFWLYHW\SHRI
GHVLJQVHWWLQJPDWHULDORUVXEMHFWVPHWKRGVUHVXOWVDQGFRQFOXVLRQV7KHQXPEHURI
ZRUGVLQDQDEVWUDFWVKRXOGJHQHUDOO\EHOHVVWKDQIRUXQVWUXFWXUHGDEVWUDFWVDQGOHVV
WKDQIRUVWUXFWXUHGDEVWUDFWV6RPHHOHFWURQLFGDWDEDVHVDUHSURJUDPPHGWRDFFHSW
RQO\XSWRWKLVOLPLWHGQXPEHURIZRUGV$EVWUDFWVDUHJHQHUDOO\ZULWWHQLQWKHSDVWWHQVH
7KHDEVWUDFWVKRXOGEHVHOIFRQWDLQHGDQGDEOHWRVWDQGDORQHZLWKRXWQHHGWRFRQVXOWWKH
IXOOWH[W$VVXFKLWVKRXOGQRWLQFOXGHUHIHUHQFHVWROLWHUDWXUHRUWRILJXUHVDQGWDEOHVLQ
WKHERG\RISDSHUVKRXOGQRWLQFOXGHLQIRUPDWLRQWKDWLVQRWLQWKHSDSHUDQGVKRXOGQRW
FRQWDLQDEEUHYLDWLRQVRUDFURQ\PVXQOHVVVWDQGDUGRUYHU\ZHOONQRZQ
0RVWVFLHQWLILFMRXUQDOVUHTXLUHDXWKRUVWRSURYLGHWRNH\ZRUGVRUVKRUWSKUDVHV
WKDWZLOODVVLVWLQGH[HUVLQFURVVLQGH[LQJWKHDUWLFOH.H\ZRUGVDUHXVXDOO\SODFHG
EHQHDWKWKHDEVWUDFW7HUPVIURPWKH0HGLFDO6XEMHFW+HDGLQJV0H6+OLVWRI3XE0HG
861DWLRQDO/LEUDU\RI0HGLFLQHVKRXOGEHXVHGZKHUHYHUSRVVLEOHWRIDFLOLWDWH
LQGH[LQJDQGUHWULHYDOVHH$QQH[
11.4 Article structure

$VFLHQWLILFDUWLFOHJHQHUDOO\FRQVLVWVRIIRXUVHFWLRQVZLWKWKHDFURQ\P,05$'
,QWURGXFWLRQ0HWKRGV5HVXOWVDQG'LVFXVVLRQ7KHVHVHFWLRQVDUHGHVFULEHGE\WKH
IROORZLQJTXHVWLRQVFDOOHGWKH%UDGIRUG+LOOTXHVWLRQVDIWHUWKHDXWKRU+LOO
,QWURGXFWLRQ :K\GLGWKHDXWKRUVVWDUW"
0HWKRGV :KDWGLGWKH\GR"
5HVXOWV :KDWGLGWKH\ILQG"
'LVFXVVLRQ :KDWGRWKHUHVXOWVPHDQ"
5HDVRQLQJLQWKHSDSHUVKRXOGIROORZDVWUDLJKWOLQH7KHIORZVKRXOGQRWVWUD\IURP
WKHREMHFWLYHRUUHVHDUFKTXHVWLRQ,WFDQQRWEHZULWWHQLQWKHVW\OHRIDVWRU\RUQRYHO
ZKHUHWKHDXWKRUFDQPRYHEHWZHHQWKHFKDUDFWHUVDQGFDQMXPSEHWZHHQGLIIHUHQWWLPH
HSLVRGHV
11.5 Writing the Introduction

7KHLQWURGXFWLRQVKRXOG
WHOOWKHUHDGHUZK\WKHUHVHDUFKZDVVWDUWHGDQGPDNHFOHDUZKDWTXHVWLRQWKHUHVHDUFK
ZDVGHVLJQHGWRDQVZHU5HVHDUFKLVQRWDILVKLQJH[SHGLWLRQ,WLVGHVLJQHGZLWKD
VSHFLILFTXHVWLRQLQPLQG
UDLVHWKHLQWHUHVWRIWKHUHDGHU7KHILUVWIHZOLQHVLQWKHSDSHUPD\DWWUDFWRUSXWRIIWKH
UHDGHU,QYHVWLJDWRUVDUHDGYLVHGWRFRQYH\WKHLUHQWKXVLDVPEXWQRWWRH[DJJHUDWH
7KHLQWURGXFWLRQVKRXOGQRW
H[SODLQZKDWFDQEHIRXQGLQDQ\WH[WERRNLQWKHILHOG
EHRYHUUHIHUHQFHGLWVKRXOGJLYHRQO\VWULFWO\SHUWLQHQWUHIHUHQFHV
LQFOXGHGDWDRUFRQFOXVLRQVIURPWKHZRUNEHLQJUHSRUWHG
11.6 Writing the Methods section
Principles
5HSOLFDELOLW\RIUHVXOWVLVWKHKHDUWRIVFLHQFH7KHPHWKRGVVHFWLRQVKRXOGSURYLGH
DGHWDLOHGH[SRVLWLRQRIWKHUHVHDUFKGHVLJQ$UHDGHURIWKHPHWKRGVVHFWLRQVKRXOGEH
DEOHWRUHSHDWWKHVWXG\DQGWRYDOLGDWHWKHILQGLQJV$PHWKRGVVHFWLRQOHVVWKDQWZR
GRXEOHVSDFHGSDJHVLVSUREDEO\LQDGHTXDWH
7KHPHWKRGVVHFWLRQVKRXOGEHRUJDQL]HGXQGHUPHDQLQJIXOVXEKHDGLQJVDQG
GHVFULEHWHFKQLTXHVXVHGLQVXIILFLHQWGHWDLOWRDOORZRWKHUVWRUHSOLFDWHWKHVWXG\
(VWDEOLVKHGPHWKRGVVKRXOGEHUHIHUHQFHGEXWQRGHVFULSWLRQLVQHFHVVDU\)RUSXEOLVKHG
EXWQRWZHOONQRZQPHWKRGVDUHIHUHQFHDVZHOODVDEULHIGHVFULSWLRQVKRXOGEHJLYHQ
1HZRUVXEVWDQWLDOO\PRGLILHGPHWKRGVVKRXOGEHFOHDUO\GHVFULEHGZLWKUHDVRQVJLYHQ
IRUXVLQJWKHPDQGZLWKWKHLUOLPLWDWLRQVRXWOLQHG
7KHPHWKRGVVHFWLRQVKRXOGQRW
UHIHUWRSDWLHQWVDQGDQLPDOVDVPDWHULDOSDWLHQWVDQGDQLPDOVDUHOLYLQJWKLQJVQRW
LQDQLPDWH³PDWHULDO´7KHWHUP³PDWHULDO´VKRXOGEHXVHGRQO\LILQDQLPDWHVSHFLPHQV
KDYHEHHQXVHG
XVHSURSULHWDU\QDPHVRIGUXJVJHQHULFQDPHVVKRXOGEHXVHG
Ethics
:KHQUHSRUWLQJH[SHULPHQWVRQKXPDQVXEMHFWVDXWKRUVVKRXOGLQGLFDWHZKHWKHU
WKHSURFHGXUHVIROORZHGZHUHLQDFFRUGDQFHZLWKWKHHWKLFDOVWDQGDUGVRIWKHUHVSRQVLEOH
FRPPLWWHHRQKXPDQH[SHULPHQWDWLRQLQVWLWXWLRQDORUUHJLRQDODQGZLWKWKH+HOVLQNL
'HFODUDWLRQ
3DWLHQWV¶QDPHVLQLWLDOVRUKRVSLWDOQXPEHUVVKRXOGQRWEHXVHG3DUWLFXODUFDUH
VKRXOGEHWDNHQWKDWWKHVHGRQRWDSSHDULQLOOXVWUDWLYHPDWHULDO
:KHQUHSRUWLQJH[SHULPHQWVRQDQLPDOVDXWKRUVVKRXOGLQGLFDWHZKHWKHUWKH
LQVWLWXWLRQDORUQDWLRQDOJXLGHOLQHVRUODZVRQWKHFDUHDQGXVHRIODERUDWRU\DQLPDOV
ZHUHIROORZHG
Statistics
6WDWLVWLFDOPHWKRGVVKRXOGEHGHVFULEHGLQVXIILFLHQWGHWDLOWRHQDEOHDNQRZOHGJHDEOH
UHDGHUZLWKDFFHVVWRWKHRULJLQDOGDWDWRYHULI\WKHUHSRUWHGUHVXOWV5HIHUHQFHVIRU
VWDWLVWLFDOPHWKRGVVKRXOGEHWRVWDQGDUGZRUNVZKHQSRVVLEOH$Q\FRPSXWHUSURJUDPV
XVHGVKRXOGEHLGHQWLILHG6WDWLVWLFDOWHUPVDEEUHYLDWLRQVDQGV\PEROVVKRXOGEH
GHILQHG
'HWDLOVDERXWUDQGRPL]DWLRQLIXVHGVKRXOGEHJLYHQDVZHOODVFRQFHDOPHQW
RIDOORFDWLRQWRWUHDWPHQWJURXSVDQGWKHPHWKRGRIPDVNLQJEOLQGLQJ/RVVHVWR
REVHUYDWLRQVXFKDVGURSRXWVIURPDFOLQLFDOWULDOVKRXOGEHUHSRUWHG
,WLVUHFRPPHQGHGWRLQFOXGHWKHZRUG³FRQVLGHUHG´LQGHVFULSWLRQVRIVWDWLVWLFDO
VLJQLILFDQFHVXFKDV³D3YDOXHRIOHVVWKDQZDVFRQVLGHUHGVWDWLVWLFDOO\VLJQLILFDQW´
VLQFHWKHFKRLFHRIWKLVFXWRIISRLQWLVDUELWUDU\
,WLVEHWWHUWRDYRLGQRQWHFKQLFDOXVHVRIWHFKQLFDOVWDWLVWLFDOWHUPVVXFKDV³UDQGRP´
³VLJQLILFDQW´³FRUUHODWLRQ´DQG³VDPSOH´LQQRQVWDWLVWLFDOFRQWH[WV
11.7 Writing the Results
Principles
7KHREMHFWLYHRIWKHUHVHDUFKVKRXOGEHNHSWLQPLQG5HVXOWVWKDWGRQRWUHODWHWRWKH
UHVHDUFKREMHFWLYHVKRXOGQRWEHPHQWLRQHG6XIILFLHQWGHWDLOVKRXOGEHJLYHQWRDOORZ
RWKHUVFLHQWLVWVWRDVVHVVWKHYDOLGLW\DQGDFFXUDF\RIWKHUHVXOWV6WDWLVWLFVVKRXOGQRW
WDNHRYHUWKHSDSHUEXWVWDWLVWLFDODQDO\VLVRIWKHUHVXOWVVKRXOGEHDGHTXDWHO\GHVFULEHG
5HVXOWVVKRXOGEHSUHVHQWHGLQDORJLFDOVHTXHQFHLQWKHWH[WWDEOHVDQGLOOXVWUDWLRQV
7DEOHVDQGJUDSKVDUHRIWHQH[WUHPHO\KHOSIXOLQVXPPDUL]LQJODUJHDPRXQWVRIGDWD
$XWKRUVVKRXOGQRWUHSHDWLQWKHWH[WWKHQXPHULFDOGDWDFRQWDLQHGLQILJXUHVDQG
WDEOHV
7KHQXPEHURIWDEOHVDQGILJXUHVVKRXOGEHUHVWULFWHGWRWKRVHQHHGHGWRH[SODLQWKH
DUJXPHQWRIWKHSDSHUDQGWRVXSSRUWLWVILQGLQJV$JRRGUXOHDERXWZKHWKHUWRLQFOXGH
ILJXUHVRUQRWLV:KHQLQGRXEWOHDYHLWRXW
Tables
7DEOHVVKRXOGEHXVHGWRVKRZWKHH[DFWYDOXHVRIPRUHGDWDWKDQFDQEHVXPPDUL]HG
LQDIHZVHQWHQFHVRIWH[WRUZKHQWKHREMHFWLYHRISUHVHQWLQJGDWDLVWRSUHVHQWVSHFLILF
LQWHUUHODWLRQVKLSV7DEOHVVKRXOGQRWEHXVHGZKHQWKHGDWDFDQEHHDVLO\SUHVHQWHGLQ
WKHWH[WWDEOHVDUHPRUHH[SHQVLYHWRW\SHVHWWKDQWH[WRUZKHQWKHUHLVQRUHODWLRQ
EHWZHHQWKHGDWDRUWRDWLPHVHTXHQFH
$WDEOHVKRXOGEHUHDGLO\XQGHUVWRRGZLWKRXWUHIHUHQFHWRWKHWH[W$IWHUUHDGLQJ
WKHWLWOHDQGDEVWUDFWPDQ\UHDGHUVRIWHQJODQFHWKURXJKWKHWDEOHVDQGLOOXVWUDWLRQV
EHIRUHGHFLGLQJZKHWKHURUQRWWRUHDGWKHWH[W$WDEOHVKRXOGEHFLWHGLQWKHWH[WEH
QXPEHUHGDQGKDYHDWLWOHZKLFKH[DFWO\GHVFULEHVWKHFRQWHQWRIWKHWDEOH,WVKRXOG
KDYHVKRUWRUDEEUHYLDWHGKHDGLQJVIRUFROXPQVDQGURZVDQGLIQHFHVVDU\DIRRWQRWH
IRUH[SODQDWLRQRIQRQVWDQGDUGDEEUHYLDWLRQVWKDWDUHXVHGDQGIRULGHQWLILFDWLRQRI
VWDWLVWLFDOPHDVXUHVRIYDULDWLRQVVXFKDVVWDQGDUGGHYLDWLRQDQGVWDQGDUGHUURURIWKH
PHDQ7DEOHVVKRXOGKDYHDORJLFDOVWUXFWXUH&ROXPQVVKRXOGEHDUUDQJHGIURPOHIWWR
ULJKWLQDORJLFDOVHTXHQFHHJWRUHIOHFWWKHVHTXHQFHLQZKLFKGDWDZHUHFROOHFWHGRU
FKDQJHVRYHUWLPH5RZVVKRXOGEHDUUDQJHGIURPWRSWRERWWRPLQDORJLFDORUGHUHJ
E\DVFHQGLQJRUGHURIDJH
$WDEOHVKRXOGQRWLQFOXGHLQLWVWLWOHDQ\XQQHFHVVDU\ZRUGVQRUDUHSHWLWLRQRI
FROXPQDQGURZKHDGLQJV7KHUHVKRXOGEHQRDPELJXLW\DERXWWKHSXUSRVHRIWKH
FROXPQVDQGURZV:KHQFROXPQKHDGLQJVDUHJURXSHGDVWUDGGOHOLQHVKRXOGEHXVHGWR
HOLPLQDWHDQ\XQFHUWDLQW\DERXWZKLFKFROXPQKHDGLQJVDUHLQFOXGHGXQGHUWKHJURXSHG
FROXPQKHDGLQJV,WHPVLQURZKHDGLQJVPD\EHLQGHQWHGWRLQGLFDWHJURXSLQJV
)RUSXUSRVHVRISXEOLFDWLRQ
7KHWDEOHVKRXOGQRWH[FHHGWKHZLGWKRIWKHMRXUQDOFROXPQV$VLQJOHFROXPQWDEOH
LQDMRXUQDOZLWKDGRXEOHFROXPQSDJHVKRXOGQRWLQFOXGHPRUHWKDQFKDUDFWHUV
DQGHTXLYDOHQWVSDFHVLQDURZZLWKLWVURZKHDGLQJ$WDEOHUXQQLQJWKHIXOO
ZLGWKRIDSDJHVKRXOGQRWLQFOXGHPRUHWKDQFKDUDFWHUVLQDURZ
(DFKWDEOHVKRXOGEHW\SHGRUSULQWHGZLWKGRXEOHVSDFLQJRQDVHSDUDWHVKHHWRI
SDSHU7DEOHVVKRXOGQRWEHVXEPLWWHGDVSKRWRJUDSKVRULPDJHV
7DEOHVVKRXOGQRWKDYHLQWHUQDOKRUL]RQWDODQGYHUWLFDOUXOHV
7DEOHVVKRXOGEHQXPEHUHGFRQVHFXWLYHO\LQWKHRUGHURIWKHLUILUVWFLWDWLRQLQWKH
WH[W(DFKWDEOHVKRXOGEHFLWHGLQWKHWH[W
,IGDWDDUHXVHGIURPDQRWKHUSXEOLVKHGRUXQSXEOLVKHGVRXUFHSHUPLVVLRQLVQHHGHG
DQGVKRXOGEHDFNQRZOHGJHIXOO\
7KHXVHRIWRRPDQ\WDEOHVLQUHODWLRQWRWKHOHQJWKRIWKHWH[WPD\SURGXFHGLIILFXOWLHV
LQWKHOD\RXWRISDJHV,VVXHVRIWKHMRXUQDOWRZKLFKWKHSDSHUZLOOEHVXEPLWWHG
FDQEHFKHFNHGWRHVWLPDWHKRZPDQ\WDEOHVFDQEHXVHGSHUZRUGVRIWH[W
$JHQHUDOUXOHLVQRPRUHWKDQRQHWDEOHRULOOXVWUDWLRQSHUZRUGVRIWH[W
SDJHVRIPDQXVFULSW
7KHHGLWRURQDFFHSWLQJDSDSHUPD\UHFRPPHQGWKDWDGGLWLRQDOWDEOHVFRQWDLQLQJ
LPSRUWDQW EDFNXS GDWD WRR H[SHQVLYH WR SXEOLVK EH GHSRVLWHG ZLWK DQ DUFKLYDO
VHUYLFHVXFKDVWKH1DWLRQDO$X[LOLDU\3XEOLFDWLRQ6HUYLFHLQWKH8QLWHG6WDWHVRU
PDGHDYDLODEOHE\WKHDXWKRURQUHTXHVW,QWKDWHYHQWDQDSSURSULDWHVWDWHPHQWZLOO
EHDGGHGWRWKHWH[W6XFKWDEOHVVKRXOGEHVXEPLWWHGIRUFRQVLGHUDWLRQZLWKWKH
SDSHU
Illustrations
,OOXVWUDWLRQVVKRXOGEHXVHGRQO\IRUDVSHFLILFSXUSRVH$QLOOXVWUDWLRQPD\EHXVHG
DVHYLGHQFHWRVXSSRUWWKHDUJXPHQWVLQFH³VHHLQJLVEHOLHYLQJ´,OOXVWUDWLRQVPD\EH
XVHGDVDPRUHHIILFLHQWZD\LQSUHVHQWLQJGDWD$IORZFKDUWLVVXFKDQH[DPSOH7KH
XVHRILOOXVWUDWLRQVIRUHPSKDVLVMXVWWRVWUHVVDSRLQWLVQRWDJRRGSXUSRVH,WPD\EH
PRUHDSSURSULDWHIRUDSUHVHQWDWLRQWKDQDZULWWHQSDSHU
*UDSKVDUHXVHGWRLOOXVWUDWHUHODWLRQVKLSV,IH[DFWYDOXHVDUHLPSRUWDQWDWDEOH
LVSUHIHUDEOHWRDJUDSKZKHQWUHQGVDQGUHODWLRQVKLSVDUHPRUHLPSRUWDQWWKDQH[DFW
YDOXHVDJUDSKLVPRUHHIILFLHQW$JUDSKLVDEHWWHUDOWHUQDWLYHWKDQDWDEOHZLWKPDQ\
HQWULHV7KHVDPHGDWDVKRXOGQRWEHUHSHDWHGLQILJXUHVDQGWDEOHV
)RUSXUSRVHVRISXEOLFDWLRQ
)LJXUHVVKRXOGEHSURIHVVLRQDOO\GUDZQDQGSKRWRJUDSKHGIUHHKDQGRUW\SHZULWWHQ
OHWWHULQJLVXQDFFHSWDEOH
,QVWHDGRIRULJLQDOGUDZLQJV;UD\ILOPVDQGRWKHUPDWHULDODXWKRUVVKRXOGVXEPLW
VKDUSJORVV\EODFNDQGZKLWHSKRWRJUDSKLFSULQWVXVXDOO\îPPîLQFKHV
EXW QRW ODUJHU WKDQ îPP î LQFKHV /HWWHUV QXPEHUV DQG V\PEROV
VKRXOGEHFOHDUDQGHYHQWKURXJKRXWDQGRIVXIILFLHQWVL]HWKDWZKHQUHGXFHGIRU
SXEOLFDWLRQHDFKLWHPZLOOVWLOOEHOHJLEOH
7LWOHVDQGGHWDLOHGH[SODQDWLRQVEHORQJLQWKHOHJHQGVIRULOOXVWUDWLRQVQRWRQWKH
LOOXVWUDWLRQVWKHPVHOYHV
(DFKILJXUHVKRXOGKDYHDODEHOSDVWHGRQLWVEDFNLQGLFDWLQJWKHQXPEHURIWKH
ILJXUHDXWKRU¶VQDPHDQGWRSRIWKHILJXUH'RQRWZULWHRQWKHEDFNRIWKHILJXUHV
RUVFUDWFKRUPDUWKHPE\XVLQJSDSHUFOLSV'RQRWEHQGILJXUHVRUPRXQWWKHPRQ
FDUGERDUG
3KRWRPLFURJUDSKVVKRXOGKDYHLQWHUQDOVFDOHPDUNHUV6\PEROVDUURZVRUOHWWHUV
XVHGLQPLFURSKRWRJUDSKVVKRXOGFRQWUDVWZLWKWKHEDFNJURXQG
,ISKRWRJUDSKVRISHRSOHDUHXVHGHLWKHUWKHVXEMHFWVPXVWQRWEHLGHQWLILDEOHRUWKHLU
SLFWXUHVPXVWEHDFFRPSDQLHGE\ZULWWHQSHUPLVVLRQWRXVHWKHSKRWRJUDSKV
)LJXUHVVKRXOGEHQXPEHUHGFRQVHFXWLYHO\DFFRUGLQJWRWKHRUGHULQZKLFKWKH\KDYH
EHHQILUVWFLWHGLQWKHWH[W
,IDILJXUHKDVEHHQSXEOLVKHGWKHRULJLQDOVRXUFHKDVWREHDFNQRZOHGJHGDQGD
ZULWWHQSHUPLVVLRQIURPWKHFRS\ULJKWKROGHUWRUHSURGXFHWKHPDWHULDOVKRXOGEH
VXEPLWWHG
3HUPLVVLRQLVUHTXLUHGLUUHVSHFWLYHRIDXWKRUVKLSRUSXEOLVKHUH[FHSWIRUGRFXPHQWV
LQWKHSXEOLFGRPDLQ
)RULOOXVWUDWLRQVLQFRORXULWLVLPSRUWDQWWRDVFHUWDLQZKHWKHUWKHMRXUQDOUHTXLUHV
FRORXU QHJDWLYHVSRVLWLYH WUDQVSDUHQFLHVRU FRORXU SULQWV 6RPH MRXUQDOV SXEOLVK
LOOXVWUDWLRQVLQFRORXURQO\LIWKHDXWKRUSD\VIRUWKHH[WUDFRVW
/HJHQGVIRULOOXVWUDWLRQVVKRXOGEHW\SHGRUSULQWHGXVLQJGRXEOHVSDFLQJVWDUWLQJ
RQDVHSDUDWHSDJHZLWK$UDELFQXPHUDOVFRUUHVSRQGLQJWRWKHLOOXVWUDWLRQV
:KHQV\PEROVDUURZVQXPEHUVRUOHWWHUVDUHXVHGWRLGHQWLI\SDUWVRIWKHLOOXVWUDWLRQV
HDFKRQHVKRXOGEHH[SODLQHGFOHDUO\LQWKHOHJHQG7KHLQWHUQDOVFDOHDQGWKHPHWKRG
RIVWDLQLQJLQPLFURSKRWRJUDSKVVKRXOGEHVWDWHG
11.8 Writing the Discussion and Conclusions

7KLVVHFWLRQRIWKHSDSHUVKRXOGHPSKDVL]HWKHQHZDQGLPSRUWDQWDVSHFWVRIWKH
VWXG\DQGWKHFRQFOXVLRQVWKDWIROORZIURPWKHP,WVKRXOGQRWUHSHDWLQGHWDLOGDWDRU
RWKHUPDWHULDOJLYHQLQWKH,QWURGXFWLRQRU5HVXOWVVHFWLRQV
*RRGSDSHUVKDYHDWDUJHWHGGLVFXVVLRQWRNHHSLWIRFXVHG7KHGLVFXVVLRQVKRXOG
SUHIHUDEO\EHVWUXFWXUHGWRLQFOXGHWKHIROORZLQJVL[FRPSRQHQWV'RFKHUW\DQG6PLWK

VWDWHPHQWRISULQFLSDOILQGLQJV
VWUHQJWKVDQGZHDNQHVVHVRIWKHVWXG\
VWUHQJWKVDQGZHDNQHVVHVLQUHODWLRQWRRWKHUVWXGLHV
PHDQLQJ RI WKH VWXG\ SRVVLEOH PHFKDQLVPV DQG LPSOLFDWLRQV IRU FOLQLFLDQV DQG
SROLF\PDNHUV
XQDQVZHUHGTXHVWLRQVDQGIXWXUHUHVHDUFK
FRQFOXVLRQ
6WDWHPHQWRISULQFLSDOILQGLQJV7KHRSHQLQJRIWKHGLVFXVVLRQXVXDOO\JLYHVWKHDQVZHU
WRWKHUHVHDUFKTXHVWLRQRUDUHVWDWHPHQWRIWKHSULQFLSDOILQGLQJV7KLVVKRXOGQRW
QRUPDOO\EHPRUHWKDQDIHZVHQWHQFHV,WLVDGYLVDEOHWKDWWKHGLVFXVVLRQVWDUWZLWK
DVHQWHQFHWKDWFOHDUO\VKRZVWKDWWKHSDSHULQFOXGHVQHZLQIRUPDWLRQ5HYLHZHUV
RIWHQVWDUWZLWKD³QXOOK\SRWKHVLV´WKDWWKHSDSHUGRHVQRWDGGDQ\WKLQJQHZ
6WUHQJWKVDQGZHDNQHVVHVRIWKHVWXG\(TXDOHPSKDVLVVKRXOGEHJLYHQWRERWK
VWUHQJWKVDQGZHDNQHVVHV5HYLHZHUVDUHPRUHLQWHUHVWHGLQVHHLQJWKDWWKHDXWKRU
LVDZDUHRIWKHZHDNQHVVHV,IWKHUHDGHUGLVFRYHUVLQWKHSDSHUZHDNQHVVHVWKDWDUH
QRWPHQWLRQHGE\WKHDXWKRUWKHWUXVWLQWKHSDSHUZLOOEHVKDNHQ$VXEKHDGLQJVXFK
DV³OLPLWDWLRQVRIWKHVWXG\´RUGDWDLVXVHIXO)LQGLQJVWKDWKDYHQRWEHHQGHVFULEHG
LQWKHUHVXOWVVHFWLRQVKRXOGQRWEHGLVFXVVHG
6WUHQJWKVDQGZHDNQHVVHVLQUHODWLRQWRRWKHUVWXGLHV$OOHYLGHQFHEHDULQJRQWKH
DUJXPHQWZLWKRUDJDLQVWVKRXOGEHFRQVLGHUHG$XWKRUVVKRXOGGLVFXVVWKHRSSRVLQJ
SRLQWRIYLHZWDNLQJD³GHYLO¶VDGYRFDWH´SRVLWLRQ)XOOFUHGLWVKRXOGEHJLYHQIRU
VXSSRUWLQJ HYLGHQFH$XWKRUV VKRXOG DYRLG EXU\LQJ WKH FLWDWLRQ RI D SUHYLRXVO\
SXEOLVKHG SDSHU RQ WKH VDPH TXHVWLRQ ZKLFK DUULYHG DW WKH VDPH DQVZHU LQ WKH
GLVFXVVLRQ6XFKDFLWDWLRQLVEHWWHUKLJKOLJKWHGLQWKHLQWURGXFWLRQ,WLVQRWHQRXJK
WRVLPSO\VXPPDUL]HSXEOLVKHGSDSHUV7KHDXWKRUVVKRXOGFULWLFDOO\HYDOXDWHWKHLU
PHWKRGRORJ\ILQGLQJVDQGFRQFOXVLRQV,QSDUWLFXODUDQ\GLIIHUHQFHVLQUHVXOWVVKRXOG
EHGLVFXVVHGDQGSRVVLEOHH[SODQDWLRQVRIIHUHG,IWKHDXWKRUVGRQRWNQRZZK\WKHLU
UHVXOWVDUHGLIIHUHQWIURPRWKHUVWXGLHVWKH\VKRXOGVD\VREXWQRWLPSO\WKDWWKHLU
UHVXOWVDUHEHWWHU
0HDQLQJ RI WKH VWXG\ SRVVLEOH PHFKDQLVPV DQG LPSOLFDWLRQV IRU FOLQLFLDQV DQG
SROLF\PDNHUV7KLVVHFWLRQVKRXOGEHZULWWHQFDUHIXOO\$XWKRUVVKRXOGQRWPRYH
EH\RQGWKHOLPLWHGHYLGHQFHSURYLGHGE\WKHVWXG\5HVWUDLQWLQVWDWLQJLPSOLFDWLRQV
LVDYLUWXHDSSUHFLDWHGE\UHYLHZHUVDQGUHDGHUV,WPD\DOVREHUHOHYDQWWRHPSKDVL]H
QRWRQO\ZKDWWKHUHVXOWVPHDQEXWDOVRZKDWWKHUHVXOWVGRQRWPHDQ7KLVZLOONHHS
UHDGHUVIURPPDNLQJXQMXVWLILHGFRQFOXVLRQV
8QDQVZHUHGTXHVWLRQVDQGIXWXUHUHVHDUFK1HZUHVHDUFKPD\EHSURSRVHGWRSURYLGH
WKHDQVZHUWRTXHVWLRQVWKDWDUHVWLOOQRWDQVZHUHG$JRRGVWXG\VKRXOGJHQHUDWH
QHZLGHDVIRUIXUWKHUUHVHDUFK$VLPSOHVWDWHPHQWWKDWIXUWKHUUHVHDUFKLVQHHGHGLV
OHVVKHOSIXOWKDQSURYLGLQJQHZVSHFLILFUHVHDUFKTXHVWLRQVRUVXJJHVWLQJSDUWLFXODU
VWXGLHV
&RQFOXVLRQ$JRRGSDSHUHQGVZLWKVWURQJFOHDUFRQFOXVLRQV,WKDVEHHQVDLGWKDWWKH
ERG\RIDJRRGSDSHULVD³WKXQGHUEROWLQUHYHUVH´LWEHJLQVZLWKWKXQGHULQWURGXFWLRQ
DQGHQGVZLWKOLJKWQLQJFRQFOXVLRQV%\QH&RQFOXVLRQVVKRXOGEHOLQNHGZLWK
WKHJRDOVRIWKHVWXG\DQGVKRXOGEHOLPLWHGWRWKHERXQGDULHVRIWKHVWXG\$XWKRUV
VKRXOGDYRLGXQTXDOLILHGVWDWHPHQWVDQGFRQFOXVLRQVQRWFRPSOHWHO\VXSSRUWHGE\
WKHGDWD)RUH[DPSOHWKH\VKRXOGQRWPDNHVWDWHPHQWVRQHFRQRPLFEHQHILWVDQG
FRVWVXQOHVVWKHLUPDQXVFULSWLQFOXGHVHFRQRPLFGDWDDQGDQDO\VLV$XWKRUVVKRXOG
UHIUDLQIURPFODLPLQJXQMXVWLILHGSULRULW\DERXWWKHILQGLQJV,WVKRXOGEHQRWHGWKDW
DQHJDWLYHILQGLQJFRXOGEHDVLPSRUWDQWDVDSRVLWLYHILQGLQJ
11.9 Acknowledgements
$WDQDSSURSULDWHSODFHLQWKHDUWLFOHWKHWLWOHSDJHIRRWQRWHRUDQDSSHQGL[WRWKH
WH[WGHSHQGLQJRQWKHMRXUQDOUHTXLUHPHQWVRQHRUPRUHVWDWHPHQWVVKRXOGVSHFLI\
FRQWULEXWLRQVWKDWQHHGDFNQRZOHGJLQJEXWGRQRWMXVWLI\DXWKRUVKLSVXFKDVJHQHUDO
VXSSRUWE\DGHSDUWPHQWFKDLUDFNQRZOHGJHPHQWRIWHFKQLFDOKHOSDFNQRZOHGJHPHQWV
RIILQDQFLDORUPDWHULDOVXSSRUWZKLFKVKRXOGVSHFLI\WKHQDWXUHRIWKHVXSSRUWDQG
UHODWLRQVKLSVWKDWPD\SRVHDFRQIOLFWRILQWHUHVW
3HUVRQVZKRKDYHFRQWULEXWHGLQWHOOHFWXDOO\WRWKHSDSHUEXWZKRVHFRQWULEXWLRQV
GRQRWMXVWLI\DXWKRUVKLSPD\EHQDPHGDQGWKHLUIXQFWLRQRUFRQWULEXWLRQGHVFULEHG
IRUH[DPSOH³VFLHQWLILFDGYLVHU´³FULWLFDOUHYLHZRIVWXG\SURSRVDO´³GDWDFROOHFWLRQ´
RU³SDUWLFLSDWLRQLQFOLQLFDOWULDO´6XFKSHUVRQVPXVWKDYHJLYHQWKHLUSHUPLVVLRQWR
EHQDPHG$XWKRUVDUHUHVSRQVLEOHIRUREWDLQLQJZULWWHQSHUPLVVLRQIURPSHUVRQV
DFNQRZOHGJHGE\QDPHEHFDXVHUHDGHUVPD\LQIHUWKHLUHQGRUVHPHQWRIWKHGDWDDQG
FRQFOXVLRQV7HFKQLFDOKHOSLVEHWWHUDFNQRZOHGJHGLQDSDUDJUDSKVHSDUDWHIURPWKDW
DFNQRZOHGJLQJRWKHUFRQWULEXWLRQV
11.10 Citation of references

7KHUHIHUHQFHVHFWLRQLVDQLPSRUWDQWSDUWRIDVFLHQWLILFSDSHU7KHQXPEHURI
UHIHUHQFHVVKRXOGEHUHVWULFWHGWRWKRVHWKDWKDYHDGLUHFWEHDULQJRQWKHZRUNGHVFULEHG
([FHSWIRUUHYLHZDUWLFOHVLWLVUDUHO\QHFHVVDU\WRKDYHPRUHWKDQUHIHUHQFHVLQWKH
ORQJHVWSDSHU+DOVH\
5HIHUHQFHVVKRXOGEHFDUHIXOO\FKHFNHG7KH\VKRXOGEHYHULILHGDJDLQVWRULJLQDO
GRFXPHQWV2QHVWXG\KDVVKRZQWKDWLQDUDQGRPFKHFNRIUHIHUHQFHVLQSXEOLVKHG
SDSHUVZHUHPLVTXRWHGZLWKKDOIRIWKHPLVTXRWDWLRQVEHLQJVHULRXVO\PLVOHDGLQJ
'H/DFH\HWDO8VHIXODGYLFHIRUWKHDXWKRULVWRSKRWRFRS\WKHILUVWSDJHRIHYHU\
UHIHUHQFHFLWHG7KLVSDJHQRUPDOO\LQFOXGHVDOOWKHLQIRUPDWLRQQHHGHGIRUFRUUHFWO\
FLWLQJWKHUHIHUHQFH
'LIIHUHQWVWDQGDUGIRUPDWVIRUFLWLQJUHIHUHQFHVDUHXVHGLQGLIIHUHQWVFLHQWLILF
GLVFLSOLQHV7KHVHIRUPDWVLQFOXGH0/$6W\OHHVWDEOLVKHGE\WKH0RGHUQ/DQJXDJH
$VVRFLDWLRQ$3$ 6W\OH JRYHUQHG E\ WKH 3XEOLFDWLRQ 0DQXDO RI WKH$PHULFDQ
3V\FKRORJLFDO$VVRFLDWLRQ&06)RRWQRWH6W\OHFRQIRUPLQJWRWKH&KLFDJR0DQXDORI
6W\OHDQG&%(1XPEHU6W\OHHVWDEOLVKHGE\WKH&RXQFLORI%LRORJ\(GLWRUV
,QELRPHGLFDOVFLHQFHVWKHUHDUHWZRPDMRUVW\OHVIRUFLWLQJWKHUHIHUHQFHVWKH
+DUYDUGV\VWHPDQGWKH9DQFRXYHUV\VWHP
,QWKH+DUYDUGV\VWHPWKHRUGHURIUHIHUHQFHVDWWKHHQGRIWKHSDSHULVVWULFWO\
DOSKDEHWLFDOUHJDUGOHVVRIWKHFKURQRORJ\,QWKHWH[WRIWKHSDSHUUHIHUHQFHVDUHFLWHG
E\JLYLQJLQSDUHQWKHVHVWKHQDPHRIWKHDXWKRUDQGWKH\HDURISXEOLFDWLRQ:KHQWKH
DXWKRU¶VQDPHLVSDUWRIDVHQWHQFHRQO\WKH\HDULVSXWLQSDUHQWKHVHV:KHQVHYHUDO
UHIHUHQFHVDUHJLYHQWRJHWKHUWKH\VKRXOGEHOLVWHGLQFKURQRORJLFDORUGHUDQGVHSDUDWHG
E\DVHPLFRORQ:KHQDSDSHUZULWWHQE\WZRDXWKRUVLVTXRWHGERWKQDPHVDUHJLYHQ,I
WKHUHDUHPRUHWKDQWZRDXWKRUVDOOWKHQDPHVPD\EHJLYHQWKHILUVWWLPHWKHUHIHUHQFH
LVFLWHG2WKHUZLVHLWLVVXIILFLHQWWRJLYHWKHQDPHRIWKHILUVWDXWKRURQO\DGGLQJ³HW
DO´7KHWHUP³HWDO´PHDQV³DQGRWKHUV´,WLVDQDEEUHYLDWLRQIRUWZR/DWLQWHUPV³HW
DOLL´PDVFXOLQHDQG³HWDOLDHÍHPLQLQH:KHQWZRFLWDWLRQVKDYHWKHVDPHDXWKRU
DQGWKHVDPH\HDURISXEOLFDWLRQDOSKDEHWLFDODQQRWDWLRQLVXVHGIRUH[DPSOH³D´
7KHRUGHURIWKHVHDOSKDEHWLFDOO\DQQRWDWHGFLWDWLRQVLGHDOO\VKRXOGEHFKURQRORJLFDO
ZLWKLQWKH\HDU
7KH9DQFRXYHU V\VWHP KDV EHHQ DGRSWHG LQ WKH ³8QLIRUP 5HTXLUHPHQWV IRU
0DQXVFULSWV6XEPLWWHGWR%LRPHGLFDO-RXUQDOVÉ\WKH,QWHUQDWLRQDO&RPPLWWHHRI
0HGLFDO-RXUQDO(GLWRUVZKRKHOGWKHLUILUVWPHHWLQJLQ9DQFRXYHU0RVWELRPHGLFDO
MRXUQDOVIROORZWKLVV\VWHP,WLVEDVHGODUJHO\RQDVWDQGDUGVW\OHDGDSWHGE\WKH86
1DWLRQDO/LEUDU\RI0HGLFLQH1/0IRULWVGDWDEDVHV$FFRUGLQJWRWKH9DQFRXYHU
VW\OHUHIHUHQFHVVKRXOGEHQXPEHUHGFRQVHFXWLYHO\LQWKHRUGHULQZKLFKWKH\DUHILUVW
PHQWLRQHGLQWKHWH[W5HIHUHQFHVLQWH[WWDEOHVDQGOHJHQGVVKRXOGEHLGHQWLILHGE\
$UDELFQXPHUDOVLQSDUHQWKHVHV5HIHUHQFHVFLWHGRQO\LQWDEOHVRUILJXUHOHJHQGVVKRXOG
EHQXPEHUHGLQDFFRUGDQFHZLWKWKHVHTXHQFHHVWDEOLVKHGE\WKHILUVWLGHQWLILFDWLRQLQ
WKHWH[WRIWKHSDUWLFXODUWDEOHRUILJXUH
,QZULWLQJWKHHDUO\GUDIWVRIWKHSDSHULWLVDGYLVDEOHWRXVHWKH+DUYDUGVW\OH,I
QXPEHUVDUHDVVLJQHGWRUHIHUHQFHVDWWKLVHDUO\VWDJHWKRVHQXPEHUVZLOOYHU\OLNHO\
KDYHWREHFKDQJHGLQVXEVHTXHQWGUDIWV,QWKHILQDOGUDIWWKHDXWKRUVFDQVZLWFKWR
WKH9DQFRXYHUVW\OH7RWUDFNWKHUHIHUHQFHVLQWKHHDUO\GUDIWVXVLQJDZRUGSURFHVVLQJ
SURJUDPRQHFDQSODFHDWWKHEHJLQQLQJRIHDFKFLWDWLRQDFKDUDFWHUQRWXVHGHOVHZKHUH
LQWKHWH[WIRUH[DPSOHDQDVWHULVN
,IMRXUQDOWLWOHVDUHDEEUHYLDWHGDVLVWKHSUDFWLFHLQPRVWEXWQRWDOOMRXUQDOVWKLV
VKRXOGEHLQOLQHZLWKWKHDEEUHYLDWLRQVLQWKH,QGH[0HGLFXVZKLFKDUHEDVHGRQDQ
LQWHUQDWLRQDOVWDQGDUG7KHOLVWRIMRXUQDOVLVSXEOLVKHGDQQXDOO\LQWKH-DQXDU\LVVXH
7KHOLVWFDQDOVREHDFFHVVHGWKURXJKWKHZHEVLWHRIWKH86/LEUDU\RI0HGLFLQHKWWS
ZZZQOPQLKJRY
8QSXEOLVKHGREVHUYDWLRQVDUHJHQHUDOO\QRWWREHXVHGDVUHIHUHQFHVSDSHUVDFFHSWHG
IRUSXEOLFDWLRQEXWQRW\HWSXEOLVKHGDQGJLYHQDVUHIHUHQFHVDUHLGHQWLILHGDV³LQSUHVV´
RU³IRUWKFRPLQJÚHVHDUFKSDSHUVVXEPLWWHGWRDMRXUQDOEXWQRW\HWDFFHSWHGDUHWREH
WUHDWHGDVXQSXEOLVKHGREVHUYDWLRQV
$XWKRUV VKRXOG DYRLG FLWLQJ D ³SHUVRQDO FRPPXQLFDWLRQ´ XQOHVV LW SURYLGHV
HVVHQWLDOLQIRUPDWLRQQRWDYDLODEOHIURPDSXEOLFVRXUFHLQZKLFKFDVHWKHQDPHRIWKH
SHUVRQDQGGDWHRIFRPPXQLFDWLRQVKRXOGEHFLWHGLQSDUHQWKHVHVLQWKHWH[W$XWKRUV
VKRXOGREWDLQSHUPLVVLRQDQGFRQILUPDWLRQRIDFFXUDF\IURPWKHVRXUFHRIDSHUVRQDO
FRPPXQLFDWLRQ
$QQH[SURYLGHVH[DPSOHVRQKRZGLIIHUHQWW\SHVRIUHIHUHQFHVVKRXOGEHFLWHG
$GGLWLRQDOLQIRUPDWLRQPD\EHREWDLQHGIURPWKHZHEVLWHKWWSZZZQOPJRYEVG
XQLIRUPBUHTXLUHPHQWVKWPO
11.11 Steps in the process of writing a paper

7KHSURFHVVRIZULWLQJDVFLHQWLILFSDSHUVKRXOGVWDUWEHIRUHGRLQJWKHUHVHDUFK
FRQWLQXHGXULQJWKHUHVHDUFKDQGEHFRPSOHWHGDIWHUWKHUHVHDUFKUHVXOWVKDYHEHHQ
GHVFULEHGDQDO\VHGDQGLQWHUSUHWHG$IWHUZULWLQJWKHSDSHULWVKRXOGEHFDUHIXOO\
UHYLVHGILUVWIRUFRQWHQWDQGWKHQIRUVW\OH
Before the research

6HDUFKWKHOLWHUDWXUHDQGNHHSDUHFRUGRIWKHUHIHUHQFHV
3UHSDUHGXPP\WDEOHVIRUUHVXOWV
During the research

5HFRUGWKHUHVXOWV
8SGDWHWKHOLWHUDWXUH
After completion of the research
8VHDV\VWHPDWLFDSSURDFKEXLOGLQJWKHSDSHUVWHSE\VWHS'RQRWWU\WRGRWKH
ZKROHWKLQJDWRQFH
6WDUWZLWKDQRXWOLQHZKLFKZLOOVHUYHDVIUDPHZRUN
7KHGLVFXVVLRQLVWKHSDUWWKDWUHTXLUHVPRVWFDUHIXOWKRXJKWDQGLQWHUSUHWDWLRQ
%HJLQZLWKWKHHDVLHVWVHFWLRQ'HDOZLWKLQGLYLGXDOVHFWLRQVRQHDWDWLPH
'HFLGHRQWKHMRXUQDOWRZKLFKWKHDUWLFOHZLOOEHVXEPLWWHGDQGVWXG\LWVIRUPDW
UHTXLUHPHQWV
:ULWHWKHURXJKGUDIW2QFH\RXVWDUWZULWHDVIDVWDV\RXFDQ'RQRWZRUU\DERXW
VW\OH
3XWWKHSDSHUDVLGHIRUVHYHUDOGD\VRUZHHNVDQGWKHQUHUHDGLW
*LYHDYHUVLRQRIWKHSDSHUWRDFROOHDJXHRUFROOHDJXHVWRUHYLHZLW
'DWHDOOGUDIWV
11.12 Revision of the manuscript for scientific content

)RUFUHDWLYHZULWLQJWKHZRUGSURFHVVRULVWKHEHVWLQYHQWLRQVLQFHWKHTXLOOSHQ7KH
GD\VRIUHW\SLQJDUHRYHU0RVWMRXUQDOVUHTXLUHDQHOHFWURQLFFRS\RIWKHSDSHU
Revision checklist
,VWKHWLWOHDFFXUDWHVXFFLQFWDQGHIIHFWLYH"
$UH NH\ZRUGV LQGH[DEOH" ,W LV EHWWHU WR XVH NH\ZRUGV IURP WKH 0HGLFDO 6XEMHFW
+HDGLQJV0H6+YRFDEXODU\RI0('/,1($QQH[
'RHVWKHDEVWUDFWUHSUHVHQWWKHFRQWHQWRIDOOWKHPDLQVHFWLRQVRIWKHSDSHUZLWKLQ
WKHOHQJWKDOORZHGE\WKHMRXUQDO"'RGDWDLQWKHDEVWUDFWDJUHHZLWKGDWDLQWKH
SDSHU"
'RHVWKHLQWURGXFWLRQVHWWKHVWDJHDGHTXDWHO\EXWFRQFLVHO\IRUWKHPDLQTXHVWLRQ
FRQVLGHUHGRUIRUWKHK\SRWKHVLVWHVWHGLQWKHSDSHU",VWKDWTXHVWLRQRUK\SRWKHVLV
PDGHFOHDUE\WKHHQGRIWKHLQWURGXFWLRQ"
$UHWKHPHWKRGVGHVFULEHGLQHQRXJKGHWDLOWRDOORZUHSOLFDWLRQRIUHVHDUFK"$UH
VWDWLVWLFDOPHWKRGVGHVFULEHG"
$UHWKHUHVXOWVSUHVHQWHGLQDZD\WKDWDOORZVRWKHULQYHVWLJDWRUVWRFKHFNDQGWR
FRPSDUH"&DQDQ\RIWKHWDEOHVRULOOXVWUDWLRQVEHRPLWWHG"&DQDQ\RIWKHWDEOHV
EHUHSODFHGE\DJUDSK"'RGDWDLQWKHWH[WDJUHHZLWKGDWDLQWKHWDEOHV"$UHDOO
WDEOHVDQGILJXUHVFLWHGLQWKHWH[W"$UHDOOWDEOHVDQGILJXUHVPHQWLRQHGLQWKHWH[W
LQFOXGHG"$UHOHJHQGVRIILJXUHVFRUUHFW"
'RHV WKH GLVFXVVLRQ SURSHUO\ LQWHUSUHW WKH VLJQLILFDQFH RI WKH GDWD" 'RHV WKH
GLVFXVVLRQUHIOHFWXSWRGDWHDZDUHQHVVRIWKHOLWHUDWXUH"$UHFRQFOXVLRQVMXVWLILHG
E\WKHUHVXOWV"
$UHDOOUHIHUHQFHVFLWHGPHQWLRQHGLQWKHWH[W"$UHDOOUHIHUHQFHVPHQWLRQHGLQWKH
WH[WFLWHG"+DYHDQ\QHFHVVDU\UHIHUHQFHVEHHQRPLWWHG"
,VWKHOHQJWKRIWKHSDSHUDSSURSULDWH"'RHVDQ\RIWKHWH[WUHSHDWLQIRUPDWLRQIRXQG
HOVHZKHUHLQWKHSDSHU"$UHWKHUHSDUDJUDSKVRUVHQWHQFHVWKDWFDQEHRPLWWHG":KHUH
SRVVLEOHLWLVJRRGWRSODQWRVXEPLWDQDUWLFOHWKDWLVVKRUWHUWKDQWKHDYHUDJHDUWLFOH
SXEOLVKHGLQWKHMRXUQDOWRZKLFKWKHSDSHUZLOOEHVHQW7KHEHVWSDSHUVDUHFRQFLVH
*HQHUDOO\DPDQXVFULSWVKRXOGRQDYHUDJHEHDERXWGRXEOHVSDFHGSDJHVRU
SXEOLVKHGSDJHVZLWKUHIHUHQFHV(DFKSULQWHGSDJHLVDERXW±GRXEOHVSDFHG
W\SHGSDJHV7KHVHFWLRQVRIDPDQXVFULSWWKDWDUHRIWHQWRRORQJDUHWKHLQWURGXFWLRQ
DQGGLVFXVVLRQ7KHVHFWLRQVWKDWDUHRIWHQWRRVKRUWDUHWKHPHWKRGVDQGUHVXOWV$
JRRGUXOHLVWRVKRUWHQWKHLQWURGXFWLRQDQGGLVFXVVLRQDQGWRH[SDQGWKHPHWKRGV
DQGUHVXOWVVHFWLRQV
$UHDOOSDJHVQXPEHUHG"
11.13 Revision of the manuscript for style

7KHDFURQ\P³.,66´³NHHSLWVLPSOHDQGVKRUW´LVWKHNH\WRJRRGVFLHQWLILFZULWLQJ
$XWKRUVVKRXOGDOZD\VFKRRVHWKHVLPSOHVWDQGVKRUWHVWZD\RIVD\LQJVRPHWKLQJ,WWDNHV
PRUHWLPHWRZULWHDJRRGFRQFLVHSDSHUWKDQDOHQJWK\RQH3DVFDORQFHZURWHWRDIULHQG
³,DPVRUU\WKLVOHWWHULVVRORQJEXW,KDGQRWLPHWRZULWHDVKRUWRQH´0RVWDXWKRUVGR
QRWVSHQGHQRXJKWLPHSODQQLQJ*RRGSODQQLQJZLOOVKRUWHQWKHWLPHVSHQWLQZULWLQJ
,QHGLWLQJRQHVHOIFRQVLGHUDWLRQVKRXOGEHJLYHQWRSDUDJUDSKVVHQWHQFHVDQG
ZRUGV7KHIROORZLQJVHFWLRQVSURYLGHDIHZXVHIXOKLQWVSDUWLFXODUO\IRUQRQ(QJOLVK
VSHDNHUV)RUDGGLWLRQDOLQIRUPDWLRQVRXUFHVVXFKDV6WUXQNFDQEHFRQVXOWHG
Paragraphs
:HOOVWUXFWXUHGSDUDJUDSKVDUHWKHNH\WRJRRGZULWLQJDQGVKRXOGFRQVLVWRID
WRSLFRUOHDGVHQWHQFHWRLQWURGXFHWKHVXEMHFWRIWKHSDUDJUDSKERG\VHQWHQFHVZKLFK
H[SDQGXSRQWKHWKHPHDQGSUHVHQWDORJLFDODUJXPHQWDQGHLWKHUDWUDQVLWLRQDOVHQWHQFH
ZKLFKOHDGVLQWRWKHQH[WSDUDJUDSKRUDFRQFOXGLQJVHQWHQFH7KHUHLVQRILUPUXOHRQ
SDUDJUDSKOHQJWKPRUHWKDQW\SHGOLQHVZRXOGEHWRRORQJIHZHUWKDQRUOLQHV
UHSUHVHQWZKDWLVUHDOO\DIUDJPHQWRIHLWKHUDGMDFHQWSDUDJUDSK$QHZSDUDJUDSKPXVW
HLWKHUOLQNWRWKDWSUHFHGLQJLWDQGRUIROORZLQJLWRUVKRXOGFOHDUO\LQWURGXFHDQHZ
VXEMHFW,QDORQJGLVFXVVLRQVXEKHDGLQJVDUHDJRRGLGHD
Sentences
7KHIROORZLQJKLQWVPD\EHKHOSIXOWRDXWKRUVLQUHYLVLQJWKHVW\OHRIWKHLUSDSHU
/RQJVHQWHQFHVPRUHWKDQWZRW\SHZULWWHQOLQHVDUHEHWWHUDYRLGHGLISRVVLEOH
7KH DFWLYH LV SUHIHUDEOH WR WKH SDVVLYH EHFDXVH LW LV PXFK FOHDUHU DQG HDVLHU WR
XQGHUVWDQGLQJHQHUDO)RUH[DPSOHUHSODFH³,WZDVIRXQGE\[É\³[IRXQGWKDW´
7KHSDVVLYHYRLFHKDVWUDGLWLRQDOO\EHHQXVHGLQVFLHQWLILFZULWLQJWRUHIHUWRWKH
WKRXJKWVRUDFWLRQVRIWKHDXWKRU7KLVWHQGHQF\LVVORZO\FKDQJLQJDQGPDQ\HGLWRUV
QRZHQFRXUDJHDXWKRUVWRXVH³,´RU³ZH´LQWKHLUZULWLQJ
$YRLGDPELJXLW\LQWKHXVHRIDGMHFWLYDODQGDGYHUELDOFODXVHVDQGSKUDVHV,WLV
RIWHQEHWWHUWRVLPSOLI\VHQWHQFHVE\VSOLWWLQJWKHVXERUGLQDWHSKUDVHVDQGFODXVHV
DQGPDNLQJWKHPVHQWHQFHVRQWKHLURZQ
$YRLGYHUERVLW\WRVD\DWKLQJLQDFRPSOLFDWHGZD\WRPDNHLWVRXQGLPSRUWDQW
RUSRPSRXVYHUELDJH
(DFKVHQWHQFHPXVWKDYHDYHUEDQGWKHYHUEVKRXOGDJUHHZLWKWKHQRXQ
(FRQRP\LVDYLUWXH6WULNHRXWXQQHHGHGZRUGVDQGSKUDVHV
³'RQRWXVHDSUHSRVLWLRQWRHQGDVHQWHQFHZLWK´²LVDJRRGUXOHZKLFKLWVHOIEUHDNV
WKHUXOH
,WLVDXVHIXOFRQYHQWLRQWRSXWDQ\WKLQJWKDWZDVGRQHLQWKHSDVWWHQVHDQGWRSXW
JHQHUDOVWDWHPHQWVLQWKHSUHVHQWWHQVH,QJHQHUDOWKHLQWURGXFWLRQDQGGLVFXVVLRQ
VHFWLRQVDUHZULWWHQLQWKHSUHVHQWWHQVHDQGWKHPHWKRGVDQGUHVXOWVVHFWLRQVDUH
ZULWWHQLQWKHVLPSOHSDVWWHQVH
Words
,WLVDGYLVDEOHWRORRNIRUDQGWU\ZKHUHSRVVLEOHWRUHSODFHWKHIROORZLQJVL[JURXSV
RIZRUGV
$EVWUDFWQRXQVQRXQVIRUPHGIURPYHUEVDQGHQGLQJLQWLRQVLRQDQFHPHQWQHVV
F\7KHVHQRXQVDUHEHWWHUUHSODFHGZLWKYHUEV)RUH[DPSOHFKDQJH³0HDVXUHPHQWV
ZHUHSHUIRUPHGRQWKHYDULDWLRQ´WR³7KHYDULDWLRQZDVPHDVXUHG´RU³ZHPHDVXUHG
WKH YDULDWLRQ´ FKDQJH ³7KH LQWHUSUHWDWLRQ RI WKH GDWD ZDV PDGH´ WR ³'DWD ZHUH
LQWHUSUHWHG´RU³ZHLQWHUSUHWHGWKHGDWD´
&RPSRXQGQRXQVQRXQFOXVWHUVHJSDWLHQWOLYHUHQ]\PHVWDWXVWKHVWDWXVRIOLYHU
HQ]\PHVLQSDWLHQWVUHVHDUFKUHVXOWGLVVHPLQDWLRQPHWKRGVPHWKRGVRIGLVVHPLQDWLQJ
UHVHDUFKUHVXOWV
$EEUHYLDWLRQVXQOHVVWKH\DUHVWDQGDUGDQGXQOHVVWKH\DUHXVHGDWOHDVWWHQWLPHV
LQWKHSDSHU$YRLGDEEUHYLDWLRQVLQWKHWLWOHDQGDEVWUDFW7KHFRPSOHWHWHUPIRU
ZKLFKDQDEEUHYLDWLRQVWDQGVVKRXOGSUHFHGHLWVILUVWXVHXQOHVVLWLVDVWDQGDUGXQLW
RIPHDVXUHPHQW
6H[LVWZRUGV'RQRWXVHWKHSURQRXQ³KH´RU³KLV´ZKHQVKHRUKHUZRXOGEHHTXDOO\
DSSURSULDWH8VHWKHSOXUDOIRUPLQVWHDG7U\WRUHSODFHZRUGVVXFKDVPDQXQOHVV
UHIHUULQJWRDPDQPDQNLQGPDQSRZHUSROLFHPDQIRUHPDQ
'HKXPDQL]LQJZRUGVHJUHIHUULQJWRSHRSOHDVFDVHVRUVXEMHFWVXVHSDWLHQWVRU
YROXQWHHUVIRUH[DPSOHXVLQJV\QGURPLFWDJVIRUSDWLHQWVPDOHIHPDOHDUHPRUH
DSSURSULDWHIRUDQLPDOVPHQDQGZRPHQDUHEHWWHUIRUKXPDQVXEMHFWV
6ODQJDQGMDUJRQZRUGVWKDWKDYHDQDUELWUDU\PHDQLQJ
'RQRWFRQIXVH$PHULFDQDQG%ULWLVK6SHOOLQJ)ROORZWKHVW\OHSUHVFULEHGE\WKH
MRXUQDO,ILQGRXEWXVHDJRRGGLFWLRQDU\GRQRWGHSHQGRQWKHVSHOOFKHFNHULQWKH
FRPSXWHUZKLFKLVRQO\DVJRRGDVLWVFRQWHQW
8QOHVVRWKHUZLVHUHTXHVWHGLQWKHMRXUQDOLQVWUXFWLRQVWRDXWKRUV
0HDVXUHPHQWVRIOHQJWKKHLJKWZHLJKWDQGYROXPHVKRXOGEHUHSRUWHGLQPHWULF
XQLWVPHWUHNLORJUDPRUOLWUHRUWKHLUGHFLPDOPXOWLSOHVDQGWHPSHUDWXUHVVKRXOG
EH JLYHQ LQ GHJUHHV &HOVLXV %ORRG SUHVVXUH VKRXOG EH JLYHQ LQ PLOOLPHWUHV RI
PHUFXU\
$OOKDHPDWRORJLFDODQGFOLQLFDOFKHPLVWU\PHDVXUHPHQWVVKRXOGEHUHSRUWHGLQWKH
PHWULFV\VWHPLQWHUPVRIWKH,QWHUQDWLRQDO6\VWHPRI8QLWV6,(GLWRUVPD\UHTXHVW
WKDWDOWHUQDWLYHRUQRQ6,XQLWVEHDGGHGE\WKHDXWKRUVEHIRUHSXEOLFDWLRQ
11.14 Writing a case report

5HSRUWVRIVLQJOHFDVHVKDYHEHFRPHOHVVDQGOHVVDFFHSWDEOHIRUSXEOLFDWLRQLQ
PDMRUMRXUQDOVPDLQO\EHFDXVHRIWKHLUWHQGHQF\WRFDUU\UHODWLYHO\OLWWOHLPSRUWDQWQHZ
LQIRUPDWLRQ7KHIROORZLQJNLQGVRIFDVHUHSRUWVVWLOOPHULWSXEOLFDWLRQ
7KHXQLTXHRUQHDUO\XQLTXHFDVHWKDWDSSHDUVWRUHSUHVHQWDSUHYLRXVO\XQGHVFULEHG
V\QGURPHRUGLVHDVH
7KHFDVHZLWKDQXQH[SHFWHGDVVRFLDWLRQRIWZRRUPRUHGLVHDVHVRUGLVRUGHUVWKDW
PD\UHSUHVHQWDSUHYLRXVO\XQVXVSHFWHGFDXVDOUHODWLRQ
7KHFDVHUHSUHVHQWLQJDQHZDQGLPSRUWDQWYDULDWLRQIURPDQH[SHFWHGSDWWHUQWKH
³RXWOLHU´FDVH
7KHFDVHZLWKDQXQH[SHFWHGHYROXWLRQWKDWVXJJHVWVDWKHUDSHXWLFRUDGYHUVHGUXJ
HIIHFW
$JRRGH[DPSOHRIDQLPSRUWDQWFDVHUHSRUWLVWKHUHSRUWE\+\PHVHWDOLQ
RIHLJKWFDVHVRIWKHUDUHVNLQWXPRXU.DSRVL¶VVDUFRPDLQ1HZ<RUN8VXDOO\DVORZO\
JURZLQJWXPRXUWKHFRXUVHLQWKHVHFDVHVZDVDJJUHVVLYH8VXDOO\DGLVHDVHRIROG
SHRSOHWKHVHFDVHVRFFXUUHGLQ\RXQJPHQ7KHSDWLHQWVZHUHDOOKRPRVH[XDOPHQ7KLV
UHSRUWILUVWDOHUWHGWKHZRUOGWRWKH$,'6HSLGHPLF
11.15 Writing a secondary scientific paper

$VHFRQGDU\VFLHQWLILFSDSHULVDUHYLHZSDSHUZKLFKVXPPDUL]HVRWKHUSDSHUV7KHUH
DUHWZRW\SHVRIUHYLHZVDQDUUDWLYHUHYLHZDQGDV\VWHPDWLFUHYLHZ7KHGLVWLQFWLRQ
EHWZHHQWKHWZRW\SHVRIUHYLHZVKRXOGEHFOHDU0HWDDQDO\VLVLVDVSHFLDOW\SHRI
V\VWHPDWLFUHYLHZ
Narrative review
,QWKHQDUUDWLYHUHYLHZWKHVWXGLHVUHYLHZHGKDYHQRWEHHQLGHQWLILHGRUDQDO\VHGLQ
DV\VWHPDWLFVWDQGDUGL]HGDQGREMHFWLYHZD\([SHUWVWRSURYLGHDQXSGDWHRQDFHUWDLQ
VXEMHFWXVXDOO\ZULWHWKHUHYLHZ
Systematic review
7KHV\VWHPDWLFUHYLHZFRQWDLQVDQH[SOLFLWVWDWHPHQWRQREMHFWLYHVZLWKDVSHOWRXW
UHVHDUFKTXHVWLRQ7KHGDWDVRXUFHVIRUWKHSDSHUVLQFOXGLQJJUH\OLWHUDWXUHDUHVWDWHG
DVZHOODVWKHPHWKRGRIVHOHFWLRQ7KHUHYLHZLVFRQGXFWHGDFFRUGLQJWRDQH[SOLFLW
DQGUHSURGXFLEOHPHWKRGRORJ\'LIIHUHQWIURPWKHQDUUDWLYHUHYLHZJHQHUDOO\ZULWWHQE\
H[SHUWVDV\VWHPDWLFUHYLHZPD\EHEHWWHUGRQHE\QRQH[SHUWVRQWKHVXEMHFWZKRDUH
H[SHUWVRQZULWLQJV\VWHPDWLFUHYLHZV
$V\VWHPDWLFUHYLHZJHQHUDOO\LQFOXGHVWKHIROORZLQJSDUWV
$EVWUDFW
,QWURGXFWLRQ$ ZHOOFRQFHLYHG V\VWHPDWLF UHYLHZ DQVZHUV D TXHVWLRQ RU FORVHO\
UHODWHGTXHVWLRQVZKLFKVKRXOGEHPDGHFOHDUDWWKHEHJLQQLQJRIWKHUHYLHZ
0HWKRGV 7KH PHWKRGV VHFWLRQ LQ D V\VWHPDWLF UHYLHZ VKRXOG IXOO\ GHVFULEH WKH
PHWKRGVXVHGIRUORFDWLQJVHOHFWLQJH[WUDFWLQJDQGV\QWKHVL]LQJWKHGDWD,WVKRXOG
RXWOLQH WKH OLWHUDWXUH VHDUFK LQFOXGLQJ WKH ELEOLRJUDSKLF LQGH[HV DQG GDWDEDVHV
VHDUFKHGOLPLWVRQ\HDUVDQGODQJXDJHVDVZHOODVVHDUFKWHUPVXVHG
%RG\RIWKHUHYLHZ7RSLFVLQWKHERG\RIWKHUHYLHZGHSHQGRQVXEMHFW7KHVHTXHQFH
VKRXOGKDYHDORJLFDOEDVLV6HTXHQFHVKRXOGEHPDGHFOHDUE\VXEKHDGLQJV7KH
DUJXPHQWVKRXOGEHFULWLFDO
$VVHVVPHQWRIWKHTXDOLW\RIV\VWHPDWLFUHYLHZVLVGLVFXVVHGLQ&KDSWHU
Meta-analysis/pooling
0HWDDQDO\VHVFULWLFDOO\UHYLHZUHVHDUFKVWXGLHVDQGVWDWLVWLFDOO\FRPELQHWKHLU
GDWDWRKHOSDQVZHUTXHVWLRQVWKDWDUHEH\RQGWKHSRZHURIVLQJOHSDSHUV³3RZHU´
LVWKHWHUPWRGHVFULEHWKHYDOXHRIWKLVWHFKQLTXH&RPELQLQJGDWDIURPDQXPEHURI
VWXGLHVLQFUHDVHVWKHVDPSOHVL]H7KHWHFKQLTXHRIPHWDDQDO\VLVKDVJUHDWSRWHQWLDO
IRUV\QWKHVL]LQJUHVHDUFKUHVXOWVDQGDGGLQJSUHFLVLRQDQGSRZHUWRRXUHVWLPDWHVRI
HIIHFW
7KHUHVXOWVRIWKHVHPHWDDQDO\VHVQRZWHQGWREHSUHVHQWHGLQDVWDQGDUGIRUPDW
EHFDXVHWKH\PRVWO\XVHDFRPPRQFRPSXWHUVRIWZDUHNQRZQDV0HWD9LHZWRGRWKH
FDOFXODWLRQDQGH[SUHVVWKHUHVXOWVLQDJUDSKLFIRUP7KLVIRUPDWLVFROORTXLDOO\NQRZQDV
D³IRUHVWSORW´RU³EOREERJUDP´,WVKRZVDQXPEHURIKRUL]RQWDOOLQHVHDFKUHSUHVHQWLQJ
RQHVWXG\7KHEORELQWKHPLGGOHRIHDFKOLQHLVWKHSRLQWHVWLPDWHDQGWKHZLGWKRIWKH
OLQHUHSUHVHQWVWKHFRQILGHQFHLQWHUYDORIWKLVHVWLPDWH$YHUWLFDOOLQHUHSUHVHQWV
³OLQHRIQRHIIHFW´,IWKHKRUL]RQWDOOLQHRIDQ\WULDOGRHVQRWFURVVWKHOLQHRIQRHIIHFW
WKHUHLVDFKDQFHWKDWWKHUHLVD³UHDO´GLIIHUHQFHEHWZHHQWKHJURXSV*UHHQKDOJK

$W\SLFDOH[DPSOHRIWKHYDOXHRIPHWDDQDO\VLVVWXGLHVLVWKHPHWDDQDO\VLVRI
VHYHQWULDOVRIWKHHIIHFWRIJLYLQJVWHURLGVWRPRWKHUVZKRZHUHH[SHFWHGWRJLYHELUWK
SUHPDWXUHO\2QO\WZRRIWKHVHYHQWULDOVVKRZHGDVWDWLVWLFDOO\VLJQLILFDQWEHQHILW%XW
ZKHQWKHUHVXOWVRIWKHVHYHQVWXGLHVZHUHSRROHGWRJHWKHUWKHVWUHQJWKRIWKHHYLGHQFH
LQIDYRXURIWKHLQWHUYHQWLRQZDVGHPRQVWUDWHG7KHPHWDDQDO\VLVVKRZHGWKDWLQIDQWV
RIPRWKHUVJLYHQFRUWLFRVWHURLGVZHUHWROHVVOLNHO\WRGLH7KH&RFKUDQH
&ROODERUDWLRQDGRSWHGWKLVH[DPSOHDVLWVORJR*UHHQKDOJK
$VVHVVPHQWRIWKHTXDOLW\RIPHWDDQDO\VLVLVGLVFXVVHGLQ&KDSWHU
11.16 Writing a paper on qualitative research

6LQFHWKHVTXDOLWDWLYHPHWKRGVRIUHVHDUFKKDYHEHHQLQFUHDVLQJO\XVHGLQ
KHDOWKUHVHDUFK7KLVKDVOHGWRDFRUUHVSRQGLQJULVHLQWKHUHSRUWLQJRITXDOLWDWLYH
UHVHDUFKVWXGLHVLQPHGLFDODQGUHODWHGMRXUQDOV7KHIROORZLQJDUHH[DPSOHVRISDSHUV
RQTXDOLWDWLYHUHVHDUFKVWXGLHVUHFHQWO\SXEOLVKHGLQWKH%ULWLVK0HGLFDO-RXUQDO
3DWLHQWV¶YLHZVDERXWWDNLQJDQWLK\SHUWHQVLYHGUXJV
<RXQJZRPHQ¶VDFFRXQWVRIIDFWRUVLQIOXHQFLQJWKHLUXVHDQGQRQXVHRIHPHUJHQF\
FRQWUDFHSWLRQLQGHSWKLQWHUYLHZVWXG\
3DWLHQWV¶XQYRLFHGDJHQGDVLQJHQHUDOSUDFWLFHFRQVXOWDWLRQVTXDOLWDWLYHVWXG\
$TXDOLWDWLYHVWXG\RIHYLGHQFHEDVHGOHDIOHWVLQPDWHUQLW\FDUH
$TXDOLWDWLYHVWXG\RIEDUULHUVWRXSWDNHRIVHUYLFHVIRUFRURQDU\KHDUWGLVHDVH
:K\GRJHQHUDOSUDFWLWLRQHUVSUHVFULEHDQWLELRWLFVIRUVRUHWKURDW"*URXQGHGWKHRU\
LQWHUYLHZVWXG\
'RFWRU¶VSHUFHSWLRQVRISDOOLDWLYHFDUHIRUKHDUWIDLOXUHIRFXVJURXSVWXG\
.QRZOHGJH DQG SHUFHSWLRQV RI JHQHUDO SUDFWLWLRQHUV DERXW LPSDLUHG JOXFRVH
WROHUDQFH
:K\JHQHUDOSUDFWLWLRQHUVGRQRWLPSOHPHQWHYLGHQFHTXDOLWDWLYHVWXG\
5HODWLRQ EHWZHHQ SULYDWH KHDOWK LQVXUDQFH DQG KLJK UDWHV RI &DHVDUHDQ VHFWLRQ
TXDOLWDWLYHDQGTXDQWLWDWLYHVWXG\
4XDOLWDWLYH DQDO\VLV RI SV\FKRVRFLDO LPSDFW RI GLDJQRVLV RI &KODP\GLD
WUDFKRPDWLV
:ULWLQJDSDSHUEDVHGRQTXDOLWDWLYHUHVHDUFKGRHVQRWQHHGWRGLIIHUIURPWKH
IUDPHZRUNXVHGIRUTXDQWLWDWLYHUHVHDUFKLQWURGXFWLRQPHWKRGVUHVXOWVDQGGLVFXVVLRQ
.LUVWL4XRWHVIURPSDUWLFLSDQWVDUHRIWHQXVHGLQWKH5HVXOWVVHFWLRQRISDSHUV
RQTXDOLWDWLYHUHVHDUFK7KHVHVKRXOGQRWUHSHDWZKDWLVLQWKHWH[W,WLVQRWQHFHVVDU\
WRLQFOXGHPRUHWKDQRQHTXRWHWRLOOXVWUDWHDSRLQW,QWUDQVODWLQJTXRWHVWR(QJOLVKWKLV
VKRXOGEHGRQHLQDSSURSULDWHVW\OHUHIOHFWLQJWKHVHQVHRIWKHTXRWHDQGQRWMXVWDOLWHUDO
WUDQVODWLRQ$VDJHQHUDOUXOHDXWKRUVVKRXOGXVHYHUEDWLPTXRWHVZKHUHYHUSRVVLEOH
DQGNHHSWKHPGRZQWRVKRUWVHJPHQWVRIWH[W
11.17 The dissertation or thesis

'LIIHUHQWIURPDVFLHQWLILFSDSHUVXEPLWWHGIRUSXEOLFDWLRQDGLVVHUWDWLRQRUWKHVLV
LVZULWWHQDQGVXEPLWWHGDVDSDUWLDORUFRPSOHWHUHTXLUHPHQWIRUDQDFDGHPLFGHJUHH
DPDVWHURUDGRFWRUDWH7KHWKHVLVLVPHDQWWRSUHVHQWDQGGHIHQGWKHUHVXOWVRID
VFLHQWLILFDOO\VRXQGSLHFHRIUHVHDUFKGLVSOD\JRRGNQRZOHGJHRIWKHILHOGRIVWXG\
VKRZIDPLOLDULW\ZLWKWKHVFLHQWLILFPHWKRGDQGGHPRQVWUDWHWKHLQWHOOHFWXDODELOLW\RI
WKHFDQGLGDWH7KHVLPSOHDFTXLVLWLRQRIYROXPLQRXVGDWDLVQRWHQRXJK,QPRVWFDVHV
WKLVDFTXLVLWLRQFRXOGKDYHEHHQGRQHHTXDOO\ZHOOE\DWHFKQLFLDQ
7KHVWHSVLQWKHSUHSDUDWLRQRIDWKHVLVIROORZWKHVDPHOLQHVRXWOLQHGLQSUHYLRXV
FKDSWHUVRQZKDWUHVHDUFKWRGRSODQQLQJRIWKHUHVHDUFKDQGVHOHFWLQJDUHVHDUFKGHVLJQ
ZULWLQJWKHUHVHDUFKSURWRFROLPSOHPHQWLQJWKHVWXG\GHVFULELQJDQGDQDO\VLQJWKH
UHVXOWVDQGWKHLUSURSHULQWHUSUHWDWLRQ:ULWLQJWKHWKHVLVDOVRIROORZVWKHVDPHJXLGHOLQHV
DQGIRUPDWIRUZULWLQJDUHVHDUFKSDSHU$OWKRXJKVSDFHLVQRWDFRQVWUDLQWEUHYLW\LV
DOZD\VDYLUWXH7KHIROORZLQJDUHVRPHDGGLWLRQDOUHPDUNVIRUWKHGLIIHUHQWVHFWLRQV
7KHLQWURGXFWLRQLVJHQHUDOO\H[SDQGHGRUUHSODFHGE\DFRPSUHKHQVLYHUHYLHZRI
WKHOLWHUDWXUH7KLVUHYLHZLVPHDQWWRGLVSOD\QRWRQO\JRRGDQGXSWRGDWHNQRZOHGJH
RIWKHILHOGEXWDOVRWKHLQWHOOHFWXDODELOLW\RIWKHFDQGLGDWH,WVKRXOGQRWLQFOXGH
LQIRUPDWLRQDOUHDG\DYDLODEOHLQWH[WERRNV,WVKRXOGLQFOXGHRQO\LQIRUPDWLRQUHOHYDQW
WRWKHZRUNGRQH,WVKRXOGEHDQDO\WLFDODQGFULWLFDO,WVKRXOGVKRZWKHDELOLW\RIWKH
FDQGLGDWHWRV\QWKHVL]HDQGSXWWRJHWKHULQIRUPDWLRQIURPGLIIHUHQWVRXUFHV,WVKRXOG
SURSHUO\UHFRJQL]HWKHZRUNRISUHYLRXVUHVHDUFKHUV
7KHREMHFWLYHVVKRXOGEHFDUHIXOO\VWDWHG7KHWKHVLVZLOOEHMXGJHGDJDLQVWKRZ
HDFKREMHFWLYHZDVDFKLHYHG
7KHLQIRUPDWLRQLQWKHPHWKRGVVHFWLRQVKRXOGEHDGHTXDWHWRDOORZRWKHUUHVHDUFKHUV
WRUHSOLFDWHWKHVWXG\$OUHDG\HVWDEOLVKHGPHWKRGVGRQRWQHHGWREHGHVFULEHGLQDQ\
GHWDLO4XDOLW\FRQWURORIWKHPHDVXUHPHQWVVKRXOGEHH[SODLQHG
7KHUHVXOWVVHFWLRQVKRXOGJLYHHTXDOHPSKDVLVWRQHJDWLYHDQGSRVLWLYHILQGLQJV
DQGVKRXOGEHSUHVHQWHGLQDGHTXDWHGHWDLOWRDOORZRWKHULQYHVWLJDWRUVWRUHSOLFDWHWKH
ILQGLQJV
'LVFXVVLRQVKRXOGEHOLPLWHGWRWKHUHVXOWVRIWKHVWXG\7KHOLPLWDWLRQVRIWKHVWXG\
VKRXOGEHEURXJKWXS&RQFOXVLRQVVKRXOGQRWJREH\RQGZKDWWKHFDQGLGDWHGLGDQG
IRXQG
$FNQRZOHGJHPHQWVVKRXOGEHJHQHURXVDQGJLYHFUHGLWWRDOOZKRKDYHKHOSHGWKH
LQYHVWLJDWRU
,WLVQRWWKHQXPEHURIUHIHUHQFHVWKDWPDWWHUVEXWWKHLUUHOHYDQFH7KH\VKRXOG
LQFOXGHRULJLQDODUWLFOHVDQGQRWEHODUJHO\EDVHGRQUHYLHZV7KH\VKRXOGEHXSWRGDWH
LQGLFDWLQJWKDWWKHFDQGLGDWHZDVIROORZLQJWKHOLWHUDWXUHGXULQJDQGDIWHUWKHVWXG\
5HIHUHQFHVIURPQDWLRQDOVRXUFHVRUUHJLRQDOVRXUFHVVKRXOGEHLQFOXGHGWRJHWKHUZLWK
WKRVHIURPWKHLQWHUQDWLRQDOOLWHUDWXUH,WLVDVVXPHGWKDWWKHFDQGLGDWHKDVUHDGDOOWKH
UHIHUHQFHV7KHUHIHUHQFHVVKRXOGEHFDUHIXOO\FKHFNHGDJDLQVWRULJLQDOGRFXPHQWV
7KHWKHVLVVKRXOGEHFKHFNHGIRUVW\OH6SHOOLQJDQGJUDPPDUPLVWDNHVLQGLFDWH
VORSSLQHVVRQWKHSDUWRIWKHFDQGLGDWHDQGPD\OHDGWKHH[DPLQHUWRVXVSHFWVORSSLQHVV
LQWKHZRUNLWVHOI:RUGSURFHVVRUVFDQKHOSWKHFDQGLGDWHWRUHFRJQL]HDQGFRUUHFWWKHVH
PLVWDNHVEXWFRQWDLQKLGGHQGDQJHUVDQGVKRXOGQRWEHUHOLHGRQEOLQGO\
,QSUHVHQWLQJWKHWKHVLVWKHVDPHJXLGHOLQHVIRUVFLHQWLILFSUHVHQWDWLRQVRXWOLQHG
LQWKHQH[WFKDSWHUVKRXOGEHIROORZHG8QOLNHDSUHVHQWDWLRQWRDVFLHQWLILFPHHWLQJ
TXHVWLRQVWRWKHFDQGLGDWHZLOOWDNHPRUHWKDQWKHWLPHRIWKHSUHVHQWDWLRQ7KHFDQGLGDWH
KDVWRH[SODLQKLVKHUILQGLQJVDQGGLVSOD\JHQHUDONQRZOHGJHLQWKHILHOG'HIHQGLQJWKH
ZRUNGRHVQRWPHDQWU\LQJWRFRYHUXSZHDNQHVVHVLQWKHVWXG\

Baker P.N. How to set about writing your first paper. In: O’Brien PMS, Pipkin FB, eds.
Introduction to research methodology for specialists and trainees. London, Royal College
of Obstetricians and Gynaecologists Press, 1999: 225–230.
Wilkins, 1998.
Crowley P. Corticosteroids prior to pre-term delivery, (updated January 1996). Cochrane
Database of Systemic Reviews. London, BMJ Books, 1996.
DeLacey G, Record C, Wade J. How accurate are quotations and references in medical
journals. British Medical Journal, 1985, 291: 884–886.
Docherty M, Smith R..The case for structuring the discussion of scientific papers (editorial).
Forgacs J. How to write a review. In: Hall GM, ed. How to write a paper, 2nd edition.
London, BMJ Books, 1998: 77–82.
BMJ Books, 1997:122; 119–123.
Hall GM, ed. How to write a paper, 2nd edition. London, BMJ Books, 1998.
Halsy MJ. Revising prose structure and style. In: Hall GM, ed. How to write a paper. 2nd
Herod JJO. How to prepare a thesis. In: O’Brien PMS, Pipkin FB, eds. Introduction to
Hill B. The reason for writing. British Medical Journal, 1965, 2:870.
Huth EJ. How to write and publish papers in the medical sciences. 2nd edition. Baltimore,
Williams & Wilkins, 1990.
Hymes KB, Cheung T et al. Kaposi’s sarcoma in homosexual men: A report of eight
cases. Lancet 1981, 2: 598–600.
November 2003. (http://www.icmje.org accessed 24/2/2004)
358: 483–88.
Lester JD, Lester JD, Jr. Writing research papers: a complete guide, 10th edition. New
York, Longman, 2002.
Pearce N. Style: What is it and does it matter? In: Hall GM, ed. How to write a paper, 2nd
Pipkin FB. How a thesis or dissertation is assessed or examined. In: O’Brien PMS, Pipkin
FB, eds. Introduction to research methodology for specialists and trainees. London, Royal
College of Obstetricians and Gynaecologists Press, 1999: 248–253.
Skelton JR, Edwards SJL. The function of the discussion section in academic medical
writing. British Medical Journal, 2000, 320: 1269–1270.
Strunk W Jr. The elements of style. 4th edition. New York, Longman, 2000.
Wildsmith JAW. How to write a case report. In: Hall GM, ed. How to write a paper. 2nd
Chapter 12
Publishing a scientific paper
12.1 Introduction
3XEOLFDWLRQRIUHVHDUFKZRUNLVHVVHQWLDOLQRUGHUWRDGYDQFHVFLHQFHDQGWRLPSURYH
KHDOWK,WLVDOVRHVVHQWLDOIRUSHRSOHSXUVXLQJDVFLHQWLILFFDUHHU7KHLUUHFRJQLWLRQDV
UHVHDUFKHUVGHSHQGVRQWKHLUSXEOLFDWLRQVDQGFRQWULEXWLRQVWRVFLHQWLILFSURJUHVV
6FLHQWLVWVOLYHLQDFXOWXUHRI³SXEOLVKRUSHULVK´5HVHDUFKHUVVKRXOGOHDUQQRWRQO\
KRZWRZULWHDVFLHQWLILFSDSHUEXWDOVRKRZWRJHWLWSXEOLVKHG6FLHQWLILFMRXUQDOV
KDYHWHFKQLFDOUHTXLUHPHQWVDQGDXWKRUVVKRXOGPDNHWKHPVHOYHVIDPLOLDUZLWKWKHVH
UHTXLUHPHQWV5HVHDUFKHUVGHVHUYHWRKDYHWKHFUHGLWIRUWKHLUZRUNEXWRQO\LIWKH\
KDYHFRQWULEXWHGLQWHOOHFWXDOO\WRLW(WKLFDOVWDQGDUGVDSSO\WRVFLHQWLILFSXEOLFDWLRQDQG
VKRXOGEHREVHUYHGE\DXWKRUVDQGHQVXUHGE\HGLWRUV
12.2 How to get your paper published

7KH HGLWRU¶V GHFLVLRQ WR DFFHSW RU UHMHFW D SDSHU LV JHQHUDOO\ EDVHG RQ WKH
IROORZLQJ
WKHPHVVDJHRIWKHSDSHUKRZFOHDULPSRUWDQWDQGQHZLVWKHPHVVDJH"
WKH UHOHYDQFH RI WKH SDSHU WR WKH MRXUQDO¶V VFRSH DQG LWV DXGLHQFH WKH MRXUQDO¶V
EDFNORJRIDFFHSWHGSDSHUVLVDOVRDIDFWRULQWKHFRQVLGHUDWLRQ
VFLHQWLILFYDOLGLW\RIWKHHYLGHQFHVXSSRUWLQJWKHSDSHU¶VFRQFOXVLRQV
TXDOLW\RIWKHPDQXVFULSW
The message
7KHSDSHUPXVWKDYHDPHVVDJH$JRRGPHVVDJHFDQEHSXWLQRQHVHQWHQFH6RPH
MRXUQDOVQRZUHTXLUHWKLVRQHVHQWHQFHEHQHDWKWKHWLWOHRIWKHSDSHULQRUGHUWRSXW
LWLQWKHWDEOHRIFRQWHQWV$VHFRQGLVVXHLVWKH³VRZKDW´WHVW'RWKHILQGLQJVKDYH
LPSOLFDWLRQV":KHWKHUDMRXUQDODFFHSWVDSDSHURIWHQKLQJHVRQZKHWKHULWVPHVVDJHLV
QHZH[SDQGVRQFRQILUPVRUUHMHFWVDSUHYLRXVO\SXEOLVKHGPHVVDJH
Matching the topic and the journal

$GHFLVLRQRQZKLFKMRXUQDOWRVXEPLWWKHSDSHUWRPXVWEHPDGHEHIRUHWKHSDSHULV
ILQDOO\ZULWWHQ7KHSDSHUPXVWEHZULWWHQLQFRQIRUPLW\ZLWKWKHVW\OHRIWKHMRXUQDO7KH
OLVWRIMRXUQDOVLQGH[HGLQ3XE0HG0('/,1(RIWKH861DWLRQDO/LEUDU\RI0HGLFLQH
LQFOXGHVRYHUSHHUUHYLHZHGMRXUQDOVJURXSHGE\VXEMHFWILHOG$SHHUUHYLHZHG
MRXUQDOLVRQHWKDWVXEPLWVPRVWRILWVSXEOLVKHGDUWLFOHVIRUUHYLHZE\H[SHUWVZKRDUH
QRWSDUWRIWKHHGLWRULDOVWDII,WLVLPSRUWDQWWRHQVXUHWKDWWKHWRSLFRIWKHSDSHUIDOOV
ZLWKLQWKHVFRSHRIWKHMRXUQDOVHOHFWHG7KHIRUPDWRIWKHSDSHUVKRXOGDOVREHRQHWKDW
LVDFFHSWHGE\WKHMRXUQDO
+LJK SUHVWLJH MRXUQDOV KDYH KLJK UHMHFWLRQ UDWHV VRPHWLPHV DV KLJK DV
5HMHFWLRQGRHVQRWQHFHVVDULO\PHDQWKDWWKHSDSHULVQRWJRRG-RXUQDOVFDQQRWSXEOLVK
DOOWKHJRRGSDSHUVWKH\UHFHLYH)RUWKHDXWKRUVUHMHFWLRQPHDQVORVVRIZHHNVRUPRQWKV
EHIRUHWKHSDSHULVVXEPLWWHGDJDLQWRDQRWKHUMRXUQDO3XEOLFDWLRQODJLVWKHLQWHUYDO
EHWZHHQDFFHSWDQFHDQGSXEOLFDWLRQWKHDYHUDJHODJLVVHYHQPRQWKV(YHQVRLWLVQRW
DFFHSWDEOHWRVHQGWKHVDPHSDSHUVLPXOWDQHRXVO\WRPRUHWKDQRQHMRXUQDO7KHMRXUQDO
FRQVLGHUVWKHSDSHURQWKHDVVXPSWLRQWKDWLWKDVQRWEHHQVXEPLWWHGHOVHZKHUH$PRQJ
WKHSULQFLSDOFRQVLGHUDWLRQVWKDWKDYHOHGWRWKLVSROLF\DUHWKHSRWHQWLDOIRUGLVDJUHHPHQW
ZKHQWZRMRXUQDOVFODLPWKHULJKWWRSXEOLVKWKHVDPHPDQXVFULSWDQGWKHSRVVLELOLW\WKDW
WZRRUPRUHMRXUQDOVZLOOXQNQRZLQJO\DQGXQQHFHVVDULO\GRWKHZRUNRISHHUUHYLHZ
DQGHGLWLQJRIWKHVDPHPDQXVFULSWDQGHYHQSXEOLVKWKHVDPHDUWLFOH
$VLQJOHSDSHULVPRUHOLNHO\WREHDFFHSWHGWKDQRQHLQDVHULHV$UELWUDU\FDUYLQJ
XSRIFOHDUO\UHODWHGDVSHFWVRIRQHVWXG\LVUHIHUUHGWRDV³VDODPLVFLHQFH´DQGLVQRW
HQFRXUDJHG
Scientific validity
,QWHUQDOYDOLGLW\UHIHUVWRWKHGHJUHHWRZKLFKWKHLQYHVWLJDWRU¶VFRQFOXVLRQVFRUUHFWO\
GHVFULEHZKDWDFWXDOO\KDSSHQHGLQWKHVWXG\,WPHDQVWKDWZLWKLQWKHFRQILQHVRIWKH
VWXG\UHVXOWVDSSHDUWREHDFFXUDWHWKHPHWKRGVDQGDQDO\VLVXVHGVWDQGXSWRVFUXWLQ\
DQGWKHLQWHUSUHWDWLRQRIWKHLQYHVWLJDWRUVDSSHDUVWREHVXSSRUWHG
([WHUQDOYDOLGLW\DOVRFDOOHGJHQHUDOL]DELOLW\UHIHUVWRWKHGHJUHHWRZKLFKWKH
ILQGLQJVRIWKHVWXG\PD\EHJHQHUDOL]HGWRWKHSRSXODWLRQIURPZKLFKWKHVDPSOHIRU
WKHVWXG\ZDVGUDZQ3RRUPHWKRGVDQGLQDGHTXDWHUHVXOWVDUHPRVWRIWHQUHVSRQVLEOH
IRUUHMHFWLRQ
Quality of the manuscript

7KLVKDVEHHQGLVFXVVHGLQGHWDLOLQ&KDSWHU
Publishing a scientific paper 153
12.3 Uniform requirements for manuscripts submitted to

biomedical journals
$JURXSRIHGLWRUVRIJHQHUDOPHGLFDOMRXUQDOVPHWLQIRUPDOO\LQ9DQFRXYHU%ULWLVK
&ROXPELD&DQDGDLQLQRUGHUWRHVWDEOLVKJXLGHOLQHVIRUWKHIRUPDWRIPDQXVFULSWV
VXEPLWWHGWRWKHLUMRXUQDOV7KHJURXSEHFDPHNQRZQDVWKH9DQFRXYHU*URXS,WV
UHTXLUHPHQWVIRUPDQXVFULSWVLQFOXGLQJIRUPDWVIRUFLWLQJELEOLRJUDSKLFUHIHUHQFHV
ZHUHILUVWSXEOLVKHGLQ7KH9DQFRXYHU*URXSH[SDQGHGDQGHYROYHGLQWRWKH
,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUV,&0-(ZKLFKPHHWVDQQXDOO\
DQGKDVJUDGXDOO\EURDGHQHGLWVFRQFHUQV
7KH&RPPLWWHHKDVSURGXFHGVHYHUDOHGLWLRQVRIWKH8QLIRUP5HTXLUHPHQWVIRU
0DQXVFULSWV6XEPLWWHGWR%LRPHGLFDOMRXUQDOV:ULWLQJDQG(GLWLQJIRU%LRPHGLFDO
3XEOLFDWLRQ2YHUWKH\HDUVLVVXHVKDYHDULVHQWKDWJREH\RQGPDQXVFULSWSUHSDUDWLRQ
6RPHRIWKHVHLVVXHVKDYHEHHQFRYHUHGLQVXEVHTXHQWHGLWLRQVRWKHUVDUHDGGUHVVHG
LQVHSDUDWHVWDWHPHQWV(DFKVWDWHPHQWKDVEHHQSXEOLVKHGLQDVFLHQWLILFMRXUQDO,Q
WKHODWHVWUHYLVLRQ1RYHPEHUWKHFRPPLWWHHUHYLVHGDQGUHRUJDQL]HGWKHHQWLUH
GRFXPHQWDQGLQFRUSRUDWHGWKHVHSDUDWHVWDWHPHQWVLQWKHWH[WKWWSZZZLFPMHRUJ
7KHWRWDOFRQWHQWRIWKH8QLIRUP5HTXLUHPHQWVIRU0DQXVFULSWV6XEPLWWHGWR%LRPHGLFDO
-RXUQDOVPD\EHUHSURGXFHGIRUHGXFDWLRQDOQRWIRUSURILWSXUSRVHVZLWKRXWUHJDUGIRU
FRS\ULJKW7KH&RPPLWWHHHQFRXUDJHVGLVWULEXWLRQRIWKHPDWHULDO
7KH 8QLIRUP 5HTXLUHPHQWV DUH LQVWUXFWLRQV WR DXWKRUV RQ KRZ WR SUHSDUH
PDQXVFULSWVQRWWRHGLWRUVRQSXEOLFDWLRQVW\OH%XWPDQ\MRXUQDOVKDYHGUDZQRQ
WKHPIRUHOHPHQWVRIWKHLUSXEOLFDWLRQVW\OHV,IDXWKRUVSUHSDUHPDQXVFULSWVLQWKH
VW\OHVSHFLILHGLQWKHVHUHTXLUHPHQWVHGLWRUVRIWKHSDUWLFLSDWLQJMRXUQDOVZLOOQRWUHWXUQ
WKHPDQXVFULSWVIRUFKDQJHVLQVW\OHEHIRUHFRQVLGHULQJWKHPIRUSXEOLFDWLRQ,QWKH
SXEOLVKLQJSURFHVVKRZHYHUDMRXUQDOPD\DOWHUDFFHSWHGPDQXVFULSWVWRFRQIRUPWR
GHWDLOVRILWVSXEOLFDWLRQVW\OH$XWKRUVVHQGLQJPDQXVFULSWVWRDSDUWLFLSDWLQJMRXUQDO
VKRXOGQRWWU\WRSUHSDUHWKHPLQDFFRUGDQFHZLWKWKHSXEOLFDWLRQVW\OHRIWKDWMRXUQDO
EXWVKRXOGIROORZWKH8QLIRUP5HTXLUHPHQWV
$XWKRUVPXVWDOVRIROORZWKHLQVWUXFWLRQVWRDXWKRUVLQWKHMRXUQDODVWRZKDWWRSLFV
DUHVXLWDEOHIRUWKDWMRXUQDODQGWKHW\SHVRISDSHUVWKDWPD\EHVXEPLWWHGIRUH[DPSOH
RULJLQDODUWLFOHVUHYLHZVRUFDVHUHSRUWV,QDGGLWLRQWKHMRXUQDO¶VLQVWUXFWLRQVDUHOLNHO\
WRFRQWDLQRWKHUUHTXLUHPHQWVXQLTXHWRWKDWMRXUQDOVXFKDVWKHQXPEHURIFRSLHVRI
DPDQXVFULSWWKDWDUHUHTXLUHGDFFHSWDEOHODQJXDJHVOHQJWKRIDUWLFOHVDQGDSSURYHG
DEEUHYLDWLRQV
3DUWLFLSDWLQJMRXUQDOVRYHULQWHUQDWLRQDOO\DUHH[SHFWHGWRVWDWHLQWKHLU
LQVWUXFWLRQVWRDXWKRUVWKDWWKHLUUHTXLUHPHQWVDUHLQDFFRUGDQFHZLWKWKH8QLIRUP
5HTXLUHPHQWVIRU0DQXVFULSWV6XEPLWWHGWR%LRPHGLFDO-RXUQDOVDQGWRFLWHDSXEOLVKHG
YHUVLRQ
7KHIROORZLQJVHFWLRQVDUHODUJHO\EDVHGRQWKHVHXQLIRUPUHTXLUHPHQWV
12.4 Summary of technical instructions for submission of

papers
7\SHRUSULQWRXWWKHPDQXVFULSWRQZKLWHERQGSDSHUîPPRU,62
$îPPZLWKPDUJLQVRIDWOHDVWPP7\SHRUSULQWRQRQO\RQHVLGH
RIWKHSDSHU8VHGRXEOHVSDFLQJWKURXJKRXWLQFOXGLQJIRUWKHWLWOHSDJHDEVWUDFW
WH[WDFNQRZOHGJHPHQWVUHIHUHQFHVLQGLYLGXDOWDEOHVDQGOHJHQGV1XPEHUSDJHV
FRQVHFXWLYHO\EHJLQQLQJZLWKWKHWLWOHSDJH3XWWKHSDJHQXPEHULQWKHXSSHURUORZHU
ULJKWKDQGFRUQHURIHDFKSDJH%HJLQHDFKVHFWLRQRUFRPSRQHQWRQDQHZSDJH
3ODFHHDFKWDEOHRQDVHSDUDWHSDJH,OOXVWUDWLRQVDQGXQPRXQWHGSULQWVVKRXOGEHQR
ODUJHUWKDQîPP$XWKRUVVKRXOGVXEPLWWKHUHTXLUHGQXPEHURISDSHUFRSLHV
DQGDUHDGYLVHGWRNHHSFRSLHVRIHYHU\WKLQJVXEPLWWHG
7KHWLWOHSDJHVKRXOGFDUU\
WLWOHRIWKHDUWLFOHZKLFKVKRXOGEHFRQFLVHEXWLQIRUPDWLYH
QDPHE\ZKLFKHDFKDXWKRULVNQRZQZLWKKLVRUKHUKLJKHVWDFDGHPLFGHJUHHV
DQGLQVWLWXWLRQDODIILOLDWLRQ
QDPHRIWKHGHSDUWPHQWVDQGLQVWLWXWLRQVWRZKLFKWKHZRUNVKRXOGEHDWWULE
XWHG
GLVFODLPHUVLIDQ\
QDPHDQGDGGUHVVRIWKHDXWKRUUHVSRQVLEOHIRUFRUUHVSRQGHQFHDERXWWKHPDQXVFULSW
WKHQDPHDQGDGGUHVVRIWKHDXWKRUWRZKRPUHTXHVWVIRUUHSULQWVVKRXOGEHDGGUHVVHG
RUDVWDWHPHQWWKDWUHSULQWVZLOOQRWEHDYDLODEOHIURPWKHDXWKRUV
VRXUFHVRIVXSSRUWLQWKHIRUPRIJUDQWVHTXLSPHQWGUXJVRUDOORIWKHVH
VKRUWUXQQLQJKHDGRUIRRWOLQHRIQRPRUHWKDQFKDUDFWHUVFRXQWOHWWHUVDQGVSDFHV
DWWKHIRRWRIWKHWLWOHSDJH
$QLQFUHDVLQJQXPEHURIMRXUQDOVUHTXLUHHOHFWURQLFVXEPLVVLRQRIPDQXVFULSWV
ZKHWKHURQGLVNDVDWWDFKPHQWWRHOHFWURQLFPDLORUE\GRZQORDGLQJGLUHFWO\RQWRWKH
MRXUQDOZHEVLWH(OHFWURQLFVXEPLVVLRQVVDYHWLPHDVZHOODVSRVWDJHFRVWVDQGDOORZWKH
PDQXVFULSWWREHKDQGOHGLQHOHFWURQLFIRUPWKURXJKRXWWKHHGLWRULDOSURFHVVIRUH[DPSOH
ZKHQLWLVVHQWRXWWRUHYLHZHUV$XWKRUVFDQIROORZWKHFRXUVHRIWKHLUSDSHUE\DFFHVVLQJ
WKHZHEVLWHRIWKHMRXUQDO$XWKRUVVKRXOGFRQVXOWWKHMRXUQDO¶VLQVWUXFWLRQVWRDXWKRUVIRU
DFFHSWDEOHZRUGSURFHVVLQJIRUPDWVFRQYHQWLRQVIRUQDPLQJILOHVDQGRWKHUGHWDLOV
:KHQSDSHUPDQXVFULSWVDUHVXEPLWWHGMRXUQDOVFRPPRQO\UHTXLUHDXWKRUVWRSURYLGH
DFRS\LQHOHFWURQLFIRUPRQDGLVNZKHQWKHSDSHUVDUHFORVHWRILQDODFFHSWDQFH7KH
GLVNVKRXOGEHFOHDUO\ODEHOOHGZLWKWKHIRUPDWRIWKHILOHDQGWKHILOHQDPH
12.5 Sending the manuscript to the journal

7KHUHTXLUHGQXPEHURIFRSLHVRIWKHPDQXVFULSWVKRXOGEHVHQWLQDKHDY\SDSHU
HQYHORSHHQFORVLQJWKHFRSLHVDQGILJXUHVLQFDUGERDUGLIQHFHVVDU\WRSUHYHQWWKH
SKRWRJUDSKVIURPEHLQJEHQW3KRWRJUDSKVDQGWUDQVSDUHQFLHVDUHEHWWHUSXWLQDVHSDUDWH
KHDY\SDSHUHQYHORSH
0DQXVFULSWVPXVWEHDFFRPSDQLHGE\DFRYHULQJOHWWHUVLJQHGE\DOOFRDXWKRUV
7KLVPXVWQRUPDOO\LQFOXGH
LQIRUPDWLRQRQSULRURUGXSOLFDWHSXEOLFDWLRQRUVXEPLVVLRQHOVHZKHUHRIDQ\SDUW
RIWKHZRUN
DVWDWHPHQWRIILQDQFLDORURWKHUUHODWLRQVKLSVWKDWPLJKWOHDGWRFRQIOLFWRILQWHU
HVW
DVWDWHPHQWWKDWWKHPDQXVFULSWKDVEHHQUHDGDQGDSSURYHGE\DOOWKHDXWKRUVWKDW
WKHUHTXLUHPHQWVIRUDXWKRUVKLSKDYHEHHQPHWDQGWKDWHDFKDXWKRUEHOLHYHVWKDW
WKHPDQXVFULSWUHSUHVHQWVKRQHVWZRUNDQG
WKHQDPHDGGUHVVDQGWHOHSKRQHQXPEHURIWKHFRUUHVSRQGLQJDXWKRUZKRLVUHVSRQ
VLEOHIRUFRPPXQLFDWLQJZLWKWKHRWKHUDXWKRUVDERXWUHYLVLRQVDQGILQDODSSURYDO
RIWKHSURRIV
7KHOHWWHUVKRXOGJLYHDQ\DGGLWLRQDOLQIRUPDWLRQWKDWPD\EHKHOSIXOWRWKHHGLWRU
VXFKDVWKHW\SHRIDUWLFOHLQWKHSDUWLFXODUMRXUQDOWKDWWKHPDQXVFULSWUHSUHVHQWVDQG
ZKHWKHUWKHDXWKRUVZRXOGEHZLOOLQJWRPHHWWKHFRVWRIFRORXULOOXVWUDWLRQV
&RSLHVRIDQ\SHUPLVVLRQWRUHSURGXFHSXEOLVKHGPDWHULDOWRXVHLOOXVWUDWLRQVRU
UHSRUWLQIRUPDWLRQDERXWLGHQWLILDEOHSHRSOHRUWRQDPHSHRSOHIRUWKHLUFRQWULEXWLRQV
PXVWDFFRPSDQ\WKHPDQXVFULSW
$WUDQVIHURIFRS\ULJKWPD\EHUHTXLUHGDWWKLVVWDJHRUDIWHUWKHSDSHUKDVEHHQ
DFFHSWHGIRUSXEOLFDWLRQ
12.6 After submitting the manuscript

$FNQRZOHGJHPHQWRIUHFHLSWRIWKHPDQXVFULSWLVXVXDOO\UHFHLYHGZLWKLQ±
ZHHNV$GHFLVLRQUHJDUGLQJSXEOLFDWLRQLVXVXDOO\PDGHZLWKLQ±ZHHNVGHSHQGLQJRQ
UHYLHZHUV¶UHVSRQVHV5HMHFWLRQUDWHVRIWKHEHVWMRXUQDOVDUHRYHU3UREDEO\RQO\
RUVRRISDSHUVDUHDFFHSWHGZLWKRXWFKDQJHUHFRPPHQGHGDVDUHVXOWRISHHUUHYLHZ
7KHUHYLHZHUV¶UHVSRQVHVPD\VXJJHVWWKDW WKDW WKH SDSHU FDQ EH PDGH PRUH
DFFHSWDEOHE\UHYLVLRQV7KHLQYHVWLJDWRUVGRQRWQHHGWRPDNHDOOWKHFKDQJHVVXJJHVWHG
DXWRPDWLFDOO\7KH\VKRXOGDGRSWUHYLVLRQVWKDWZLOOVDWLVI\WKHUHYLHZHUV¶FULWLFLVPV
ZKHUHYHUSRVVLEOHDQGMXVWLI\DQ\GHFLVLRQQRWWRGRVR,WLVJRRGWRLQGLFDWHLQDVHSDUDWH
SDJHWKHFULWLFLVPPDGHDQGKRZWKHUHYLVHGSDSHUUHVSRQGVWRWKHP7KLVZLOOIDFLOLWDWH
DGHFLVLRQE\WKHHGLWRU
12.7 Authorship in scientific papers

$Q³DXWKRU´LVJHQHUDOO\FRQVLGHUHGWREHVRPHRQHZKRKDVPDGHVXEVWDQWLDO
LQWHOOHFWXDOFRQWULEXWLRQWRDSXEOLVKHGVWXG\7KH,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO
-RXUQDO(GLWRUVLVVXHGWKHIROORZLQJJXLGHOLQHVDERXWDXWKRUVKLS
(DFKDXWKRUVKRXOGKDYHSDUWLFLSDWHGVXIILFLHQWO\LQWKHZRUNWRWDNHSXEOLFUHVSRQ
VLELOLW\IRUDSSURSULDWHSRUWLRQVRIWKHFRQWHQW
$XWKRUVKLSFUHGLWVKRXOGEHEDVHGRQVXEVWDQWLDOFRQWULEXWLRQVWR
FRQFHSWLRQDQGGHVLJQRUDFTXLVLWLRQRIGDWDRUDQDO\VLVDQGLQWHUSUHWDWLRQRI
GDWDDQG
GUDIWLQJWKHDUWLFOHRUUHYLVLQJLWFULWLFDOO\IRULPSRUWDQWLQWHOOHFWXDOFRQWHQW
DQG
ILQDODSSURYDORIWKHYHUVLRQWREHSXEOLVKHG
$XWKRUVVKRXOGPHHWFRQGLWLRQVDQG
$FTXLVLWLRQ RI IXQGLQJ FROOHFWLRQ RI GDWD RU JHQHUDO VXSHUYLVLRQ RI WKH UHVHDUFK
JURXSGRHVQRWMXVWLI\DXWKRUVKLS
7RSURYLGHLQIRUPDWLRQRQWKHZRUNGRQHE\DXWKRUVDQGWRUHVROYHWKHLQFRQVLVWHQF\
EHWZHHQWKHLQIRUPDWLRQSURYLGHGIRUWKRVHQDPHGLQWKHE\OLQHYHUVXVWKRVHOLVWHGLQWKH
DFNQRZOHGJHPHQWVVRPHMRXUQDOVUHTXLUHDXWKRUVWRLQGLFDWHWKHVSHFLILFFRQWULEXWLRQV
RIDOOWKRVHLQYROYHG&RQVHTXHQWO\DXWKRUVDUHUHTXLUHGWRGHVFULEHWKHLUVSHFLILF
FRQWULEXWLRQVDVZHOODVWKHFRQWULEXWLRQVRIWKRVHDFNQRZOHGJHGEXWQRWOLVWHGLQWKH
E\OLQH:KLOHPDQ\LQGLYLGXDOVPD\FRQWULEXWHWRWKHZRUNRIDQDUWLFOHWKHFRQWULEXWRUV
PXVWGHFLGHIRUWKHPVHOYHVZKDWWKHLUFRQWULEXWLRQVKDYHEHHQDQGZKDWOHYHORI
FRQWULEXWLRQPHULWVDSODFHRQWKHE\OLQH,WLVVXJJHVWHGWKDWWKRVHLQWKHE\OLQHVKRXOG
EHOLVWHGLQRUGHURIDFWXDOFRQWULEXWLRQPDGHDVGHFLGHGE\WKHDXWKRUV
$Q\FRQWULEXWRUVZKRGRQRWPHHWWKHFULWHULDIRUDXWKRUVKLSVKRXOGEHOLVWHGLQWKH
DFNQRZOHGJHPHQWVHFWLRQ%HFDXVHUHDGHUVPD\LQIHUWKHLUHQGRUVHPHQWRIWKHGDWDDQG
FRQFOXVLRQVDOOSHUVRQVOLVWHGPXVWJLYHZULWWHQSHUPLVVLRQWREHDFNQRZOHGJHG
12.8 Patents and publication

7KHUHLVDJURZLQJXQGHUVWDQGLQJRILQWHOOHFWXDOSURSHUW\ULJKWVE\DFDGHPLFV
DQGVFLHQWLILFLQVWLWXWLRQV7KHLPSRUWDQFHRIWKHLVVXHKDVDOUHDG\EHHQGLVFXVVHGLQ
&KDSWHU,WLVDFFHSWHGWKDWDSULYDWHRUSXEOLFVSRQVRURIWKHVWXG\KDVWKHULJKWWR
UHYLHZDPDQXVFULSWIRUDGHILQHGSHULRGIRUH[DPSOHWRGD\VEHIRUHSXEOLFDWLRQ
WRDOORZIRUWKHILOLQJRIDGGLWLRQDOSDWHQWSURWHFWLRQLIUHTXLUHG+RZHYHUWKHVSRQVRU
PXVWLPSRVHQRLPSHGLPHQWGLUHFWRULQGLUHFWRQWKHVXEVHTXHQWSXEOLFDWLRQRIWKHIXOO
UHVXOWVRIWKHVWXG\
12.9 Ethics in scientific publication

12.9.1 Credit
5HVHDUFKHUVPXVWJHWWKHFUHGLWIRUWKHUHVHDUFKWKH\KDYHFDUULHGRXW+RZHYHUDV
H[SODLQHGLQVHFWLRQQRRQHVKRXOGJHWFUHGLWZLWKRXWKDYLQJDFWLYHO\SDUWLFLSDWHGLQ
WKHUHVHDUFK$OODXWKRUVVKRXOGDJUHHWRKDYHWKHLUQDPHVRQWKHSDSHUDQGWRWDNHSXEOLF
UHVSRQVLELOLW\IRULW7KHRUGHURIDXWKRUVVKRXOGEHE\DJUHHPHQWDPRQJWKHDXWKRUV
7KHZRUNRISUHYLRXVLQYHVWLJDWRUVRQWKHWRSLFLQTXHVWLRQVKRXOGEHFLWHG7KH
LQYHVWLJDWRUVKRXOGQRWFODLPFUHGLWIRUDQLGHDWKDWKDVDOUHDG\EHHQSXWIRUZDUGRU
VWXGLHGE\RWKHUVDQGVKRXOGLQGLFDWHSUHYLRXVVWXGLHVWKDWPD\KDYHVKRZQGLIIHUHQW
UHVXOWVDQGFRQFOXVLRQV
7KHFRQWULEXWLRQRIRWKHUVZKRKDYHKHOSHGLQWKHLPSOHPHQWDWLRQRIWKHUHVHDUFK
VKRXOG EH DFNQRZOHGJHG DQG WKH VRXUFH RI VXSSRUW IRU WKH UHVHDUFK VKRXOG EH
LGHQWLILHG
12.9.2 Respect of copyright

&RS\ULJKWVKRXOGEHUHVSHFWHG7KHSULQFLSOHEHKLQGWKHFRS\ULJKWODZLVUHODWLYHO\
VLPSOH&RS\ULJKWEHJLQVDWWKHWLPHDFUHDWLYHZRUNLVUHFRUGHGLQVRPHWDQJLEOHIRUP
,QVFKRODUO\ZRUNWKHUHLVVHOGRPDILQDQFLDOFRPSHQVDWLRQIRUFRS\ULJKWDVLQRWKHU
ILHOGVEXWWKHUHLVFHUWDLQO\WKHQHHGIRUUHFRJQLWLRQ1RILJXUHRUWDEOHIURPSUHYLRXVO\
SXEOLVKHGZRUNVKRXOGEHLQFOXGHGZLWKRXWZULWWHQSHUPLVVLRQIURPWKHSXEOLVKHUDQG
DXWKRU)XOOFUHGLWWRWKHVRXUFHVKRXOGEHLQFOXGHGLQWKHSDSHU³5HSURGXFHGZLWK
SHUPLVVLRQIURP«´
3ODJLDULVPLVDPDMRUHWKLFDORIIHQFH8VLQJDQGFODLPLQJWKHZRUGVRULGHDV
RIDQRWKHUSHUVRQDVRQH¶VRZQZLWKRXWDFNQRZOHGJLQJWKHLUFRQWULEXWLRQLVQRW
DFFHSWDEOH
12.9.3 Conflict of interest

³'LVLQWHUHVWHGQHVV´LVDQRUPRIVFLHQFH:KHQLQYHVWLJDWRUVKDYHYHVWHGLQWHUHVWV
LQWKHUHVHDUFKWKLVVKRXOGEHH[SOLFLWO\GLVFORVHG$VWDWHPHQWRQFRQIOLFWRILQWHUHVWLV
QRZUHTXLUHGE\PDQ\MRXUQDOVEHIRUHFRQVLGHULQJDSDSHUIRUSXEOLFDWLRQ$VFRPPHUFH
DQGDFDGHPLDZRUNFORVHUWRJHWKHUWKHUHLVWKHSRWHQWLDOIRUILQDQFLDODQGIXQGLQJWLHVWR
GLVWRUWWKHZRUN6RPHVWXGLHVZKLFKUHYLHZHGSXEOLVKHGUHSRUWVRIFOLQLFDOWULDOVKDYH
VXJJHVWHGWKDWFOLQLFDOWULDOVZHUHPRUHOLNHO\WRUHDFKFRQFOXVLRQVWKDWZHUHIDYRXUDEOH
WRWKHLQWHUYHQWLRQZKHQVXSSRUWHGE\IRUSURILWRUJDQL]DWLRQV$OV1LHOVHQ
12.9.4 Redundant or duplicate publication

5HGXQGDQW RU GXSOLFDWH SXEOLFDWLRQ LV SXEOLFDWLRQ RI D SDSHU WKDW RYHUODSV
VXEVWDQWLDOO\ZLWKRQHDOUHDG\SXEOLVKHGE\WKHVDPHDXWKRUV
5HDGHUVRISULPDU\VRXUFHSHULRGLFDOVVKRXOGEHDEOHWRWUXVWWKDWZKDWWKH\DUH
UHDGLQJLVRULJLQDOXQOHVVWKHUHLVDFOHDUVWDWHPHQWWKDWWKHDUWLFOHLVEHLQJUHSXEOLVKHG
E\WKHFKRLFHRIWKHDXWKRUDQGHGLWRU7KLVSRVLWLRQLVEDVHGRQLQWHUQDWLRQDOFRS\ULJKW
ODZVHWKLFDOFRQGXFWDQGFRVWHIIHFWLYHXVHRIUHVRXUFHV
0RVWMRXUQDOVGRQRWZLVKWRUHFHLYHSDSHUVRQZRUNWKDWKDVDOUHDG\EHHQUHSRUWHG
LQODUJHSDUWLQDSXEOLVKHGDUWLFOHRULVFRQWDLQHGLQDQRWKHUSDSHUWKDWKDVEHHQVXEPLWWHG
RUDFFHSWHGIRUSXEOLFDWLRQHOVHZKHUHLQSULQWRULQHOHFWURQLFPHGLD7KLVSROLF\GRHVQRW
SUHYHQWWKHMRXUQDOIURPFRQVLGHULQJDSDSHUWKDWKDVEHHQUHMHFWHGE\DQRWKHUMRXUQDO
RUDFRPSOHWHUHSRUWWKDWIROORZVSXEOLFDWLRQRIDSUHOLPLQDU\UHSRUWVXFKDVDQDEVWUDFW
RUSRVWHUGLVSOD\HGIRUFROOHDJXHVDWDSURIHVVLRQDOPHHWLQJ1RUGRHVLWSUHYHQWMRXUQDOV
IURPFRQVLGHULQJDSDSHUWKDWKDVEHHQSUHVHQWHGDWDVFLHQWLILFPHHWLQJEXWQRWSXEOLVKHG
LQIXOORUWKDWLVEHLQJFRQVLGHUHGIRUSXEOLFDWLRQLQSURFHHGLQJVRUVLPLODUIRUPDW
:KHQVXEPLWWLQJDSDSHUWKHDXWKRUVKRXOGDOZD\VPDNHDIXOOVWDWHPHQWWRWKH
HGLWRUDERXWDOOVXEPLVVLRQVDQGSUHYLRXVUHSRUWVWKDWPLJKWEHUHJDUGHGDVUHGXQGDQW
RUGXSOLFDWHSXEOLFDWLRQRIWKHVDPHRUYHU\VLPLODUZRUN7KHDXWKRUVKRXOGDOHUWWKH
HGLWRULIWKHZRUNLQFOXGHVWRSLFVDERXWZKLFKDSUHYLRXVUHSRUWKDVEHHQSXEOLVKHG
$Q\VXFKZRUNVKRXOGEHUHIHUUHGWRDQGUHIHUHQFHGLQWKHQHZSDSHU&RSLHVRIVXFK
PDWHULDOVKRXOGEHLQFOXGHGZLWKWKHVXEPLWWHGSDSHUWRKHOSWKHHGLWRUGHFLGHKRZWR
KDQGOHWKHPDWWHU
,IUHGXQGDQWRUGXSOLFDWHSXEOLFDWLRQLVDWWHPSWHGRURFFXUVZLWKRXWVXFKQRWLILFDWLRQ
DXWKRUVVKRXOGH[SHFWHGLWRULDODFWLRQWREHWDNHQ$WWKHOHDVWSURPSWUHMHFWLRQRIWKH
VXEPLWWHGPDQXVFULSWVKRXOGEHH[SHFWHG,IWKHHGLWRUZDVQRWDZDUHRIWKHYLRODWLRQDQG
WKHDUWLFOHKDVDOUHDG\EHHQSXEOLVKHGWKHQDQRWLFHRIUHGXQGDQWRUGXSOLFDWHSXEOLFDWLRQ
ZLOOSUREDEO\EHSXEOLVKHGZLWKRUZLWKRXWWKHDXWKRU¶VH[SODQDWLRQRUDSSURYDO
Acceptable secondary publication

6HFRQGDU\SXEOLFDWLRQLQWKHVDPHRUDQRWKHUODQJXDJHHVSHFLDOO\LQRWKHUFRXQWULHV
LVMXVWLILDEOHDQGFDQEHEHQHILFLDOSURYLGHGDOORIWKHIROORZLQJFRQGLWLRQVDUHPHW
7KHDXWKRUVKDYHUHFHLYHGDSSURYDOIURPWKHHGLWRUVRIERWKMRXUQDOVWKHHGLWRU
FRQFHUQHGZLWKVHFRQGDU\SXEOLFDWLRQPXVWKDYHDSKRWRFRS\UHSULQWRUPDQXVFULSW
RIWKHSULPDU\YHUVLRQ
7KHSULRULW\RIWKHSULPDU\SXEOLFDWLRQLVUHVSHFWHGE\DSXEOLFDWLRQLQWHUYDORIDW
OHDVWRQHZHHNXQOHVVVSHFLILFDOO\QHJRWLDWHGRWKHUZLVHE\ERWKHGLWRUV
7KHSDSHUIRUVHFRQGDU\SXEOLFDWLRQLVLQWHQGHGIRUDGLIIHUHQWJURXSRIUHDGHUVDQ
DEEUHYLDWHGYHUVLRQFRXOGEHVXIILFLHQW
7KHVHFRQGDU\YHUVLRQFDUHIXOO\UHIOHFWVWKHGDWDDQGLQWHUSUHWDWLRQVRIWKHSULPDU\
YHUVLRQ
7KHIRRWQRWHRQWKHWLWOHSDJHRIWKHVHFRQGDU\YHUVLRQLQIRUPVUHDGHUVSHHUVDQG
GRFXPHQWLQJDJHQFLHVWKDWWKHSDSHUKDVEHHQSXEOLVKHGLQZKROHRULQSDUWDQG
VWDWHVWKHSULPDU\UHIHUHQFH$VXLWDEOHIRRWQRWHPLJKWUHDG³7KLVDUWLFOHLVEDVHG
RQDVWXG\ILUVWUHSRUWHGLQ>WLWOHRIMRXUQDOZLWKIXOOUHIHUHQFH@´
3HUPLVVLRQIRUVXFKVHFRQGDU\SXEOLFDWLRQVKRXOGEHIUHHRIFKDUJH
12.9.5 Protection of patients’ rights to privacy

3DWLHQWVKDYHDULJKWWRSULYDF\WKDWVKRXOGQRWEHLQIULQJHGZLWKRXWWKHLULQIRUPHG
FRQVHQW,GHQWLI\LQJLQIRUPDWLRQVKRXOGQRWEHSXEOLVKHGLQZULWWHQGHVFULSWLRQV
SKRWRJUDSKVDQGSHGLJUHHVXQOHVVWKHLQIRUPDWLRQLVHVVHQWLDOIRUVFLHQWLILFSXUSRVHV
DQGWKHSDWLHQWRUSDUHQWRUJXDUGLDQJLYHVZULWWHQLQIRUPHGFRQVHQWIRUSXEOLFDWLRQ
,QIRUPHGFRQVHQWIRUWKLVSXUSRVHUHTXLUHVWKDWWKHSDWLHQWKDVWKHULJKWWREHVKRZQWKH
PDQXVFULSWWREHSXEOLVKHG
,GHQWLI\LQJGHWDLOVVKRXOGEHRPLWWHGLIWKH\DUHQRWHVVHQWLDOEXWSDWLHQWGDWDVKRXOG
QHYHUEHDOWHUHGRUIDOVLILHGLQDQDWWHPSWWRDWWDLQDQRQ\PLW\&RPSOHWHDQRQ\PLW\PD\
EHGLIILFXOWWRDFKLHYHDQGLQIRUPHGFRQVHQWVKRXOGEHREWDLQHGLIWKHUHLVDQ\GRXEW
)RUH[DPSOHPDVNLQJWKHH\HUHJLRQVLQSKRWRJUDSKVRISDWLHQWVLVLQDGHTXDWHSURWHFWLRQ
RIDQRQ\PLW\
7KH UHTXLUHPHQW IRU LQIRUPHG FRQVHQW LV QRUPDOO\ LQFOXGHG LQ WKH MRXUQDO¶V
LQVWUXFWLRQIRUDXWKRUV:KHQLQIRUPHGFRQVHQWKDVEHHQREWDLQHGLWVKRXOGEHLQGLFDWHG
LQWKHSXEOLVKHGDUWLFOH
12.9.6 Release of results to public media

5HVHDUFKHUVVKRXOGORRNIRUUHFRJQLWLRQSULPDULO\DPRQJWKHLUSHHUV,WLVQRW
FRQVLGHUHGHWKLFDOO\DFFHSWDEOHIRUUHVHDUFKHUVWREUHDNQHZVRIWKHLUILQGLQJVWRWKH
SXEOLFRUWKHPHGLDEHIRUHWKH\KDYHEHHQFRPPXQLFDWHGWRWKHLUSHHUVLQVFLHQWLILFSUHVV
RUPHHWLQJV3UHOLPLQDU\UHOHDVHRIVFLHQWLILFLQIRUPDWLRQGHVFULEHGLQDSDSHUWKDWKDV
EHHQDFFHSWHGEXWQRW\HWSXEOLVKHGYLRODWHVWKHSROLFLHVRIPDQ\MRXUQDOV,QH[FHSWLRQDO
DQGUDUHFDVHVDQGRQO\E\DUUDQJHPHQWZLWKWKHHGLWRUSUHOLPLQDU\UHOHDVHRIGDWDPD\
EHDFFHSWDEOHIRUH[DPSOHLIWKHUHLVDSXEOLFKHDOWKHPHUJHQF\6RPHMRXUQDOVLVVXH
SUHVVUHOHDVHVDERXWLPSRUWDQWILQGLQJVWRFRLQFLGHZLWKSXEOLFDWLRQ
12.9.7 Scientific fraud

5HVHDUFKPLVFRQGXFWFDQEHUHJDUGHGDVDFRQWLQXXPUDQJLQJIURPHUURUVRI
MXGJHPHQWWKDWLVPLVWDNHVPDGHLQJRRGIDLWKVXFKDVLQDGHTXDWHVWXG\GHVLJQ
ELDVVHOIGHOXVLRQDQGLQDSSURSULDWHVWDWLVWLFDODQDO\VLVWRZKDWPD\EHUHJDUGHGDV
PLVGHPHDQRXUVDOVRFDOOHG³WULPPLQJ´DQG³FRRNLQJ´VXFKDVGDWDPDQLSXODWLRQ
GDWDH[FOXVLRQVXSSUHVVLRQRILQFRQYHQLHQWIDFWVWKURXJKWREODWDQWIUDXGXVXDOO\
FDWHJRUL]HGDVIDEULFDWLRQIDOVLILFDWLRQDQGSODJLDULVP)DUWKLQJ7KHFXOWXUH
RIVFLHQFHLVEDVHGRQWUXVW:KHQDUHVHDUFKHUSUHVHQWVKLVKHUGDWDLQSXEOLFWKHGDWD
DUHWDNHQDWIDFHYDOXH2QHPD\LQWHUSUHWGDWDGLIIHUHQWO\TXHVWLRQWKHVWXG\GHVLJQRU
GLVDJUHHZLWKWKHVWDWLVWLFDODQDO\VLV+RZHYHULIZHFDQQRWWUXVWWKHGDWDWKHZKROH
DWPRVSKHUHRIVFLHQFHLVSRLVRQHG7KHUHLVDOVRWKHLPSDFWRQWKHSXEOLF(YHU\VLQJOH
FDVHRIIUDXGDQGPLVFRQGXFWUHGXFHVSXEOLFFRQILGHQFHLQVFLHQFH,WDOVRLQGLFDWHVWKDW
SXEOLFDQGFKDULWDEOHIXQGVPD\KDYHEHHQDEXVHG&DVHVRIVFLHQWLILFIUDXGDUHFDXVHV
IRUHPEDUUDVVPHQWDQGIUXVWUDWLRQWRWKHYDVWPDMRULW\RIKRQHVWVFLHQWLILFUHVHDUFKHUV
,QWKH8QLWHG.LQJGRPD&RPPLWWHHRQ3XEOLFDWLRQ(WKLFV&23(PDGHXSRI
PHGLFDOMRXUQDOHGLWRUVZDVHVWDEOLVKHGLQ-XO\ VRPHWZR\HDUVDIWHUDVHQLRU
J\QDHFRORJLVWZDVVWUXFNRIIWKHPHGLFDOUHJLVWHUE\WKH*HQHUDO0HGLFDO&RXQFLOIRU
IDEULFDWLQJHYLGHQFHWKDWZDVSXEOLVKHGLQFOXGLQJDFODLPWRKDYHVXFFHVVIXOO\UHORFDWHG
DQHFWRSLFSUHJQDQF\DQGDOVRD WKUHH\HDUWULDORIDKRUPRQHWUHDWPHQWIRUUHFXUUHQW
PLVFDUULDJH1HLWKHUWKHUHORFDWHGHFWRSLFSUHJQDQF\QRUWKHWULDOKDGHYHUWDNHQSODFH
,QIRUPDWLRQDERXWWKHZRUNRI&23(DQGLWVSHULRGLFUHSRUWVLVDYDLODEOHRQWKHLQWHUQHW
KWWSZZZSXEOLFDWLRQHWKLFVRUJXN
12.9.8 Ethical responsibility of journal editors

(GLWRUVVKRXOGWDNHDOOUHDVRQDEOHVWHSVWRHQVXUHWKHDFFXUDF\RIWKHPDWHULDOWKH\
SXEOLVK:KHQHYHULWLVUHFRJQL]HGWKDWDVLJQLILFDQWLQDFFXUDF\PLVOHDGLQJVWDWHPHQW
RUGLVWRUWHGUHSRUWKDVEHHQSXEOLVKHGLWPXVWEHFRUUHFWHGSURPSWO\DQGZLWKGXH
SURPLQHQFH,IDUWLFOHVSURYHWREHIUDXGXOHQWRUFRQWDLQPDMRUHUURUVWKDWDUHQRW
DSSDUHQWIURPWKHWH[WWKHQWKH\VKRXOGEHUHWUDFWHG²DQGWKHZRUGUHWUDFWLRQVKRXOG
EHXVHGLQWKHWLWOHRIWKHUHWUDFWLRQWRHQVXUHWKDWLWLVSLFNHGXSE\LQGH[LQJV\VWHPV
&RJHQWFULWLFDOUHVSRQVHVWRSXEOLVKHGPDWHULDOVKRXOGEHSXEOLVKHGXQOHVVHGLWRUVKDYH
FRQYLQFLQJUHDVRQVZK\WKH\FDQQRWEH6RPHMRXUQDOVKDYHFUHDWHGHOHFWURQLFPHDQV
RIUHVSRQGLQJVRWKDW³ODFNRIVSDFH´ZLOOQRWEHDUHDVRQIRUQRWSXEOLVKLQJDUHVSRQVH
(GLWRUVVKRXOGHQVXUHWKDWUHVHDUFKPDWHULDOWKH\SXEOLVKKDVEHHQDSSURYHGE\DQHWKLFV
FRPPLWWHH,QDGGLWLRQWKH\VKRXOGVDWLVI\WKHPVHOYHVWKDWWKHUHVHDUFKLVHWKLFDODVWKH\
FDQEHKHOGUHVSRQVLEOHIRUSXEOLVKLQJ³XQHWKLFDOÚHVHDUFKHYHQLILWKDVEHHQDSSURYHG
E\DQHWKLFVFRPPLWWHH
(GLWRUVPXVWSURWHFWWKHFRQILGHQWLDOLW\RILQIRUPDWLRQRQSDWLHQWVREWDLQHGWKURXJK
WKHGRFWRU±SDWLHQWUHODWLRQVKLS,IHQVXULQJDQRQ\PLW\LVQRWFRPSOHWHO\SRVVLEOHZULWWHQ
FRQVHQWIRUSXEOLFDWLRQIURPSDWLHQWVVKRXOGEHREWDLQHG

Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions
in randomized drug trials. Journal of the American Medical Association, 2003, 290:
921–928.
Byrne DW. Publishing Your Medical Research Paper. What they don’t teach in medical
school. New York, London, Lippincott Williams & Wilkins, 1998.
Delamothe T. Is that it? How online articles have changed over the past five years. British
Medical Journal, 2002, 325: 1475–1478.
Farthing MJG. Ethics of publication. In: Hall GM, ed. How to write a paper. 2nd edition.
London, BMJ Books,1998: 122–131.
Grant JM and Laird A. How a paper is reviewed and why it might be turned down. In: O’Brien
PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees.
London, Royal College of Obstetricians and Gynaecologists Press, 1999: 231–240.
Huth EJ. How to write and publish papers in the medical sciences, 2nd edition. Baltimore,
Williams & Wilkins, 1990.
November 2003. (http://www.icmje.org accessed 24/2/2004)
Jones J. UK watchdog issues guidelines to combat medical research fraud. British Medical
Journal, 1999, 319:660.
Weeks WB, Wallace AE. Readability of British and American medical prose at the start
of the 21st century. British Medical Journal, 2002, 325: 1451–1452.
Chapter 13
Making a scientific presentation
13.1 Introduction
7KHTXDOLW\RISUHVHQWDWLRQVLQVFLHQWLILFPHHWLQJVRIWHQOHDYHVPXFKWREHGHVLUHG
$QXPEHURIVRXUFHVDUHQRZDYDLODEOHWRKHOSUHVHDUFKHUVLPSURYHWKHLUSUHVHQWDWLRQV
6RPHDUHOLVWHGXQGHUWKHUHIHUHQFHVDQGDGGLWLRQDOVRXUFHVIRUWKLVFKDSWHU$JRRG
VFLHQWLILFSUHVHQWDWLRQPXVWIROORZWKHIROORZLQJWKUHH³3V´,WVKRXOGEH3ODQQHGZLWK
FDUH3UHSDUHGZLWKFDUHDQG3UHVHQWHGZLWKFDUH7KHIROORZLQJVHFWLRQVSURYLGHVRPH
XVHIXOJXLGHOLQHVSDUWLFXODUO\IRUEHJLQQHUV
13.2 Planning of the presentation

,QSODQQLQJDVFLHQWLILFSUHVHQWDWLRQSUHVHQWHUVQHHGWRDVNWKHRUJDQL]HUVRIWKH
VFLHQWLILFPHHWLQJDERXWWKHDXGLHQFHDQGWKHLUOHYHORINQRZOHGJHDQGLQWHUHVWLQWKH
VXEMHFWVLQFHWKHSODQQLQJRIWKHSUHVHQWDWLRQZLOOEHGLIIHUHQWIRUDVSHFLDOLVWDXGLHQFHD
JHQHUDOLVWDXGLHQFHRUDPL[HGDXGLHQFHWKHWLPHDYDLODEOHIRUWKHSUHVHQWDWLRQDQGWKH
W\SHRIYLVXDODLGVDYDLODEOH3UHVHQWHUVVKRXOGDVNWKHPVHOYHVZKDWWKHPDLQPHVVDJH
RUPHVVDJHVLVWKDWWKH\ZRXOGOLNHWRFRQYH\DQGKRZLWFDQEHFRQYH\HGWRWKHW\SH
RIDXGLHQFHFRQFHUQHGLQWKHWLPHDOORWWHG
7KHPDQXVFULSWRIDQDUWLFOHDVVXEPLWWHGIRUSXEOLFDWLRQVKRXOGQRWEHXVHGDV
VXFKIRUDVFLHQWLILFSUHVHQWDWLRQ7KHGLIIHUHQFHEHWZHHQVSHDNLQJDQGZULWLQJLVWKH
VDPHDVWKHGLIIHUHQFHEHWZHHQKHDULQJDQGUHDGLQJ$UHDGHUFKRRVHVKLVRZQSDFHWKH
OLVWHQHUPXVWDFFHSWWKHSDFHFKRVHQE\WKHVSHDNHU/LVWHQLQJWRWKHQHZVRQWHOHYLVLRQ
LVGLIIHUHQWIURPUHDGLQJWKHQHZVLQDQHZVSDSHU
7RFKDQJHDZULWWHQVFLHQWLILFSDSHULQWRDQRUDOSUHVHQWDWLRQWKHSUHVHQWHUPXVW
IROORZWKUHH³VZRUGV´6HOHFW6\QWKHVL]HDQG6LPSOLI\6HOHFWIURPWKHZULWWHQDUWLFOH
WKHSRLQWVWRSUHVHQW6\QWKHVL]HWKHLQIRUPDWLRQLQWKHDUWLFOHWRSDFNDJHLWLQWKHOLPLWHG
WLPHDYDLODEOH6LPSOLI\WKHSUHVHQWDWLRQRIWKHGDWDVRWKDWLWFDQEHHDVLO\IROORZHGDQG
XQGHUVWRRGE\WKHDXGLHQFH
,QWKHSODQQLQJVWDJHWKHWLWOHRIWKHSUHVHQWDWLRQKDVWREHGHFLGHGDQGDQDEVWUDFW
KDVWREHVXEPLWWHGWRWKHRUJDQL]HUVRIWKHVFLHQWLILFPHHWLQJ$JRRGWLWOHFDQEHGHILQHG
DVWKHIHZHVWSRVVLEOHZRUGVWKDWDGHTXDWHO\GHVFULEHWKHFRQWHQWVRIWKHSUHVHQWDWLRQ7KH
Making a scientific presentation 163
DEVWUDFWFDQDWWUDFWRUSXWRIIWKHDXGLHQFH7KHDEVWUDFWLVWKHSDUWRIWKHSUHVHQWDWLRQWKDW
ZLOOEHSXEOLVKHGLQWKHFRQIHUHQFHSURJUDPPH$JRRGDEVWUDFWVKRXOGEHDPLQLDWXUH
YHUVLRQRIWKHSUHVHQWDWLRQ7KHDEVWUDFWVKRXOGEHVHQWWRRUJDQL]HUVEHIRUHWKHGHDGOLQH
DQGLQWKHIRUPDWDQGOHQJWKUHTXHVWHG
13.3 Preparation
13.3.1 Preparation of text
,QSUHSDULQJWKHWH[WRIDVFLHQWLILFSUHVHQWDWLRQ
$YRLGWRRPXFKGHWDLODQGUHVLVWWKHWHPSWDWLRQWRRYHUORDGWKHSUHVHQWDWLRQZLWK
LQIRUPDWLRQ
$YRLGMDUJRQDQGDEEUHYLDWLRQVXQOHVVWKH\DUHFOHDUWRDOOWKHDXGLHQFH
$LPDWWKHDYHUDJHSHUVRQLQWKHDXGLHQFH
8VHSODLQ(QJOLVK
7KHVWUXFWXUHRIDSUHVHQWDWLRQLVGLIIHUHQWIURPWKHVWUXFWXUHRIDZULWWHQSDSHU
1RUPDOO\LWVKRXOGFRQVLVWRIWKUHHSDUWVLQWURGXFWLRQPDLQPHVVDJHDQGFRQFOXVLRQV
7KHLQWURGXFWLRQVKRXOGWHOOWKHDXGLHQFHZKDWWKHSUHVHQWDWLRQZLOOEHDERXW:KHUH
SRVVLEOHWKHRSHQLQJVHQWHQFHVVKRXOGFDSWXUHWKHDWWHQWLRQRIWKHDXGLHQFH,WKHOSVWR
KDYHVRPHWKLQJOLNHD³SXQFKOLQH´ZKLFKZLOODOHUWWKHDXGLHQFHWRWKHLPSRUWDQFHRI
WKHVXEMHFW
7KHPDLQPHVVDJHVKRXOGEHFOHDUDQGFRQFLVH7KHXVXDOGHWDLORIDZULWWHQSDSHU
LVXQVXLWDEOHIRUDSUHVHQWDWLRQ,WLVJHQHUDOO\XQZLVHWRLQWURGXFHPRUHWKDQRQHQHZ
LGHDHYHU\WRPLQXWHV
7KHFRQFOXVLRQVKRXOGVXPPDUL]HWKHPDLQSRLQWV7U\IRUDVWURQJILQLVK6WRSSLQJ
VSHDNLQJLVQRWILQLVKLQJ/HDYHWKHDXGLHQFHZLWKD³WDNHKRPHPHVVDJH´
13.3.2 Preparation of visual aids: speaking visually
Objectives for using visual aids

,WKDVEHHQVDLGWKDWZHUHPHPEHURIZKDWZHKHDURIZKDWZHVHHEXW
EHWZHHQDQGRIZKDWZHVHHDQGKHDU6RUJLDQG+DZNLQV$&KLQHVH
SURYHUEVD\V³$SLFWXUHLVZRUWKDWKRXVDQGZRUGV´9LVXDODLGVDUHQRWDQREMHFWLYHLQ
WKHPVHOYHV7KH\DUHXVHGWRVHUYHRQHRUPRUHRIWKHIROORZLQJREMHFWLYHV
KROGLQJWKHDWWHQWLRQRIWKHDXGLHQFH
SUHVHQWLQJWKHGDWDLQDFOHDUZD\
GHOLYHULQJWKHSUHVHQWDWLRQZLWKRXWKDYLQJWRUHDGIURPQRWHV
&RPPRQO\XVHGYLVXDODLGVLQFOXGHVOLGHVRYHUKHDGWUDQVSDUHQFLHVDQGFRPSXWHU
DVVLVWHGSUHVHQWDWLRQV
Slides
6OLGHVDUHWKHFRPPRQHVWYLVXDODLGXVHGLQVFLHQWLILFSUHVHQWDWLRQV7KH\FDQPDNH
RUEUHDNWKHSUHVHQWDWLRQ8QWLOUHFHQWO\SKRWRJUDSKLFILOPVOLGHVZHUHYHU\FRPPRQO\
XVHGQRZHOHFWURQLFVOLGHVSUHVHQWHGDVDGDWDVKRZKDYHODUJHO\WDNHQRYHU7KHEDVLF
UXOHVIRUDJRRGSUHVHQWDWLRQDUHWKHVDPHIRUILOPVOLGHVDQGHOHFWURQLFVOLGHV7KHUH
DUHWKUHHPDLQW\SHVRIVOLGHWH[WVOLGHVGDWDVOLGHVWDEOHVJUDSKVIORZFKDUWVDQG
ILJXUHVOLGHV$PL[RIWH[WGDWDDQGILJXUHVOLGHVKHOSVWRPDLQWDLQWKHLQWHUHVWRIWKH
DXGLHQFH
7H[WVOLGHVDUHQRWPHDQWWREHUHDGE\WKHVSHDNHUEXWE\WKHDXGLHQFH/HWWHULQJ
VKRXOGJHQHUDOO\EHOLPLWHGWROLQHVDQGVKRXOGQHYHUEHPRUHWKDQLQFOXGLQJWKH
WLWOH,WLVDGYLVDEOHQRWWRXVHPRUHWKDQZRUGVSHUOLQH
&RPSOLFDWHGWDEOHVDUHQRWYLVXDODLGV7KH\KDYHEHHQGHVFULEHGDVLQVWUXPHQWV
RIWRUWXUHIRUWKHDXGLHQFH7DEOHVRIGDWDVXLWDEOHIRUZULWWHQSXEOLFDWLRQDUHKLJKO\
XQVXLWDEOHIRUDVFLHQWLILFSUHVHQWDWLRQ7KHWHUP³5DLOZD\7LPHWDEOHVOLGHV´LVVRPHWLPHV
XVHGWRGHVFULEHWKHGLIILFXOW\ZLWKVOLGHVVKRZLQJFRPSOLFDWHGWDEOHV'RQRWXVHPRUH
WKDQVHYHQOLQHVLQFOXGLQJWLWOHDQGIRXUFROXPQVLQDQ\WDEOH7KHZULWLQJRQDILOP
VOLGHVKRXOGEHHDVLO\OHJLEOHE\WKHQDNHGH\H8VHWKHZKROHDUHDRIWKHVOLGH7KHUHLV
QRQHHGWRSXWWKHGDWDLQDQRXWHUER[1RWHLQWKHGHVLJQRIWKHWDEOHWKDWWKHWUDQVSDUHQW
DUHDLQDILOPVOLGHLVQRWVTXDUHEXWREORQJ&ROXPQVDUHSUHIHUDEO\VHSDUDWHGE\DVSDFH
ODUJHUWKDQWKHZLGWKRIWKHFROXPQ
*UDSKVVKRXOGUHSODFHWDEOHVZKHUHSRVVLEOHLQDYLVXDOSUHVHQWDWLRQ7KH\DUHEHWWHU
LQVKRZLQJUHODWLRQVKLSV3UHSDUDWLRQRIJUDSKVKDVQRZEHHQPDGHHDV\E\FRPSXWHU
SURJUDPV)RXUW\SHVRIJUDSKVDUHRIWHQXVHGEDURUFROXPQFKDUWVFXUYHVSLHFKDUWV
DQGVFDWWHUJUDSKV
%DUFKDUWVDUHEHWWHUIRUOHWWHULQJWKDQFROXPQFKDUWV$YRLGRYHUFURZGLQJWKHVOLGH
7KHQXPEHURIEDUVVKRXOGEHOLPLWHGWRILYHWRVHYHQ$QRYHUFURZGHGFROXPQFKDUW
LVVRPHWLPHVFDOOHGD³1HZ<RUN6N\OLQH´VOLGHWRHPSKDVL]HWKDWLWLVQRWVXLWDEOH
IRUSUHVHQWDWLRQ
1RPRUHWKDQWZRRUWKUHHFXUYHVFDQEHVKRZQRQDVOLGH6SDFHRQWKHVOLGHVKRXOG
QRWEHZDVWHG
7KH VOLFHV RI D SLHFKDUW PXVW QRW EH WRR QXPHURXV QRU WRR VPDOO7KUHH WR ILYH
GLYLVLRQVDUHLGHDO
6FDWWHUJUDSKVDUHJRRGIRUVOLGHSUHVHQWDWLRQ7KH\JLYHDFOHDUDQGVLPSOHRYHUYLHZ
RIWKHVFDWWHURIWKHGDWDWRVKRZUHODWLRQVKLS
)ORZ FKDUWV VKRXOG QRW EH FRPSOLFDWHG $ FRPSOLFDWHG IORZ FKDUW ORRNLQJ OLNH
D³VXEZD\´PDSLVQRWXVHIXOIRUDSUHVHQWDWLRQ$FRPSOLFDWHGIORZFKDUWFDQEH
EXLOWXSLQDQXPEHURIVXFFHVVLYHVOLGHV
)LJXUHVOLGHVRIGUDZLQJVDQGSLFWXUHVLIPHDQWIRUKXPRXUVKRXOGEHVHOHFWHG
ZLWKFDUHDQGVHQVLWLYLW\WRWKHW\SHRIDXGLHQFH7KH\VKRXOGQRWRIIHQGWKHIHHOLQJVRI
DQ\RQHLQWKHDXGLHQFH
Tips in slide preparation

$FRPPRQPLVWDNHLVWRWU\WRSXWWRRPXFKRQRQHVOLGH$VDJHQHUDOUXOHQRVOLGH
VKRXOGEHVKRZQXQOHVVLWFDQEHUHDGE\WKHEDFNURZRIWKHDXGLHQFH$VDJHQHUDO
UXOHOHWWHULQJRQDILOPVOLGHVKRXOGEHODUJHHQRXJKWREHUHDGE\WKHQDNHGH\H
ZLWKRXWSURMHFWLRQ
7KHVKDSHRIDILOPVOLGHLVUHFWDQJXODUîPP7KHGLPHQVLRQVRIWKHPDWHULDO
RQWKHVOLGHVKRXOGEHSUHSDUHGZLWKWKLVLQPLQG
8SSHUFDVHOHWWHUVDUHOHVVOHJLEOHWKDQORZHUFDVHOHWWHUV7KLVLVZK\ORZHUFDVHLV
FRPPRQO\XVHGLQGLUHFWLRQVLJQVRQPRWRUZD\VDQGRQWKHXQGHUJURXQG2XUH\HV
DUHPRUHDFFXVWRPHGWRVPDOOOHWWHUVLQERRNVDQGQHZVSDSHUV
:KLOHFKRLFHRIFRORXULVDPDWWHURIWDVWHDQGMXGJHPHQWWRDFHUWDLQH[WHQWFRORXU
VKRXOGQRWEHXVHGIRUGHFRUDWLRQEXWWRLPSURYHXQGHUVWDQGLQJ6HOHFWFRORXUVWKDW
SURMHFWZHOO3RSXODUFRPELQDWLRQVDUHEOXHDQGZKLWHDQGJUHHQDQG\HOORZ5HG
WH[WPD\EHPRUHGLIILFXOWWRUHDG7KHQXPEHURIFRORXUVVKRXOGEHOLPLWHGWRZKDW
LVUHDOO\QHFHVVDU\IRUSUHVHQWLQJWKHGDWDLQDFOHDUZD\
Computer software
&RPSXWHUVRIWZDUHLVXVHGIRUSUHSDUDWLRQRIHOHFWURQLFVOLGHVIRUDGDWDVKRZ
$ZLGHO\XVHGSURJUDPLV0LFURVRIW3RZHUSRLQW7KHVDPHSURJUDPFDQPDNHWKH
SUHSDUDWLRQRIPPILOPVOLGHVHDVLHUDQGEHWWHU7KHILOHRIVOLGHVFUHDWHGRQWKH
FRPSXWHUFDQEHVHQWDVDIORSS\GLVNRUYLDDPRGHPWRDEXUHDXIRUFUHDWLQJILOPVOLGHV
&RPSXWHUJHQHUDWLRQRIHOHFWURQLFRUILHOGVOLGHVRIIHUVDQXPEHURIDGGLWLRQDODGYDQWDJHV
7KHVRIWZDUHJXLGHV\RXWKURXJKWKHSUHSDUDWLRQSURYLGHVWHPSODWHVDQGUHFRPPHQGV
FRQVLVWHQWFRORXUVFKHPHV3UHSDUDWLRQRIJUDSKVLVHDV\3KRWRJUDSKVDQGGUDZLQJVFDQ
EHLPSRUWHGIURPRWKHUVRIWZDUHSURJUDPV7KHSURJUDPDOORZVHDFKVOLGHWRKDYHDWH[W
QRWHDWWDFKHGDQGWKHVOLGHDQGQRWHFDQEHSULQWHGRXWRQWKHVDPHSDSHUSDJHWRVHUYH
DVVSHDNHU¶VQRWHV$QXPEHURIVOLGHVFDQEHSULQWHGRXWRQRQHSDJHRISDSHUWREHXVHG
DVDXGLHQFHKDQGRXWV7KHVOLGHVFUHDWHGIRUDSUHVHQWDWLRQFDQEHYLHZHGDQGHGLWHGRQ
WKHFRPSXWHUVFUHHQ6OLGHVDUHVDYHGDQGFDQEHLQFOXGHGLQDQRWKHUSUHVHQWDWLRQ7KH
VOLGHVFUHDWHGIRUDSUHVHQWDWLRQFDQEHYLHZHGLQDWLPHGIDVKLRQRQWKHVFUHHQDQGWKH
WLPLQJRIWKHDFFRPSDQ\LQJWDONFDQEHFKHFNHGDQGDGMXVWHG
Overhead transparencies
7KHRYHUKHDGSURMHFWRULVDQDWXUDOVXFFHVVRUWRWKHFKDONERDUG,WLVSDUWLFXODUO\
XVHIXOLQSUHVHQWDWLRQVWRVPDOOJURXSV2YHUKHDGWUDQVSDUHQFLHVDVYLVXDODLGVKDYH
DGYDQWDJHVDQGGLVDGYDQWDJHV
7KHDGYDQWDJHVRIRYHUKHDGWUDQVSDUHQFLHVDUHWKDW
WKH\PD\QRWQHHGWRKDYHWKHURRPGDUNHQHG
WKHVSHDNHUIDFHVWKHDXGLHQFHDOORZLQJEHWWHUH\HFRQWDFW
WKH\DUHLQH[SHQVLYHWRPDNH
WKH\ FDQ EH PDGH TXLFNO\ XVLQJ WKH FRS\ PDFKLQH RU D FRPSXWHU SULQWHU ZLWK
FRPSDWLEOHWUDQVSDUHQWSODVWLFVKHHWV
RYHUKHDGSURMHFWRUVDUHXVXDOO\UHDGLO\DYDLODEOHDUHHDV\WRVHWXSDQGDUHOHVVOLNHO\
WREUHDNGRZQDSURMHFWLRQLVWLVQRWUHTXLUHG
WKHVSHDNHUFDQZULWHGLUHFWO\RQWKHILOPE\DPDUNLQJSHQ
LQIRUPDWLRQ FDQ EH EXLOW XS LQ D G\QDPLF ZD\ E\ HLWKHU GUDZLQJ GLUHFWO\ RQ WKH
WUDQVSDUHQF\RUE\DGGLQJWUDQVSDUHQWRYHUOD\V
FRORXUFDQEHHDVLO\XVHG
7KHGLVDGYDQWDJHVRIRYHUKHDGWUDQVSDUHQFLHVDUHWKDW
WKH\DUHQRWVXLWDEOHIRUODUJHDXGLHQFHV
WKHSURMHFWHGLPDJHLVQRWDVVKDUSDVWKHVOLGH
WKHSURMHFWRUFDQQRWEHSXWLQDSURMHFWLRQERRWK
WKH\FDQJLYHWKHLPSUHVVLRQRIEHLQJSUHSDUHGLQKDVWHLIQRWFDUHIXOO\UHYLVHGDQG
ZHOOSUHVHQWHG
2YHUKHDGWUDQVSDUHQFLHVDUHHDVLO\SUHSDUHG+DQGZULWLQJGRHVQRWSURGXFHDQ
HOHJDQWWUDQVSDUHQF\,WJLYHVWKHLPSUHVVLRQRIODVWPLQXWHSUHSDUDWLRQ,WPD\EH
PRUHDFFHSWDEOHLIWKHZULWLQJRUGUDZLQJLVGRQHGXULQJWKHSUHVHQWDWLRQ$SKRWRFRS\
PDFKLQHFDQSURGXFHDQLFHWUDQVSDUHQF\IURPWKHSULQWHGRXWSXWRIDZRUGSURFHVVRU
2QO\VSHFLDOWUDQVSDUHQF\VKHHWVVXLWDEOHIRUDSKRWRFRS\PDFKLQHVKRXOGEHXVHG
$FRPSXWHUSULQWHUFDQSULQWGLUHFWO\RQVSHFLDOWUDQVSDUHQF\VKHHWVVXLWDEOHIRUHLWKHU
ODVHUMHWRUFRORXULQNMHWSULQWHUV1RWHWKDWWUDQVSDUHQFLHVQHHGORQJHUGU\LQJWLPHV
WKDQUHJXODUSDSHU7KHFRPSXWHUVRIWZDUHPD\DOORZSULQWLQJWKHWUDQVSDUHQF\DVD
IOLSSHGGRFXPHQWLQZKLFKWKHWH[WDQGSLFWXUHVDUHUHYHUVHG7KHWUDQVSDUHQF\SULQWHG
LQWKLVZD\LVSURMHFWHGIDFHGRZQ7KLVDOORZVWKHVSHDNHUWRZULWHRQWKHEDFNRIWKH
WUDQVSDUHQF\GXULQJWKHSUHVHQWDWLRQ,WLVHDV\WKHQWRZLSHWKHZULWLQJRIIODWHUZLWKRXW
VFUDWFKLQJWKHRULJLQDO
Computer-assisted presentation
7KHVDPHFRPSXWHUVRIWZDUHWKDWLVXVHGWRSURGXFHPPVOLGHVFDQSURGXFHD
VFUHHQVKRZRIVOLGHVZLWKPDQXDORUDXWRPDWLFFRQWURORYHUWLPLQJEHWZHHQLQGLYLGXDO
VOLGHV7KHVOLGHVKRZFDQEHSURMHFWHGGLUHFWO\WRWKHDXGLHQFH1RWHERRNFRPSXWHUV
KDYHDSRUWWRDOORZFRQQHFWLRQWRDQH[WHUQDOPRQLWRURUWRDVSHFLDOSURMHFWRU7KH
HTXLSPHQWLVUDWKHUH[SHQVLYHEXWLWSURGXFHVDYHU\HOHJDQWSUHVHQWDWLRQLQFOXGLQJWKH
XVHRIPRYLQJWH[WDQGLPDJHV+RZHYHUGRQRWRYHUXVHWKHDQLPDWLRQIHDWXUHVDVWKH\
FDQGLVWUDFWWKHDXGLHQFHDQGEHFRPHDQQR\LQJ$JRRGSUHVHQWDWLRQLVDOVRDVLPSOH
SUHVHQWDWLRQ6OLGHVFDQEHHDVLO\VRUWHGDQGWKHLURUGHUUHDUUDQJHG7KHWHFKQRORJ\LV
UDSLGO\EHFRPLQJWKHVWDQGDUGIRUWKHXVHRIYLVXDODLGV
%HIRUHSUHSDULQJDFRPSXWHUDVVLVWHGSUHVHQWDWLRQFKHFNDERXWWKHDYDLODELOLW\RI
WKHHTXLSPHQW6LQFHWKHQHZWHFKQRORJ\LVSURQHWRHTXLSPHQWIDLOXUHLWLVDGYLVDEOHWR
KDYHDEDFNXSRIVOLGHVRURYHUKHDGWUDQVSDUHQFLHV,WLVEHWWHUQRWWRWU\XVLQJWKLVQHZ
WHFKQRORJ\IRUWKHILUVWWLPHLQDQLPSRUWDQWPHHWLQJSDUWLFXODUO\LQVHWWLQJVZKLFKPD\
QRWKDYHH[SHULHQFHZLWKLW
13.3.3 Rehearsal
7KHSUHSDUDWLRQRIWKHWH[WDQGRIWKHVOLGHVKDVWRWDNHWKHDOORWWHGWLPHLQWR
FRQVLGHUDWLRQ5HKHDUVDOLVWKHNH\WRPDNLQJVXUHWKDW\RXZLOOGHOLYHUWKHSUHVHQWDWLRQ
ZLWKRXWH[FHHGLQJWKHWLPH(YHQYHU\H[SHULHQFHGVSHDNHUVUHKHDUVHWKHLUSUHVHQWDWLRQV
<RXFDQUHKHDUVHRQ\RXURZQRUZLWKWKHKHOSRIFROOHDJXHV
$SOHDVDQWDYHUDJHUDWHRIGHOLYHU\LVQRWPRUHWKDQZRUGVDPLQXWH$ZRUG
SURFHVVRUFDQJLYHWKHH[DFWZRUGFRXQWRIDZULWWHQSUHVHQWDWLRQ$GRXEOHVSDFHG
W\SHZULWWHQSDJHLVDERXWZRUGV)RUDWHQPLQXWHSUHVHQWDWLRQSODQRQQRPRUH
WKDQILYHSDJHVRIGRXEOHVSDFHGWH[W
$JHQHUDOUXOHLVRQHVOLGHSHUPLQXWHLIWKHVOLGHFRQWDLQVLQIRUPDWLRQDQGRQH
VOLGHHYHU\VHFRQGVLIWKHVOLGHFRQWDLQVRQO\WLWOHVNH\ZRUGVRULVGHVLJQHGMXVWWR
UHPRYHDQRWKHUYLVXDOIURPWKHVFUHHQ7KHH[DFWWLPHIRUWKHQRQLQIRUPDWLRQVOLGHZLOO
DOVRGHSHQGRQWKHDPRXQWRIVFULSWWREHFRYHUHGZKLOHLWLVGLVSOD\HG+DYLQJWRVNLS
VOLGHVGXULQJWKHSUHVHQWDWLRQEHFDXVHWKHVOLGHVDUHWRRPDQ\PHDQVWKDWSUHSDUDWLRQ
RIWKHSUHVHQWDWLRQZDVSRRU
13.4 Presentation
7KHFKDOOHQJHWRWKHVSHDNHULVWRKROGWKHDWWHQWLRQRIWKHDXGLHQFH3DUWLFXODUO\
ZKHQWKHOLJKWVDUHGLPWKHDXGLHQFHFDQKDYHVZHHWGUHDPVGXULQJDERULQJSUHVHQWDWLRQ
+DUYH\HWDO
*HWUHDG\
6SHDNZHOO
0DQDJH\RXUVOLGHV
.HHSWRWKHWLPH
%HSUHSDUHGWRDQVZHUTXHVWLRQV
Getting ready
,WLVDOZD\VDGYLVDEOHWRFKHFNWKHURRPZKHUHWKHSUHVHQWDWLRQZLOOEHJLYHQ
LQDGYDQFH&KHFNWKHSRGLXPIRUWKHPLFURSKRQHWKHUHPRWHFRQWUROIRUWKHVOLGH
SURMHFWLRQWKHVOLGHSRLQWHUDQGWKHOLJKWV3URYLGH\RXUVOLGHVSURSHUO\DUUDQJHGRU
GLVNHWWHWRWKHWHFKQLFLDQIRUSURMHFWLRQ
Speaking well
3HUIHFWLRQLQVSHDNLQJLVDFTXLUHG,WLVDFTXLUHGE\SUDFWLFHE\REVHUYLQJJRRG
VSHDNHUVDQGE\OHDUQLQJIURP\RXURZQPLVWDNHVDVZHOODVWKHPLVWDNHVRIRWKHU
VSHDNHUV,I\RXDUHH[FLWHGDQGHDJHUWRVKDUHRWKHUVZLOOZDUPWR\RX,IWKHPLFURSKRQH
LVWREHDWWDFKHGDWWDFKLWWRWKHODSHORIWKHMDFNHWRUGUHVVDQGQRWWRDPRYDEOHSDUW
VXFKDVWKHQHFNWLH,WFDQSURGXFHDGLVWUDFWLQJEDFNJURXQGQRLVHZKHQ\RXPRYH/RRN
WKHDXGLHQFHLQWKHH\H
,WLVPRUHHIIHFWLYHQRWWRUHDG\RXUSUHVHQWDWLRQ,IKRZHYHU\RXUHDGIURPDVFULSW
WKHVFULSWVKRXOGEHZULWWHQIRUKHDULQJQRWUHDGLQJ3URPSWHUFDUGVRUSURPSWHUVOLGHV
FDQKHOSWKHVSHDNHUWRGHOLYHUWKHSUHVHQWDWLRQZLWKRXWKDYLQJWRUHDG7KHJHQHUDOO\
DFFHSWHGUDWHIRUHDV\KHDULQJDQGXQGHUVWDQGLQJLVQRWPRUHWKDQZRUGVDPLQXWH
DVLQGLFDWHGDERYH3DXVHVLQVSHDNLQJUHSODFHSXQFWXDWLRQLQZULWLQJFRPPDEUHDNRI
RQHVHFRQGVHPLFRORQEUHDNRIWZRVHFRQGVSHULRGIXOOVWRSEUHDNRIWKUHHVHFRQGV
SDUDJUDSKEUHDNRIIRXUVHFRQGV9DU\LQJWKHWRQHSLWFKDQGYROXPHKHOSVWRPDLQWDLQ
WKHDWWHQWLRQRIWKHDXGLHQFH
Managing slides
0DUNDQGQXPEHUILOPVOLGHV,IDVOLGHLVSURMHFWHGXSVLGHGRZQWKHUHDUHVHYHQ
SRVVLEOHZD\VRIVKRZLQJLWDJDLQZURQJO\EHIRUHWKHFRUUHFWRULHQWDWLRQLVGLVFRYHUHG
7KHLQWHUQDWLRQDOFRQYHQWLRQFDOOVIRUDVSRWWREHSODFHGLQWKHORZHUOHIWKDQGFRUQHU
DVWKHVOLGHLVYLHZHGE\WKHQDNHGH\H7KLVVKRXOGEHYLVLEOHDWWKHXSSHUULJKWFRUQHU
ZKHQWKHVOLGHLVLQVHUWHG&KHFN\RXUVOLGHVEHIRUHWKHSUHVHQWDWLRQ:HOORUJDQL]HG
FRQIHUHQFHVXVXDOO\KDYHDSUHYLHZURRPZKHUHWKLVFDQEHGRQH
5HPHPEHUWKHVD\LQJWKDWLIDQ\WKLQJFDQJRZURQJLWZLOO%HSUHSDUHGIRUWKH
SRVVLELOLW\RIEUHDNGRZQRIYLVXDOHTXLSPHQW,WLVJHQHUDOO\DGYLVDEOHWRVWDUWWKH
SUHVHQWDWLRQZLWKWKHOLJKWVRQ.HHSWKHOLJKWVRIIWLOO\RXFRPSOHWHVKRZLQJWKHVOLGHV
8VH³ILOOHU´VOLGHVLIQHHGHGWRDYRLGKDYLQJOLJKWVRQDQGRIIGXULQJWKHSUHVHQWDWLRQ
%XWLWPD\EHJRRGWRFRQFOXGHZKLOHWKHOLJKWVDUHRQWRPDNHDVWURQJILQLVK
'RQRWUHDGWKHVOLGHV<RXFDQVDIHO\DVVXPHWKDWWKHDXGLHQFHLVOLWHUDWHDQGLV
QRWEOLQG$QH[FHSWLRQFDQEHPDGHLQFDVHRIVLPXOWDQHRXVWUDQVODWLRQVRWKDWWKH
WUDQVODWRUVFDQWUDQVODWHWKHVOLGHZKLFKLVUHDG%HWWHUVWLOOSURYLGHWUDQVODWRUVZLWKD
FRS\RI\RXUWH[WQRWHV'RQRWJREDFNWRDSUHYLRXVVOLGH,QVHUWDFRS\
7KHXVHRIWZRSURMHFWRUVLQSDUDOOHOZLWKWZRVFUHHQVGXDOSURMHFWLRQDQGWZR
VHWVRIVOLGHVLVUHDOO\RQO\XVHIXOZKHQ\RXZDQWWRVKRZFKDQJHVWKDWDUHGLIILFXOWWR
GHPRQVWUDWHXQOHVVWZRVOLGHVDUHFRPSDUHGVLGHE\VLGH7KHDXGLHQFHPXVWEHJLYHQ
WLPHWRORRNDWERWKVOLGHV$JRRGUXOHLVQHYHUWRVKRZWZRWH[WVOLGHVDWWKHVDPH
WLPH
Keeping to time
7KHVSHDNHUZKRH[FHHGVKLVDOORWWHGWLPHLVJXLOW\RIJURVVEDGPDQQHUV+H
LPSRVHVQRWRQO\RQKLVDXGLHQFHEXWDOVRRQDOOWKHVSHDNHUVZKRFRPHDIWHUKLP,WLV
DVLJQRISRRUSUHSDUDWLRQ
Answering questions
$QVZHUSROLWHO\'RQRWDQVZHUTXHVWLRQVLQDGLVPLVVLYHRUFRQIURQWDWLRQDOPDQQHU
$QVZHUNQRZOHGJHDEO\5HPHPEHUWKDW³,GRQRWNQRZ´LVDJRRGDQVZHU
13.5 Guide to how to give a “bad” presentation

%DVHGRQDKXPRURXVSLHFHE\5LFKDUG6PLWKHGLWRURIWKH%ULWLVK0HGLFDO-RXUQDO

)RUJHWWLQJDOWRJHWKHUWKDW\RXDJUHHGWRVSHDNLVDJRRGZD\WRPDNHDPHVVRI
\RXUSUHVHQWDWLRQ$YDULDQWLVWRDUULYHODWH'RQ¶WDUULYHWRRODWHEHFDXVHWKH\ZLOO
VLPSO\KDYHFDQFHOOHG\RXUVHVVLRQSUREDEO\VHQGLQJDWKULOORISOHDVXUHWKURXJK
DQDXGLHQFHIDFLQJWKHSURVSHFWRIILYHFRQVHFXWLYHVSHDNHUV
2QHZD\WRSUHSDUHIRUDEDGSUHVHQWDWLRQLVQRWWRSUHSDUHDWDOO6WHSXSWRWKH
SODWIRUPRSHQ\RXUPRXWKDQGVHHZKDWFRPHVRXW7KLVLVKRZHYHUDKLJKULVN
VWUDWHJ\EHFDXVHVSRQWDQHLW\PD\LQVSLUHERWK\RXUDXGLHQFHDQG\RX,QVSLUDWLRQ
PXVWEHDYRLGHGDWDOOFRVWV
$UHDOO\EDGSUHVHQWDWLRQQHHGVFDUHIXOSUHSDUDWLRQ$JRRGSLHFHRIDGYLFHLVWR
SUHSDUHIRUWKHZURQJDXGLHQFH,WLVPXFKWKHEHVWVWUDWHJ\WRJLYHDQRYHUFRPSOLFDWHG
SUHVHQWDWLRQWKDQDQRYHUVLPSOLILHGRQH
%HVXUHWRSUHSDUHDSUHVHQWDWLRQWKDWLVWKHZURQJOHQJWK7RRORQJLVPXFKWKHEHVW
0RVWRIWKHDXGLHQFHZLOOEHGHOLJKWHGLI\RXUWDONLVWRRVKRUW%XWVRPHWKLQJWKDW
LVWRRORQJDOZD\VGHSUHVVHVDQDXGLHQFHHYHQLIZKDW\RXDUHVD\LQJLVIXOORIZLW
DQGZLVGRP
$QRWKHUWULFNLVWRLJQRUHWKHWRSLF\RXDUHJLYHQDQGVSHDNRQDFRPSOHWHO\GLIIHUHQW
VXEMHFW
<RX PD\EH DEOHWRHQKDQFH\RXU EDG SUHVHQWDWLRQ E\ VHQGLQJ WKH RUJDQL]HUV LQ
DGYDQFHDORQJDQGGXOOFXUULFXOXPYLWDHWRUHDGEHIRUH\RXUSUHVHQWDWLRQ
%DGVOLGHVDUHWKHWUDGLWLRQDODLGRIDEDGSUHVHQWDWLRQ7KH\PXVWEHIDUWRRPDQ\
FRQWDLQWRRPXFKLQIRUPDWLRQDQGEHWRRVPDOOIRUHYHQWKRVHLQWKHIURQWURZWR
UHDG)ODVKWKHPXSDVIDVWDV\RXFDQHQVXULQJWKDWWKH\DUHLQWKHZURQJRUGHUZLWK
VRPHVOLGHVXSVLGHGRZQ,GHDOO\WKHUHVKRXOGEHOLWWOHFRQQHFWLRQEHWZHHQZKDW\RX
DUHVD\LQJDQGZKDWLVRQWKHVOLGH
7KHHVVHQFHRIDEDGSUHVHQWDWLRQLVWREHERULQJ$Q\WKLQJWKDWLVQ¶WERULQJZLOO
GHWUDFWIURP\RXUEDGSUHVHQWDWLRQ
1HYHUORRNDWWKHDXGLHQFH0XPEOH\RXUSUHVHQWDWLRQDQGSUHIHUDEO\UHDGLW$
SUHVHQWDWLRQWKDWLVUHDGZLOOXVXDOO\EHVDWLVI\LQJO\EDGEXWIRUWKHIXOOHIIHFW\RX
VKRXOGKDYHORQJFRPSOLFDWHGVHQWHQFHVZLWKGR]HQVRIVXEFODXVHV
$WUXO\EDGSUHVHQWDWLRQUDUHO\SURGXFHVDQ\TXHVWLRQV0RVWSHRSOHZLOOMXVWZDQWWR
JHWDZD\,I\RXGRJHWTXHVWLRQV\RXPD\KDYHIDLOHGLQJLYLQJDEDGSUHVHQWDWLRQ
%XWDOOLVQRWORVW%\VWLFNLQJWRWKHEDVLFUXOHVRIEHLQJERULQJDQGRYHUFRPSOLFDWHG
DQGE\VSHDNLQJWRRORQJ\RXPD\VWLOOEHDEOHWRUHVFXH\RXUEDGSUHVHQWDWLRQ7KH
H[WUDUXOHRQDQVZHULQJTXHVWLRQVLVWKDWXQGHUQRFLUFXPVWDQFHVVKRXOG\RXUHDOO\
DQVZHUWKHP2QFH\RXKDYHILQLVKHGVD\³'RHVWKDWDQVZHU\RXUTXHVWLRQ"´,IWKH
TXHVWLRQHUKDVWKHHIIURQWHU\WRVD\QRWKHQGRLWDJDLQRQO\DWJUHDWHUOHQJWK

Harvey RF, Schullinger MB, Stassinopoulus A, Winkle E. Dreaming during scientific
papers. British Medical Journal, 1983, 2: 1916–1919.
Hawkins C. Speaking at meetings. In: Hawkins C, Sorgi M, eds. Research: How to plan,
speak and write about it. Berlin, Springer-Verlag, 1985: 60–84.
Hextall A, Cardozo L. Presenting a paper. In: O’Brien PMS, Pipkin FB, eds. Introduction to
Lashford LS. Presenting a scientific paper, including the pitfalls. Archives of Disease in
Childhood, 1995, 73: 168–169.
Smith R. How not to give a presentation. British Medical Journal, 2000, 321:1570–
1571.
Sorgi M, Hawkins C. Illustrating talks and articles. In: Hawkins C, Sorgi M, eds. Research:
How to plan, speak and write about it. Berlin, Springer-Verlag, 1985: 110–135.
Thompson WA et al. Scientific presentations. What to do and what not to do. Investigative
Radiology, 1987, 22: 224–45.
Chapter 14
Assessment and evaluation of
research
14.1 Introduction
5HVHDUFKHUVQHHGWRKDYHWKHVNLOOWRDVVHVVDQGHYDOXDWHWKHUHVHDUFKSDSHUVWKH\
UHDGSDUWLFXODUO\WKRVHUHODWHGWRWKHUHVHDUFKWRSLFWKH\DUHGRLQJ7KLVVKRXOGEHGRQH
EHIRUHWKHUHVHDUFKLVSODQQHGGXULQJWKHLPSOHPHQWDWLRQRIWKHSURMHFWDQGEHIRUH
GLVFXVVLQJWKHUHVXOWVDQGSUHSDULQJWRFRPPXQLFDWHWKHP5HVHDUFKHUVPD\DOVRZDQW
WRFULWLFDOO\DVVHVVDOODFFHVVLEOHSXEOLVKHGSDSHUVRQDSDUWLFXODUWRSLFLQRUGHUWRZULWHD
V\VWHPDWLFUHYLHZ7KH\VKRXOGEHDULQPLQGWKDWVFLHQFHVKRXOGQRWEHDGPLUHGVFLHQFH
VKRXOGEHTXHVWLRQHG7KHZRUGV³DXWKRU´DQG³DXWKRULW\´FRPHIURPDFRPPRQ(QJOLVK
VWRFNDQGUXQWKHGDQJHURIEHFRPLQJV\QRQ\PVLQWKHPLQGVRIVRPH$JRRGVFLHQWLVW
VKRXOGGHYHORSDVFHSWLFDODWWLWXGHZKHQUHDGLQJVFLHQWLILFSDSHUV6FHSWLFLVPLVDQ
LQKHUHQWSDUWRIWKHVFLHQWLILFDSSURDFK:KDWGHILQHVDQ\VWDWHPHQWDVEHLQJVFLHQWLILF
LVWKDWLWLVYHULILDEOHLQSULQFLSOHRUDVLWLVVRPHWLPHVSXWLWVKRXOGEH³IDOVLILDEOH´LQ
SULQFLSOH7KHUHLVKDUGO\DQ\WKHRU\LQVFLHQFHWKDWHYHUDFKLHYHVDGHJUHHRIFHUWDLQW\
EH\RQGWKHUHDFKRIFULWLFLVPRUWKHSRVVLELOLW\RIPRGLILFDWLRQ,QVFLHQFHWKHUHZLOO
DOZD\VEHPRUHEH\RQG
5HVHDUFKHUVPD\DOVREHUHTXHVWHGWRSHHUUHYLHZDVFLHQWLILFSDSHUVXEPLWWHGIRU
SXEOLFDWLRQE\RWKHUUHVHDUFKHUVRUWRDVVHVVWKHVFLHQWLILFRXWSXWRIFDQGLGDWHVIRU
DFDGHPLFSRVWV
7KHQHHGWRDVVHVVDQGHYDOXDWHUHVHDUFKLVQRWOLPLWHGWRUHVHDUFKHUV/HDUQLQJ
WRHYDOXDWHDQGXVHUHVHDUFKILQGLQJVLVDQLPSRUWDQWDQGOLIHORQJSDUWRISURIHVVLRQDO
GHYHORSPHQWIRUKHDOWKSURIHVVLRQDOV7KH\ QHHG WR FULWLFDOO\ DVVHVV WKH YDOXH RI
QHZSXEOLVKHGUHVHDUFKEHIRUHFRQVLGHULQJLWVSUDFWLFDOLPSOLFDWLRQVIRUWKHLUZRUN
+HDOWKSURIHVVLRQDOVQHHGWREHDZDUHRIWKHIDFWWKDWWKHUHDUHGLIIHUHQWOHYHOVIRU
VFLHQWLILFHYLGHQFH+HDOWKUHVHDUFKHUVVKRXOGKHOSLQRXWOLQLQJWKHVHGLIIHUHQWOHYHOVRI
HYLGHQFH
3ROLF\PDNHUVVKRXOGKDYHWKHDELOLW\WRDVVHVVUHVHDUFKUHVXOWVDQGWKHLULPSOLFDWLRQV
IRUSROLF\,QSDUWLFXODUWKH\QHHGWRDVVHVVQHZWHFKQRORJLHVDQGDOVRFXUUHQWO\XVHG
WHFKQRORJLHVWRLQWURGXFHZKDWLVQHZDQGFRVWHIIHFWLYHGLVFDUGZKDWLVQRWHIIHFWLYH
RUSRWHQWLDOO\KDUPIXOSURPRWHZKDWLVHIIHFWLYHEXWXQGHUXWLOL]HGDQGSRVWSRQHD
Assessment and evaluation of research 173
GHFLVLRQZKHUHHYLGHQFHLVVWLOOODFNLQJ+HDOWKUHVHDUFKHUVQHHGWREHDZDUHRIWKHVH
FRQVLGHUDWLRQV
5HVHDUFKLVDQLQYHVWPHQWDQGLVEHFRPLQJPRUHDQGPRUHH[SHQVLYH7KRVHZKR
IXQGWKHUHVHDUFKQHHGWRHYDOXDWHWKHUHWXUQRQWKHLULQYHVWPHQW5HVHDUFKHUVQHHGWR
EHDZDUHDERXWKRZWKHLQYHVWPHQWLQKHDOWKUHVHDUFKLVHYDOXDWHGE\IXQGLQJDJHQFLHV
SDUWLFXODUO\JRYHUQPHQWVWKHLUSXEOLFSD\PDVWHUV
7KLVFKDSWHUDGGUHVVHVWKHDVVHVVPHQWDQGHYDOXDWLRQRIUHVHDUFKE\UHVHDUFKHUV
KHDOWKSURIHVVLRQDOVSROLF\PDNHUVDQGLQYHVWRUVLQKHDOWKUHVHDUFK)RUDGGLWLRQDO
LQIRUPDWLRQRQWKHVXEMHFWWKHVRXUFHVOLVWHGLQWKHUHIHUHQFHVDQGDGGLWLRQDOVRXUFHV
IRUWKHFKDSWHUFDQEHFRQVXOWHG
14.2 Assessment and evaluation by researchers

14.2.1 Reading a research paper
7KHWLWOHRIWKHSDSHUDQGWKHDEVWUDFWJLYHDQLQGLFDWLRQRIWKHQRYHOW\DQGUHOHYDQFH
RIWKHSDSHU
)RUWKHFULWLFDOUHDGHUWKHPHWKRGVVHFWLRQVKRXOGEHWKHILUVWSDUWRIWKHSDSHUWR
DVVHVV,WZLOOWHOOZKHWKHULWLVJRRGVFLHQFHRUEDGVFLHQFH,WKDVEHHQULJKWO\VDLGWKDW
DSDSHUZLOOVLQNRUVZLPRQWKHVWUHQJWKRILWVPHWKRGVVHFWLRQ*UHHQKDOJK
$JRRGPHWKRGVVHFWLRQVKRXOGSURYLGHVXIILFLHQWGHWDLOWRDOORZRWKHULQYHVWLJDWRUVWR
UHSOLFDWHWKHVWXG\DQGFRQILUPWKHUHVXOWV,ILWGRHVQRWWKHVWXG\UHVXOWVFDQQRWEH
HDVLO\DFFHSWHG
,QPRVWSDSHUVWKHWZRPRVWLPSRUWDQWPHWKRGRORJLFDOLVVXHVUHODWHWRKRZWKHVDPSOH
ZDVVHOHFWHGDQGZKDWPHDVXUHPHQWVZHUHPDGH7KHVDPSOHPXVWEHUHSUHVHQWDWLYHRI
WKHSRSXODWLRQVWXGLHG,IWZRVDPSOHVDUHFRPSDUHGWKH\PXVWEHVHOHFWHGWREHLGHQWLFDO
IRUHYHU\UHOHYDQWYDULDEOHH[FHSWWKHRQHWREHVWXGLHG7KHFULWLFDOUHDGHUPXVWTXHVWLRQ
ZKHWKHUWKHPHDVXUHPHQWVXVHGKDYHEHHQDVVHVVHGIRUWKHLUYDOLGLW\DQGWKHLUUHOLDELOLW\
$VGLVFXVVHGLQ&KDSWHUYDOLGLW\LVDQLQGH[RIKRZZHOODWHVWRUSURFHGXUHPHDVXUHV
ZKDWLWLVLQWHQGHGWRPHDVXUH5HOLDELOLW\DVVHVVHVFRQVLVWHQF\RIPHDVXUHPHQW,WUHODWHV
WRWKHUHSURGXFLELOLW\RIPHDVXUHPHQWV:KHQUHOLDELOLW\LVKLJKDWHVWWKDWLVUHSHDWHG
RQWKHVDPHSDWLHQWDQGXQGHUWKHVDPHFRQGLWLRQVZLOO\LHOGWKHVDPHUHVXOWZKHWKHU
E\GLIIHUHQWLQYHVWLJDWRUV,QWHUUDWHUUHOLDELOLW\RUE\WKHVDPHLQYHVWLJDWRU,QWUDUDWHU
UHOLDELOLW\:KHUHDSSURSULDWHWKHLQYHVWLJDWRUVVKRXOGSURYLGHDVVXUDQFHDERXWWKH
TXDOLW\FRQWURORIWKHLUGDWD$VDQH[DPSOHRIWKHLPSRUWDQFHRILQWHUUDWHUUHOLDELOLW\
RQHVWXG\ORRNHGDWWKHDJUHHPHQWDPRQJIRXUSDWKRORJLVWVRQWKHFODVVLILFDWLRQRI
FHUYLFDOLQWUDHSLWKHOLDOQHRSODVLDFRPSDUHGZLWKWKHLQGH[SDWKRORJLVW2IFDVHVRI
FDUFLQRPDLQVLWX&,6ZHUHUHSRUWHGDVPLOGG\VSODVLDDVPRGHUDWHG\VSODVLD
DVVHYHUHG\VSODVLDDQGDV&,6GH9HWHWDO
7KHFULWLFDOUHDGHURIDVFLHQWLILFSDSHUWDNHVDFORVHORRNDWWKHUHVXOWVDQGWKHLU
LQWHUSUHWDWLRQ3LWIDOOVLQWKHLQWHUSUHWDWLRQRIUHVHDUFKUHVXOWVDUHGLVFXVVHGLQGHWDLOLQ
&KDSWHU
6WDWLVWLFDOMDUJRQVKRXOGQRWSXWRIIWKHFULWLFDOUHDGHU8VHDQGLQWHUSUHWDWLRQRI
VWDWLVWLFVFDQEHPLVOHDGLQJ'LVUDHOLLVTXRWHGDVVD\LQJ³7KHUHDUHWKUHHW\SHVRIOLHV
OLHVGDPQOLHVDQGVWDWLVWLFV´2QHGRHVQRWQHHGWREHDVWDWLVWLFLDQWRPDNHVRPH
MXGJHPHQWDERXWWKHVWDWLVWLFDODQDO\VLVRIWKHUHVHDUFK6WDWLVWLFVLVDERXWFRPPRQVHQVH
EHIRUHLWLVDERXWPDWKHPDWLFV7KHILUVWTXHVWLRQWRDVNLVZKHWKHUWKHDXWKRUVKDYHXVHG
DQ\VWDWLVWLFDOPHWKRGVDWDOO,IWKH\KDYHQRWWKHUHLVQRUHDVRQWRDFFHSWWKDWWKHUHVXOWV
DUHQRWEHLQJFDXVHGE\FKDQFHDORQH7KHVHFRQGTXHVWLRQLVZKHWKHUWKHDXWKRUVKDYH
VHOHFWHGWKHULJKWVWDWLVWLFDOPHWKRGVWRDQDO\VHWKHLUGDWD7KHWKLUGTXHVWLRQLVZKHWKHU
WKH\KDYHGUDZQWKHULJKWFRQFOXVLRQVIURPWKHVWDWLVWLFDODQDO\VLV,WLVWHPSWLQJWRPDNH
ZURQJFRQFOXVLRQVRQWKHEDVLVRIVWDWLVWLFDODQDO\VLV7KHUHLVDOLPLWWRZKDWVWDWLVWLFV
FDQWHOOXV
14.2.2 Peer review

3HHUUHYLHZLVWKHFULWLFDODVVHVVPHQWRIPDQXVFULSWVVXEPLWWHGWRVFLHQWLILFMRXUQDOV
E\H[SHUWVZKRDUHQRWSDUWRIWKHHGLWRULDOSURFHVV7KHSURFHVVRISHHUUHYLHZKHOSV
HGLWRUVWRGHFLGHZKLFKPDQXVFULSWVDUHVXLWDEOHIRUSXEOLFDWLRQDQGKHOSVDXWKRUVWR
LPSURYHWKHTXDOLW\RIWKHLUSDSHUV$SHHUUHYLHZHGMRXUQDOLVDMRXUQDOWKDWVXEPLWV
PRVWRILWVSXEOLVKHGUHVHDUFKDUWLFOHVIRURXWVLGHUHYLHZ
,QWKHSHHUUHYLHZSURFHVVHGLWRUVJHQHUDOO\SURYLGHUHYLHZHUVZLWKDIRUPDWIRU
WKHDVVHVVPHQWRIDOOFRPSRQHQWVRIWKHSDSHUIURPWKHWLWOHWRWKHUHIHUHQFHV7KHUHLV
DFRPPRQPLVFRQFHSWLRQWKDWILQGLQJIODZVLVNH\WRWKHKLJKTXDOLW\RISHHUUHYLHZ
7KHREMHFWLYHRIWKHSHHUUHYLHZSURFHVVLVQRWWRILQGVRPHWKLQJWRFULWLFL]H)LQGLQJ
IODZVLVFHUWDLQO\LPSRUWDQWDQGVFHSWLFLVPLVUHYHUHGLQVFLHQWLILFWUDGLWLRQ$XWKRUV
FDQEHQHILWIURPFRQVWUXFWLYHFULWLFLVPRIJRRGUHYLHZHUV+RZHYHUUHVSRQGLQJWR
PLVJXLGHGFRPPHQWVPD\ZDVWHWLPHDQGHIIRUW
7KHUHDUHHWKLFDOFRQVLGHUDWLRQVLQWKHSHHUUHYLHZSURFHVV5HYLHZHUVPXVWGLVFORVH
WRHGLWRUVDQ\FRQIOLFWVWKDWFRXOGELDVWKHLURSLQLRQVRIWKHPDQXVFULSWDQGWKH\VKRXOG
GLVTXDOLI\WKHPVHOYHVIURPUHYLHZLQJVSHFLILFPDQXVFULSWVLIDSSURSULDWH(GLWRUVVKRXOG
DYRLGVHOHFWLQJH[WHUQDOSHHUUHYLHZHUVZLWKREYLRXVSRWHQWLDOFRQIOLFWRILQWHUHVWIRU
H[DPSOHWKRVHZKRZRUNLQWKHVDPHGHSDUWPHQWRULQVWLWXWLRQ5HYLHZHUVPXVWQRWXVH
NQRZOHGJHRIWKHZRUNEHIRUHLWVSXEOLFDWLRQWRIXUWKHUWKHLURZQVFLHQWLILFLQWHUHVWV
14.3 Assessment and evaluation by health professionals

14.3.1 Levels of evidence
+HDOWKSURIHVVLRQDOVUHDGLQJVFLHQWLILFSDSHUVIRUSRVVLEOHFOLQLFDODSSOLFDWLRQ
VKRXOGUHFRJQL]HWKDWWKHUHLVDKLHUDUFK\RIWKHOHYHORIHYLGHQFHREWDLQHGIURPGLIIHUHQW
VWXG\GHVLJQV,QDVVHVVLQJWKHHIIHFWLYHQHVVRILQWHUYHQWLRQVWKH863UHYHQWLYH
6HUYLFHV7DVN)RUFHLQFOXGLQJDPHPEHUSDQHORIVFLHQWLILFDQGPHGLFDO
H[SHUWVSURSRVHGWKHIROORZLQJJXLGHIRUUDWLQJWKHTXDOLW\RIHYLGHQFHIRUFOLQLFDO
HIIHFWLYHQHVV
/HYHO,HYLGHQFH(YLGHQFHREWDLQHGIURPDWOHDVWRQHSURSHUO\GHVLJQHGUDQGRPL]HG
FRQWUROOHGWULDO
/HYHO,,HYLGHQFH(YLGHQFHREWDLQHGIURPZHOOGHVLJQHGFRQWUROOHGWULDOVZLWKRXW
UDQGRPL]DWLRQ
/HYHO,,HYLGHQFH(YLGHQFHREWDLQHGIURPZHOOGHVLJQHGFRKRUWRUFDVHFRQWURO
VWXGLHV,QWKHVHREVHUYDWLRQDOVWXGLHVWKHLQYHVWLJDWRUKDVQRUROHLQDVVLJQPHQWRI
VWXG\H[SRVXUHEXWUDWKHUREVHUYHVWKHQDWXUDOFRXUVHRIHYHQWVRIH[SRVXUHDQG
RXWFRPH
/HYHO ,, HYLGHQFH 7KLV FDWHJRU\ LQFOXGHV FURVVVHFWLRQDO VWXGLHV ZKLFK DUH
REVHUYDWLRQDOVWXGLHVWKDWDVVHVVWKHVWDWXVRILQGLYLGXDOVZLWKUHVSHFWWRWKHSUHVHQFH
RUDEVHQFHRIERWKH[SRVXUHDQGRXWFRPHDWDSDUWLFXODUWLPH7KHFDWHJRU\DOVR
LQFOXGHVXQFRQWUROOHGLQWHUYHQWLRQVWXGLHV7KH\PD\GHPRQVWUDWHLPSUHVVLYHUHVXOWV
EXWLQWKHDEVHQFHRIDFRQWUROJURXSWKHUHVXOWVPD\EHDWWULEXWDEOHWRIDFWRUVRWKHU
WKDQWKHLQWHUYHQWLRQRUWUHDWPHQW'UDPDWLFUHVXOWVLQXQFRQWUROOHGH[SHULPHQWVVXFK
DVWKHUHVXOWVRIWKHLQWURGXFWLRQRISHQLFLOOLQWUHDWPHQWLQWKHVPD\KRZHYHU
EHGLIILFXOWWRGLVPLVV
/HYHO,,,HYLGHQFH7KLVFDWHJRU\LQFOXGHVGHVFULSWLYHVWXGLHVVXFKDVFDVHUHSRUWV
DQGFDVHVHULHV,WDOVRLQFOXGHVH[SHUWRSLQLRQRIWHQEDVHGRQFOLQLFDOH[SHULHQFH
14.3.2 Systematic reviews and meta-analyses

5HVXOWVRIVFLHQWLILFVWXGLHVDUHRIWHQQRWXQLIRUP7RWU\WRGUDZFRQFOXVLRQVIURP
WKHVHVWXGLHVV\VWHPDWLFUHYLHZVDUHXQGHUWDNHQE\UHVHDUFKHUV$V\VWHPDWLFUHYLHZ
DVRXWOLQHGLQ&KDSWHULVDQRYHUYLHZRISULPDU\VWXGLHVWKDWFRQWDLQVDQH[SOLFLW
VWDWHPHQWRIREMHFWLYHVPDWHULDOVDQGPHWKRGVDQGKDVEHHQFRQGXFWHGDFFRUGLQJWR
H[SOLFLWDQGUHSURGXFLEOHPHWKRGRORJ\,WLVGLIIHUHQWIURPDQDUUDWLYHUHYLHZZKLFKLV
DQRYHUYLHZRISULPDU\VWXGLHVWKDWKDYHQRWEHHQLGHQWLILHGRUDQDO\VHGLQDV\VWHPDWLF
VWDQGDUGL]HGDQGREMHFWLYHZD\
7KHTXDOLW\RIV\VWHPDWLFUHYLHZVVKRXOGJHQHUDOO\EHMXGJHGE\WKHIROORZLQJWZR
FULWHULD
+DYHWKHDXWKRUVSHUIRUPHGDWKRURXJKOLWHUDWXUHUHYLHZRUSUHVHQWHGRQO\VHOHFWHG
UHVHDUFKILQGLQJV"
+DYHWKH\DFFHSWHGWKHSULPDU\UHVHDUFKHUV¶LQWHUSUHWDWLRQRIVWXG\GDWDXQFULWLFDOO\
RUGRWKH\LQFOXGHPHWKRGRORJLFDOFRPPHQWDU\DORQJZLWKWKHLUFRQWHQWUHYLHZ"
$PHWDDQDO\VLVDVGLVFXVVHGLQ&KDSWHULVDVSHFLDOW\SHRIV\VWHPDWLFUHYLHZ
WKDWFRPELQHVUHVXOWVIURPPRUHWKDQRQHLQYHVWLJDWLRQWRREWDLQDZHLJKWHGDYHUDJH
RIWKHHIIHFWRIDYDULDEOHRULQWHUYHQWLRQRQDGHILQHGRXWFRPH&RPELQLQJGDWDIURP
DQXPEHURIVWXGLHVLQFUHDVHVWKHVDPSOHVL]HDQGWKHSRZHURIWKHVWXG\WRSURYLGH
VWDWLVWLFDOO\VLJQLILFDQWFRQFOXVLRQV$PHWLFXORXVO\FRQGXFWHGPHWDDQDO\VLVLQZKLFKDOO
WKHSULPDU\VWXGLHVRQDSDUWLFXODUVXEMHFWKDYHEHHQKXQWHGRXWDQGFULWLFDOO\DSSUDLVHG
DFFRUGLQJWRULJRURXVFULWHULDKDVDYHU\KLJKSODFHLQWKHKLHUDUFK\RIHYLGHQFH
,QUHDGLQJDPHWDDQDO\VLVVWXG\LWVKRXOGEHUHFRJQL]HGWKDWDPHWDDQDO\VLVFDQ
RQO\EHDVJRRGDVWKHTXDOLW\RILWVLQGLYLGXDOFRPSRQHQWV$VVHVVPHQWRITXDOLW\RID
PHWDDQDO\VLVKDVWRDGGUHVVWKHIROORZLQJTXHVWLRQV
,VWKHSRROLQJGRQHRQO\DPRQJVWXGLHVZKHUHWKHUHLVUHDVRQDEOHDVVXUDQFHWKDW
VXEMHFWV DQG WUHDWPHQWV DUH VLPLODU" 0LVOHDGLQJ FRQFOXVLRQV FDQ EH GUDZQ IURP
SRROLQJWRJHWKHUKHWHURJHQHRXVGDWD
+DVFDUHEHHQWDNHQWRH[FOXGHSXEOLFDWLRQELDVWRZDUGSRVLWLYHUHVXOWV"6WXGLHV
ZLWKSRVLWLYHUHVXOWVDUHPRUHOLNHO\WREHSXEOLVKHGOHDGLQJWRSUREOHPVZLWKPHWD
DQDO\VLVLQWHUSUHWDWLRQPDQ\UHVHDUFKHUVDUHUHOXFWDQWWRSXUVXHDQGSXEOLVKQHJDWLYH
UHVXOWV
14.3.3 Cochrane Collaboration

7KH&RFKUDQH&ROODERUDWLRQIRFXVHVRQLGHQWLI\LQJUHOLDEOHHYLGHQFHDQGSUHSDULQJ
V\VWHPDWLFUHYLHZVRIWKHUDSHXWLFLQWHUYHQWLRQVXVLQJUDQGRPL]HGFRQWUROOHGWULDOV5&7V
%HURDQG5HQQLH$UFKLH&RFKUDQHZDVD6FRWWLVKHSLGHPLRORJLVWZKRZRUNHGLQ
:DOHVIRUPRVWRIKLVOLIH,QKHZURWHDERRNLQZKLFKKHKLJKOLJKWHGWKHDEVHQFH
RIDQDGHTXDWHNQRZOHGJHEDVHIRUPXFKRIWKHKHDOWKFDUHSURYLGHG+HPDGHDVWURQJ
FDVHIRUWKHHYDOXDWLRQRIQHZDQGFXUUHQWIRUPVRIFDUHLQFRQWUROOHGWULDOVZKLFKXVH
UDQGRPL]DWLRQWRJHQHUDWHXQELDVHGFRPSDULVRQJURXSV&RFKUDQHILUVWFKDOOHQJHGWKH
SURIHVVLRQRIREVWHWULFVWRVHHNJRRGHYLGHQFHIRULWVSUDFWLFH7KHFKDOOHQJHZDVWDNHQ
XSDQGWKHGDWDEDVHRISHULQDWDOWULDOVZDVWKHILUVWWRFRPHRXW+DYLQJGHPRQVWUDWHG
WKDWWKHDSSURDFKZDVSRVVLEOHZLWKRQHVSHFLDOW\WKHZRUNZDVH[WHQGHGWRRWKHUDUHDVRI
KHDOWKFDUH,QWKHILUVW&RFKUDQH&HQWUHZDVRSHQHGLQ2[IRUGDQGWKH&RFKUDQH
&ROODERUDWLRQZDVODXQFKHGLQWHUQDWLRQDOO\RQH\HDUODWHU7KH&RFKUDQH/LEUDU\KWWS
ZZZXSGDWHVRIWZDUHFRPFRFKUDQHLVFXUUHQWO\FRQVLGHUHGRQHRIWKHEHVWVLQJOH
VRXUFHVRIFULWLFDOHYLGHQFHIRUKHDOWKFDUHLQWHUYHQWLRQV7KHOLEUDU\SXEOLVKHVDGDWDEDVH
VROHO\RI5&7V,WLVSXEOLVKHGRQDTXDUWHUO\EDVLVDQGPDGHDYDLODEOHERWKRQ&'520
DQGRQWKHLQWHUQHW,WLVHDVLO\DFFHVVLEOHLQDXVHUIULHQGO\IRUPDW,WLVWKHUHVXOWRI
FROODERUDWLYHKDQGVHDUFKLQJHIIRUWVDQGHOHFWURQLFVHDUFKLQJIURPPDQ\RIWKHGLIIHUHQW
UHYLHZJURXSVDQGFHQWUHVRIWKH&RFKUDQH&ROODERUDWLRQ&ROODERUDWLYHUHYLHZJURXSV
KDYHHYROYHGZKLFKFRYHUPRVWDUHDVRIKHDOWKFDUH
14.4 Assessment and evaluation by policy-makers

7KHUHKDVEHHQDQH[SORVLRQRIWHFKQRORJLHVLQWKHSDVWIHZGHFDGHVDVDQRXWFRPHRI
WKHH[SDQVLRQLQKHDOWKUHVHDUFK7KHVHWHFKQRORJLHVSURYLGHJUHDWRSSRUWXQLWLHVLQKHDOWK
FDUH7KHDVVHVVPHQWRIWKHVHWHFKQRORJLHVSUHVHQWVPDMRUFKDOOHQJHVWRKHDOWKSROLF\
PDNHUV$PDMRUFKDOOHQJHLVKRZWKHVHWHFKQRORJLHVFDQEHDVVHVVHGWRGHWHUPLQHWKHLU
DSSURSULDWHQHVV$VVHVVPHQWVKRXOGQRWEHOLPLWHGWRQHZO\LQWURGXFHGWHFKQRORJLHV
7KHUHLVDQHHGDOVRWRDVVHVVWHFKQRORJLHVFXUUHQWO\LQXVHZKLFKPD\QRWEHHIIHFWLYH
RUHYHQSRWHQWLDOO\KDUPIXO7KHUHDUHDOVREHQHILFLDOWHFKQRORJLHVZKLFKPD\EHXQGHU
XWLOL]HG7HFKQRORJ\FDQEHGHILQHGDVWKHLPSOHPHQWDWLRQRIVFLHQWLILFNQRZOHGJHLQ
RUGHUWRVDWLVI\KXPDQQHHGV+HDOWKWHFKQRORJLHVLQFOXGHWKHGUXJVGHYLFHVHTXLSPHQW
DQGPHGLFDODQGVXUJLFDOSURFHGXUHVXVHGLQWKHSUHYHQWLRQGHWHFWLRQGLDJQRVLVDQG
WUHDWPHQWDQGUHKDELOLWDWLRQRIGLVHDVH
7KH UHVSRQVLELOLW\ IRU DVVHVVPHQW RI KHDOWK WHFKQRORJLHV LV LOO GHILQHG 'UXJ
UHJXODWRU\DXWKRULWLHVKDYHUHVSRQVLELOLW\IRUWKHDSSURYDORIGUXJVIRUKXPDQXVH
%DVHGRQSUHFOLQLFDODQGFOLQLFDOVWXGLHVWKHDXWKRULW\GHFLGHVZKHWKHUWKHGUXJLV
VDIHDQGHIIHFWLYHWRGRZKDWLWLVFODLPHGWRGR%XWLWLVQRWWKHEXVLQHVVRIWKHGUXJ
UHJXODWRU\DXWKRULW\WRFRPSDUHWKHGUXJZLWKRWKHUDYDLODEOHGUXJV,WRQO\HQVXUHVWKDW
WKHPDQXIDFWXUHUPDNHVQRXQMXVWLILHGFODLPV7KLVLVWKHVWDWXVRIGUXJUHJXODWLRQEXW
KHDOWKWHFKQRORJLHVLQFOXGHDOVRGHYLFHVHTXLSPHQWDQGSURFHGXUHV'HYLFHVDUHRQO\
UHJXODWHGLIWKH\DUHXVHGLQVLGHWKHKXPDQERG\0HGLFDOHTXLSPHQWDQGPHGLFDODQG
VXUJLFDOSURFHGXUHVDUHQRWLQJHQHUDOVXEMHFWWRUHJXODWLRQE\DXWKRULWLHVQRWWKDWVXFK
UHJXODWLRQLVGHVLUDEOHLQDUDSLGO\DGYDQFLQJILHOG
7KHIROORZLQJIRXUTXHVWLRQVQHHGWREH FDUHIXOO\ H[DPLQHG EHIRUH DQ\ QHZ
WHFKQRORJ\LVFRQVLGHUHGDSSURSULDWH
,VWKHWHFKQRORJ\HYLGHQFHEDVHG"
,VLWJRRGYDOXHIRUPRQH\"
,VLWFXOWXUDOO\DQGHWKLFDOO\DFFHSWDEOH"
$UHWKHV\VWHPUHTXLUHPHQWVIRULWVLQWURGXFWLRQDYDLODEOH"
Is the technology evidence-based?

7KHUHLVDQHHGWRFULWLFDOO\DVVHVVWKHHYLGHQFHEHIRUHDGRSWLQJDQ\QHZWHFKQRORJ\
7KLVLVSDUWLFXODUO\LPSRUWDQWZKHQWKHUHDUHVWURQJFRPPHUFLDOLQWHUHVWVLQYROYHG
7KHSUDFWLFHRIPHGLFLQHKDVEHHQUDSLGO\HYROYLQJIURPEHLQJDXWKRULW\EDVHGWR
EHLQJHYLGHQFHEDVHG7KHKLVWRU\RIRXUPHGLFDOSUDFWLFHLVQRWVKRUWRIH[DPSOHV
RIWHFKQRORJLHVZKLFKZHUHZLGHO\XVHGDQGVXEVHTXHQWO\SURYHGQRWXVHIXORUHYHQ
KDUPIXO
7KHUHDUHRQJRLQJHIIRUWVWRDVVHVVFXUUHQWO\DYDLODEOHKHDOWKWHFKQRORJLHV,Q
DQRQJRLQJDVVHVVPHQWRIUHSURGXFWLYHKHDOWKWHFKQRORJLHV:+2FODVVLILHGWKHVH
WHFKQRORJLHVLQWRWKHIROORZLQJVL[FDWHJRULHVEHQHILFLDOOLNHO\WREHEHQHILFLDOZLWK
DWUDGHRIIRIXQNQRZQHIIHFWLYHQHVVOLNHO\WREHLQHIIHFWLYHDQGOLNHO\WREHKDUPIXO
:+2,QWKH8.WKH1DWLRQDO,QVWLWXWHIRU&OLQLFDO([FHOOHQFH1,&(ZDVVHW
XSDVDVSHFLDOKHDOWKDXWKRULW\IRU(QJODQGDQG:DOHVLQ,WVUROHLVWRSURYLGH
SDWLHQWVKHDOWKSURIHVVLRQDOVDQGWKHSXEOLFZLWKDXWKRULWDWLYHUREXVWDQGUHOLDEOH
JXLGDQFHRQFXUUHQW³EHVWSUDFWLFH´ZZZQLFHRUJXN
Is the technology good value for money?

,IWKHWHFKQRORJ\LVHYLGHQFHEDVHGWKHQH[WTXHVWLRQLVZKHWKHULWLVJRRGYDOXH
IRUPRQH\7KLVLVDGLIIHUHQWTXHVWLRQIURPWKHLVVXHRIDIIRUGDELOLW\(FRQRPLVWVKDYH
VKRZQDQLQFUHDVLQJLQWHUHVWLQZKDWKHDOWKSURIHVVLRQDOVDUHGRLQJFRQWULEXWLQJDQHZ
GLVFLSOLQHRIKHDOWKHFRQRPLFV:LWKWKHLQFUHDVLQJLQWURGXFWLRQRIKHDOWKWHFKQRORJLHV
KHDOWKFDUHKDVEHFRPHWRRFRVWO\WREHOHIWWRKHDOWKFDUHSURYLGHUVDORQH5HVHDUFKRQ
KHDOWKHFRQRPLFVLVGLVFXVVHGLQ&KDSWHU
+HDOWKHFRQRPLVWVLQWURGXFHGWZRLPSRUWDQWFRQFHSWVWRFRQVLGHULQGHFLGLQJZKHWKHU
DQHZWHFKQRORJ\LVJRRGYDOXHIRUPRQH\FRVWHIIHFWLYHQHVVDQGRSSRUWXQLW\FRVW&RVW
HIIHFWLYHQHVVPHDVXUHVWKHQHWFRVWRISURYLGLQJDVHUYLFHDVZHOODVWKHHIIHFWLYHQHVVRI
WKHVHUYLFH7KHUHVXOWRIFRVWHIIHFWLYHQHVVDQDO\VLVLVH[SUHVVHGDVWKHPRQHWDU\FRVW
SHUXQLWRIHIIHFWLYHQHVV7RLOOXVWUDWHWKLVFRQFHSWOHWXVWDNHWKHH[DPSOHRIDQDVVLVWHG
UHSURGXFWLRQWHFKQRORJ\SURFHGXUH7KHFRVWLVPHDVXUHGDJDLQVWWKHGHVLUHGRXWFRPH
³DWDNHKRPHEDE\´QRWVLPSO\E\WKHFRVWRIWKHSURFHGXUH,IWKHVXFFHVVUDWHLVVD\
WKHQWKHFRVWSHUWDNHKRPHEDE\LVIRXUWLPHVWKHFRVWRIWKHSURFHGXUH,IDQHZ
WHFKQRORJ\LVFODLPHGWRUDLVHWKHVXFFHVVUDWHE\EXWWKHSURFHGXUHDOVRKDVDQ
DGGLWLRQDOFRVWZHQHHGWREHDULQPLQGWKDWIRUHDFKRQHDGGLWLRQDO³WDNHKRPHEDE\´
WHQSDWLHQWVPXVWUHFHLYHWKLVQHZSURFHGXUH7KHDGGLWLRQDOFRVWRIRQH³WDNHKRPH
EDE\´ZLOOEHWHQWLPHVWKHDGGLWLRQDOFRVWRIWKHQHZSURFHGXUH
7KHVHFRQGHFRQRPLFFRQFHSWLQMXGJLQJZKHWKHUDWHFKQRORJ\LVJRRGYDOXHIRU
PRQH\LVWKHRSSRUWXQLW\FRVW7KHFRQFHSWLPSOLHVWKDWLIUHVRXUFHVDUHXVHGLQRQH
ZD\DQRSSRUWXQLW\WRSURYLGHVRPHRWKHUEHQHILWKDVWREHUHQRXQFHG7RLOOXVWUDWH
WKLVFRQFHSWWDNHWKHH[DPSOHRIDKHDOWKSROLF\PDNHUGHFLGLQJRQZKHWKHUWRSURYLGH
LQIHUWLOLW\SDWLHQWVZLWKIUHHDVVLVWHGUHSURGXFWLRQVHUYLFHV7KHLVVXHLVQRWVLPSO\DERXW
KDYLQJHQRXJKEXGJHW7KHUHDUHRWKHUKHDOWKVHUYLFHVZKLFKFDQEH³ERXJKW´ZLWKWKH
VDPHOHYHORIUHVRXUFHV7KHLVVXHLVZKDWRSSRUWXQLWLHVWKHSROLF\PDNHUZLOOPLVVLI
UHVRXUFHVDUHDOORFDWHGWRWKLVVHUYLFH
Is the technology culturally and ethically acceptable?

7KHQH[WTXHVWLRQWRDGGUHVVLVZKHWKHUWKHKHDOWKWHFKQRORJ\LVFXOWXUDOO\DQG
HWKLFDOO\DFFHSWDEOH7KHDVVHVVPHQWKDVWREHGRQHLQWKHFRQWH[WRIHDFKFRXQWU\DQG
UHOLJLRQ7KLVTXHVWLRQLVSDUWLFXODUO\LPSRUWDQWLQUHSURGXFWLYHKHDOWKWHFKQRORJLHV
$VVLVWHG UHSURGXFWLRQ WHFKQRORJLHV DQG IHUWLOLW\ FRQWURO WHFKQRORJLHV DUH VXFK
H[DPSOHV
Are the system requirements available?

³6\VWHPUHTXLUHPHQWV´KDYHWREHFDUHIXOO\FKHFNHGEHIRUHDQ\QHZWHFKQRORJ\LV
FRQVLGHUHG7KLVWHUPLVXVHGLQFRPSXWHUMDUJRQ,IZHZDQWWRLQVWDOODQHZVRIWZDUH
SURJUDPRQWKHFRPSXWHUZHDUHDVNHGWRFKHFNWKDWWKHV\VWHPUHTXLUHPHQWVDUH
DYDLODEOHLQWHUPVRIRSHUDWLQJV\VWHPIUHHPHPRU\HWF,IZHGRQRWKDYHWKHV\VWHP
UHTXLUHPHQWVDQGZHVWLOOWU\WRLQVWDOOWKHVRIWZDUHWKHDWWHPSWZLOOEHUHMHFWHG1HZ
KHDOWKWHFKQRORJLHVKDYHV\VWHPUHTXLUHPHQWVLQWHUPVRIIDFLOLWLHVTXDOLILHGDQGWUDLQHG
SHUVRQQHOPDLQWHQDQFHDQGVXSSO\ORJLVWLFV,IZHWU\WRLQVWDOODQHZWHFKQRORJ\ZKHUH
WKHV\VWHPUHTXLUHPHQWVDUHODFNLQJLWZLOOQRWEHUHMHFWHGE\WKHV\VWHPEXWLWZLOOQRW
SHUIRUPDVGHVLUHGDQGPD\HYHQGRPRUHKDUPWKDQJRRGZDVWLQJUHVRXUFHVLQWKH
SURFHVV
6RFLDO FRQFHUQV DUH RIWHQ H[SUHVVHG DERXW WKH SUROLIHUDWLRQ RI QHZ KHDOWK
WHFKQRORJLHV+HDOWKSURIHVVLRQDOVQHHGWREHVRFLDOO\FRQVFLRXVDQGIXOO\DZDUHRI
WKHVHFRQFHUQV7KHUHLVFRQFHUQWKDWWKHSUROLIHUDWLRQRIKHDOWKWHFKQRORJLHVLVJHWWLQJ
RXWRIKDQGFRQWULEXWLQJWRHVFDODWLQJDQGVRDULQJFRVWVRIKHDOWKFDUH7KHUHLVFRQFHUQ
WKDWWKHKHDOWKGLYLGHEHWZHHQULFKDQGSRRUPD\ZLGHQLIWKHQHZWHFKQRORJLHVDUH
PRUHUHVSRQVLYHWRWKHQHHGVRIWKHULFKDQGDUHDYDLODEOHRQO\WRWKRVHZKRFDQDIIRUG
WKHLUKLJKFRVW7KHQWKHUHLVWKHFRQFHUQWKDWPHGLFLQHPD\EHPRYLQJWRRIDUDZD\
IURPLWVVRFLDOURRWVDQGWKDWKHDOWKSURIHVVLRQDOVDUHEHFRPLQJWHFKQLFLDQVUDWKHUWKDQ
KXPDQHSK\VLFLDQV+LSSRFUDWHVZURWHLQDERXW%&³:KRHYHUZLVKHVWRLQYHVWLJDWH
PHGLFLQHSURSHUO\VKRXOGSURFHHGWKXVLQWKHILUVWSODFHWRFRQVLGHUWKHVHDVRQVRIWKH
\HDU7KHQWKHZLQGV,QWKHVDPHPDQQHUZKHQRQHFRPHVLQWRDFLW\LQZKLFKKHLVD
VWUDQJHUKHVKRXOGFRQVLGHULWVVLWXDWLRQWKHZDWHUZKLFKWKHLQKDELWDQWVXVH«DQGWKH
PRGHLQZKLFKWKHLQKDELWDQWVOLYHDQGZKDWDUHWKHLUSXUVXLWV´1RZPHGLFDOWHDFKHUV
DGYLVHZKRHYHUZDQWVWRLQYHVWLJDWHPHGLFLQHSURSHUO\WRVWXG\PROHFXODUELRORJ\
SHUKDSVIRUJHWWLQJLQWKHSURFHVVWKDWWKHVHPROHFXOHVDQGFHOOVPDNHXSDKXPDQEHLQJ
ZLWKDVRFLDOOLIHRIKHURUKLVRZQ0DFKLQHVQRZVWDQGEHWZHHQGRFWRUVDQGSDWLHQWV
:LWKWKHREVHVVLRQZLWKWKH³WHFKQRORJ\IL[´WKHKXPDQHSK\VLFLDQPD\EHLQGDQJHU
RIEHFRPLQJRQHGD\DQHQGDQJHUHGVSHFLHV)DWKDOOD
14.5 Assessment and evaluation by investors in research

,QYHVWRUVLQKHDOWKUHVHDUFKH[SHFWDUHWXUQRQWKHLULQYHVWPHQW,WLVLQHYLWDEOHWKDW
WKHXQSUHGLFWDEOHQDWXUHRIPXFKVFLHQWLILFUHVHDUFKVKRXOGLQYLWHTXHVWLRQVDERXWYDOXH
IRUPRQH\$FRPPLWPHQWWRHYDOXDWLRQDQGDFFRXQWDELOLW\RQWKHSDUWRIWKHVFLHQWLILF
FRPPXQLW\LVIXQGDPHQWDOLIVFLHQFHLVQRWWREHPDUJLQDOL]HGLQWKHSXEOLFDQGSROLWLFDO
DJHQGDV5HVHDUFKLVDQLQYHVWPHQW
7KUHHDSSURDFKHVFDQEHSXUVXHGDQGDUHEHLQJXVHGWRHYDOXDWHWKHUHWXUQRQWKH
LQYHVWPHQWLQUHVHDUFKLPSDFWRQDGYDQFHPHQWRIVFLHQFHLPSDFWRQKHDOWKSURPRWLRQ
DQGLPSDFWRQZHDOWKFUHDWLRQ
Impact on the advancement of science

,QYHVWPHQWLQUHVHDUFKPD\EHHYDOXDWHGRQWKHEDVLVRIWKHTXDQWLW\DQGTXDOLW\
RIWKHVFLHQWLILFRXWSXW7KHVHDUHWKHFULWHULDFRPPRQO\XVHGIRUWKHHYDOXDWLRQRI
UHVHDUFKHUVDQGVFLHQWLILFLQVWLWXWLRQV*RYHUQPHQWVRQWKHEDVLVRIVXFKPHDVXUHVPD\
DOORFDWHIXQGLQJ&RPSXWHUVQRZDOORZELEOLRPHWULFDQDO\VLVWRSURYLGHPHDVXUHPHQW
RI SXEOLFDWLRQ RXWSXWV 6FLHQWLILF TXDOLW\ LV JHQHUDOO\ EDVHG RQ RULJLQDOLW\ RI WKH
VXEMHFWWKRXJKWDQGPHWKRG4XDQWLWDWLYHO\LWPD\EHPHDVXUHGDVWKHFRQWULEXWLRQ
WRWKHDGYDQFHPHQWRIVFLHQFHUHIOHFWHGRQWKHQXPEHURIWLPHVDSDSHUKDVEHHQ
FLWHGDVDUHIHUHQFHE\VXEVHTXHQWDXWKRUV7KLVLQIRUPDWLRQLVUHDGLO\DYDLODEOHIURP
WKH6FLHQFH&LWDWLRQ,QGH[6&,SURGXFHGE\WKH,QVWLWXWHRI6FLHQWLILF,QIRUPDWLRQ
,6,ZZZLVLQHWFRPLVLSURGXFWVFLWDWLRQVFL7KHMRXUQDOLQZKLFKWKHSDSHUKDV
EHHQSXEOLVKHGDOVRPDWWHUV-RXUQDOVDUHDVVLJQHG³LPSDFWIDFWRUV´7KHLPSDFWIDFWRU
PHDVXUHVWKHIUHTXHQF\ZLWKZKLFKWKH³DYHUDJHDUWLFOH´LQDMRXUQDOKDVEHHQFLWHG
LQDSDUWLFXODU\HDURUSHULRG,WSURYLGHVDZD\WRMXGJHWKHSUHVWLJHDQGLQIOXHQFHRID
SDUWLFXODUMRXUQDO
2QH RI WKH SULPDU\ REMHFWLYHV RI UHVHDUFK LV WR DGYDQFH VFLHQFH 6FLHQFH LV
DGYDQFHGVWHSE\VWHSWKURXJKWKHUHVHDUFKHIIRUWVRIVXFFHVVLYHLQYHVWLJDWRUV)URP
WKLVSHUVSHFWLYHLQWKHVFLHQWLILFFRPPXQLW\WKHLPSDFWRIUHVHDUFKLVQRWRQO\DERXWKRZ
ZLGHO\LWLVGLVVHPLQDWHGDQGUHDGWKHLPSDFWLVDOVRDERXWKRZPXFKLWFRQWULEXWHVWR
WKHDGYDQFHPHQWRIVFLHQFHE\EHLQJXVHGLQVXEVHTXHQWZRUNRIRWKHUUHVHDUFKHUV
6FLHQWLILFMRXUQDOVDUHQRWUDQNHGE\VFLHQWLVWVDFFRUGLQJWRWKHLUFLUFXODWLRQEXWE\
WKHLULPSDFWIDFWRUV7KHLPSDFWIDFWRUIRUDMRXUQDOLVFDOFXODWHGE\WKH6FLHQFH&LWDWLRQ
,QGH[,QVWLWXWHRI6FLHQWLILF,QIRUPDWLRQZZZLVLQHWFRP-RXUQDO&LWDWLRQ5HSRUWV
FDOFXODWHWKHQXPEHURIWLPHVWKDWDUWLFOHVIURPWKHMRXUQDOKDYHEHHQFLWHGGXULQJWKH
SUHYLRXVWZR\HDUVGLYLGHGE\WKHWRWDOQXPEHURIDUWLFOHVSXEOLVKHGE\WKHMRXUQDO
GXULQJWKLVSHULRG7KHLPSDFWIDFWRUJLYHVDFOXHWRLWVUHODWLYHLQWHOOHFWXDOLQIOXHQFH
6RPH-RXUQDOVZLWKKLJKLPSDFWIDFWRUVKDYHUHODWLYHO\VPDOOFLUFXODWLRQ)RUH[DPSOH
WKHMRXUQDO1DWXUHKDVDFLUFXODWLRQRIDERXWDQGDQHVWLPDWHGLPSDFWIDFWRURI
WKH-RXUQDORIWKH$PHULFDQ0HGLFDO$VVRFLDWLRQKDVDFLUFXODWLRQRIDERXW
DQGDQLPSDFWIDFWRUOHVVWKDQ%\UQH7KHFRQWULEXWLRQRIDVFLHQWLVWWRWKH
DGYDQFHPHQWRIVFLHQFHLVPHDVXUHGQRWE\WKHQXPEHURISXEOLFDWLRQVEXWE\WKHLPSDFW
RIWKHVHSXEOLFDWLRQV7KHLPSDFWRIWKHSXEOLFDWLRQVLVDVVHVVHGLQGLUHFWO\E\WKHLPSDFW
IDFWRUVRIWKHMRXUQDOVLQZKLFKWKH\ZHUHSXEOLVKHGDQGE\VXEVHTXHQWFLWDWLRQRIWKH
DUWLFOHVE\RWKHUDXWKRUV&LWDWLRQDQDO\VLVWHOOVXVWKDWEHWZHHQDWKLUGDQGRQHKDOIRI
SXEOLVKHGSDSHUVDUHQHYHUFLWHGHYHQRQFHLQVXEVHTXHQWUHIHUHQFHOLVWV/RFN
0DQ\DUWLFOHVDUHKDUGO\UHDGDWDOO
7RRPXFKHPSKDVLVKDVEHHQSXWRQLPSDFWIDFWRUVDQGWKLVHPSKDVLVKDVVHYHUDO
GUDZEDFNV6HJOHQ7KHLPSDFWPD\EHWHFKQLFDOO\XQUHODWHGWRWKHVFLHQWLILF
TXDOLW\RIWKHSXEOLFDWLRQ,WVKRXOGDOVREHQRWHGWKDWFLWDWLRQLPSDFWLQFUHDVHVDVRQH
PRYHVIURPFOLQLFDOWREDVLFUHVHDUFK'DZVRQHWDO$VVHVVPHQWRIWKHLPSDFW
IDFWRUGRHVQRWGRMXVWLFHWRDUHDVRIUHVHDUFKGLUHFWO\DSSOLFDEOHWRLPSURYHPHQWRI
KHDOWK
Impact on health promotion

7KHPDLQDLPRIKHDOWKUHVHDUFKLVWRLPSURYHWKHKHDOWKRIWKHSHRSOH6FLHQWLILF
TXDOLW\DQGLPSDFWRQKHDOWKGRQRWDOZD\VJRWRJHWKHU0XFKUHVHDUFKWKDWVFLHQWLVWVPD\
MXGJHWREHRIKLJKTXDOLW\KDVQRPHDVXUDEOHLPSDFWRQKHDOWKRIWHQEHFDXVHWKHUHPD\
EHGHFDGHVEHIRUHLWKDVDQLPSDFW,QFRQWUDVWUHVHDUFKWKDWPD\QRWEHMXGJHGDVKLJK
TXDOLW\E\VFLHQWLVWVEHFDXVHRILWVODFNRIJODPRXUPD\KDYHLPPHGLDWHKHDOWKEHQHILWV
LILWKDVLPSRUWDQWKHDOWKSROLF\LPSOLFDWLRQV(YDOXDWLRQRIWKHLQYHVWPHQWLQUHVHDUFK
LQWHUPVRILPSDFWRQKHDOWKSURPRWLRQLVQRWHDV\+RZHYHUWKLVLVQRWDUHDVRQIRUQRW
GRLQJLWZLWKWKHDSSOLFDWLRQRITXDOLWDWLYHDVZHOODVTXDQWLWDWLYHPHWKRGRORJLHV,WLV
QHHGHGDQGLWLVQHFHVVDU\IRUSXEOLFDQGQRWIRUSURILWSULYDWHLQYHVWRUVLQUHVHDUFK
,QWKHHYDOXDWLRQRIWKHLPSDFWRIUHVHDUFKRQKHDOWKSURPRWLRQWKHUHLVDQHFRQRPLF
UHWXUQZKLFKVKRXOGQRWEHXQGHUYDOXHG+XPDQOLYHVDUHVDYHGDQGDKXPDQOLIHKDV
PRQHWDU\ZRUWKLQLWVLPSDFWRQHFRQRPLFSURGXFWLYLW\+HDOWKLVZHDOWK:KDWPD\
QRWEHJHQHUDOO\DSSUHFLDWHGLVWKDWWKHUHDUHVDYLQJVIRUWKHKHDOWKVHUYLFHE\XVLQJ
DSSURSULDWHWHFKQRORJLHVDQGGLVFDUGLQJLQHIIHFWLYHSURFHGXUHVRULQWHUYHQWLRQVDQG
UDWLRQDODOORFDWLRQRIUHVRXUFHV([SHQGLWXUHRQUHVHDUFKE\WKH8.1DWLRQDO+HDOWK
6HUYLFH1+6KDVEHHQHVWLPDWHGWREHPRUHWKDQPLOOLRQSRXQGVVWHUOLQJHYHU\
\HDU:HOOFRPH7UXVW,QMXVWLI\LQJDUHODWLYHO\KLJKOHYHORIH[SHQGLWXUHRQKHDOWK
UHVHDUFKWKH1+6DIILUPHGWKHWUXLVPWKDWSXEOLFO\IXQGHGUHVHDUFKLVDVLPSRUWDQWLQ
WKH1+6WRHQDEOHPDQDJHUVWRVDYHPRQH\DVLWLVLQLQGXVWU\IRUPDNLQJPRQH\RQ
QHZSURGXFWVDQGVHUYLFHV5R\DO&ROOHJHRI3DWKRORJLVWV
0DU\/DVNHUDZHOONQRZQSKLODQWKURSLVWZKRSOD\HGDFHQWUDOUROHLQWKHUDSLG
H[SDQVLRQRIPHGLFDOUHVHDUFKDQGSXEOLFKHDOWKLQWKH86$KDVEHHQTXRWHGDVVD\LQJ
³,I\RXWKLQNUHVHDUFKLVH[SHQVLYHWU\GLVHDVH´,QWKH/DVNHU)RXQGDWLRQWKURXJK
LWV)XQGLQJ)LUVWLQLWLDWLYHDVNHGQLQHDFDGHPLFHFRQRPLVWVIURPWKHXQLYHUVLWLHVRI
&KLFDJR&ROXPELD+DUYDUG6WDQIRUGDQG<DOHWRIRFXVRQWKHHFRQRPLFYDOXHRI
WKHLQFUHDVHLQOLIHH[SHFWDQF\DQGWKHLPSUHVVLYHGHFOLQHLQPRUWDOLW\7KHUHSRUW
³([FHSWLRQDOUHWXUQVWKHHFRQRPLFYDOXHRI$PHULFD¶VLQYHVWPHQWLQPHGLFDOUHVHDUFK´
KWWSZZZODVNHUIRXQGDWLRQRUJUHSRUWVSGIH[FHSWLRQDOSGIHVWLPDWHGWKHLQFUHDVHLQ
OLIHH[SHFWDQF\LQWKH8QLWHG6WDWHVEHWZHHQDQGWREHZRUWKURXJKO\86
WULOOLRQD\HDU5HGXFHGPRUWDOLW\IURPFDUGLRYDVFXODUGLVHDVHDORQHZDVHVWLPDWHGWREH
ZRUWK86WULOOLRQD\HDU(YHQLIRQO\DVPDOOSHUFHQWDJHRIWKLVJDLQLVDWWULEXWHGWR
DGYDQFHVLQUHVHDUFKWKHUHWXUQRQWKHUHVHDUFKLQYHVWPHQWZRXOGEHHQRUPRXV
7KHUHDUHDOVRFRVWVDYLQJVWRWKHKHDOWKVHUYLFHDVDUHVXOWRISURSHUO\FRQGXFWHG
KHDOWKUHVHDUFK&RVWVDYLQJVLQFOXGHPRQH\VDYHGIURPKRVSLWDOL]DWLRQDYRLGHGDQGIURP
SURGXFWLRQZRUNJDLQHGIURPPHGLFDOSURFHGXUHVQRWUHTXLUHG)RUH[DPSOHSUHYHQWLQJ
KLSIUDFWXUHVLQSRVWPHQRSDXVDOZRPHQDWULVNRIRVWHRSRURVLVFDQVDYHKXQGUHGVRI
PLOOLRQVRIGROODUVDQQXDOO\LQWUHDWPHQWFRVWVDSDUWIURPORVVRISURGXFWLYLW\2QHVWXG\
LQWKH86$LQGLFDWHGWKDWIRUHYHU\GROODULQYHVWHGWKURXJKRXWWKHSXEOLFDQGSULYDWH
VHFWRUVWKHUHZDVDUHWXUQRIDWOHDVWWKUHHWRRQHIURPFRVWVDYLQJVDORQH5RVHQEHUJ

Impact on wealth creation

+HDOWKUHVHDUFKPD\EHYLHZHGDVDQHQJLQHIRUHFRQRPLFJURZWKLQGHYHORSHG
DQGDOVRUHFHQWO\LQVRPHGHYHORSLQJFRXQWULHV7KHKHDOWKLQGXVWU\LVRQHRIWKHIDVWHVW
JURZLQJLQGXVWULHVDQGRQHRIWKHPRVWSURILWDEOH,WKDVEHHQHVWLPDWHGWKDWFRPSDQLHV
LQWKHKHDOWKFDUHPDUNHWSODFHFRQWULEXWHDERXWRIWKHJURVVGHYHORSPHQWSURGXFWLQ
WKH8.DQGJHQHUDWHDWUDGHVXUSOXVRIVRPHELOOLRQSRXQGVVWHUOLQJ5R\DO&ROOHJHRI
3DWKRORJLVWV-REFUHDWLRQLQWKHSULYDWHVHFWRULVDQRWKHUSDUDPHWHU,WKDVEHHQ
HVWLPDWHGWKDWWKHUHDUHPRUHWKDQSHRSOHHPSOR\HGLQWKH86ELRSKDUPDFHXWLFDO
LQGXVWU\EHFDXVHRIFRPPLWPHQWVWRUHVHDUFKDQGGHYHORSPHQW5RVHQEHUJ7KHVH
KLJKSD\LQJHPSOR\PHQWRSSRUWXQLWLHVZRXOGQRWKDYHH[LVWHGLIJRYHUQPHQWZDVQRW
SULPLQJWKHVFLHQWLILFSXPSE\VXSSRUWLQJUHVHDUFK
*RYHUQPHQWVHQFRXUDJHDQGVXSSRUWEDVLFUHVHDUFKWKDWFDQSURYLGHSURPLVLQJOHDGV
IRUGLVFRYHU\LQQRYDWLRQDQGZHDOWKFUHDWLRQ)RULPSDFWVRQZHDOWKFUHDWLRQSDWHQW
FLWDWLRQLQGLFDWRUVKDYHEHHQXVHGWRHYDOXDWHWKHLQYHVWPHQWLQUHVHDUFK86SDWHQWVFLWH
SDSHUVDV³SULRUDUW´WKDWLVWKHUHVHDUFKWKDWKDVIRUPHGWKHEDVLVIRUWKHGHYHORSPHQW
RIDQHZDQGQRYHOSURGXFW7KH:HOOFRPHWUXVWIRUH[DPSOHPDLQWDLQV7HFK7UDFDQ
LQKRXVHGDWDEDVHWROLQNSXEOLFDWLRQVLQWKH8.ZLWKWKH86SDWHQWSULRUDUWLQIRUPDWLRQ
'DZVRQHWDO
7KH LPSRUWDQFH RI KHDOWK UHVHDUFK IRU GHYHORSPHQW KDV UHFHLYHG LQFUHDVLQJ
LQWHUQDWLRQDODWWHQWLRQRYHUWKHSDVW±\HDUV,Q2FWREHUDQ,QWHUQDWLRQDO
&RQIHUHQFHRQ+HDOWK5HVHDUFKIRU'HYHORSPHQWZDVFRQYHQHGLQ%DQJNRNFR
VSRQVRUHGE\WKH&RXQFLORQ+HDOWK5HVHDUFKIRU'HYHORSPHQWWKH*OREDO)RUXPIRU
+HDOWK5HVHDUFKWKH:RUOG%DQNDQGWKH:RUOG+HDOWK2UJDQL]DWLRQ7KH&RQIHUHQFH
LVVXHGDGHFODUDWLRQ$QQH[$PLQLVWHULDOVXPPLWRQKHDOWKUHVHDUFKLVSODQQHGE\
:+2IRU1RYHPEHULQ0H[LFR

Reading the medical literature. Applying evidence to practice. Washington, DC, American
College of Obstetricians and Gynaecologists, 1998.
Bero L, Rennie D. The Cochrane Collaboration: preparing, maintaining and disseminating
systematic reviews of the effects of health care. Journal of the American Medical Association,
1995, 274: 1935–8.
Byrne DW. Publishing your medical research paper. Baltimore, Williams & Wilkins, 1998:
52.
Dawson G, Lucocq B, Cottrell R, Lewinson G. Mapping the landscape. National biomedical
research outputs 1988–95. Policy report No. 9. London, The Wellcome Trust, 1998: 47.
de Vet HCW, Knipschild PG, Schouten HJA, et al. Interobserver variation in histopathological
grading of cervical dysplasia. Journal of Clininical Epidemiology, 1990, 43: 1395–1398.
Fathalla MF. Appropriate technology in reproductive health. Egyptian Fertility and Sterility
Society Journal, 2003, 7: 37–41.
Fathalla MF. When medicine rediscovered its social roots. Bulletin of the World Health
Organization, 2000, 78: 677–678.
Farquhar CM. Evidence-based medicine and getting research into practice. In: O’Brien
PMS, Pipkin FB, eds. Introduction to research methodology for specialists and trainees.
London, Royal College of Obstetricians and Gynaecologists Press, 1999: 84–93.
Friedland DJ, ed. Evidence-based medicine: A framework for clinical practice. Stamford,
Appleton & Lange, 1998.
Gehlbach SH. Interpreting the medical literature. 3rd edition. New York, McGraw-Hill
Inc., 1993.
BMJ Books, 1997: 53.
Lock S. Foreword. In: Hawkins C, Sorgi M, eds. Research: how to plan, speak and write
about it. Berlin, Springer-Verlag, 1985: vii.
McAlister FA, Straus SE, Guyatt GH, Haynes RB, for the Evidence-based Medicine
Working Group. Users’ guides to the medical literature XX. Integrating research evidence
with the care of the individual patient. Journal of the American Medical Association, 2000,
283: 2829–2836.
Rosenberg LE. Exceptional economic returns on investments in medical research. Medical
Journal of Australia, 2002, 177: 368–371.
Sustaining the strength of the UK in healthcare and life sciences R&D: Competition,
cooperation and cultural change. A report on the third SmithKline Beecham R&D Policy
Symposium. Oxted, ScienceBridge, 1996: 12.
Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based
medicine: how to practice and teach EBM, 2nd edition. Edinburgh, New York, Churchill
Livingstone, 2000.
Seglen P.O. Why the impact factor of journals should not be used for evaluating research.
British Medical Journal, 1997, 314: 497.
U.S.Preventive Services Task Force. Guide to clinical preventive services: An assessment
of the effectiveness of 169 interventions. Baltimore, Williams & Wilkins, 1989.
Wellcome Trust and National Health Service Executive. Putting NHS research on the
map: an analysis of scientific publications in England 1990–1997. London, The Wellcome
Trust, 2001. (http://www.wellcome.ac.uk. accessed 30/3/2004).
World Health Organization Department of Reproductive Health and Research, 2002. The
WHO Reproductive Health Library, No. 5 [CD-ROM]. Geneva (WHO/RHR/02.1).
Annex 1
World Medical Association
Declaration of Helsinki
Ethical principles for medical
research involving human subjects
$GRSWHGE\WKHWK:RUOG0HGLFDO$VVRFLDWLRQ:0$*HQHUDO$VVHPEO\

+HOVLQNL)LQODQG-XQH
DQGDPHQGHGE\WKH
WK:0$*HQHUDO$VVHPEO\7RN\R-DSDQ2FWREHU
WK:0$*HQHUDO$VVHPEO\9HQLFH,WDO\2FWREHU
VW:0$*HQHUDO$VVHPEO\+RQJ.RQJ6HSWHPEHU
WK:0$*HQHUDO$VVHPEO\6RPHUVHW:HVW5HSXEOLFRI6RXWK$IULFD
2FWREHU
DQGWKH
QG:0$*HQHUDO$VVHPEO\(GLQEXUJK6FRWODQG2FWREHU
1RWHRIFODULILFDWLRQRQSDUDJUDSKDGGHGE\WKH:0$*HQHUDO$VVHPEO\
:DVKLQJWRQ
A. Introduction
7KH :RUOG 0HGLFDO$VVRFLDWLRQ KDV GHYHORSHG WKH 'HFODUDWLRQ RI +HOVLQNL DV D
VWDWHPHQWRIHWKLFDOSULQFLSOHVWRSURYLGHJXLGDQFHWRSK\VLFLDQVDQGRWKHUSDUWLFLSDQWV
LQPHGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWV0HGLFDOUHVHDUFKLQYROYLQJKXPDQ
VXEMHFWVLQFOXGHVUHVHDUFKRQLGHQWLILDEOHKXPDQPDWHULDORULGHQWLILDEOHGDWD
,WLVWKHGXW\RIWKHSK\VLFLDQWRSURPRWHDQGVDIHJXDUGWKHKHDOWKRIWKHSHRSOH7KH
SK\VLFLDQ¶VNQRZOHGJHDQGFRQVFLHQFHDUHGHGLFDWHGWRWKHIXOILOPHQWRIWKLVGXW\
7KH'HFODUDWLRQRI*HQHYDRIWKH:RUOG0HGLFDO$VVRFLDWLRQELQGVWKHSK\VLFLDQ
ZLWKWKHZRUGV³7KHKHDOWKRIP\SDWLHQWZLOOEHP\ILUVWFRQVLGHUDWLRQ´DQGWKH
,QWHUQDWLRQDO&RGHRI0HGLFDO(WKLFVGHFODUHVWKDW³$SK\VLFLDQVKDOODFWRQO\LQ
WKHSDWLHQW¶VLQWHUHVWZKHQSURYLGLQJPHGLFDOFDUHZKLFKPLJKWKDYHWKHHIIHFWRI
ZHDNHQLQJWKHSK\VLFDODQGPHQWDOFRQGLWLRQRIWKHSDWLHQW´
0HGLFDO SURJUHVV LV EDVHG RQ UHVHDUFK ZKLFK XOWLPDWHO\ PXVW UHVW LQ SDUW RQ
H[SHULPHQWDWLRQLQYROYLQJKXPDQVXEMHFWV
,QPHGLFDOUHVHDUFKRQKXPDQVXEMHFWVFRQVLGHUDWLRQVUHODWHGWRWKHZHOOEHLQJRIWKH
KXPDQVXEMHFWVKRXOGWDNHSUHFHGHQFHRYHUWKHLQWHUHVWVRIVFLHQFHDQGVRFLHW\
7KHSULPDU\SXUSRVHRIPHGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWVLVWRLPSURYH
SURSK\ODFWLFGLDJQRVWLFDQGWKHUDSHXWLFSURFHGXUHVDQGWKHXQGHUVWDQGLQJRIWKH
DHWLRORJ\DQGSDWKRJHQHVLVRIGLVHDVH(YHQWKHEHVWSURYHQSURSK\ODFWLFGLDJQRVWLF
DQGWKHUDSHXWLFPHWKRGVPXVWFRQWLQXRXVO\EHFKDOOHQJHGWKURXJKUHVHDUFKIRUWKHLU
HIIHFWLYHQHVVHIILFLHQF\DFFHVVLELOLW\DQGTXDOLW\
,QFXUUHQWPHGLFDOSUDFWLFHDQGLQPHGLFDOUHVHDUFKPRVWSURSK\ODFWLFGLDJQRVWLF
DQGWKHUDSHXWLFSURFHGXUHVLQYROYHULVNVDQGEXUGHQV
0HGLFDOUHVHDUFKLVVXEMHFWWRHWKLFDOVWDQGDUGVWKDWSURPRWHUHVSHFWIRUDOOKXPDQ
EHLQJVDQGSURWHFWWKHLUKHDOWKDQGULJKWV6RPHUHVHDUFKSRSXODWLRQVDUHYXOQHUDEOH
DQGQHHGVSHFLDOSURWHFWLRQ7KHSDUWLFXODUQHHGVRIWKHHFRQRPLFDOO\DQGPHGLFDOO\
GLVDGYDQWDJHGPXVWEHUHFRJQL]HG6SHFLDODWWHQWLRQLVDOVRUHTXLUHGIRUWKRVHZKR
FDQQRWJLYHRUUHIXVHFRQVHQWIRUWKHPVHOYHVIRUWKRVHZKRPD\EHVXEMHFWWRJLYLQJ
FRQVHQWXQGHUGXUHVVIRUWKRVHZKRZLOOQRWEHQHILWSHUVRQDOO\IURPWKHUHVHDUFK
DQGIRUWKRVHIRUZKRPWKHUHVHDUFKLVFRPELQHGZLWKFDUH
5HVHDUFK,QYHVWLJDWRUVVKRXOGEHDZDUHRIWKHHWKLFDOOHJDODQGUHJXODWRU\UHTXLUHPHQWV
IRUUHVHDUFKRQKXPDQVXEMHFWVLQWKHLURZQFRXQWULHVDVZHOODVDSSOLFDEOHLQWHUQDWLRQDO
UHTXLUHPHQWV1RQDWLRQDOHWKLFDOOHJDORUUHJXODWRU\UHTXLUHPHQWVKRXOGEHDOORZHG
WRUHGXFHRUHOLPLQDWHDQ\RIWKHSURWHFWLRQVIRUKXPDQVXEMHFWVVHWIRUWKLQWKLV
'HFODUDWLRQ
B. Basic principles for all medical research

,WLVWKHGXW\RIWKHSK\VLFLDQLQPHGLFDOUHVHDUFKWRSURWHFWWKHOLIHKHDOWKSULYDF\
DQGGLJQLW\RIWKHKXPDQVXEMHFW
0HGLFDO UHVHDUFK LQYROYLQJ KXPDQ VXEMHFWV PXVW FRQIRUP WR JHQHUDOO\ DFFHSWHG
VFLHQWLILFSULQFLSOHVEHEDVHGRQDWKRURXJKNQRZOHGJHRIWKHVFLHQWLILFOLWHUDWXUHRWKHU
UHOHYDQWVRXUFHVRILQIRUPDWLRQDQGRQDGHTXDWHODERUDWRU\DQGZKHUHDSSURSULDWH
DQLPDOH[SHULPHQWDWLRQ
$SSURSULDWHFDXWLRQPXVWEHH[HUFLVHGLQWKHFRQGXFWRIUHVHDUFKZKLFKPD\DIIHFW
WKHHQYLURQPHQWDQGWKHZHOIDUHRIDQLPDOVXVHGIRUUHVHDUFKPXVWEHUHVSHFWHG
7KHGHVLJQDQGSHUIRUPDQFHRIHDFKH[SHULPHQWDOSURFHGXUHLQYROYLQJKXPDQVXEMHFWV
VKRXOGEHFOHDUO\IRUPXODWHGLQDQH[SHULPHQWDOSURWRFRO7KLVSURWRFROVKRXOGEH
VXEPLWWHGIRUFRQVLGHUDWLRQFRPPHQWJXLGDQFHDQGZKHUHDSSURSULDWHDSSURYDO
WRDVSHFLDOO\DSSRLQWHGHWKLFDOUHYLHZFRPPLWWHHZKLFKPXVWEHLQGHSHQGHQWRI
WKHLQYHVWLJDWRUWKHVSRQVRURUDQ\RWKHUNLQGRIXQGXHLQIOXHQFH7KLVLQGHSHQGHQW
Declaration of Helsinki 187
FRPPLWWHHVKRXOGEHLQFRQIRUPLW\ZLWKWKHODZVDQGUHJXODWLRQVRIWKHFRXQWU\LQ
ZKLFKWKHUHVHDUFKH[SHULPHQWLVSHUIRUPHG7KHFRPPLWWHHKDVWKHULJKWWRPRQLWRU
RQJRLQJWULDOV7KHUHVHDUFKHUKDVWKHREOLJDWLRQWRSURYLGHPRQLWRULQJLQIRUPDWLRQWR
WKHFRPPLWWHHHVSHFLDOO\DQ\VHULRXVDGYHUVHHYHQWV7KHUHVHDUFKHUVKRXOGDOVRVXEPLW
WRWKHFRPPLWWHHIRUUHYLHZLQIRUPDWLRQUHJDUGLQJIXQGLQJVSRQVRUVLQVWLWXWLRQDO
DIILOLDWLRQVRWKHUSRWHQWLDOFRQIOLFWVRILQWHUHVWDQGLQFHQWLYHVIRUVXEMHFWV
7KHUHVHDUFKSURWRFROVKRXOGDOZD\VFRQWDLQDVWDWHPHQWRIWKHHWKLFDOFRQVLGHUDWLRQV
LQYROYHGDQGVKRXOGLQGLFDWHWKDWWKHUHLVFRPSOLDQFHZLWKWKHSULQFLSOHVHQXQFLDWHG
LQWKLV'HFODUDWLRQ
0HGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWVVKRXOGEHFRQGXFWHGRQO\E\VFLHQWLILFDOO\
TXDOLILHGSHUVRQVDQGXQGHUWKHVXSHUYLVLRQRIDFOLQLFDOO\FRPSHWHQWPHGLFDOSHUVRQ
7KHUHVSRQVLELOLW\IRUWKHKXPDQVXEMHFWPXVWDOZD\VUHVWZLWKDPHGLFDOO\TXDOLILHG
SHUVRQDQGQHYHUUHVWRQWKHVXEMHFWRIWKHUHVHDUFKHYHQWKRXJKWKHVXEMHFWKDV
JLYHQFRQVHQW
(YHU\PHGLFDOUHVHDUFKSURMHFWLQYROYLQJKXPDQ VXEMHFWVVKRXOG EH SUHFHGHGE\
FDUHIXODVVHVVPHQWRISUHGLFWDEOHULVNVDQGEXUGHQVLQFRPSDULVRQZLWKIRUHVHHDEOH
EHQHILWV WR WKH VXEMHFW RU WR RWKHUV 7KLV GRHV QRW SUHFOXGH WKH SDUWLFLSDWLRQ RI
KHDOWK\YROXQWHHUVLQPHGLFDOUHVHDUFK7KHGHVLJQRIDOOVWXGLHVVKRXOGEHSXEOLFO\
DYDLODEOH
3K\VLFLDQVVKRXOGDEVWDLQIURPHQJDJLQJLQUHVHDUFKSURMHFWVLQYROYLQJKXPDQVXEMHFWV
XQOHVVWKH\DUHFRQILGHQWWKDWWKHULVNVLQYROYHGKDYHEHHQDGHTXDWHO\DVVHVVHGDQG
FDQEHVDWLVIDFWRULO\PDQDJHG3K\VLFLDQVVKRXOGFHDVHDQ\LQYHVWLJDWLRQLIWKHULVNV
DUHIRXQGWRRXWZHLJKWKHSRWHQWLDOEHQHILWVRULIWKHUHLVFRQFOXVLYHSURRIRISRVLWLYH
DQGEHQHILFLDOUHVXOWV
0HGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWVVKRXOGRQO\EHFRQGXFWHGLIWKHLPSRUWDQFH
RI WKH REMHFWLYH RXWZHLJKV WKH LQKHUHQW ULVNV DQG EXUGHQV WR WKH VXEMHFW 7KLV LV
HVSHFLDOO\LPSRUWDQWZKHQWKHKXPDQVXEMHFWVDUHKHDOWK\YROXQWHHUV
0HGLFDO UHVHDUFK LV RQO\ MXVWLILHG LI WKHUH LV D UHDVRQDEOH OLNHOLKRRG WKDW WKH
SRSXODWLRQVLQZKLFKWKHUHVHDUFKLVFDUULHGRXWVWDQGWREHQHILWIURPWKHUHVXOWVRI
WKHUHVHDUFK
7KHVXEMHFWVPXVWEHYROXQWHHUVDQGLQIRUPHGSDUWLFLSDQWVLQWKHUHVHDUFKSURMHFW
7KHULJKWRIUHVHDUFKVXEMHFWVWRVDIHJXDUGWKHLULQWHJULW\PXVWDOZD\VEHUHVSHFWHG
(YHU\SUHFDXWLRQVKRXOGEHWDNHQWRUHVSHFWWKHSULYDF\RIWKHVXEMHFWWKHFRQILGHQWLDOLW\
RIWKHSDWLHQW¶VLQIRUPDWLRQDQGWRPLQLPL]HWKHLPSDFWRIWKHVWXG\RQWKHVXEMHFW¶V
SK\VLFDODQGPHQWDOLQWHJULW\DQGRQWKHSHUVRQDOLW\RIWKHVXEMHFW
,QDQ\UHVHDUFKRQKXPDQEHLQJVHDFKSRWHQWLDOVXEMHFWPXVWEHDGHTXDWHO\LQIRUPHG
RIWKHDLPVPHWKRGVVRXUFHVRIIXQGLQJDQ\SRVVLEOHFRQIOLFWVRILQWHUHVWLQVWLWXWLRQDO
DIILOLDWLRQVRIWKHUHVHDUFKHUWKHDQWLFLSDWHGEHQHILWVDQGSRWHQWLDOULVNVRIWKHVWXG\
DQGWKHGLVFRPIRUWLWPD\HQWDLO7KHVXEMHFWVKRXOGEHLQIRUPHGRIWKHULJKWWRDEVWDLQ
IURP SDUWLFLSDWLRQ LQ WKH VWXG\ RU WR ZLWKGUDZ FRQVHQW WR SDUWLFLSDWH DW DQ\ WLPH
ZLWKRXWUHSULVDO$IWHUHQVXULQJWKDWWKHVXEMHFWKDVXQGHUVWRRGWKHLQIRUPDWLRQWKH
SK\VLFLDQVKRXOGWKHQREWDLQWKHVXEMHFW¶VIUHHO\JLYHQLQIRUPHGFRQVHQWSUHIHUDEO\
LQZULWLQJ,IWKHFRQVHQWFDQQRWEHREWDLQHGLQZULWLQJWKHQRQZULWWHQFRQVHQWPXVW
EHIRUPDOO\GRFXPHQWHGDQGZLWQHVVHG
:KHQREWDLQLQJLQIRUPHGFRQVHQWIRUWKHUHVHDUFKSURMHFWWKHSK\VLFLDQVKRXOGEH
SDUWLFXODUO\FDXWLRXVLIWKHVXEMHFWLVLQDGHSHQGHQWUHODWLRQVKLSZLWKWKHSK\VLFLDQ
RUPD\FRQVHQWXQGHUGXUHVV,QWKDWFDVHWKHLQIRUPHGFRQVHQWVKRXOGEHREWDLQHG
E\DZHOOLQIRUPHGSK\VLFLDQZKRLVQRWHQJDJHGLQWKHLQYHVWLJDWLRQDQGZKRLV
FRPSOHWHO\LQGHSHQGHQWRIWKLVUHODWLRQVKLS
)RUDUHVHDUFKVXEMHFWZKRLVOHJDOO\LQFRPSHWHQWSK\VLFDOO\RUPHQWDOO\LQFDSDEOH
RIJLYLQJFRQVHQWRULVDOHJDOO\LQFRPSHWHQWPLQRUWKHLQYHVWLJDWRUPXVWREWDLQ
LQIRUPHG FRQVHQW IURP WKH OHJDOO\ DXWKRUL]HG UHSUHVHQWDWLYH LQ DFFRUGDQFH ZLWK
DSSOLFDEOHODZ7KHVHJURXSVVKRXOGQRWEHLQFOXGHGLQUHVHDUFKXQOHVVWKHUHVHDUFK
LVQHFHVVDU\WRSURPRWHWKHKHDOWKRIWKHSRSXODWLRQUHSUHVHQWHGDQGWKLVUHVHDUFK
FDQQRWLQVWHDGEHSHUIRUPHGRQOHJDOO\FRPSHWHQWSHUVRQV
:KHQDVXEMHFWGHHPHGOHJDOO\LQFRPSHWHQWVXFKDVDPLQRUFKLOGLVDEOHWRJLYH
DVVHQWWRGHFLVLRQVDERXWSDUWLFLSDWLRQLQUHVHDUFKWKHLQYHVWLJDWRUPXVWREWDLQWKDW
DVVHQWLQDGGLWLRQWRWKHFRQVHQWRIWKHOHJDOO\DXWKRUL]HGUHSUHVHQWDWLYH
5HVHDUFKRQLQGLYLGXDOVIURPZKRPLWLVQRWSRVVLEOHWRREWDLQFRQVHQWLQFOXGLQJ
SUR[\RUDGYDQFHFRQVHQWVKRXOGEHGRQHRQO\LIWKHSK\VLFDOPHQWDOFRQGLWLRQWKDW
SUHYHQWV REWDLQLQJ LQIRUPHG FRQVHQW LV D QHFHVVDU\ FKDUDFWHULVWLF RI WKH UHVHDUFK
SRSXODWLRQ7KHVSHFLILFUHDVRQVIRULQYROYLQJUHVHDUFKVXEMHFWVZLWKDFRQGLWLRQWKDW
UHQGHUVWKHPXQDEOHWRJLYHLQIRUPHGFRQVHQWVKRXOGEHVWDWHGLQWKHH[SHULPHQWDO
SURWRFROIRUFRQVLGHUDWLRQDQGDSSURYDORIWKHUHYLHZFRPPLWWHH7KHSURWRFROVKRXOG
VWDWHWKDWFRQVHQWWRUHPDLQLQWKHUHVHDUFKVKRXOGEHREWDLQHGDVVRRQDVSRVVLEOH
IURPWKHLQGLYLGXDORUDOHJDOO\DXWKRUL]HGVXUURJDWH
%RWKDXWKRUVDQGSXEOLVKHUVKDYHHWKLFDOREOLJDWLRQV,QSXEOLFDWLRQRIWKHUHVXOWVRI
UHVHDUFKWKHLQYHVWLJDWRUVDUHREOLJHGWRSUHVHUYHWKHDFFXUDF\RIWKHUHVXOWV1HJDWLYH
DVZHOODVSRVLWLYHUHVXOWVVKRXOGEHSXEOLVKHGRURWKHUZLVHSXEOLFO\DYDLODEOH6RXUFHV
RIIXQGLQJLQVWLWXWLRQDODIILOLDWLRQVDQGDQ\SRVVLEOHFRQIOLFWVRILQWHUHVWVKRXOGEH
GHFODUHGLQWKHSXEOLFDWLRQ5HSRUWVRIH[SHULPHQWDWLRQQRWLQDFFRUGDQFHZLWKWKH
SULQFLSOHVODLGGRZQLQWKLV'HFODUDWLRQVKRXOGQRWEHDFFHSWHGIRUSXEOLFDWLRQ
Declaration of Helsinki 189
C. Additional principles for medical research combined with

medical care
7KHSK\VLFLDQPD\FRPELQHPHGLFDOUHVHDUFKZLWKPHGLFDOFDUHRQO\WRWKHH[WHQW
WKDWWKHUHVHDUFKLVMXVWLILHGE\LWVSRWHQWLDOSURSK\ODFWLFGLDJQRVWLFRUWKHUDSHXWLF
YDOXH:KHQPHGLFDOUHVHDUFKLVFRPELQHGZLWKPHGLFDOFDUHDGGLWLRQDOVWDQGDUGV
DSSO\WRSURWHFWWKHSDWLHQWVZKRDUHUHVHDUFKVXEMHFWV
7KH EHQHILWV ULVNV EXUGHQV DQG HIIHFWLYHQHVV RI D QHZ PHWKRG VKRXOG EH WHVWHG
DJDLQVWWKRVHRIWKHEHVWFXUUHQWSURSK\ODFWLFGLDJQRVWLFDQGWKHUDSHXWLFPHWKRGV
7KLVGRHVQRWH[FOXGHWKHXVHRISODFHERRUQRWUHDWPHQWLQVWXGLHVZKHUHQRSURYHQ
SURSK\ODFWLFGLDJQRVWLFRUWKHUDSHXWLFPHWKRGH[LVWV6HHIRRWQRWH
$WWKHFRQFOXVLRQRIWKHVWXG\HYHU\SDWLHQWHQWHUHGLQWRWKHVWXG\VKRXOGEHDVVXUHGRI
DFFHVVWRWKHEHVWSURYHQSURSK\ODFWLFGLDJQRVWLFDQGWKHUDSHXWLFPHWKRGVLGHQWLILHG
E\WKHVWXG\
7KHSK\VLFLDQVKRXOGIXOO\LQIRUPWKHSDWLHQWZKLFKDVSHFWVRIWKHFDUHDUHUHODWHG
WRWKHUHVHDUFK7KHUHIXVDORIDSDWLHQWWRSDUWLFLSDWHLQDVWXG\PXVWQHYHULQWHUIHUH
ZLWKWKHSDWLHQWSK\VLFLDQUHODWLRQVKLS
,QWKHWUHDWPHQWRIDSDWLHQWZKHUHSURYHQSURSK\ODFWLFGLDJQRVWLFDQGWKHUDSHXWLF
PHWKRGVGRQRWH[LVWRUKDYHEHHQLQHIIHFWLYHWKHSK\VLFLDQZLWKLQIRUPHGFRQVHQW
IURPWKHSDWLHQWPXVWEHIUHHWRXVHXQSURYHQRUQHZSURSK\ODFWLFGLDJQRVWLFDQG
WKHUDSHXWLFPHDVXUHVLILQWKHSK\VLFLDQ¶VMXGJHPHQWLWRIIHUVKRSHRIVDYLQJOLIH
UHHVWDEOLVKLQJKHDOWKRUDOOHYLDWLQJVXIIHULQJ:KHUHSRVVLEOHWKHVHPHDVXUHVVKRXOG
EHPDGHWKHREMHFWRIUHVHDUFKGHVLJQHGWRHYDOXDWHWKHLUVDIHW\DQGHIILFDF\,QDOO
FDVHVQHZLQIRUPDWLRQVKRXOGEHUHFRUGHGDQGZKHUHDSSURSULDWHSXEOLVKHG7KH
RWKHUUHOHYDQWJXLGHOLQHVRIWKLV'HFODUDWLRQVKRXOGEHIROORZHG
)RRWQRWH 1RWH RI FODULILFDWLRQ RQ SDUDJUDSK RI WKH:0$ 'HFODUDWLRQ RI
+HOVLQNL
7KH:0$KHUHE\UHDIILUPVLWVSRVLWLRQWKDWH[WUHPHFDUHPXVWEHWDNHQLQPDNLQJ
XVHRIDSODFHERFRQWUROOHGWULDODQGWKDWLQJHQHUDOWKLVPHWKRGRORJ\VKRXOGRQO\EH
XVHGLQWKHDEVHQFHRIH[LVWLQJSURYHQWKHUDS\+RZHYHUDSODFHERFRQWUROOHGWULDO
PD\EHHWKLFDOO\DFFHSWDEOHHYHQLISURYHQWKHUDS\LVDYDLODEOHXQGHUWKHIROORZLQJ
FLUFXPVWDQFHV
:KHUH IRU FRPSHOOLQJ DQG VFLHQWLILFDOO\ VRXQG PHWKRGRORJLFDO UHDVRQV LWV XVH
LV QHFHVVDU\ WR GHWHUPLQH WKH HIILFDF\ RU VDIHW\ RI D SURSK\ODFWLF GLDJQRVWLF RU
WKHUDSHXWLFPHWKRGRU
:KHUHDSURSK\ODFWLFGLDJQRVWLFRUWKHUDSHXWLFPHWKRGLVEHLQJLQYHVWLJDWHGIRU
DPLQRUFRQGLWLRQDQGWKHSDWLHQWVZKRUHFHLYHSODFHERZLOOQRWEHVXEMHFWWRDQ\
DGGLWLRQDOULVNRIVHULRXVRULUUHYHUVLEOHKDUP
$OORWKHUSURYLVLRQVRIWKH'HFODUDWLRQRI+HOVLQNLPXVWEHDGKHUHGWRHVSHFLDOO\
WKHQHHGIRUDSSURSULDWHHWKLFDODQGVFLHQWLILFUHYLHZ
Annex 2
International ethical guidelines for
biomedical research involving human
subjects
3UHSDUHGE\WKH&RXQFLOIRU,QWHUQDWLRQDO2UJDQL]DWLRQVRI0HGLFDO6FLHQFHV
&,206LQFROODERUDWLRQZLWKWKH:RUOG+HDOWK2UJDQL]DWLRQ:+2&,206*HQHYD
7KHWH[WRIWKHJXLGHOLQHVUHSURGXFHGKHUHGRHVQRWLQFOXGHWKHFRPPHQWDU\
SURYLGHGLQWKHIXOOGRFXPHQW7KLVFDQEHIRXQGDWKWWS??ZZZFLRPVFK?IUDPHB
JXLGHOLQHVBQRYBKWP
Guideline 1: Ethical justification and scientific validity of

biomedical research involving human beings
7KHHWKLFDOMXVWLILFDWLRQRIELRPHGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWVLVWKH
SURVSHFWRIGLVFRYHULQJQHZZD\VRIEHQHILWLQJSHRSOH¶VKHDOWK6XFKUHVHDUFKFDQEH
HWKLFDOO\MXVWLILDEOHRQO\LILWLVFDUULHGRXWLQZD\VWKDWUHVSHFWDQGSURWHFWDQGDUHIDLUWR
WKHVXEMHFWVRIWKDWUHVHDUFKDQGDUHPRUDOO\DFFHSWDEOHZLWKLQWKHFRPPXQLWLHVLQZKLFK
WKHUHVHDUFKLVFDUULHGRXW0RUHRYHUEHFDXVHVFLHQWLILFDOO\LQYDOLGUHVHDUFKLVXQHWKLFDO
LQWKDWLWH[SRVHVUHVHDUFKVXEMHFWVWRULVNVZLWKRXWSRVVLEOHEHQHILWLQYHVWLJDWRUVDQG
VSRQVRUVPXVWHQVXUHWKDWSURSRVHGVWXGLHVLQYROYLQJKXPDQVXEMHFWVFRQIRUPWR
JHQHUDOO\DFFHSWHGVFLHQWLILFSULQFLSOHVDQGDUHEDVHGRQDGHTXDWHNQRZOHGJHRIWKH
SHUWLQHQWVFLHQWLILFOLWHUDWXUH
Guideline 2: Ethical review committees

$OOSURSRVDOVWRFRQGXFWUHVHDUFKLQYROYLQJKXPDQVXEMHFWVPXVWEHVXEPLWWHGIRU
UHYLHZRIWKHLUVFLHQWLILFPHULWDQGHWKLFDODFFHSWDELOLW\WRRQHRUPRUHVFLHQWLILFUHYLHZ
DQGHWKLFDOUHYLHZFRPPLWWHHV7KHUHYLHZFRPPLWWHHVPXVWEHLQGHSHQGHQWRIWKH
UHVHDUFKWHDPDQGDQ\GLUHFWILQDQFLDORURWKHUPDWHULDOEHQHILWWKH\PD\GHULYHIURPWKH
UHVHDUFKVKRXOGQRWEHFRQWLQJHQWRQWKHRXWFRPHRIWKHLUUHYLHZ7KHLQYHVWLJDWRUPXVW
REWDLQWKHLUDSSURYDORUFOHDUDQFHEHIRUHXQGHUWDNLQJWKHUHVHDUFK7KHHWKLFDOUHYLHZ
FRPPLWWHHVKRXOGFRQGXFWIXUWKHUUHYLHZVDVQHFHVVDU\LQWKHFRXUVHRIWKHUHVHDUFK
LQFOXGLQJPRQLWRULQJRIWKHSURJUHVVRIWKHVWXG\
Guideline 3: Ethical review of externally sponsored research

$QH[WHUQDOVSRQVRULQJRUJDQL]DWLRQDQGLQGLYLGXDOLQYHVWLJDWRUVVKRXOGVXEPLW
WKHUHVHDUFKSURWRFROIRUHWKLFDODQGVFLHQWLILFUHYLHZLQWKHFRXQWU\RIWKHVSRQVRULQJ
RUJDQL]DWLRQDQGWKHHWKLFDOVWDQGDUGVDSSOLHGVKRXOGEHQROHVVVWULQJHQWWKDQWKH\
ZRXOGEHIRUUHVHDUFKFDUULHGRXWLQWKDWFRXQWU\7KHKHDOWKDXWKRULWLHVRIWKHKRVW
FRXQWU\DVZHOODVDQDWLRQDORUORFDOHWKLFDOUHYLHZFRPPLWWHHVKRXOGHQVXUHWKDWWKH
SURSRVHGUHVHDUFKLVUHVSRQVLYHWRWKHKHDOWKQHHGVDQGSULRULWLHVRIWKHKRVWFRXQWU\DQG
PHHWVWKHUHTXLVLWHHWKLFDOVWDQGDUGV
Guideline 4: Individual informed consent

)RUDOOELRPHGLFDOUHVHDUFKLQYROYLQJKXPDQVWKHLQYHVWLJDWRUPXVWREWDLQWKH
YROXQWDU\LQIRUPHGFRQVHQWRIWKHSURVSHFWLYHVXEMHFWRULQWKHFDVHRIDQLQGLYLGXDO
ZKRLVQRWFDSDEOHRIJLYLQJLQIRUPHGFRQVHQWWKHSHUPLVVLRQRIDOHJDOO\DXWKRUL]HG
UHSUHVHQWDWLYHLQDFFRUGDQFHZLWKDSSOLFDEOHODZ:DLYHURILQIRUPHGFRQVHQWLVWREH
UHJDUGHGDVXQFRPPRQDQGH[FHSWLRQDODQGPXVWLQDOOFDVHVEHDSSURYHGE\DQHWKLFDO
UHYLHZFRPPLWWHH
Guideline 5: Obtaining informed consent: Essential

information for prospective research subjects
%HIRUHUHTXHVWLQJDQLQGLYLGXDO¶VFRQVHQWWRSDUWLFLSDWHLQUHVHDUFKWKHLQYHVWLJDWRU
PXVWSURYLGHWKHIROORZLQJLQIRUPDWLRQLQODQJXDJHRUDQRWKHUIRUPRIFRPPXQLFDWLRQ
WKDWWKHLQGLYLGXDOFDQXQGHUVWDQG
WKDWWKHLQGLYLGXDOLVLQYLWHGWRSDUWLFLSDWHLQUHVHDUFKWKHUHDVRQVIRUFRQVLGHULQJ
WKHLQGLYLGXDOVXLWDEOHIRUWKHUHVHDUFKDQGWKDWSDUWLFLSDWLRQLVYROXQWDU\
WKDWWKHLQGLYLGXDOLVIUHHWRUHIXVHWRSDUWLFLSDWHDQGZLOOEHIUHHWRZLWKGUDZIURP
WKHUHVHDUFKDWDQ\WLPHZLWKRXWSHQDOW\RUORVVRIEHQHILWVWRZKLFKKHRUVKHZRXOG
RWKHUZLVHEHHQWLWOHG
WKHSXUSRVHRIWKHUHVHDUFKWKHSURFHGXUHVWREHFDUULHGRXWE\WKHLQYHVWLJDWRUDQG
WKHVXEMHFWDQGDQH[SODQDWLRQRIKRZWKHUHVHDUFKGLIIHUVIURPURXWLQHPHGLFDO
FDUH
IRUFRQWUROOHGWULDOVDQH[SODQDWLRQRIIHDWXUHVRIWKHUHVHDUFKGHVLJQHJUDQGRPL]DWLRQ
GRXEOHEOLQGLQJDQGWKDWWKHVXEMHFWZLOOQRWEHWROGRIWKHDVVLJQHGWUHDWPHQWXQWLO
WKHVWXG\KDVEHHQFRPSOHWHGDQGWKHEOLQGKDVEHHQEURNHQ
Biomedical research involving human subjects 193
WKHH[SHFWHGGXUDWLRQRIWKHLQGLYLGXDO¶VSDUWLFLSDWLRQLQFOXGLQJQXPEHUDQGGXUDWLRQ

RIYLVLWVWRWKHUHVHDUFKFHQWUHDQGWKHWRWDOWLPHLQYROYHGDQGWKHSRVVLELOLW\RIHDUO\
WHUPLQDWLRQRIWKHWULDORURIWKHLQGLYLGXDO¶VSDUWLFLSDWLRQLQLW
ZKHWKHUPRQH\RURWKHUIRUPVRIPDWHULDOJRRGVZLOOEHSURYLGHGLQUHWXUQIRUWKH
LQGLYLGXDO¶VSDUWLFLSDWLRQDQGLIVRWKHNLQGDQGDPRXQW
WKDWDIWHUFRPSOHWLRQRIWKHVWXG\VXEMHFWVZLOOEHLQIRUPHGRIWKHILQGLQJVRIWKH
UHVHDUFK LQ JHQHUDO DQG LQGLYLGXDO VXEMHFWV ZLOO EH LQIRUPHG RI DQ\ ILQGLQJ WKDW
UHODWHVWRWKHLUSDUWLFXODUKHDOWKVWDWXV
WKDWVXEMHFWVKDYHWKHULJKWRIDFFHVVWRWKHLUGDWDRQGHPDQGHYHQLIWKHVHGDWD
ODFNLPPHGLDWHFOLQLFDOXWLOLW\XQOHVVWKHHWKLFDOUHYLHZFRPPLWWHHKDVDSSURYHG
WHPSRUDU\RUSHUPDQHQWQRQGLVFORVXUHRIGDWDLQZKLFKFDVHWKHVXEMHFWVKRXOGEH
LQIRUPHGRIDQGJLYHQWKHUHDVRQVIRUVXFKQRQGLVFORVXUH
DQ\ IRUHVHHDEOH ULVNV SDLQ RU GLVFRPIRUW RU LQFRQYHQLHQFH WR WKH LQGLYLGXDO RU
RWKHUVDVVRFLDWHGZLWKSDUWLFLSDWLRQLQWKHUHVHDUFKLQFOXGLQJULVNVWRWKHKHDOWKRU
ZHOOEHLQJRIDVXEMHFW¶VVSRXVHRUSDUWQHU
WKHGLUHFWEHQHILWVLIDQ\H[SHFWHGWRUHVXOWWRVXEMHFWVIURPSDUWLFLSDWLQJLQWKH
UHVHDUFK
WKHH[SHFWHGEHQHILWVRIWKHUHVHDUFKWRWKHFRPPXQLW\RUWRVRFLHW\DWODUJHRU
FRQWULEXWLRQVWRVFLHQWLILFNQRZOHGJH
ZKHWKHUZKHQDQGKRZDQ\SURGXFWVRULQWHUYHQWLRQVSURYHQE\WKHUHVHDUFKWREH
VDIHDQGHIIHFWLYHZLOOEHPDGHDYDLODEOHWRVXEMHFWVDIWHUWKH\KDYHFRPSOHWHGWKHLU
SDUWLFLSDWLRQLQWKHUHVHDUFKDQGZKHWKHUWKH\ZLOOEHH[SHFWHGWRSD\IRUWKHP
DQ\FXUUHQWO\DYDLODEOHDOWHUQDWLYHLQWHUYHQWLRQVRUFRXUVHVRIWUHDWPHQW
WKHSURYLVLRQVWKDWZLOOEHPDGHWRHQVXUHUHVSHFWIRUWKHSULYDF\RIVXEMHFWVDQGIRU
WKHFRQILGHQWLDOLW\RIUHFRUGVLQZKLFKVXEMHFWVDUHLGHQWLILHG
WKHOLPLWVOHJDORURWKHUWRWKHLQYHVWLJDWRUV¶DELOLW\WRVDIHJXDUGFRQILGHQWLDOLW\DQG
WKHSRVVLEOHFRQVHTXHQFHVRIEUHDFKHVRIFRQILGHQWLDOLW\
SROLF\ZLWKUHJDUGWRWKHXVHRIUHVXOWVRIJHQHWLFWHVWVDQGIDPLOLDOJHQHWLFLQIRUPDWLRQ
DQGWKHSUHFDXWLRQVLQSODFHWRSUHYHQWGLVFORVXUHRIWKHUHVXOWVRIDVXEMHFW¶VJHQHWLF
WHVWVWRLPPHGLDWHIDPLO\UHODWLYHVRUWRRWKHUVHJLQVXUDQFHFRPSDQLHVRUHPSOR\HUV
ZLWKRXWWKHFRQVHQWRIWKHVXEMHFW
WKHVSRQVRUVRIWKHUHVHDUFKWKHLQVWLWXWLRQDODIILOLDWLRQRIWKHLQYHVWLJDWRUVDQGWKH
QDWXUHDQGVRXUFHVRIIXQGLQJIRUWKHUHVHDUFK
WKHSRVVLEOHUHVHDUFKXVHVGLUHFWRUVHFRQGDU\RIWKHVXEMHFW¶VPHGLFDOUHFRUGVDQG
RIELRORJLFDOVSHFLPHQVWDNHQLQWKHFRXUVHRIFOLQLFDOFDUH
ZKHWKHU LW LV SODQQHG WKDW ELRORJLFDO VSHFLPHQV FROOHFWHG LQ WKH UHVHDUFK ZLOO EH
GHVWUR\HGDWLWVFRQFOXVLRQDQGLIQRWGHWDLOVDERXWWKHLUVWRUDJHZKHUHKRZIRU
KRZORQJDQGILQDOGLVSRVLWLRQDQGSRVVLEOHIXWXUHXVHDQGWKDWVXEMHFWVKDYHWKH
ULJKWWRGHFLGHDERXWVXFKIXWXUHXVHWRUHIXVHVWRUDJHDQGWRKDYHWKHPDWHULDO
GHVWUR\HG
ZKHWKHU FRPPHUFLDO SURGXFWV PD\ EH GHYHORSHG IURP ELRORJLFDO VSHFLPHQV DQG
ZKHWKHUWKHSDUWLFLSDQWZLOOUHFHLYHPRQHWDU\RURWKHUEHQHILWVIURPWKHGHYHORSPHQW
RIVXFKSURGXFWV
ZKHWKHUWKHLQYHVWLJDWRULVVHUYLQJRQO\DVDQLQYHVWLJDWRURUDVERWKLQYHVWLJDWRUDQG
WKHVXEMHFW¶VSK\VLFLDQ
WKH H[WHQW RI WKH LQYHVWLJDWRU¶V UHVSRQVLELOLW\ WR SURYLGH PHGLFDO VHUYLFHV WR WKH
SDUWLFLSDQW
WKDWWUHDWPHQWZLOOEHSURYLGHGIUHHRIFKDUJHIRUVSHFLILHGW\SHVRIUHVHDUFKUHODWHG
LQMXU\RUIRUFRPSOLFDWLRQVDVVRFLDWHGZLWKWKHUHVHDUFKWKHQDWXUHDQGGXUDWLRQRI
VXFKFDUHWKHQDPHRIWKHRUJDQL]DWLRQRULQGLYLGXDOWKDWZLOOSURYLGHWKHWUHDWPHQW
DQGZKHWKHUWKHUHLVDQ\XQFHUWDLQW\UHJDUGLQJIXQGLQJRIVXFKWUHDWPHQW
LQZKDWZD\DQGE\ZKDWRUJDQL]DWLRQWKHVXEMHFWRUWKHVXEMHFW¶VIDPLO\RUGHSHQGDQWV
ZLOO EH FRPSHQVDWHG IRU GLVDELOLW\ RU GHDWK UHVXOWLQJ IURP VXFK LQMXU\ RU ZKHQ
LQGLFDWHGWKDWWKHUHDUHQRSODQVWRSURYLGHVXFKFRPSHQVDWLRQ
ZKHWKHURUQRWLQWKHFRXQWU\LQZKLFKWKHSURVSHFWLYHVXEMHFWLVLQYLWHGWRSDUWLFLSDWH
LQUHVHDUFKWKHULJKWWRFRPSHQVDWLRQLVOHJDOO\JXDUDQWHHG
WKDWDQHWKLFDOUHYLHZFRPPLWWHHKDVDSSURYHGRUFOHDUHGWKHUHVHDUFKSURWRFRO
Guideline 6: Obtaining informed consent: Obligations of

sponsors and investigators
6SRQVRUVDQGLQYHVWLJDWRUVKDYHDGXW\WR
UHIUDLQIURPXQMXVWLILHGGHFHSWLRQXQGXHLQIOXHQFHRULQWLPLGDWLRQ
VHHN FRQVHQW RQO\ DIWHU DVFHUWDLQLQJ WKDW WKH SURVSHFWLYH VXEMHFW KDV DGHTXDWH
XQGHUVWDQGLQJRIWKHUHOHYDQWIDFWVDQGRIWKHFRQVHTXHQFHVRISDUWLFLSDWLRQDQG
KDVKDGVXIILFLHQWRSSRUWXQLW\WRFRQVLGHUZKHWKHUWRSDUWLFLSDWH
DVDJHQHUDOUXOHREWDLQIURPHDFKSURVSHFWLYHVXEMHFWDVLJQHGIRUPDVHYLGHQFHRI
LQIRUPHGFRQVHQW²LQYHVWLJDWRUVVKRXOGMXVWLI\DQ\H[FHSWLRQVWRWKLVJHQHUDOUXOH
DQGREWDLQWKHDSSURYDORIWKHHWKLFDOUHYLHZFRPPLWWHH
UHQHZWKHLQIRUPHGFRQVHQWRIHDFKVXEMHFWLIWKHUHDUHVLJQLILFDQWFKDQJHVLQWKH
FRQGLWLRQVRUSURFHGXUHVRIWKHUHVHDUFKRULIQHZLQIRUPDWLRQEHFRPHVDYDLODEOH
WKDWFRXOGDIIHFWWKHZLOOLQJQHVVRIVXEMHFWVWRFRQWLQXHWRSDUWLFLSDWHDQG
UHQHZWKHLQIRUPHGFRQVHQWRIHDFKVXEMHFWLQORQJWHUPVWXGLHVDWSUHGHWHUPLQHG
LQWHUYDOVHYHQLIWKHUHDUHQRFKDQJHVLQWKHGHVLJQRUREMHFWLYHVRIWKHUHVHDUFK
Guideline 7: Inducement to participate

6XEMHFWVPD\EHUHLPEXUVHGIRUORVWHDUQLQJVWUDYHOFRVWVDQGRWKHUH[SHQVHV
LQFXUUHGLQWDNLQJSDUWLQDVWXG\WKH\PD\DOVRUHFHLYHIUHHPHGLFDOVHUYLFHV6XEMHFWV
SDUWLFXODUO\WKRVHZKRUHFHLYHQRGLUHFWEHQHILWIURPUHVHDUFKPD\DOVREHSDLGRU
RWKHUZLVHFRPSHQVDWHGIRULQFRQYHQLHQFHDQGWLPHVSHQW7KHSD\PHQWVVKRXOGQRW
EHVRODUJHKRZHYHURUWKHPHGLFDOVHUYLFHVVRH[WHQVLYHDVWRLQGXFHSURVSHFWLYH
VXEMHFWVWRFRQVHQWWRSDUWLFLSDWHLQWKHUHVHDUFKDJDLQVWWKHLUEHWWHUMXGJHPHQW³XQGXH
LQGXFHPHQW´$OOSD\PHQWVUHLPEXUVHPHQWVDQGPHGLFDOVHUYLFHVSURYLGHGWRUHVHDUFK
VXEMHFWVPXVWKDYHEHHQDSSURYHGE\DQHWKLFDOUHYLHZFRPPLWWHH
Guideline 8: Benefits and risks of study participation

)RUDOOELRPHGLFDOUHVHDUFKLQYROYLQJKXPDQVXEMHFWVWKHLQYHVWLJDWRUPXVWHQVXUH
WKDWSRWHQWLDOEHQHILWVDQGULVNVDUHUHDVRQDEO\EDODQFHGDQGULVNVDUHPLQLPL]HG
,QWHUYHQWLRQVRUSURFHGXUHVWKDWKROGRXWWKHSURVSHFWRIGLUHFWGLDJQRVWLFWKHUDSHXWLF
RUSUHYHQWLYHEHQHILWIRUWKHLQGLYLGXDOVXEMHFWPXVWEHMXVWLILHGE\WKHH[SHFWDWLRQ
WKDWWKH\ZLOOEHDWOHDVWDVDGYDQWDJHRXVWRWKHLQGLYLGXDOVXEMHFWLQWKHOLJKWRI
IRUHVHHDEOHULVNVDQGEHQHILWVDVDQ\DYDLODEOHDOWHUQDWLYH5LVNVRIVXFK³EHQHILFLDO´
LQWHUYHQWLRQVRUSURFHGXUHVPXVWEHMXVWLILHGLQUHODWLRQWRH[SHFWHGEHQHILWVWRWKH
LQGLYLGXDOVXEMHFW
5LVNVRILQWHUYHQWLRQVWKDWGRQRWKROGRXWWKHSURVSHFWRIGLUHFWGLDJQRVWLFWKHUDSHXWLF
RUSUHYHQWLYHEHQHILWIRUWKHLQGLYLGXDOPXVWEHMXVWLILHGLQUHODWLRQWRWKHH[SHFWHG
EHQHILWVWRVRFLHW\JHQHUDOL]DEOHNQRZOHGJH7KHULVNVSUHVHQWHGE\VXFKLQWHUYHQWLRQV
PXVWEHUHDVRQDEOHLQUHODWLRQWRWKHLPSRUWDQFHRIWKHNQRZOHGJHWREHJDLQHG
Guideline 9: Special limitations on risk when research

involves individuals who are not capable of giving informed
consent
:KHQWKHUHLVHWKLFDODQGVFLHQWLILFMXVWLILFDWLRQWRFRQGXFWUHVHDUFKZLWKLQGLYLGXDOV
LQFDSDEOHRIJLYLQJLQIRUPHGFRQVHQWWKHULVNIURPUHVHDUFKLQWHUYHQWLRQVWKDWGRQRW
KROGRXWWKHSURVSHFWRIGLUHFWEHQHILWIRUWKHLQGLYLGXDOVXEMHFWVKRXOGEHQRPRUHOLNHO\
DQGQRWJUHDWHUWKDQWKHULVNDWWDFKHGWRURXWLQHPHGLFDORUSV\FKRORJLFDOH[DPLQDWLRQ
RIVXFKSHUVRQV6OLJKWRUPLQRULQFUHDVHVDERYHVXFKULVNPD\EHSHUPLWWHGZKHQWKHUH
LVDQRYHUULGLQJVFLHQWLILFRUPHGLFDOUDWLRQDOHIRUVXFKLQFUHDVHVDQGZKHQDQHWKLFDO
UHYLHZFRPPLWWHHKDVDSSURYHGWKHP
Guideline 10: Research in populations and communities with

limited resources
%HIRUHXQGHUWDNLQJUHVHDUFKLQDSRSXODWLRQRUFRPPXQLW\ZLWKOLPLWHGUHVRXUFHV
WKHVSRQVRUDQGWKHLQYHVWLJDWRUPXVWPDNHHYHU\HIIRUWWRHQVXUHWKDW
WKHUHVHDUFKLVUHVSRQVLYHWRWKHKHDOWKQHHGVDQGWKHSULRULWLHVRIWKHSRSXODWLRQRU
FRPPXQLW\LQZKLFKLWLVWREHFDUULHGRXWDQG
DQ\ LQWHUYHQWLRQ RU SURGXFW GHYHORSHG RU NQRZOHGJH JHQHUDWHG ZLOO EH PDGH
UHDVRQDEO\DYDLODEOHIRUWKHEHQHILWRIWKDWSRSXODWLRQRUFRPPXQLW\
Guideline 11: Choice of control in clinical trials

$VDJHQHUDOUXOHUHVHDUFKVXEMHFWVLQWKHFRQWUROJURXSRIDWULDORIDGLDJQRVWLF
WKHUDSHXWLFRUSUHYHQWLYHLQWHUYHQWLRQVKRXOGUHFHLYHDQHVWDEOLVKHGHIIHFWLYHLQWHUYHQWLRQ
,QVRPHFLUFXPVWDQFHVLWPD\EHEHHWKLFDOO\DFFHSWDEOHWRXVHDQDOWHUQDWLYHFRPSDUDWRU
VXFKDVSODFHERRU³QRWUHDWPHQW´
3ODFHERPD\EHXVHG
ZKHQWKHUHLVQRHVWDEOLVKHGHIIHFWLYHLQWHUYHQWLRQ
ZKHQZLWKKROGLQJDQHVWDEOLVKHGHIIHFWLYHLQWHUYHQWLRQZRXOGH[SRVHVXEMHFWVWRDW
PRVWWHPSRUDU\GLVFRPIRUWRUGHOD\LQUHOLHIRIV\PSWRPV
ZKHQXVHRIDQHVWDEOLVKHGHIIHFWLYHLQWHUYHQWLRQDVFRPSDUDWRUZRXOGQRW\LHOG
VFLHQWLILFDOO\UHOLDEOHUHVXOWVDQGXVHRISODFHERZRXOGQRWDGGDQ\ULVNRIVHULRXV
RULUUHYHUVLEOHKDUPWRWKHVXEMHFWV
Guideline 12: Equitable distribution of burdens and benefits

in the selection of groups of subjects in research
*URXSVRUFRPPXQLWLHVWREHLQYLWHGWREHVXEMHFWVRIUHVHDUFKVKRXOGEHVHOHFWHG
LQVXFKDZD\WKDWWKHEXUGHQVDQGEHQHILWVRIWKHUHVHDUFKZLOOEHHTXLWDEO\GLVWULEXWHG
7KHH[FOXVLRQRIJURXSVRUFRPPXQLWLHVWKDWPLJKWEHQHILWIURPVWXG\SDUWLFLSDWLRQ
PXVWEHMXVWLILHG
Guideline 13: Research involving vulnerable persons

6SHFLDOMXVWLILFDWLRQLVUHTXLUHGIRULQYLWLQJYXOQHUDEOHLQGLYLGXDOVWRVHUYHDV
UHVHDUFKVXEMHFWVDQGLIWKH\DUHVHOHFWHGWKHPHDQVRISURWHFWLQJWKHLUULJKWVDQG
ZHOIDUHPXVWEHVWULFWO\DSSOLHG
Guideline 14: Research involving children

%HIRUHXQGHUWDNLQJUHVHDUFKLQYROYLQJFKLOGUHQWKHLQYHVWLJDWRUPXVWHQVXUHWKDW
WKHUHVHDUFKPLJKWQRWHTXDOO\ZHOOEHFDUULHGRXWZLWKDGXOWV
WKHSXUSRVHRIWKHUHVHDUFKLVWRREWDLQNQRZOHGJHUHOHYDQWWRWKHKHDOWKQHHGVRI
FKLOGUHQ
DSDUHQWRUOHJDOUHSUHVHQWDWLYHRIHDFKFKLOGKDVJLYHQSHUPLVVLRQ
WKHDJUHHPHQWDVVHQWRIHDFKFKLOGKDVEHHQREWDLQHGWRWKHH[WHQWRIWKHFKLOG¶V
FDSDELOLWLHVDQG
DFKLOG¶VUHIXVDOWRSDUWLFLSDWHRUFRQWLQXHLQWKHUHVHDUFKZLOOEHUHVSHFWHG
Guideline 15: Research involving individuals who by reason

of mental or behavioural disorders are not capable of giving
adequately informed consent
%HIRUHXQGHUWDNLQJUHVHDUFKLQYROYLQJLQGLYLGXDOVZKRE\UHDVRQRIPHQWDORU
EHKDYLRXUDOGLVRUGHUVDUHQRWFDSDEOHRIJLYLQJDGHTXDWHO\LQIRUPHGFRQVHQWWKH
LQYHVWLJDWRUPXVWHQVXUHWKDW
VXFKSHUVRQVZLOOQRWEHVXEMHFWVRIUHVHDUFKWKDWPLJKWHTXDOO\ZHOOEHFDUULHGRXW
RQSHUVRQVZKRVHFDSDFLW\WRJLYHDGHTXDWHO\LQIRUPHGFRQVHQWLVQRWLPSDLUHG
WKHSXUSRVHRIWKHUHVHDUFKLVWRREWDLQNQRZOHGJHUHOHYDQWWRWKHSDUWLFXODUKHDOWK
QHHGVRISHUVRQVZLWKPHQWDORUEHKDYLRXUDOGLVRUGHUV
WKHFRQVHQWRIHDFKVXEMHFWKDVEHHQREWDLQHGWRWKHH[WHQWRIWKDWSHUVRQ¶VFDSDELOLWLHV
DQGDSURVSHFWLYHVXEMHFW¶VUHIXVDOWRSDUWLFLSDWHLQUHVHDUFKLVDOZD\VUHVSHFWHG
XQOHVVLQH[FHSWLRQDOFLUFXPVWDQFHVWKHUHLVQRUHDVRQDEOHPHGLFDODOWHUQDWLYHDQG
ORFDOODZSHUPLWVRYHUULGLQJWKHREMHFWLRQDQG
LQFDVHVZKHUHSURVSHFWLYHVXEMHFWVODFNFDSDFLW\WRFRQVHQWSHUPLVVLRQLVREWDLQHG
IURPDUHVSRQVLEOHIDPLO\PHPEHURUDOHJDOO\DXWKRUL]HGUHSUHVHQWDWLYHLQDFFRUGDQFH
ZLWKDSSOLFDEOHODZ
Guideline 16: Women as research subjects

,QYHVWLJDWRUVVSRQVRUVRUHWKLFDOUHYLHZFRPPLWWHHVVKRXOGQRWH[FOXGHZRPHQRI
UHSURGXFWLYHDJHIURPELRPHGLFDOUHVHDUFK7KHSRWHQWLDOIRUEHFRPLQJSUHJQDQWGXULQJ
DVWXG\VKRXOGQRWLQLWVHOIEHXVHGDVDUHDVRQIRUSUHFOXGLQJRUOLPLWLQJSDUWLFLSDWLRQ
+RZHYHUDWKRURXJKGLVFXVVLRQRIULVNVWRWKHSUHJQDQWZRPDQDQGWRKHUIHWXVLV
DSUHUHTXLVLWHIRUWKHZRPDQ¶VDELOLW\WRPDNHDUDWLRQDOGHFLVLRQWRHQUROLQDFOLQLFDO
VWXG\,QWKLVGLVFXVVLRQLISDUWLFLSDWLRQLQWKHUHVHDUFKPLJKWEHKD]DUGRXVWRDIHWXV
RUDZRPDQLIVKHEHFRPHVSUHJQDQWWKHVSRQVRUVLQYHVWLJDWRUVVKRXOGJXDUDQWHHWKH
SURVSHFWLYHVXEMHFWDSUHJQDQF\WHVWDQGDFFHVVWRHIIHFWLYHFRQWUDFHSWLYHPHWKRGVEHIRUH
WKHUHVHDUFKFRPPHQFHV:KHUHVXFKDFFHVVLVQRWSRVVLEOHIRUOHJDORUUHOLJLRXVUHDVRQV
LQYHVWLJDWRUVVKRXOGQRWUHFUXLWIRUVXFKSRVVLEO\KD]DUGRXVUHVHDUFKZRPHQZKRPLJKW
EHFRPHSUHJQDQW
Guideline 17: Pregnant women as research participants

3UHJQDQWZRPHQVKRXOGEHSUHVXPHGWREHHOLJLEOHIRUSDUWLFLSDWLRQLQELRPHGLFDO
UHVHDUFK,QYHVWLJDWRUVDQGHWKLFDOUHYLHZFRPPLWWHHVVKRXOGHQVXUHWKDWSURVSHFWLYH
VXEMHFWVZKRDUHSUHJQDQWDUHDGHTXDWHO\LQIRUPHGDERXWWKHULVNVDQGEHQHILWVWR
WKHPVHOYHVWKHLUSUHJQDQFLHVWKHIHWXVDQGWKHLUVXEVHTXHQWRIIVSULQJDQGWRWKHLU
IHUWLOLW\
5HVHDUFKLQWKLVSRSXODWLRQVKRXOGEHSHUIRUPHGRQO\LILWLVUHOHYDQWWRWKHSDUWLFXODU
KHDOWKQHHGVRIDSUHJQDQWZRPDQRUKHUIHWXVRUWRWKHKHDOWKQHHGVRISUHJQDQWZRPHQ
LQJHQHUDODQGZKHQDSSURSULDWHLILWLVVXSSRUWHGE\UHOLDEOHHYLGHQFHIURPDQLPDO
H[SHULPHQWVSDUWLFXODUO\DVWRULVNVRIWHUDWRJHQLFLW\DQGPXWDJHQLFLW\
Guideline 18:Safeguarding confidentiality

7KHLQYHVWLJDWRUPXVWHVWDEOLVKVHFXUHVDIHJXDUGVRIWKHFRQILGHQWLDOLW\RIVXEMHFWV¶
UHVHDUFKGDWD6XEMHFWVVKRXOGEHWROGWKHOLPLWVOHJDORURWKHUWRWKHLQYHVWLJDWRUV¶
DELOLW\WRVDIHJXDUGFRQILGHQWLDOLW\DQGWKHSRVVLEOHFRQVHTXHQFHVRIEUHDFKHVRI
FRQILGHQWLDOLW\
Guideline 19: Right of injured subjects to treatment and

compensation
,QYHVWLJDWRUVVKRXOGHQVXUHWKDWUHVHDUFKVXEMHFWVZKRVXIIHULQMXU\DVDUHVXOWRI
WKHLUSDUWLFLSDWLRQDUHHQWLWOHGWRIUHHPHGLFDOWUHDWPHQWIRUVXFKLQMXU\DQGWRVXFK
ILQDQFLDORURWKHUDVVLVWDQFHDVZRXOGFRPSHQVDWHWKHPHTXLWDEO\IRUDQ\UHVXOWDQW
LPSDLUPHQWGLVDELOLW\RUKDQGLFDS,QWKHFDVHRIGHDWKDVDUHVXOWRIWKHLUSDUWLFLSDWLRQ
WKHLUGHSHQGDQWVDUHHQWLWOHGWRFRPSHQVDWLRQ6XEMHFWVPXVWQRWEHDVNHGWRZDLYHWKH
ULJKWWRFRPSHQVDWLRQ
Guideline 20: Strengthening capacity for ethical and scientific

review and biomedical research
0DQ\FRXQWULHVODFNWKHFDSDFLW\WRDVVHVVRUHQVXUHWKHVFLHQWLILFTXDOLW\RUHWKLFDO
DFFHSWDELOLW\RIELRPHGLFDOUHVHDUFKSURSRVHGRUFDUULHGRXWLQWKHLUMXULVGLFWLRQV,Q
H[WHUQDOO\VSRQVRUHGFROODERUDWLYHUHVHDUFKVSRQVRUVDQGLQYHVWLJDWRUVKDYHDQHWKLFDO
REOLJDWLRQWRHQVXUHWKDWELRPHGLFDOUHVHDUFKSURMHFWVIRUZKLFKWKH\DUHUHVSRQVLEOHLQ
VXFKFRXQWULHVFRQWULEXWHHIIHFWLYHO\WRQDWLRQDORUORFDOFDSDFLW\WRGHVLJQDQGFRQGXFW
ELRPHGLFDOUHVHDUFKDQGWRSURYLGHVFLHQWLILFDQGHWKLFDOUHYLHZDQGPRQLWRULQJRIVXFK
UHVHDUFK
&DSDFLW\EXLOGLQJPD\LQFOXGHEXWLVQRWOLPLWHGWRWKHIROORZLQJDFWLYLWLHV
HVWDEOLVKLQJDQGVWUHQJWKHQLQJLQGHSHQGHQWDQGFRPSHWHQWHWKLFDOUHYLHZSURFHVVHV
FRPPLWWHHV
VWUHQJWKHQLQJUHVHDUFKFDSDFLW\
GHYHORSLQJWHFKQRORJLHVDSSURSULDWHWRKHDOWKFDUHDQGELRPHGLFDOUHVHDUFK
WUDLQLQJRIUHVHDUFKDQGKHDOWKFDUHVWDII
HGXFDWLQJWKHFRPPXQLW\IURPZKLFKUHVHDUFKVXEMHFWVZLOOEHGUDZQ
Guideline 21: Ethical obligation of external sponsors to

provide health-care services
([WHUQDOVSRQVRUVDUHHWKLFDOO\REOLJHGWRHQVXUHWKHDYDLODELOLW\RI
KHDOWKFDUHVHUYLFHVWKDWDUHHVVHQWLDOWRWKHVDIHFRQGXFWRIWKHUHVHDUFK
WUHDWPHQWIRUVXEMHFWVZKRVXIIHULQMXU\DVDFRQVHTXHQFHRIUHVHDUFKLQWHUYHQWLRQV
DQG
VHUYLFHVWKDWDUHDQHFHVVDU\SDUWRIWKHFRPPLWPHQWRIDVSRQVRUWRPDNHDEHQHILFLDO
LQWHUYHQWLRQRUSURGXFWGHYHORSHGDVDUHVXOWRIWKHUHVHDUFKUHDVRQDEO\DYDLODEOHWR
WKHSRSXODWLRQRUFRPPXQLW\FRQFHUQHG
Annex 3
Searching the literature
1. The US National Library of Medicine

7KH861DWLRQDO/LEUDU\RI0HGLFLQH1/0LVWKHODUJHVWOLEUDU\LQWKHZRUOG,WKDV
EHHQLQGH[LQJWKHELRPHGLFDOOLWHUDWXUHVLQFHWRKHOSSURYLGHKHDOWKSURIHVVLRQDOV
DFFHVVWRLQIRUPDWLRQQHFHVVDU\IRUUHVHDUFKKHDOWKFDUHDQGHGXFDWLRQ,WPDNHV
DYDLODEOHWRUHVHDUFKHUVDYDVWGDWDEDVHWKDWLVXSGDWHGDQGFKDQJHGIUHTXHQWO\
MEDLINE
0('/,1(LV1/0¶VSUHPLHUELEOLRJUDSKLFGDWDEDVHFRYHULQJWKHILHOGVRIPHGLFLQH
QXUVLQJGHQWLVWU\YHWHULQDU\PHGLFLQHDQGWKHSUHFOLQLFDOVFLHQFHV0('/,1(KDV
EHHQDYDLODEOHIRURQOLQHVHDUFKLQJVLQFH,WKDVSUDFWLFDOO\UHSODFHGWKHIDPLOLDU
EXON\YROXPHVRISULQWHGLQGH[PHGLFXVWKHPRQWKO\VXEMHFWDXWKRUJXLGHWRELRPHGLFDO
OLWHUDWXUHIRUPHUO\SDLQVWDNLQJO\KDQGVHDUFKHG$GYDQWDJHVRIRQOLQHVHDUFKLQFOXGH
VSHHGRIUHWULHYDODFFHVVWRPRUHMRXUQDOVDYDLODELOLW\RIDEVWUDFWVIRUPDQ\UHIHUHQFHV
VHDUFKLQJE\QRQ0H6+0HGLFDO6XEMHFW+HDGLQJVWHUPVLQWLWOHVDQGDEVWUDFWVDQG
VKRUWODJSHULRGVLQFHSXEOLFDWLRQ
)UHH0('/,1(VHDUFKLQJKDVEHHQLQWURGXFHGVLQFH0('/,1(FDQEH
DFFHVVHGWKURXJKWKH1/0ZHEVLWHKWWSZZZQOPQLKJRY1RUHJLVWUDWLRQLVUHTXLUHG
IRUDFFHVV
-RXUQDODUWLFOHVDUHLQGH[HGIRU0('/,1(DQGWKHLUFLWDWLRQVDUHVHDUFKDEOH
0('/,1(LQFOXGHVDUWLFOHVIURPPRUHWKDQLQWHUQDWLRQDOELRPHGLFDOMRXUQDOV
&RYHUDJHLVZRUOGZLGHRIMRXUQDOVSXEOLVKHG LQ WKH 8QLWHG 6WDWHV DQG RWKHU
FRXQWULHVEXWPRVWUHFRUGVDUHIURP(QJOLVKODQJXDJHVRXUFHVRUKDYH(QJOLVK
DEVWUDFWV7KHILOHFRQWDLQVRYHUPLOOLRQUHFRUGVGDWLQJEDFNWR,WLVXSGDWHG
ZHHNO\ZLWKDERXWQHZFLWDWLRQVDGGHGHDFKPRQWK
PubMed
,QDGGLWLRQWRSURYLGLQJDFFHVVWR0('/,1(3XE0HGSURYLGHVDFFHVVWRRWKHU
FLWDWLRQVDQGWRFLWDWLRQVWKDWSUHFHGHWKHGDWHWKDWDMRXUQDOZDVVHOHFWHGIRU0('/,1(
LQGH[LQJ,WDOVRLQFOXGHVDFFHVVWR3XE0HG&HQWUDO
PubMed Central
3XE0HG&HQWUDOLVDQDUFKLYHRIOLIHVFLHQFHVMRXUQDOV$VRI2FWREHULW
SURYLGHVIXOOWH[WRIRYHUDUWLFOHVIURPRYHUMRXUQDOVDQGWKHQXPEHU
LVLQFUHDVLQJ,WLVOLQNHGWR3XE0HGDQGLVIXOO\VHDUFKDEOH$FFHVVLVIUHHDQGQR
UHJLVWUDWLRQLVUHTXLUHG
MeSH (Medical Subject Headings)

0H6+LV1/0¶VFRQWUROOHGYRFDEXODU\XVHGIRULQGH[LQJDUWLFOHVLQ3XE0HG0H6+
WHUPLQRORJ\SURYLGHVDFRQVLVWHQWZD\WRUHWULHYHLQIRUPDWLRQWKDWPD\XVHGLIIHUHQW
WHUPLQRORJ\IRUWKHVDPHWRSLF0H6+WHUPVDUHVLPLODUWRWKHNH\ZRUGVXVHGLQRWKHU
ZHEVHDUFKHV$OO0H6+WHUPVRYHUDUHDUUDQJHGDOSKDEHWLFDOO\DVZHOODVLQ
VXEMHFWJURXSV:LWKLQJURXSV0H6+WHUPVDUHDUUDQJHGLQKLHUDUFKLFDOOHYHOVNQRZQDV
³WUHHVWUXFWXUHV´LQZKLFKDOOWKHWHUPVDUHDUUDQJHGIURPWKHPRVWJHQHUDOWRWKHPRVW
VSHFLILF7KHVSHFLILFLW\UXOHLVWKDWSDSHUVDUHDOZD\VLQGH[HGXQGHUWKHPRVWVSHFLILF
0H6+KHDGLQJVDYDLODEOHDQGQRWXQGHUJHQHUDODOOHPEUDFLQJWHUPV1/0LQGH[HUV
H[DPLQHDUWLFOHVDQGDVVLJQWKHPRVWVSHFLILF0H6+WRGHVFULEHLW7KHLQGH[HUVZLOO
DVVLJQDVPDQ\0H6+KHDGLQJVDVDSSURSULDWHWRFRYHUWKHWRSLFRIWKHDUWLFOHJHQHUDOO\
±0H6+KHDGLQJVDUHFRQVWDQWO\XQGHUUHYLHZDQGQHZKHDGLQJVDUHUHJXODUO\
LQWURGXFHG7KH0H6+GDWDEDVHFDQEHVHDUFKHGIURPWKH0('/,1(3XE0HGZHE
SDJH6XJJHVWHG0H6+WLWOHVZLOOEHSURYLGHGIRUDQ\VHDUFKWHUPHQWHUHGE\WKHVHDUFKHU
$OWHUQDWLYHO\WKHUHVHDUFKHUFDQQDYLJDWHWKH0H6+WUHHIURPWKHWRSGRZQ
MEDLINE search
6HDUFKFDQEHPDGHE\DXWKRUWRSLFRUMRXUQDOWLWOH
/RJLFDORU³%RROHDQ´RSHUDWRUV$1'25$1'127FDQEHXVHGWRQDUURZWKH
VHDUFKDVLQRWKHUZHEVHDUFKGLVFXVVHGEHORZ
/LPLWVFDQEHVHWIRUWKHVHDUFK)RUH[DPSOHWKHVHDUFKPD\EHOLPLWHGE\ODQJXDJH
W\SHRISXEOLFDWLRQGDWHDQGWRZKHWKHUDQDEVWUDFWLVDYDLODEOH
&LWDWLRQVLQFOXGHWKH(QJOLVKDEVWUDFWZKHQSXEOLVKHGZLWKWKHDUWLFOHDSSUR[LPDWHO\
RIWKHPRVWFXUUHQW\HDUV+\SHUOLQNVWRUHODWHGDUWLFOHVDUHDOVRDYDLODEOH
Searching the literature 203
2. Searching the internet
The internet and the World Wide Web

7KHLQWHUQHWLVQRZDPDMRUVRXUFHRIUHVHDUFKLQIRUPDWLRQ,WRIIHUVLQVWDQWDFFHVV
WRPLOOLRQVRIFRPSXWHUILOHVUHODWLQJWRDOPRVWDQ\WRSLF)RUHDV\DFFHVVWRWKLVKXJH
QHWZRUNWKH:RUOG:LGH:HE:::LVXVHG,WLVDVHWRIILOHVFRQQHFWHGE\K\SHUWH[W
OLQNVDQGDFFHVVHGE\PHDQVRIDEURZVHUVXFKDV0LFURVRIW([SORUHURU1HWVFDSH
QDYLJDWRU7KH:::WKXVSURYLGHVDQLQWHUIDFHWRYDULRXVIRUPVRILQIRUPDWLRQRQWKH
,QWHUQHW7KHZRUOGZLGHZHEKDVEHHQGHVFULEHGDVWKHXQLYHUVHRIQHWZRUNDFFHVVLEOH
LQIRUPDWLRQWKHHPERGLPHQWRIKXPDQNQRZOHGJH
6LWHVRQWKHLQWHUQHWKDYHDGGUHVVHVFDOOHG8QLIRUP5HVRXUFH/RFDWRUV85/
ZULWWHQLQDXQLIRUPVW\OH$QH[DPSOHRID85/PD\EHKWWSZZZJHRUJHWRZQHGX
KRPHOLEUDULHVKWPO
³KWWS´VWDQGVIRU³K\SHUWH[WWUDQVIHUSURWRFRO´ZKLFKLVXVHGWRWUDQVPLWWKHGDWD
³ZZZ´VWDQGVIRUWKH:RUOG:LGH:HEWKHJOREDO,QWHUQHWVHUYLFHWKDWFRQQHFWVWKH
PXOWLWXGHRIFRPSXWHUVDQGWKH,QWHUQHWILOHV
³JHRUJHWRZQHGX´LVFDOOHGWKH³GRPDLQ´ZKLFKQDPHVWKHRUJDQL]DWLRQIHHGLQJWKH
LQIRUPDWLRQLQWKLVFDVH*HRUJHWRZQ8QLYHUVLW\7KHVXIIL[LQWKHGRPDLQLQGLFDWHV
WKHW\SHRIRUJDQL]DWLRQIRUH[DPSOHHGXHGXFDWLRQDOFRPFRPPHUFLDOJRY
JRYHUQPHQWRUJRUJDQL]DWLRQQHWQHWZRUNRUJDQL]DWLRQ
³KRPHOLEUDULHVÚHSUHVHQWVWKHKRPHSDJHRIWKHZHEVLWHDQGWKHILOHWREHVHDUFKHG
IRU
³KWPO´LVWKHK\SHUWH[WPDUNXSODQJXDJHZKLFKLVWKHFRPSXWHUODQJXDJHXVHGWR
ZULWHWKHILOH
Search engines
6HYHUDOFRPSDQLHVEXWWUHVVHGE\DGYHUWLVLQJRQWKHLUVLWHVKDYHFUHDWHGPHWKRGV
RILQVWDQWDQHRXVO\VHDUFKLQJWKHFRQWHQWRIHYHU\SXEOLFO\DFFHVVLEOHZHEVLWH7KHVH
VHDUFKHQJLQHVDUHLPSRUWDQWEHFDXVHQHZZHEVLWHVDUHFRQWLQXDOO\DGGHGDQGPDQ\
FKDQJHWKHLUORFDWLRQ85/7KHUHDUHQXPHURXVVHDUFKHQJLQHVDYDLODEOH(DFKVHDUFK
HQJLQHRSHUDWHVGLIIHUHQWO\DQGFRQVHTXHQWO\KDVGLIIHUHQWVWUHQJWKVDQGZHDNQHVVHV
5DWKHUWKDQDVLPSOHOLVWRIILOHQDPHVRU85/VPDQ\VHDUFKHQJLQHVSURYLGHDVPDOO
H[WUDFWRURWKHULQIRUPDWLRQDERXWWKHILOH³+LWV´FDQEHUDQNHGLQRUGHURIUHOHYDQF\WR
WKHVHDUFKWHUPVUHTXHVWHGFDOFXODWHGE\WKHIUHTXHQF\ZLWKZKLFKWKHWHUPVDSSHDULQ
DGRFXPHQWWKHLUSUR[LPLW\WRRQHDQRWKHURUWKHLUUHODWLYHSRVLWLRQLQDZHESDJH7KH
ZHEEURZVHUXVXDOO\KDVDOLVWRIVHDUFKHQJLQHVDQGHDFKKDVLQIRUPDWLRQDERXWLWVHOI
$OOKDYHKHOSSDJHVH[SODLQLQJWKHYDULRXVVHDUFKRSWLRQV
6RPHVHDUFKHQJLQHVDUHKXPDQGULYHQLQIRUPDWLRQFRPSLOHGDQGLQGH[HGE\
SHRSOH2WKHUVDUHURERWGULYHQ0HWDVHDUFKHQJLQHVZLOOVHDUFKIRUWKHWRSLFLQVHYHUDO
RIWKHVHDUFKHQJLQHV
6HDUFKHQJLQHVXVXDOO\RIIHUVXEMHFWGLUHFWRULHVDQGNH\ZRUGVHDUFKHV+\SHUWH[W
OLQNVZLOODOORZPRYLQJIURPDFHUWDLQVLWHWRDQRWKHU7KHLQGLFDWLRQWKDWDK\SHUWH[WOLQN
LVDYDLODEOHLVVKRZQZKHQDWH[WLVXQGHUOLQHGDQGRUFRORXUHGDQGZKHQWKHEURZVHU
SRLQWHUFKDQJHVLWVVKDSH
Search using subject directories

$VXEMHFWGLUHFWRU\WDNHVWKHVHDUFKHUWKURXJKDVHTXHQFHRIWRSLFV6XEMHFWWUHH
GLUHFWRULHVDUHKLHUDUFKLFDOPRYLQJIURPEURDGHUWRQDUURZHUWRSLFVDQGWKHJHQHUDOWR
WKHPRUHVSHFLILF6HYHUDOGLUHFWRULHVKDYHHQWLUHRUJDQL]HGVHFWLRQVRIPHGLFLQHUHODWHG
LQIRUPDWLRQRIWHQGLYLGLQJUHVRXUFHVE\FOLQLFDOVSHFLDOW\RUJHQHUDOKHDOWKDQGPHGLFDO
VXEMHFWKHDGLQJV'LUHFWRULHVFKDUDFWHULVWLFDOO\OHQGWKHPVHOYHVWR³FDVXDOEURZVLQJ´
7KHELJJHVWDGYDQWDJHRIPDQXDOO\FUHDWHGGLUHFWRULHVLVWKHDELOLW\WRLQFOXGHDQ
DQQRWDWLRQGHVFULELQJWKHUHVRXUFH²DOWKRXJKQRWDOOGLUHFWRULHVFKRRVHWRGRWKLV
Using a keyword search

8VLQJDNH\ZRUGVHDUFKQHHGVWREHFDUHIXOO\RSWLPL]HG6HOHFWLRQRIWKHNH\ZRUGV
LQWKHVHDUFKSURFHVVLVVLPLODUWRWKHVHOHFWLRQRIDVFUHHQLQJWHVWIRUGLVHDVHV2QHFDQ
VHOHFWDWHVWWKDWLVKLJKO\VHQVLWLYHEXWZLOOSLFNPDQ\IDOVHSRVLWLYHV2URQHFDQVHOHFWD
WHVWWKDWLVYHU\VSHFLILFEXWZLOOPLVVPDQ\IDOVHQHJDWLYHV3URIHVVLRQDOVHDUFKHUVUHIHUWR
VHQVLWLYLW\E\WKHWHUP³UHFDOOUDWLR´DQGWRVSHFLILFLW\E\³SUHFLVLRQUDWLR´2QHNH\ZRUG
VHOHFWLRQPD\EHKLJKO\VHQVLWLYHEXWORZLQVSHFLILFLW\LWZLOOSLFNXSDOOVLWHVUHOHYDQW
WRWKHVXEMHFWEXWDOVRWRRPDQ\LUUHOHYDQWVLWHV$QRWKHUVHWFDQEHLQVHQVLWLYHDQGPLVV
PDQ\UHOHYDQWVLWHVZKLOHEHLQJKLJKO\VSHFLILFSLFNLQJRQO\KLJKO\UHOHYDQWVLWHV
Boolean logic
6RPHVRIWZDUHSDFNDJHVDOORZWKHXVHRIOLQNDJHRIVHDUFKWHUPVWRUDLVHWKH
VSHFLILFLW\RIUHIHUHQFHVUHWULHYHG0RUHWKDQRQHWHUPFDQEHXVHGLQWKHVHDUFKOLQNHG
E\ORJLFDORU³%RROHDQ´RSHUDWRUV$1'25$1'1277KH\DUHQDPHGDIWHU&KDUOHV
%RROHD%ULWLVKORJLFLDQDQGPDWKHPDWLFLDQRIWKHWKFHQWXU\7KH\LQGLFDWHWRWKH
FRPSXWHUKRZ\RXZDQWWKHWHUPVWUHDWHGLQUHODWLRQWRHDFKRWKHUGXULQJWKHVHDUFK
$1'%RWKWHUPVPXVWEHIRXQGLQHDFKUHIHUHQFH
25(LWKHUWHUPPXVWEHSUHVHQWLQHDFKUHIHUHQFH
1275HIHUHQFHVFRQWDLQLQJWKHWHUPDUHH[FOXGHG
6RPH VHDUFK HQJLQHV DOORZ DOVR WKH XVH RI PHDQV WR QDUURZ RU IDFLOLWDWH WKH
VHDUFK
³3UR[LPLW\RSHUDWRUV´6$0(DQG:,7+LQGLFDWHKRZFORVHO\WKHWHUPVWKH\
FRQQHFWPXVWEHOLQNHGLQDUHIHUHQFH
,IDSKUDVHLVXVHGDVWKHNH\ZRUGUDWKHUWKDQZRUGVLWVKRXOGEHOLPLWHGE\
TXRWDWLRQPDUNV
:LOGFDUGVWUXQFDWLRQ:KHQVHDUFKLQJIRUDZRUGWKHVHDUFKV\VWHPORRNVIRU
DQH[DFWPDWFKXQOHVVWKHZRUGHQGVZLWKDQDVWHULVN 7KHDVWHULVNV\PERODFWVDV
D³ZLOGFDUG´DQGPDWFKHVDOOZRUGVWKDWEHJLQZLWKWKHVWULQJRIFKDUDFWHUVEHIRUHWKH
DVWHULVN)RUH[DPSOHHQWHULQJDUWHU ZLOOUHWULHYHGRFXPHQWVFRQWDLQLQJZRUGVVXFKDV
DUWHU\DUWHULHVDUWHULDOHWF
8VXDOO\FDVHXSSHURUORZHULVLJQRUHGLQNH\ZRUGV
Health information on the web

+HDOWKLQIRUPDWLRQLVRIWHQVDLGWREHRQHRIWKHPRVWUHWULHYHGW\SHVRILQIRUPDWLRQ
RQ WKH ZHE %HFDXVH WKH ,QWHUQHW LV DQ XQUHJXODWHG FRQVWDQWO\ FKDQJLQJ VHW RI
FRPSXWHUVDURXQGWKHZRUOGWKHTXDOLW\RILQIRUPDWLRQYDULHVVXEVWDQWLDOO\IURPVLWH
WRVLWH1RQHWKHOHVVWKHUHDUH³RIILFLDO´ZHESDJHVGHYHORSHGE\RUJDQL]DWLRQVWKDWGR
KDYHDUHSXWDWLRQDWVWDNHLQFOXGLQJSDJHVIURPKLJKTXDOLW\SHHUUHYLHZHGMRXUQDOV
JRYHUQPHQWLQVWLWXWLRQVDQGPDQ\HGXFDWLRQDOLQVWLWXWLRQV7KHVHVLWHVDUHWKHUHDO
EDFNERQHRIKHDOWKLQIRUPDWLRQRQWKHZHEEXWWKHUHDUHDOVRFRPPHUFLDOPHGLFDO
LQIRUPDWLRQVLWHVLQFRPSHWLWLRQZLWKHDFKRWKHUWKDWDUHPRUHDJJUHVVLYHO\DQG
UHJXODUO\XSGDWHG
3. Free access to medical journals on the internet

³2SHQ$FFHVVQRZ´DQHZVOHWWHUFDPSDLJQLQJIRUIUHHGRPRIUHVHDUFKLQIRUPDWLRQ
DQGSXEOLVKHGE\%LR0HG&HQWUDOSURYLGHVLQIRUPDWLRQWRUHVHDUFKHUVLQWKHOLIHVFLHQFHV
DERXWRUJDQL]DWLRQVLQYROYHGLQ2SHQ$FFHVVSXEOLVKLQJDQGOLQNVWRWKHLUZHEVLWHV
KWWSZZZELRPHGFHQWUDOFRPRSHQDFFHVVFRQWDFWDVS
Open Access links

2SHQ$FFHVVQHZVKWWSZZZHDUOKDPHGXaSHWHUVIRV7KLVVLWHSURYLGHVQHZV
DQGGLVFXVVLRQVRQRSHQDFFHVVWRUHVHDUFKOLWHUDWXUH
3XE0HG &HQWUDO KWWSZZZSXEPHGFHQWUDOQLKJRY $ GLJLWDO DUFKLYH RI OLIH
VFLHQFHVMRXUQDOOLWHUDWXUHZLWKIUHHDQGXQUHVWULFWHGDFFHVV
'LUHFWRU\RIRSHQDFFHVVMRXUQDO/XQG8QLYHUVLW\KWWSZZZGRDMRUJ7KLV
VHUYLFHFRYHUVIUHHIXOOWH[WTXDOLW\FRQWUROOHGVFLHQWLILFDQGVFKRODUO\MRXUQDOV7KH
'LUHFWRU\DLPVWRLQFOXGHRSHQDFFHVVMRXUQDOVLQDOOVXEMHFWVDQGODQJXDJHV
%XGDSHVW 2SHQ$FFHVV ,QLWLDWLYH KWWSZZZVRURVRUJRSHQDFFHVVLQGH[VKWPO
7KLVLQLWLDWLYHZDVFUHDWHGLQFRQQHFWLRQZLWKWKH6RURV)RXQGDWLRQDWDPHHWLQJ
LQ%XGDSHVWLQ'HFHPEHUWRDFFHOHUDWHSURJUHVVLQWKHLQWHUQDWLRQDOHIIRUWWR
PDNHUHVHDUFKDUWLFOHVLQDOODFDGHPLFILHOGVIUHHO\DYDLODEOHRQWKH,QWHUQHW
3XEOLF /LEUDU\ RI 6FLHQFH KWWSZZZSXEOLFOLEUDU\RIVFLHQFHRUJ$ QRQSURILW
RUJDQL]DWLRQRIVFLHQWLVWVFRPPLWWHGWRPDNLQJWKHZRUOG¶VVFLHQWLILFDQGPHGLFDO
OLWHUDWXUHIUHHO\DFFHVVLEOHWRVFLHQWLVWVDQGWRWKHSXEOLFDURXQGWKHZRUOG
63$5&KWWSZZZDUORUJVSDUF63$5&LVDQDOOLDQFHRIXQLYHUVLWLHVUHVHDUFK
OLEUDULHVDQGRUJDQL]DWLRQVEXLOWDVDFRQVWUXFWLYHUHVSRQVHWRPDUNHWG\VIXQFWLRQVLQ
WKHVFKRODUO\FRPPXQLFDWLRQV\VWHP7KHVHG\VIXQFWLRQVKDYHUHGXFHGGLVVHPLQDWLRQ
RIVFKRODUVKLSDQGFULSSOHGOLEUDULHV63$5&VHUYHVDVDFDWDO\VWIRUDFWLRQKHOSLQJ
WRFUHDWHV\VWHPVWKDWH[SDQGLQIRUPDWLRQGLVVHPLQDWLRQDQGXVHLQDQHWZRUNHG
GLJLWDOHQYLURQPHQWZKLOHUHVSRQGLQJWRWKHQHHGVRIVFKRODUVDQGDFDGHPH
6FL(/2KWWSZZZVFLHOREU7KHVFLHQWLILF(OHFWURQLF/LEUDU\2QOLQH6FL(/2LV
DQHOHFWURQLFOLEUDU\FRYHULQJDVHOHFWHGFROOHFWLRQRI%UD]LOLDQVFLHQWLILFMRXUQDOV
+HDOWK,QWHU1HWZRUNKWWSZZZKHDOWKLQWHUQHWZRUNRUJVFLSXESKS7KH+HDOWK
,QWHU1HWZRUNZDVODXQFKHGE\WKH6HFUHWDU\*HQHUDORIWKH8QLWHG1DWLRQVDQGLVOHG
E\WKH:RUOG+HDOWK2UJDQL]DWLRQWREULGJHWKH³GLJLWDOGLYLGH´LQKHDOWK,WDLPVWR
HQVXUHWKDWKHDOWKLQIRUPDWLRQDQGWKHWHFKQRORJLHVWRGHOLYHULWDUHZLGHO\DYDLODEOH
DQGHIIHFWLYHO\XVHGE\KHDOWKSHUVRQQHOSURIHVVLRQDOVUHVHDUFKHUVVFLHQWLVWVDQG
SROLF\PDNHUV
)UHH0HGLFDO-RXUQDOVFRPKWWSZZZIUHHPHGLFDOMRXUQDOVFRP'HGLFDWHGWRWKH
SURPRWLRQRIIUHHDFFHVVWRPHGLFDOMRXUQDOVRYHUWKH,QWHUQHWWKHVLWHFDUULHVOLVWLQJV
RIIUHHIXOOWH[WMRXUQDOV
4. Searching the Health InterNetwork Access to Research

Initiative (HINARI)
KWWSZZZKHDOWKLQWHUQHWZRUNRUJVFLSXESKS"ODQJ HQ$FFHVVHG
%DFNJURXQGLQIRUPDWLRQRQ+,1$5,KDVEHHQSURYLGHGLQ&KDSWHUVHFWLRQ
Using journals through HINARI

-RXUQDODEVWUDFWVDUHDYDLODEOHWRDOOXVHUVZLWKRXWUHJLVWUDWLRQ5HJLVWHUHG+,1$5,
XVHUVKDYHIXOOWH[WDFFHVVWRMRXUQDO1RQ+,1$5,XVHUVPD\VWLOOKDYHIXOOWH[WDFFHVV
WKURXJKWKH+,1$5/2*,1PHQXLIWKHLULQVWLWXWLRQVVXEVFULEHWRWKHMRXUQDOV
Finding journals
)URPWKHPHQXSDJH\RXFDQILQGMRXUQDOVDOSKDEHWLFDOO\E\WLWOHRUE\VXEMHFW7R
ILQGMRXUQDOVE\WLWOHFOLFNRQDOHWWHUIRUDQDOSKDEHWLFDOOLVWRIMRXUQDOWLWOHVVWDUWLQJZLWK
WKDWOHWWHUWKHQVHOHFWDMRXUQDOWLWOHWRJRGLUHFWO\WRWKDWMRXUQDO
Finding articles
'HWDLOHGVHDUFKLQJIRUDUWLFOHVFDQEHGRQHWKURXJK3XEPHG0HGOLQHGDWDEDVHRU
E\YLVLWLQJWKHZHEVLWHVRILQGLYLGXDOSXEOLVKHUV7RVHDUFKWKURXJK3XEPHGXVHUVFDQ
FOLFNRQ³6HDUFKIRUDUWLFOHVWKURXJK3XEPHG0HGOLQH´DQGWKHQKDYHWZRRSWLRQV
5HWULHYHFLWDWLRQVWRDOODUWLFOHVDERXWDVXEMHFW6RPHRIWKHVHDUWLFOHVPD\QRWEH
RQOLQHRUPD\QRWEHDFFHVVLEOHWR+,1$5,XVHUV
5HWULHYHFLWDWLRQVRQO\WRDUWLFOHVWKDWDUHDFFHVVLEOHWKURXJK+,1$5,
Indexes to regional journals

7KHPHQXSDJHSURYLGHVOLQNVWRWKHIROORZLQJ
$IULFDQ,QGH[0HGLFXV$,0
,QGH[0HGLFXVIRUWKH:+2(DVWHUQ0HGLWHUUDQHDQ5HJLRQ,0(05
/DWLQ$PHULFDQDQG&DULEEHDQ&HQWHURQ+HDOWK6FLHQFHV,QIRUPDWLRQ/,/$&6
,QGH[0HGLFXVIRU6RXWK(DVW$VLD5HJLRQ,06($5
7KHXVHUFDQFOLFNIRUDVKRUWFXWWRLQGH[LQIRUPDWLRQ
Reference sources full text

/LQNV DUH SURYLGHG WR GDWDEDVHV HQF\FORSHGLDV ERRNV DQG RWKHU IXOO WH[W
UHVRXUFHV
Links to other free collections

7KHVHVLWHVRIIHUIUHHDFFHVVWRMRXUQDOFROOHFWLRQV
%LR0HG&HQWUDO
)UHH0HGLFDO-RXUQDO
)UHHERRNVIRUGRFWRUV
3XE0HG&HQWUDO
6FL(/2
HINARI registration
$FDGHPLFJRYHUQPHQWRUUHVHDUFKLQVWLWXWLRQVORFDWHGLQRQHRIWKHFRXQWULHV
HOLJLEOHIRUDFFHVVWR+,1$5,FDQUHJLVWHUE\FRPSOHWLQJDUHJLVWUDWLRQIRUP2QFHWKH
UHJLVWUDWLRQIRUPLVUHFHLYHGDFRPPRQXVHUQDPHDQGSDVVZRUGZLOOEHLVVXHGIRUDOO
VWDIIDWWKHLQVWLWXWLRQ,WLVVXJJHVWHGWKDWWKHLQVWLWXWLRQ¶VOLEUDULDQEHWKHPDLQFRQWDFW
SRLQW
$VRI)HEUXDU\WKHIROORZLQJFRXQWULHVLQWKH:+2(DVWHUQ0HGLWHUUDQHDQ
5HJLRQDUHHOLJLEOHIRUDFFHVVWR+,1$5,
$IJKDQLVWDQ'MLERXWL,UDT-RUGDQ0RURFFR6XGDQ6\ULDQ$UDE5HSXEOLF7XQLVLD
:HVW%DQNDQG*D]D<HPHQ
5. Searching library resources of the WHO Regional Office

for the Eastern Mediterranean (EMRO)
,QIRUPDWLRQRQWKH(DVWHUQ0HGLWHUUDQHDQ5HJLRQ,QGH[0HGLFXVLVSURYLGHGLQ
&KDSWHUVHFWLRQ
7KHIROORZLQJ&'520'DWDEDVHVDUHDYDLODEOHLQWKH(052OLEUDU\KWWS
ZZZHPURZKRLQW/LEUDU\/LEUDU\'DWDEDVHV+70$FFHVVHG
&'0$5&%LEOLRJUDSKLF/LEUDU\RI&RQJUHVV
7KH &'520 'LUHFWRU\ SURYLGHV FRPSUHKHQVLYH GHWDLOV RQ &'520 WLWOHV
FRPPHUFLDOO\DYDLODEOH
&RPSXWHUUHODWHGGDWDEDVHV
How to write references 209
(0%$6( 'UXJ DQG 3KDUPDFHXWLFDO 7KLV GDWDEDVH FRQWDLQV RYHU
DEVWUDFWVDQGFLWDWLRQVIURPWKHODVW\HDUVDQGFRYHUVFRPSUHKHQVLYHO\WKHGUXJV
DQGSKDUPDFRORJ\OLWHUDWXUHLQFOXGLQJHIIHFWDQGXVHRIDOOGUXJVDQGSRWHQWLDOGUXJV
FOLQLFDO DQG H[SHULPHQWDO DVSHFWV DQG SKDUPDFRNLQHWLFV DQG SKDUPDFRG\QDPLFV
$OVRH[WHQVLYHO\FRYHUHGDUHWKHVLGHHIIHFWVRIDQGDGYHUVHUHDFWLRQVWRGUXJV
(5,&(GXFDWLRQDO5HVRXUFHV,QIRUPDWLRQ&HQWUH
([WUD0('FRQWDLQVWKHFRQWHQWVRIRYHUELRPHGLFDOMRXUQDOVIURPDOORYHUWKH
ZRUOGPDLQO\IURPGHYHORSLQJFRXQWULHV,WZDVHVWDEOLVKHGRQWKHLQLWLDWLYHRIWKH
:RUOG+HDOWK2UJDQL]DWLRQ8VHUVZLOOEHDEOHWRXVHLQGH[LQJWRROVSURYLGHGRQWKH
GLVNWRORFDWHUHOHYDQWDUWLFOHVDQGFDQWKHQSULQWRXWWKRVHRISDUWLFXODULQWHUHVW
)RRGDQG+XPDQ1XWULWLRQIRFXVHVRQVXEMHFWVIURPDQLQWHUQDWLRQDOSHUVSHFWLYH
ZKLFKLQFOXGHVRYHUSDUWLFLSDWLQJFRXQWULHVFRYHUHGLQRYHUDTXDUWHURIDPLOOLRQ
UHFRUGV
*OREDO%RRNVLQ3ULQW3OXV7KLVWLWOHFRQWDLQVELEOLRJUDSKLFDOLQIRUPDWLRQIURP
VL[(QJOLVKODQJXDJHGDWDEDVHV
/,/$&6&'520/DWLQ$PHULFDQDQG&DULEEHDQ+HDOWK6FLHQFHV/LWHUDWXUH7KH
RQO\FRPSOHWHDQGXSGDWHGGDWDEDVHFRYHULQJKHDOWKUHODWHGOLWHUDWXUHSXEOLVKHGLQ
WKH/DWLQ$PHULFDQDQGWKH&DULEEHDQUHJLRQV
0('/,1(7KH0('/,1(GDWDEDVHHQFRPSDVVHVLQIRUPDWLRQIURPWKUHHSULQWHG
LQGH[HV,QGH[0HGLFXV,QGH[WR'HQWDO/LWHUDWXUHDQGWKH,QWHUQDWLRQDO1XUVLQJ
,QGH[DVZHOODVDGGLWLRQDOLQIRUPDWLRQQRWSXEOLVKHGLQWKH,QGH[0HGLFXV
2[IRUG(QJOLVK'LFWLRQDU\6HFRQG(GLWLRQRQ&RPSDFW'LVF
323/,1(LVDELEOLRJUDSKLFGDWDEDVHFRQWDLQLQJPRUHWKDQFLWDWLRQVRQ
SRSXODWLRQIDPLO\SODQQLQJDQGUHODWHGKHDOWKFDUHODZDQGSROLF\LVVXHV
8OULFK¶V,QWHUQDWLRQDO3HULRGLFDOV'LUHFWRU\
Annex 4
Guidelines on how to write references
for scientific papers
1. General
7KLV$QQH[VXSSOHPHQWVLQIRUPDWLRQSURYLGHGLQ&KDSWHUVHFWLRQE\
SURYLGLQJH[DPSOHVRQKRZGLIIHUHQWW\SHVRIUHIHUHQFHVFDQEHFLWHG,WLVEDVHGRQWKH
8QLIRUP5HTXLUHPHQWVIRU0DQXVFULSWVVXEPLWWHGWR%LRPHGLFDO-RXUQDOVLVVXHGE\WKH
,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUV7KH8QLIRUP5HTXLUHPHQWVVW\OH
WKH9DQFRXYHUVW\OHLVEDVHGODUJHO\RQDQ$16,VWDQGDUGVW\OHDGDSWHGE\WKH1/0
IRULWVGDWDEDVHVKWWSZZZQOPQLKJRYEVGXQLIRUPBUHTXLUHPHQWVKWPO$XWKRUV
VKRXOGHQVXUHWKDWWKH\IROORZDQ\H[DPSOHVRIVW\OHJLYHQE\WKHMRXUQDOWRZKLFKWKH\
DUHVXEPLWWLQJDSDSHU
2. Journal articles
6WDQGDUGMRXUQDODUWLFOH
9HJD.-3LQD,.UHYVN\%+HDUWWUDQVSODQWDWLRQLVDVVRFLDWHGZLWKDQLQFUHDVHGULVN
IRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG-XQ±
,IWKH-RXUQDOFDUULHVFRQWLQXRXVSDJLQDWLRQWKURXJKRXWDYROXPHDVPDQ\PHGLFDO
MRXUQDOVGRWKHPRQWKDQGLVVXHQXPEHUPD\EHRPLWWHG
IRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG±
,IPRUHWKDQVL[DXWKRUVOLVWWKHILUVWVL[DXWKRUVIROORZHGE\HWDO
9HJD.-3LQD,.UHYVN\%HWDO+HDUWWUDQVSODQWDWLRQLVDVVRFLDWHGZLWKDQLQFUHDVHG
ULVNIRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG±
2UJDQL]DWLRQDVDQDXWKRU
7KH&DUGLDF6RFLHW\RI$XVWUDOLDDQG1HZ=HDODQG+HDUWWUDQVSODQWDWLRQLVDVVRFLDWHG
ZLWKDQLQFUHDVHGULVNIRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG±
1RDXWKRUJLYHQ
+HDUWWUDQVSODQWDWLRQLVDVVRFLDWHGZLWKDQLQFUHDVHGULVNIRUSDQFUHDWRELOLDU\GLVHDVH
>HGLWRULDO@$QQ,QWHUQ0HG±
$UWLFOHQRWLQ(QJOLVK
'RQRWSURYLGHWUDQVODWLRQ
9ROXPHZLWKVXSSOHPHQW
ULVNIRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG6XSSO±
,VVXHZLWKVXSSOHPHQW
ULVNIRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG6XSSO±
9ROXPHZLWKSDUW
IRUSDQFUHDWRELOLDU\GLVHDVH$QQ,QWHUQ0HG3W±
±
,VVXHZLWKQRYROXPH
IRUSDQFUHDWRELOLDU\GLVHDVH&OLQ2UWKR±
1RLVVXHRUYROXPH
IRUSDQFUHDWRELOLDU\GLVHDVH&XUU2SLQ*HQ6XUJ±
3DJLQDWLRQLQ5RPDQQXPHUDOV
IRUSDQFUHDWRELOLDU\GLVHDVH6XUJ&OLQ1RUWK$P$SULO[L±[LL
3. Books and other Monographs

)RUPDODXWKRUV
5LQJVYHQ0.%RQG'*HURQWRORJ\DQGOHDGHUVKLSVNLOOVIRUQXUVHVQGHG$OEDQ\
1<'HOPDU3XEOLVKHUV
(GLWRUVFRPSLOHUVDVDXWKRU

5LQJVYHQ0.%RQG'HGLWRUV*HURQWRORJ\DQGOHDGHUVKLSVNLOOVIRUQXUVHVQGHG
$OEDQ\1<'HOPDU3XEOLVKHUV
2UJDQL]DWLRQDVDXWKRUDQGSXEOLVKHU
,QVWLWXWHRI0HGLFLQH86*HURQWRORJ\DQGOHDGHUVKLSVNLOOVIRUQXUVHV:DVKLQJWRQ
7KH,QVWLWXWH
&KDSWHULQDERRN
3KLOOLSV6-:KLVQDQW-3$QLQWURGXFWLRQWRJHURQWRORJ\,Q5LQJVYHQ0.%RQG'
HGLWRUV*HURQWRORJ\DQGOHDGHUVKLSVNLOOVIRUQXUVHVQGHG$OEDQ\1<'HOPDU
3XEOLVKHUVS±
&RQIHUHQFHSURFHHGLQJV
5LQJVYHQ0.%RQG'HGLWRUV*HURQWRORJ\DQGOHDGHUVKLSVNLOOVIRUQXUVHV3URFHHGLQJV
RIWKHWK,QWHUQDWLRQDO&RQJUHVVRI1XUVHV2FW±.\RWR-DSDQ$OEDQ\
1<'HOPDU3XEOLVKHUV
&RQIHUHQFHSDSHU
3KLOOLSV6-:KLVQDQW-3$QLQWURGXFWLRQWRJHURQWRORJ\,Q5LQJVYHQ0.%RQG
'HGLWRUV*HURQWRORJ\DQGOHDGHUVKLSVNLOOVIRUQXUVHV3URFHHGLQJVRIWKHWK
,QWHUQDWLRQDO&RQJUHVVRI1XUVHV2FW.\RWR-DSDQ$OEDQ\1<'HOPDU
3XEOLVKHUVS±
6FLHQWLILFRUWHFKQLFDOUHSRUWLVVXHGE\IXQGLQJVSRQVRULQJDJHQF\
6PLWK3*ROODGD\.3D\PHQWIRUGXUDEOHPHGLFDOHTXLSPHQWLQVNLOOHGQXUVLQJIDFLOLWLHV
)LQDOUHSRUW'DOODV7;'HSDUWPHQWRI+HDOWKDQG+XPDQ6HUYLFHV862IILFHRI
(YDOXDWLRQDQG,QVSHFWLRQ2FW5HSRUW1R++6,*2(,
4. Unpublished material
,QSUHVV
1RWH1/0SUHIHUV³)RUWKFRPLQJÉHFDXVHQRWDOOLWHPVZLOOEHSULQWHG
/HVKQHU$,0ROHFXODUPHFKDQLVPVRIFRFDLQHDGGLFWLRQ1(QJO-0HG,QSUHVV

(OHFWURQLFPDWHULDO
-RXUQDODUWLFOHLQHOHFWURQLFIRUPDW
0RUVH66)DFWRUVLQWKHHPHUJHQFHRILQIHFWLRXVGLVHDVHV(PHUJ,QIHFW'LV>VHULDO
RQOLQH@-DQ±0DU>FLWHG-XQ@>VFUHHQV@$YDLODEOHIURP85/KWWS
ZZZFGFJRYQFLGRG(,'HLGKWP
0RQRJUDSKLQHOHFWURQLFIRUPDW
&',FOLQLFDOGHUPDWRORJ\LOOXVWUDWHG>PRQRJUDSKRQ&'5RP@5HHYHV-570DLEDFK+
&0($0XOWLPHGLD*URXSSURGXFHUVQGHG9HUVLRQ6DQ'LHJR&0($
5. How to order references

0RVWMRXUQDOVLQPHGLFLQHDQGWKHRWKHUPHGLFDOVFLHQFHVXVHWKH9DQFRXYHURU
FLWDWLRQE\UHIHUHQFHQXPEHUV\VWHPLQZKLFKWKHUHIHUHQFHVLQWKHUHIHUHQFHOLVWDUH
QXPEHUHGLQWKHRUGHULQZKLFKWKH\DUHILUVWFLWHGLQWKHWH[W
6RPHMRXUQDOVVWLOOXVHWKHFLWDWLRQE\DXWKRUDQGGDWHV\VWHPDOVRNQRZQDV
WKH+DUYDUGV\VWHPLQZKLFKWKHSDSHUFLWHGLVLGHQWLILHGE\DXWKRUQDPHDQG\HDURI
SXEOLFDWLRQ
,QDFRPELQHG$OSKDEHW1XPEHU6\VWHPUHIHUHQFHVDUHOLVWHGLQDOSKDEHWLFDORUGHU
DFFRUGLQJWRWKHSULPDU\DXWKRU¶VQDPHDQGFLWHGE\QXPEHUVLQWKHWH[W
(YHQLIWKHMRXUQDOWRZKLFKWKHSDSHULVVXEPLWWHGXVHVWKHFLWDWLRQE\UHIHUHQFH
QXPEHUV\VWHPLWLVDGYLVDEOHWRXVHWKH+DUYDUGV\VWHPIRUWKHFLWDWLRQVLQWKHILUVW
DQGRWKHUHDUO\GUDIWV,IQXPEHUVDUHDVVLJQHGWRUHIHUHQFHVDWWKLVHDUO\VWDJHWKRVH
QXPEHUVZLOOYHU\OLNHO\KDYHWREHFKDQJHGLQVXEVHTXHQWGUDIWV:LWKDZRUGSURFHVVLQJ
SURJUDPWKH³VHDUFKDQGUHSODFHÍXQFWLRQRQHFDQSODFHDWWKHEHJLQQLQJRIHDFK
FLWDWLRQDFKDUDFWHUQRWXVHGHOVHZKHUHLQWKHWH[WIRUH[DPSOHDQDVWHULVN
Annex 5
Bangkok Declaration on Health
Research for Development
7KH,QWHUQDWLRQDO&RQIHUHQFHRQ+HDOWK5HVHDUFKIRU'HYHORSPHQWEURXJKWWRJHWKHU
PRUHWKDQSDUWLFLSDQWVUHSUHVHQWLQJDZLGHUDQJHRIVWDNHKROGHUVLQKHDOWKUHVHDUFK
IURPGHYHORSLQJDQGGHYHORSHGFRXQWULHV&RQIHUHQFHSDUWLFSDQWVIURPRYHURQHKXQGUHG
FRXQWULHVZHOFRPHGWKHLQWHUDFWLYHDQGSDUWLFLSDWRU\QDWXUHRIWKHGLVFXVVLRQV
+DYLQJUHYLHZHGWKHUHSRUWVIURPWKHYDULRXVUHJLRQDODQGFRXQWU\FRQVXOWDWLRQV
DQGWDNLQJLQWRDFFRXQWERWKWKHLQGHSWKDQDO\VLVRISURJUHVVLQKHDOWKUHVHDUFKRYHU
WKHSDVWGHFDGHDQGWKHGLVFXVVLRQVEHIRUHDQGGXULQJWKHPHHWLQJ:HWKHSDUWLFLSDQWV
PDNHWKHIROORZLQJ'HFODUDWLRQ
7KH&RQIHUHQFHUHDIILUPVWKDWKHDOWKLVDEDVLFKXPDQULJKW+HDOWKUHVHDUFK
LV HVVHQWLDOIRULPSURYHPHQWVQRWRQO\LQKHDOWK EXW DOVR LQ VRFLDO DQG HFRQRPLF
GHYHORSPHQW5DSLGJOREDOL]DWLRQQHZXQGHUVWDQGLQJRIKXPDQELRORJ\DQGWKH
LQIRUPDWLRQWHFKQRORJ\UHYROXWLRQSRVHQHZFKDOOHQJHVDQGRSSRUWXQLWLHV6RFLDO
DQGKHDOWKGLVSDULWLHVERWKZLWKLQDQGEHWZHHQFRXQWULHVDUHJURZLQJ*LYHQWKHVH
JOREDOWUHQGVDIRFXVRQVRFLDODQGJHQGHUHTXLW\VKRXOGEHFHQWUDOWRKHDOWKUHVHDUFK
,QDGGLWLRQKHDOWKUHVHDUFKLQFOXGLQJLQVWLWXWLRQDODUUDQJHPHQWVVKRXOGEHEDVHGRQ
FRPPRQXQGHUO\LQJYDOXHV7KHUHVKRXOGEH
DFOHDUDQGVWURQJHWKLFDOEDVLVJRYHUQLQJWKHGHVLJQFRQGXFWDQGXVHRIUHVHDUFK
WKHLQFOXVLRQRIDJHQGHUSHUVSHFWLYH
D FRPPLWPHQW WKDW NQRZOHGJH GHULYHG IURP SXEOLFO\ IXQGHG UHVHDUFK VKRXOG EH
DYDLODEOHDQGDFFHVVLEOHWRDOO
DQXQGHUVWDQGLQJWKDWUHVHDUFKLVDQLQYHVWPHQWLQKXPDQGHYHORSPHQW
DUHFRJQLWLRQWKDWUHVHDUFKLVDQLQYHVWPHQWLQKXPDQGHYHORSPHQWDQG
DUHFRJQLWLRQWKDWUHVHDUFKVKRXOGEHLQFOXVLYHLQYROYLQJDOOVWDNHKROGHUVLQFOXGLQJ
FLYLOVRFLHW\LQSDUWQHUVKLSVDWORFDOQDWLRQDOUHJLRQDODQGJOREDOOHYHOV
$QHIIHFWLYHKHDOWKUHVHDUFKV\VWHPUHTXLUHV
FRKHUHQWDQGFRRUGLQDWHGKHDOWKUHVHDUFKVWUDWHJLHVDQGDFWLRQVWKDWDUHEDVHGRQ
PXWXDOO\EHQHILFLDOSDUWQHUVKLSVEHWZHHQDQGZLWKLQFRXQWULHV
Bangkok declaration on health research for development 215
DQHIIHFWLYHJRYHUQDQFHV\VWHP
DUHYLWDOL]HGHIIRUWIURPDOOLQYROYHGLQKHDOWKUHVHDUFKWRJHQHUDWHQHZNQRZOHGJH
ZKLFKDGGUHVVHVWKHSUREOHPVRIWKHZRUOG¶VGLVDGYDQWDJHGDQGLQFUHDVHVWKHXVH
RIKLJKTXDOLW\UHOHYDQWHYLGHQFHLQGHFLVLRQPDNLQJ
,WLVWKHUHVSRQVLELOLW\RIDQDFWLYHFLYLOVRFLHW\WKURXJKWKHLUJRYHUQPHQWVDQGRWKHU
FKDQQHOVWRVHWWKHGLUHFWLRQIRUWKHKHDOWKUHVHDUFKV\VWHPQXUWXUHDQGVXSSRUWKHDOWK
UHVHDUFKDQGHQVXUHWKDWWKHRXWFRPHVRIUHVHDUFKDUHXVHGWREHQHILWDOOWKHLUSHRSOHV
DQGWKHJOREDOFRPPXQLW\
:HWKHSDUWLFLSDQWVFRPPLWRXUVHOYHVWRHQVXULQJWKDWKHDOWKUHVHDUFKLPSURYHVWKH
KHDOWKDQGTXDOLW\RIOLIHRIDOOSHRSOHV
7KHZRUNFDUULHGRXWLQSUHSDUDWLRQIRUDQGGXULQJWKH&RQIHUHQFHVKRXOGFRQWLQXH
WKURXJKDSURFHVVWKDWZLOODOORZDOOVWDNHKROGHUVWRFRQWULEXWHWRGHEDWHDQGGHFLVLRQV
RQWKHNH\LVVXHVIRUWKHIXWXUHRIKHDOWKUHVHDUFKIRUGHYHORSPHQW
6RXUFHZZZJOREDOIRUXPKHDOWKRUJ?QRQFRPSOLDQWBSDJHV?IRUXP?GHFODUDWLRQKWP
7KH,QWHUQDWLRQDO&RQIHUHQFHRQ+HDOWK5HVHDUFKIRU'HYHORSPHQWZDVRUJDQL]HG
E\
7KH&RXQFLORQ+HDOWK5HVHDUFKIRU'HYHORSPHQW&2+5('ZZZFRKUHGFK
7KH*OREDO)RUXPIRU+HDOWK5HVHDUFKZZZJOREDOIRUXPKHDOWKRUJ
7KH:RUOG%DQNZZZZRUOGEDQNRUJ
7KH:RUOG+HDOWK2UJDQL]DWLRQZZZZKRLQW
Glossary of terms in health research
$EVWUDFW$QDEEUHYLDWHGVXPPDU\RIDUHVHDUFKSDSHUJHQHUDOO\DWWKHEHJLQQLQJRIWKHSDSHU
$FWLRQUHVHDUFK$VW\OHRIUHVHDUFKLQZKLFKWKHUHVHDUFKHUVZRUNZLWKWKHSHRSOHDQGIRUWKH
SHRSOHUDWKHUWKDQXQGHUWDNHUHVHDUFKRQWKHP7KHIRFXVRIDFWLRQUHVHDUFKLVRQJHQHUDWLQJ
VROXWLRQVWRSUREOHPVLGHQWLILHGE\WKHSHRSOHZKRDUHJRLQJWRXVHWKHUHVXOWVRIUHVHDUFK
$GMXVWHGUDWHV7HUPVXVHGZKHQUHVXOWVKDYHXQGHUJRQHVWDWLVWLFDOWUDQVIRUPDWLRQWRSHUPLWIDLU
FRPSDULVRQEHWZHHQJURXSVGLIIHULQJLQVRPHFKDUDFWHULVWLFWKDWPD\DIIHFWULVNRIGLVHDVH
$QDO\WLFDOVWXG\$QREVHUYDWLRQDOVWXG\WKDWGHVFULEHVDVVRFLDWLRQVDQGDQDO\VHVWKHPIRU
SRVVLEOHFDXVHDQGHIIHFW
$OWHUQDWLYHK\SRWKHVLV7KHK\SRWKHVLVWKDWWKHUHVHDUFKHULVWHVWLQJLQWKHVWXG\,QVFLHQWLILF
PHWKRGRORJ\ZHVWDUWZLWKWKHDVVXPSWLRQWKDWLWLVQRWWUXHXQWLOSURYHGRWKHUZLVHE\UHMHFWLQJ
WKHQXOOK\SRWKHVLV
$QRQ\PRXVOLQNHGLQIRUPDWLRQ,QIRUPDWLRQZKLFKFDQQRWEHOLQNHGWRWKHSHUVRQWRZKRPLW
UHIHUVHQVXULQJWKDWWKHLQYHVWLJDWRUFDQQRWNQRZWKHLGHQWLW\RIWKHSHUVRQDQGWKHUHLVFRPSOHWH
FRQILGHQWLDOLW\LQDVWXG\
$VVLJQPHQW7KHSURFHVVLQDQH[SHULPHQWZKHUHWKHUHVHDUFKHUDOORFDWHVVXEMHFWVWRWZRRUPRUH
JURXSVWU\LQJWRDFKLHYHKDYLQJJURXSVDVLGHQWLFDODVSRVVLEOHWRDOORZDYDOLGFRPSDULVRQRI
WKHUHVXOWV0DWFKLQJDQGUDQGRPDVVLJQPHQWDUHWKHWZRPRVWFRPPRQPHWKRGV
$WWULEXWDEOHULVN$QHVWLPDWHWRTXDQWLI\WKHFRQWULEXWLRQZKLFKDSDUWLFXODUULVNIDFWRUPDNHV
LQSURGXFLQJWKHGLVHDVHZLWKLQDSRSXODWLRQ
$XGLWRIDWULDO$V\VWHPDWLFH[DPLQDWLRQFDUULHGRXWLQGHSHQGHQWO\RIWKRVHGLUHFWO\LQYROYHG
LQWKHFOLQLFDOWULDO
%DURUFROXPQFKDUWV$JUDSKLFPHWKRGRIGHVFULELQJWKHGDWDZKHUHWKHIUHTXHQF\RID
SDUWLFXODUFDWHJRU\LVUHIOHFWHGLQWKHKHLJKWRIWKHEDULQWKHJUDSK
%DVHOLQH $ SKDVH LQ DQ LQWHUYHQWLRQ VWXG\ ZKHUH WKH SDUWLFLSDQWV KDYH QRW UHFHLYHG DQ\
LQWHUYHQWLRQ
%DVLFULVN$QH[SUHVVLRQRIWKHOLNHOLKRRGWKDWDSDUWLFXODUHYHQWZLOORFFXUZLWKLQDSDUWLFXODU
SRSXODWLRQ
%HIRUHDQGDIWHUVWXG\$PHWKRGRIFRQWUROLQZKLFKUHVXOWVIURPH[SHULPHQWDOVXEMHFWVDUH
FRPSDUHGZLWKRXWFRPHVIURPSDWLHQWVWUHDWHGEHIRUHWKHQHZLQWHUYHQWLRQZDVDYDLODEOH7KHVH
DUHFDOOHGKLVWRULFFRQWUROV
%HOOVKDSHGFXUYH7KHFKDUDFWHULVWLFVKDSHRIWKHFXUYHRIDQRUPDOGLVWULEXWLRQZKHUHWKHGDWD
DUHHTXDOO\GLVWULEXWHGDURXQGWKHPHDQ
Glossary 217
%HQHILFHQFH$QHWKLFDOSULQFLSOHLPSO\LQJWKDWHYHU\HIIRUWVKRXOGEHPDGHWRPD[LPL]HWKH
EHQHILWVWRWKHVXEMHFWVLQKHDOWKUHVHDUFK
%LDV,IWKHVWXG\VDPSOHLVQRWUHSUHVHQWDWLYHRIWKHSRSXODWLRQWKHLQIHUHQFHZHPDNHIURPWKH
UHVXOWPD\EHPLVOHDGLQJ
%OLQGLQJ$UDQGRPL]HGFRQWUROOHGWULDOPD\EHEOLQGHGLISDUWLFLSDQWVLQWKHWULDODUHOLNHO\WR
FKDQJHWKHLUEHKDYLRXULQDV\VWHPDWLFZD\WKDWPD\LQIOXHQFHWKHRXWFRPHRIWKHVWXG\ZKHQ
WKH\DUHDZDUHRIZKLFKLQWHUYHQWLRQWKH\UHFHLYH7KHWHUP³PDVNLQJ´LVRIWHQXVHGLQVWHDGRI
³EOLQGLQJ´
&DVH±FRQWUROVWXG\$W\SHRIREVHUYDWLRQDODQDO\WLFDOORQJLWXGLQDOUHWURVSHFWLYHVWXG\LQZKLFK
DJURXSRIVXEMHFWVZLWKDVSHFLILHGRXWFRPHFDVHVDQGDJURXSZLWKRXWWKDWRXWFRPHFRQWUROV
DUHLGHQWLILHG,QYHVWLJDWRUVWKHQFRPSDUHWKHH[WHQWWRZKLFKHDFKVXEMHFWZDVSUHYLRXVO\H[SRVHG
WRWKHYDULDEOHRILQWHUHVWVXFKDVULVNIDFWRUDWUHDWPHQWRUDQLQWHUYHQWLRQ
&DWHJRULFDOYDULDEOHV'DWDZKHUHHDFKLQGLYLGXDOYDULDEOHLVRQHRIDQXPEHURIPXWXDOO\
H[FOXVLYHFODVVHV
&HQWUDOWHQGHQF\7KHDYHUDJHPHDQPLGGOHPHGLDQRUPRVWFRPPRQPRGHVFRUHIRU
QXPHULFDOGDWDLQDIUHTXHQF\GLVWULEXWLRQ
&KLVTXDUHȤ$VWDWLVWLFDOWHVWXVHGIRUFDWHJRULFDOGDWD,WLVEDVHGRQDFRPSDULVRQRIWKH
IUHTXHQFLHVREVHUYHGDQGWKHIUHTXHQFLHVH[SHFWHGLQWKHYDULRXVFDWHJRULHV
&OXVWHUVDPSOLQJ$W\SHRIUDQGRPVDPSOLQJEDVHGILUVWRQWKHUDQGRPVHOHFWLRQRIFHUWDLQ
VXEJURXSVIURPZKLFKWKHVDPSOHFDQEHWDNHQ
&RGLQJ$PHWKRGRIDQDO\VLVRITXDOLWDWLYHGDWDREWDLQHGIRUH[DPSOHLQLQWHUYLHZVZKHUH
FDWHJRULHVDUHODEHOOHGWRIDFLOLWDWHFRPSXWHUDQDO\VLVDQGH[DPLQDWLRQRIUHODWLRQVKLSV
&RKRUWVWXG\7KHWHUPXVHGLQFOLQLFDODQGHSLGHPLRORJLFDOUHVHDUFKWRGHVFULEHDORQJLWXGLQDO
SURVSHFWLYHREVHUYDWLRQDOVWXG\
&RQILGHQFHLQWHUYDO$VWDWLVWLFRIWKHH[SHFWHGUDQJHLQZKLFKWKHSRSXODWLRQYDOXHZLOOEHIRXQG
DWDJLYHQOHYHORIFRQILGHQFHRUSUREDELOLW\
&RQIOLFWRILQWHUHVW,QYHVWLJDWRUVPD\KDYHYHVWHGLQWHUHVWVLQWKHUHVHDUFK7KHVHPD\EH
LQWHOOHFWXDOSURSHUW\LQWHUHVWVDVZHOODVFRPPHUFLDOLQWHUHVWV6XFKLQWHUHVWVKRXOGEHH[SOLFLWO\
GHFODUHG
&RQIRXQGHU,QVLPSOHWHUPVFRQIRXQGHUVDUHDOORIWKH³RWKHUWKLQJV´WKDWFRXOGH[SODLQWKH
UHVXOWRIWKHUHVHDUFK,QWHFKQLFDOWHUPVFRQIRXQGHUVDUHIDFWRUVWKDWDUHDVVRFLDWHGZLWKERWK
H[SRVXUHDQGRXWFRPH
&RQVHFXWLYHVDPSOLQJ$VDPSOLQJSURFHGXUHLQZKLFKVXEMHFWVDUHVHOHFWHGE\WDNLQJHYHU\
LQGLYLGXDOWKDWSUHVHQWVRYHUDVSHFLILHGSHULRGRIWLPH
&RQWLQXRXVYDULDEOHV'DWDZKLFKDUHPHDVXUHGRQDFRQWLQXRXVVFDOH7KH\DUHQXPEHUVWKDW
FDQEHDGGHGVXEWUDFWHGPXOWLSOLHGDQGGLYLGHG
&RUUHODWLRQ7KHVWUHQJWKDQGGLUHFWLRQRIWKHDVVRFLDWLRQEHWZHHQWZRYDULDEOHV&RUUHODWLRQ
GRHVQRWPHDQFDXVDWLRQ
&RUUHODWLRQFRHIILFLHQW$VWDWLVWLFGHVLJQHGWRPHDVXUHWKHVL]HDQGGLUHFWLRQRIWKHDVVRFLDWLRQ
EHWZHHQWZRYDULDEOHV7KHYDOXHYDULHVEHWZHHQDQGPHDQVFRPSOHWHFRUUHODWLRQ
&RVW±EHQHILWDQDO\VLV$W\SHRIHFRQRPLFVWXG\GHVLJQLQZKLFKERWKFRVWVDQGEHQHILWV
RILQWHUYHQWLRQVDUHH[SUHVVHGLQPRQHWDU\XQLWVDOORZLQJGLUHFWFRPSDULVRQRIFRPSHWLQJ
LQWHUYHQWLRQV
&RVW±HIIHFWLYHQHVVDQDO\VLV$W\SHRIHFRQRPLFVWXG\GHVLJQLQZKLFKWKHQHWPRQHWDU\FRVWV
RIDKHDOWKFDUHLQWHUYHQWLRQSHUXQLWPHDVXUHRIFOLQLFDORXWFRPHRUHIIHFWLYHQHVVDOORZVGLUHFW
FRPSDULVRQRIFRPSHWLQJLQWHUYHQWLRQV
&URVVRYHUVWXG\$VSHFLDOGHVLJQRIFRQWUROOHGWULDOVLQZKLFKKDOIRIWKHSDUWLFLSDQWVDUH
UDQGRPO\DVVLJQHGWRVWDUWZLWKWKHSODFHERDQGWKHQVZLWFKWRDFWLYHWUHDWPHQWZKLOHWKHRWKHU
KDOIGRHVWKHRSSRVLWH
&URVVVHFWLRQDOVWXG\$QREVHUYDWLRQDOVWXG\GHVLJQLQZKLFKPHDVXUHPHQWVDUHPDGHRQD
VLQJOHRFFDVLRQ
&URVVWDEXODWLRQWDEOHV)UHTXHQF\GLVWULEXWLRQWDEOHVWKDWH[DPLQHWKHUHODWLRQVKLSEHWZHHQ
VHYHUDORIWKHYDULDEOHVDWRQFHIRUEHWWHUGHVFULSWLRQRIWKHGDWDRULQRUGHUWRORRNIRUGLIIHUHQFHV
RUUHOHYDQWDVVRFLDWLRQV
&UXGHUDWHV7HUPVXVHGZKHQUHVXOWVKDYHQRWEHHQDGMXVWHGIRUFRQIRXQGLQJIDFWRUV
'HSHQGHQWRURXWSXWYDULDEOHV5HVSRQVHVRUFRQVHTXHQWVWKDWDUHFRQWLQJHQWRQLQGHSHQGHQW
YDULDEOHV
'HVFULSWLYHVWDWLVWLFV6WDWLVWLFVGHVLJQHGWRVXPPDUL]HDQGGHVFULEHFKDUDFWHULVWLFVRIWKHGDWD
'HVFULSWLYHVWDWLVWLFVKHOSVXVWRPDNHVHQVHRIDODUJHYROXPHRIGDWD
'HVFULSWLYH VWXG\$Q REVHUYDWLRQDO VWXG\ WKDW VLPSO\ GHVFULEHV WKH GLVWULEXWLRQ RI D
FKDUDFWHULVWLF
'LUHFWLRQDOUHVHDUFKK\SRWKHVLV7KHUHVHDUFKK\SRWKHVLVRXWOLQLQJDUHODWLRQVKLSPD\EH
GLUHFWLRQDORUQRQGLUHFWLRQDO)RUH[DPSOHDUHODWLRQVKLSEHWZHHQVPRNLQJDQGFDUGLRYDVFXODU
GLVHDVHFDQRQO\EHGLUHFWLRQDO,WLVH[SHFWHGLQWKHK\SRWKHVLVWKDWLWZLOOLQFUHDVHFDUGLRYDVFXODU
GLVHDVH7KHUHODWLRQVKLSEHWZHHQRUDOKRUPRQDOFRQWUDFHSWLYHVDQGFHUWDLQGLVHDVHFRQGLWLRQVFDQ
EHQRQGLUHFWLRQDO7KHGLVHDVHFRQGLWLRQVPD\LQFUHDVHRUGHFUHDVHDVDUHVXOWRIRUDOKRUPRQDO
FRQWUDFHSWLYHXVH
'LVDELOLW\DGMXVWHGOLIH\HDUV'$/<VORVW$QLQWHUQDWLRQDOPHDVXUHRIWKHEXUGHQRIGLVHDVH
WKDWH[SUHVVHVERWKWLPHORVWWKURXJKSUHPDWXUHGHDWKDQGWLPHOLYHGZLWKDGLVDELOLW\
'LVFUHWHRUGLVFRQWLQXRXVGDWD1XPHULFDOYDULDEOHVWKDWDUHQRWPHDVXUHGRQDFRQWLQXRXV
VFDOH
'LVWULEXWLYHMXVWLFH$QHWKLFDOSULQFLSOHLPSO\LQJWKDWSDUWLFLSDWLRQLQWKHUHVHDUFKVKRXOG
FRUUHODWHZLWKH[SHFWHGEHQHILWV1RSRSXODWLRQJURXSVKRXOGFDUU\DQXQGXHEXUGHQRIUHVHDUFK
IRUWKHEHQHILWRIDQRWKHUJURXS
'XSOLFDWHRUUHGXQGDQWSXEOLFDWLRQ3XEOLFDWLRQRIDSDSHUWKDWRYHUODSVVXEVWDQWLDOO\ZLWKRQH
DOUHDG\SXEOLVKHGE\WKHVDPHDXWKRUV
Glossary 219
(IIHFWVL]H7KHDPRXQWRIFKDQJHDVVRFLDWHGZLWKDQLQWHUYHQWLRQRUULVNIDFWRU,WLVLPSRUWDQW
LQGHWHUPLQLQJKRZVLJQLILFDQWWKHILQGLQJVDUHLQDFWXDOSUDFWLFH
(SKHPHUDOOLWHUDWXUH/LWHUDWXUHMXGJHGWRKDYHDVKRUWSHULRGRIXVHIXOQHVVDQGRQO\IRUDVPDOO
DXGLHQFHQRWQRUPDOO\FRQVLGHUHGZRUWKLQGH[LQJRUFDWDORJXLQJ,WPD\KRZHYHUEHLPSRUWDQW
,WLQFOXGHVUHSRUWVSURFHHGLQJVRIFRQIHUHQFHVDQGRWKHUW\SHVRISXEOLFDWLRQ
(VVHQWLDOQDWLRQDOKHDOWKUHVHDUFK(DFKGHYHORSLQJFRXQWU\VKRXOGHVWDEOLVKDQGVWUHQJWKHQ
DQDSSURSULDWHKHDOWKUHVHDUFKEDVHWRXQGHUVWDQGLWVRZQSUREOHPVLPSURYHKHDOWKSROLF\
DQG PDQDJHPHQW HQKDQFH WKH HIIHFWLYHQHVV RI OLPLWHG UHVRXUFHV IRVWHU LQQRYDWLRQ DQG
H[SHULPHQWDWLRQDQGSURYLGHWKHIRXQGDWLRQIRUDVWURQJHUGHYHORSLQJFRXQWU\YRLFHLQVHWWLQJ
LQWHUQDWLRQDOSULRULWLHV
([SHULPHQWDORULQWHUYHQWLRQVWXG\$VWXG\GHVLJQLQZKLFKWKHLQYHVWLJDWRUVWHVWWKHHIIHFWRI
DQLQWHUYHQWLRQRQWKHHYHQWVWDNLQJSODFHLQWKHVWXG\
([WHUQDOYDOLGLW\7KHH[WHQWWRZKLFKWKHUHVXOWVRIWKHVWXG\VDPSOHPD\EHJHQHUDOL]HGWRWKH
SRSXODWLRQIURPZKLFKWKHVDPSOHZDVZLWKGUDZQDOVRFDOOHGJHQHUDOL]DELOLW\
)RFXVJURXSGLVFXVVLRQ$PHWKRGRITXDOLWDWLYHUHVHDUFKXVHGZKHQLQIRUPDWLRQDQGLQVLJKWVZLOO
EHEHWWHUJDLQHGIURPWKHLQWHUDFWLRQRIDJURXSWKDQIURPLQGHSWKLQWHUYLHZVZLWKLQGLYLGXDOV
)RUFHGFKRLFHIRUPDW$IRUPDWIRUFORVHGUHVSRQVHTXHVWLRQVXVHGWRHOLFLWDWWLWXGHVRIWKH
UHVSRQGHQWVWRDFHUWDLQVWDWHPHQW7KHUHVSRQGHQWFKRLFHVDUHOLPLWHGWRIRXUVWURQJO\DJUHH
DJUHHGLVDJUHHDQGVWURQJO\GLVDJUHH7KLVIRUPDWGLIIHUHQWIURPWKH/LNHUWIRUPDWGRHVQRW
DOORZDQXQGHFLGHGDQVZHU
)UDXG6FLHQWLILFIUDXGLVGHOLEHUDWHGHFHSWLRQDQGPD\WDNHWKHIRUPRIIDEULFDWLQJGDWDLQYHQWLQJ
SDWLHQWVRUPDQLSXODWLQJGDWDWRSURYLGHDGHVLUHGDQVZHU
)UHTXHQF\GLVWULEXWLRQ7KHZD\LQZKLFKVFRUHVZLWKLQDJLYHQVDPSOHDUHGLVWULEXWHG
)UHTXHQF\GLVWULEXWLRQFXUYH$JUDSKLFPHWKRGIRUVXPPDUL]LQJGDWDDQGORRNLQJDWWKHPLQ
ZKLFKHDFKYDULDEOHLVSORWWHGDJDLQVWWKHIUHTXHQF\ZLWKZKLFKLWLVIRXQG
)UHTXHQF\GLVWULEXWLRQWDEOH$WDEOHWKDWJLYHVWKHIUHTXHQF\ZLWKZKLFKDSDUWLFXODUYDOXH
DSSHDUVLQWKHGDWD
*DXVVLDQGLVWULEXWLRQ$EHOOVKDSHGIUHTXHQF\GLVWULEXWLRQFXUYHDOVRGHVFULEHGDV³QRUPDO´
*RRGFOLQLFDOSUDFWLFH*&36WDQGDUGIRUFOLQLFDOVWXGLHVZKLFKHQFRPSDVVHVWKHGHVLJQ
FRQGXFWPRQLWRULQJWHUPLQDWLRQDXGLWDQDO\VHVUHSRUWLQJDQGGRFXPHQWDWLRQRIWKHVWXGLHVDQG
ZKLFKHQVXUHVWKDWWKHVWXGLHVDUHVFLHQWLILFDOO\DQGHWKLFDOO\VRXQGDQGWKDWWKHFOLQLFDOSURSHUWLHV
RIWKHSKDUPDFHXWLFDOSURGXFWXQGHULQYHVWLJDWLRQDUHSURSHUO\GRFXPHQWHG
*UDQWVPDQVKLS7KHDELOLW\WRVHFXUHJUDQWVWRVXSSRUWUHVHDUFKSURMHFWV
+DZWKRUQHHIIHFW$QHIIHFWZKLFKUHVXOWVLQWKHLPSURYHPHQWRIVXEMHFWV¶SHUIRUPDQFHVWKURXJK
EHLQJREVHUYHGDQGRUVRFLDOFRQWDFW,WLVDQH[DPSOHRIDSODFHERHIIHFW
+LVWRJUDP$PHWKRGRISORWWLQJIUHTXHQF\GLVWULEXWLRQV
+\SRWKHVLV7KHUHVHDUFKK\SRWKHVLVLVDWHQWDWLYHVWDWHPHQWWKDWFDQEHWHVWHGE\DVFLHQWLILF
UHVHDUFKGHVLJQ
,PSDFWIDFWRU$PHDVXUHRIWKHIUHTXHQF\ZLWKZKLFKWKH³DYHUDJHDUWLFOH´LQDMRXUQDOKDV
EHHQFLWHGLQDSDUWLFXODU\HDURUSHULRG,WSURYLGHVDZD\WRMXGJHWKHSUHVWLJHDQGLQIOXHQFHRI
DSDUWLFXODUMRXUQDO
,QFLGHQFH,QFLGHQFHUDWHVUHODWHWKHQXPEHURIQHZFDVHVRIDFRQGLWLRQLQDSRSXODWLRQZLWKLQ
DWLPHSHULRG
,QGHSHQGHQWRULQSXWYDULDEOHV9DULDEOHVWKDWKDYHYDOXHVWKDWDUHDXWRQRPRXVRIWKHGHSHQGHQW
RURXWFRPHYDULDEOHV%HFDXVHLQGHSHQGHQWYDULDEOHVSUHFHGHGHSHQGHQWYDULDEOHVWKH\DUHRIWHQ
FDOOHGSUHGLFWRUV,QHSLGHPLRORJ\LQGHSHQGHQWYDULDEOHVDUHRIWHQFDOOHGULVNIDFWRUVRUH[SRVXUH
YDULDEOHV
,QIHUHQFH$JHQHUDOL]DWLRQPDGHDERXWDSRSXODWLRQIURPWKHVWXG\RIDVXEVHWRUVDPSOHRIWKDW
SRSXODWLRQ
,QIRUPHGFRQVHQW$QHWKLFDOUHTXLUHPHQWIRUSDUWLFLSDWLRQLQDUHVHDUFKVWXG\LQGLFDWLQJWKDWD
FRPSHWHQWSHUVRQLQSRVVHVVLRQRIDOOWKHUHOHYDQWLQIRUPDWLRQIUHHO\DJUHHVWRSDUWLFLSDWH
,QWHUQDOYDOLGLW\7KHGHJUHHWRZKLFKWKHLQYHVWLJDWRU¶VFRQFOXVLRQVFRUUHFWO\GHVFULEHZKDW
DFWXDOO\KDSSHQHGLQWKHVWXG\,WPHDQVWKDWZLWKLQWKHFRQILQHVRIWKHVWXG\UHVXOWVDSSHDUWR
EHDFFXUDWHWKHPHWKRGVDQGDQDO\VLVXVHGVWDQGXSWRVFUXWLQ\DQGWKHLQWHUSUHWDWLRQRIWKH
LQYHVWLJDWRUVDSSHDUVVXSSRUWHG
,QWHUREVHUYHUUHOLDELOLW\7KHH[WHQWWRZKLFKREVHUYHUVUDWLQJRUPHDVXULQJDSDUWLFXODU
SKHQRPHQRQDJUHHZLWKHDFKRWKHU
,QWUDREVHUYHUUHOLDELOLW\7KHH[WHQWWRZKLFKDQREVHUYHUUDWLQJRUPHDVXULQJDSDUWLFXODU
SKHQRPHQRQDJUHHVZLWKKHUKLVUDWLQJRUPHDVXUHPHQWZKHQSUHVHQWHGZLWKWKHVDPHWDVNRQ
WZRGLIIHUHQWRFFDVLRQV
,QWHUTXDUWLOHUDQJH7KHGLVWDQFHEHWZHHQWKHVFRUHVUHSUHVHQWLQJWKHWKDQGWKSHUFHQWLOH
UDQNVLQDGLVWULEXWLRQ
/LNHUWIRUPDW$IRUPDWIRUFORVHGUHVSRQVHTXHVWLRQVXVHGWRHOLFLWDWWLWXGHVRIWKHUHVSRQGHQWV
WRDFHUWDLQVWDWHPHQW7KHUHVSRQGHQWFKRRVHVIURPDPRQJILYHFDWHJRULHVVWURQJO\DJUHHDJUHH
XQGHFLGHGGLVDJUHHVWURQJO\GLVDJUHH
/LWHUDWXUH3UHYLRXVUHVHDUFKGRQHLQWKHDUHDXQGHUVWXG\
/RJLVWLFUHJUHVVLRQ0HWKRGFRPPRQO\XVHGE\VWDWLVWLFLDQVIRUPXOWLYDULDWHDQDO\VLV
/RQJLWXGLQDOVWXG\$QREVHUYDWLRQDOVWXG\GHVLJQLQZKLFKPHDVXUHPHQWVDUHPDGHRYHUD
SHULRGRIWLPH
/RQJLWXGLQDOSURVSHFWLYHVWXG\$QREVHUYDWLRQDOVWXG\GHVLJQLQZKLFKWKHLQYHVWLJDWRUVIROORZ
VXEMHFWVIRUIXWXUHHYHQWV
0DWFKLQJ$VDPSOLQJPHWKRGWRHQVXUHWKDWWKHWZRJURXSVWREHFRPSDUHGKDYHVLPLODU
FKDUDFWHULVWLFV,QDQLQWHUYHQWLRQVWXG\SDLUVRIVLPLODU³PDWFKHG´VXEMHFWVDUHIRUPHGDQGWKHQ
Glossary 221
RQHPHPEHURIWKHSDLULVUDQGRPO\DVVLJQHGWRRQHJURXSDQGWKHRWKHUPHPEHUWRWKHRWKHU
JURXS
0HDQ7KHDYHUDJHRIDJURXSRIVFRUHV7KHPHDQLVGHULYHGE\VXPPLQJXSWKHLQGLYLGXDO
YDOXHVDQGGLYLGLQJE\WKHWRWDOQXPEHURIPHDVXUHPHQWV
0HDVXUHPHQWRULQIRUPDWLRQELDV0HDVXUHPHQWELDVRFFXUVZKHQWKHPHWKRGVRIPHDVXUHPHQW
DUHFRQVLVWHQWO\GLVVLPLODULQGLIIHUHQWJURXSVRISDWLHQWV
0HGLDQ7KHPHGLDQRIDGLVWULEXWLRQLVDPLGSRLQWDWZKLFKRQHKDOIRIWKHREVHUYDWLRQVIDOO
EHORZDQGRQHKDOIIDOODERYHWKHYDOXH
0('/,1($ELEOLRJUDSKLFGDWDEDVHZKLFKSURYLGHVGHWDLOVRIDUWLFOHVDQGWKHLUDEVWUDFWVIURP
SHHUUHYLHZHGMRXUQDOV0('/,1(LVIXQGHGE\WKH861DWLRQDO,QVWLWXWHVRI+HDOWK
0HWDDQDO\VLV$PHWKRGRORJ\WRFULWLFDOO\UHYLHZUHVHDUFKVWXGLHVDQGVWDWLVWLFDOO\FRPELQHWKHLU
GDWDWRKHOSDQVZHUTXHVWLRQVWKDWDUHEH\RQGWKHSRZHURIVLQJOHSDSHUV
0RGH7KHPRVWIUHTXHQWPHDVXUHPHQWLQDGLVWULEXWLRQ
0XOWLYDULDWHDQDO\VLV$VVHVVPHQWRIWKHLQGHSHQGHQWFRQWULEXWLRQRIPXOWLSOHLQGHSHQGHQW
YDULDEOHVRQDGHSHQGHQWYDULDEOHWRLGHQWLI\WKRVHLQGHSHQGHQWYDULDEOHVPRVWVLJQLILFDQWLQ
H[SODLQLQJWKHYDULDWLRQRIWKHGHSHQGHQWYDULDEOH
1HJDWLYHFRUUHODWLRQ$QHJDWLYHFRUUHODWLRQEHWZHHQWZRYDULDEOHVLPSOLHVWKDWDVRQHYDULDEOH
JHWVELJJHUWKHYDOXHRIWKHRWKHUYDULDEOHEHFRPHVVPDOOHU
1RPLQDOFDWHJRULFDOGDWD'DWDLQZKLFKWKHFDWHJRULHVFDQQRWEHRUGHUHGRQHDERYHDQRWKHU
([DPSOHVRIFDWHJRULFDOQRPLQDOYDULDEOHVDUHVH[DQGPDULWDOVWDWXV
1RQPDOHILFHQFH$QHWKLFDOSULQFLSOHLPSO\LQJWKDWZKHUHUHVHDUFKLQYROYHVH[SHULPHQWDWLRQRQ
KXPDQVXEMHFWVWKHVXEMHFWVVKRXOGVXIIHUQRKDUP
1RQQRPLQDOOLQNHGLQIRUPDWLRQ,QIRUPDWLRQOLQNHGWRWKHSHUVRQE\DFRGHQRWLQFOXGLQJ
SHUVRQDOLGHQWLILFDWLRQNQRZQWRWKHLQYHVWLJDWRU
1RQSDUDPHWULFWHVWV6WDWLVWLFDOWHVWVWKDWFDQEHDSSOLHGZKHQWKHGDWDIDOOLQDIUHTXHQF\
GLVWULEXWLRQFXUYHWKDWLVVNHZHG$OVRFDOOHG³GLVWULEXWLRQIUHH´VWDWLVWLFV
1RUPDOGLVWULEXWLRQFXUYH$EHOOVKDSHGFXUYHRIWKHIUHTXHQF\GLVWULEXWLRQRIWKHGDWD
1XOOK\SRWKHVLV,QVFLHQWLILFPHWKRGRORJ\ZHGRQRWWHVWWKHUHVHDUFKK\SRWKHVLVGLUHFWO\
,QVWHDGZHVWDUWZLWKDQDVVXPSWLRQWKDWWKHUHLVQRGLIIHUHQFHRUDVVRFLDWLRQEHWZHHQWKH
YDULDEOHVFRPSDUHG7KLVLVFDOOHGWKHQXOOK\SRWKHVLV+,IVWDWLVWLFDODQDO\VLVUHMHFWVWKHQXOO
K\SRWKHVLVLWPHDQVWKDWWKHDOWHUQDWLYHK\SRWKHVLVLVSUREDEO\WUXHDQGWKDWWKHUHDGLIIHUHQFH
EHWZHHQWKHJURXSRUDUHODWLRQVKLSEHWZHHQWKHYDULDEOHV
1XPHULFDOYDULDEOHV'DWDH[SUHVVHGLQQXPEHUV
2EMHFWLYLW\2EMHFWLYHPHDVXUHVDUHPDGHLQDSURFHVVLQYROYLQJDPLQLPXPDPRXQWRIKXPDQ
LQWHUSUHWDWLRQIRUH[DPSOHPHDVXUHPHQWRIKHLJKW
2EVHUYDWLRQDOVWXG\$VWXG\GHVLJQLQZKLFKWKHLQYHVWLJDWRUVREVHUYHDQGUHFRUGHYHQWVWDNLQJ
SODFHLQWKHVWXG\
2GGVUDWLR7HUPXVHGLQFDVHFRQWUROVWXGLHVDVDPHDVXUHRIWKHRGGVRIKDYLQJWKHULVNIDFWRU
DPRQJSHRSOHZLWKWKHGLVHDVHGLYLGHGE\WKHRGGVRIKDYLQJWKHULVNIDFWRUDPRQJSHRSOHZLWKRXW
WKHGLVHDVH
2QHWDLOHGWHVW$VWDWLVWLFDOWHVWZKHUHDGLIIHUHQFHEHWZHHQWZRJURXSVLIWUXHLVH[SHFWHGWR
EHLQRQHGLUHFWLRQ)RUH[DPSOHWKHGLIIHUHQFHEHWZHHQSDVVLYHVPRNHUVDQGQRQVPRNHUVLQ
WKHRFFXUUHQFHRIOXQJFDQFHULVH[SHFWHGWREHLQRQHGLUHFWLRQ,WLVQRWH[SHFWHGWKDWVPRNLQJ
ZLOOSURWHFWIURPOXQJFDQFHUDQGVRWKHUHLVQRQHHGWRWHVWIRULW$RQHWDLOHGWHVWZLOOQHHGD
VPDOOHUVDPSOHVL]HWKDQDWZRWDLOHGWHVW
2SHQHQGHGTXHVWLRQ$TXHVWLRQDVNHGZLWKRXWSURYLGLQJDSUHGHILQHGVHWRIUHVSRQVHVWR
VHOHFWIURP
2UGLQDOFDWHJRULFDOGDWD&DWHJRULFDOGDWDLQZKLFKWKHYDULDEOHVFDQEHRUGHUHGRQHDERYH
DQRWKHU$QH[DPSOHRIRUGLQDOFDWHJRULFDOGDWDLVWKHQXPEHURIFKLOGUHQDZRPDQKDV
3YDOXH7KHSUREDELOLW\WKDWDGLIIHUHQFHRUDQDVVRFLDWLRQDVODUJHDVWKHRQHREVHUYHGFRXOG
KDYHRFFXUUHGE\FKDQFHDORQH
3DUDPHWULFWHVWV6WDWLVWLFDOWHVWVWKDWFDQEHDSSOLHGZKHQWKHGDWDIDOOLQDQRUPDOGLVWULEXWLRQ
WKDWLVZKHQWKH\DUHVSUHDGHYHQO\DURXQGWKHPHDQDQGWKHIUHTXHQF\GLVWULEXWLRQFXUYHLV
EHOOVKDSHGRU*DXVVLDQ
3HHUUHYLHZHGMRXUQDO$MRXUQDOLQZKLFKWKHDUWLFOHVDUHYHWWHGE\LQGHSHQGHQWUHIHUHHVIRU
TXDOLW\DQGLQWHUHVWDQGLVWKHUHIRUHPRUHKLJKO\UHJDUGHG
3KDVH,FOLQLFDOWULDOV)LUVWWULDOVRIDQHZDFWLYHLQJUHGLHQWRUQHZIRUPXODWLRQLQKXPDQVRIWHQ
FDUULHGRXWLQKHDOWK\YROXQWHHUV
3KDVH,,FOLQLFDOWULDOV7ULDOVSHUIRUPHGLQDOLPLWHGQXPEHURIVXEMHFWVDQGRIWHQRIDFRPSDUDWLYH
HJSODFHERFRQWUROOHGGHVLJQWRGHPRQVWUDWHWKHUDSHXWLFDFWLYLW\DQGWRDVVHVVWKHVKRUWWHUP
VDIHW\RIWKHDFWLYHLQJUHGLHQWLQSDWLHQWVVXIIHULQJIURPDGLVHDVHRUFRQGLWLRQIRUZKLFKWKH
DFWLYHLQJUHGLHQWLVLQWHQGHG
3KDVH,,,FOLQLFDOWULDOV7ULDOVLQFOXGLQJODUJHUDQGSRVVLEO\YDULHGSDWLHQWJURXSVZLWKWKH
SXUSRVHRIGHWHUPLQLQJWKHVKRUWDQGORQJWHUPVDIHW\HIILFDF\EDODQFHRIIRUPXODWLRQVRIWKH
DFWLYHLQJUHGLHQWDQGRIDVVHVVLQJLWVRYHUDOODQGUHODWLYHWKHUDSHXWLFYDOXH
3KDVH,9FOLQLFDOWULDOV6WXGLHVSHUIRUPHGDIWHUPDUNHWLQJRIWKHSKDUPDFHXWLFDOSURGXFWWR
GLVFRYHUUDUHDQGUHPRWHVLGHHIIHFWV
3LHFKDUW$JUDSKLFDOPHWKRGRIUHSUHVHQWLQJWKHIUHTXHQF\GLVWULEXWLRQRIDVHWRIFDWHJRULFDO
GDWDLQWKHVKDSHRIDSLH
3LORWVWXG\$SUHOLPLQDU\VWXG\WRWHVWWKHIHDVLELOLW\RIWKHSURWRFROEHIRUHLPSOHPHQWLQJWKH
VWXG\SURSHU,WPD\DOVREHFDOOHG³SUHWHVW´
3ODFHERHIIHFW7KHSKHQRPHQRQZKHUHLQDQLQWHUYHQWLRQVWXG\VXEMHFWVUHFHLYLQJZLWKRXW
NQRZLQJDQLQHUWGUXJVKRZDQLPSURYHPHQWRUSHUFHSWLRQRILPSURYHPHQWLQWKHLUFRQGLWLRQ
SUREDEO\GXHWRWKHLUH[SHFWDWLRQV
Glossary 223
3RSXODWLRQ$QHQWLUHVHWRISHUVRQVDQLPDOVREMHFWVRUHYHQWVZKLFKWKHUHVHDUFKHULQWHQGVWR
VWXG\
3RVLWLYHFRUUHODWLRQ$SRVLWLYHFRUUHODWLRQEHWZHHQWZRYDULDEOHVLPSOLHVWKDWDVRQHYDULDEOH
JHWVELJJHUWKHYDOXHRIWKHRWKHUYDULDEOHDOVREHFRPHVELJJHU
3RZHU$VWDWLVWLFLQGLFDWLQJWKHSUREDELOLW\RIUHMHFWLQJWKHQXOOK\SRWKHVLVZKHQWKHDOWHUQDWLYH
K\SRWKHVLVLVWUXH6WDWLVWLFDOSRZHURIDVWXG\LVWKXVWKHSUREDELOLW\RIREVHUYLQJDQHIIHFWRID
VSHFLILHGHIIHFWVL]HLIRQHH[LVWV
3UHGLFWLYHYDOXH7KHIUHTXHQF\ZLWKZKLFKDSRVLWLYHGLDJQRVWLFWHVWDFWXDOO\VLJQLILHVGLVHDVH
3UHWHVW$SUHOLPLQDU\VWXG\WRWHVWWKHIHDVLELOLW\DQGDSSURSULDWHQHVVRIDTXHVWLRQQDLUHEHIRUH
LPSOHPHQWLQJWKHVWXG\SURSHU
3UHWHVWSRVWWHVWGHVLJQ$QH[SHULPHQWDOUHVHDUFKGHVLJQLQZKLFKPHDVXUHPHQWVRIWKHJURXSV
DUHPDGHERWKEHIRUHDQGDIWHUDQLQWHUYHQWLRQ
3UHYDOHQFH7KHRYHUDOORFFXUUHQFHRIDSDUWLFXODUFRQGLWLRQLQDVSHFLILFSRSXODWLRQDWDVSHFLILF
SRLQWRIWLPH
3UREDELOLW\7KHFKDQFHRUOLNHOLKRRGRIDQHYHQWKDSSHQLQJ3UREDELOLW\PD\YDU\LQYDOXHIURP
QRFKDQFHWRFHUWDLQ5HVHDUFKHUVKDYHWRVHWWKHOHYHORISUREDELOLW\FHUWDLQW\WKH\DUH
ZLOOLQJWRDFFHSWIRUWKHLUILQGLQJV
3URSRUWLRQ7KHUDWLRRIRQHYDOXHWRDQRWKHUH[SUHVVHGDVDIUDFWLRQRIRQH)RUH[DPSOHWKH
SURSRUWLRQRIZRPHQDPRQJSDWLHQWVZLWKFDUGLRYDVFXODUGLVHDVH
3URSRVDO$GRFXPHQWZULWWHQIRUWKHSXUSRVHRIREWDLQLQJIXQGLQJIRUDUHVHDUFKSURMHFW
3URWRFRO7KHGHWDLOHGZULWWHQSODQRIWKHVWXG\$Q\UHVHDUFKVWXG\VKRXOGKDYHDSURWRFRO
3XE0HG&HQWUDO$SXEOLFZHEEDVHGDUFKLYHRIIHULQJEDUULHUIUHHDFFHVVWRSHHUUHYLHZHG
SULPDU\UHVHDUFKUHSRUWVLQWKHOLIHVFLHQFHVIXQGHGE\WKH861DWLRQDO,QVWLWXWHVRI+HDOWK
4XDOLW\DVVXUDQFH$V\VWHPWRHQVXUHWKDWWKHVWXG\LVSHUIRUPHGDQGWKHGDWDDUHJHQHUDWHG
UHFRUGHGDQGUHSRUWHGLQFRPSOLDQFHZLWKWKHSURWRFROJRRGFOLQLFDOSUDFWLFHDQGQDWLRQDO
UHJXODWLRQV
4XDOLWDWLYH PHWKRGV $ UHVHDUFK DSSURDFK WKDW HPSKDVL]HV WKH QRQQXPHULFDO GDWD DQG
LQWHUSUHWLYHDQDO\VLV
4XDQWLWDWLYHPHWKRGV$UHVHDUFKDSSURDFKWKDWHPSKDVL]HVWKHFROOHFWLRQRIQXPHULFDOGDWDRU
GDWDWKDQFDQEHTXDQWLILHGDQGVWDWLVWLFDODQDO\VLV
4XHVWLRQQDLUH$PHDQVRIFROOHFWLQJGDWDIURPSHRSOHZKHUHWKH\SURYLGHZULWWHQUHVSRQVHVWR
DVHWRITXHVWLRQVHLWKHULQWKHLURZQZRUGVRSHQHQGHGTXHVWLRQVRUE\VHOHFWLQJIURPDPRQJ
SUHGHILQHGDQVZHUVFORVHGUHVSRQVHTXHVWLRQV
5DQGRPVDPSOLQJ$VDPSOLQJSURFHGXUHLQZKLFKDVDPSOHLVGUDZQIURPDSRSXODWLRQVXFK
WKDWHDFKPHPEHURIWKHSRSXODWLRQKDVKDGDQHTXDOFKDQFHRIVHOHFWLRQ5DQGRPVDPSOLQJLV
QRWKDSKD]DUGVDPSOLQJ
5DQGRPL]HGFRQWUROOHGWULDOV,QWHUYHQWLRQVWXGLHVFKDUDFWHUL]HGE\WKHSURVSHFWLYHDVVLJQPHQW
RIVXEMHFWVWKURXJKDUDQGRPPHWKRGLQWRDQH[SHULPHQWDOJURXSDQGDFRQWUROJURXS
5DQJH,QDJURXSRIVFRUHVWKHUDQJHLVWKHGLIIHUHQFHEHWZHHQWKHPD[LPXPDQGPLQLPXP
VFRUHV
5DWLR$QXPHULFDOH[SUHVVLRQRIWKHUHODWLRQVKLSEHWZHHQRQHVHWRIIUHTXHQFLHVDQGDQRWKHU$Q
H[DPSOHLVWKHUDWLRRIPDOHVWRIHPDOHVLQDVDPSOH
5DWH$QXPHULFDOH[SUHVVLRQRIWKHIUHTXHQF\RIDFRQGLWLRQLQDJLYHQSRSXODWLRQPHDVXUHGLQ
DVSHFLILHGSHULRGRIWLPH
5HJUHVVLRQHTXDWLRQ$QHTXDWLRQWRGHVFULEHWKHFRUUHODWLRQEHWZHHQWZRYDULDEOHVPHDQLQJ
WKDWZKHQRQHRIWKHPFKDQJHVE\DFHUWDLQDPRXQWWKHRWKHUFKDQJHVRQWKHDYHUDJHE\DFHUWDLQ
DPRXQW
5HJUHVVLRQOLQH$OLQHGUDZQRQDVFDWWHUGLDJUDPWRLOOXVWUDWHWKHGHJUHHDQGGLUHFWLRQRIWKH
FRUUHODWLRQEHWZHHQWZRYDULDEOHV
5HJUHVVLRQFRHIILFLHQW7KHWHUPXVHGWRVLJQLI\WKHDPRXQWE\ZKLFKDFKDQJHLQRQHYDULDEOH
PXVWEHPXOWLSOLHGWRJLYHWKHFRUUHVSRQGLQJDYHUDJHFKDQJHLQWKHRWKHUYDULDEOH,WUHSUHVHQWV
WKHGHJUHHWRZKLFKWKHUHJUHVVLRQOLQHVORSHVXSZDUGVRUGRZQZDUGV
5HJUHVVLRQWRWKHPHDQ$SKHQRPHQRQZKHUHXSRQUHPHDVXUHPHQWSUHYLRXVH[WUHPHYHU\
KLJKRUORZVFRUHVWHQGWRPRYHWRZDUGVUHJUHVVWRWKHDYHUDJHVFRUH
5HODWLYHULVN7KHUDWLRRIWKHLQFLGHQFHRIWKHRXWFRPHLQWKHH[SRVHGJURXSWRWKHLQFLGHQFHRI
WKHRXWFRPHLQWKHXQH[SRVHGJURXS
5HOLDELOLW\7KHH[WHQWWRZKLFKDWHVWRUPHDVXUHPHQWUHVXOWLVUHSURGXFLEOH
5HSUHVHQWDWLYHVDPSOH$VDPSOHWKDWDFFXUDWHO\UHIOHFWVWKHFKDUDFWHULVWLFVRIWKHSRSXODWLRQ
IURPZKLFKLWLVGUDZQ,WLVDSUHFLVHPLQLDWXUL]HGUHSUHVHQWDWLRQRIWKHSURSRUWLRQRIHOHPHQWV
RIWKHSRSXODWLRQ
5HWURVSHFWLYHVWXG\$QREVHUYDWLRQDOVWXG\GHVLJQLQZKLFKWKHLQYHVWLJDWRUVVWXG\SUHVHQWDQG
SDVWHYHQWV
5LVNIDFWRUV$IDFWRUWKDWLVEHOLHYHGWRLQFUHDVHWKHSUREDELOLW\RIDFHUWDLQRXWFRPHRULOOQHVV
5RVHQWKDOHIIHFW7KHSKHQRPHQRQZKHUHWKHH[SHFWDWLRQVRIWKHUHVHDUFKHUVLQDVWXG\LQIOXHQFH
WKHRXWFRPH
6DPSOH$VXEVHWVHOHFWHGIRUWKHVWXG\IURPWKHODUJHUSRSXODWLRQ
6DPSOLQJHUURU7KHGLVFUHSDQF\EHWZHHQWKHYDOXHVREWDLQHGIURPWKHUHODWLYHO\VPDOOVDPSOH
DQGWKHODUJHUSRSXODWLRQIURPZKLFKWKHVDPSOHZDVGUDZQ
6FDWWHUGLDJUDP$JUDSKGLVSOD\LQJWKHVFDWWHURIWKHUHODWLRQVKLSEHWZHHQWZRYDULDEOHV7KH
VFDWWHUGLDJUDPJLYHVDQLQGLFDWLRQRIZKHWKHUDFRUUHODWLRQPD\H[LVWDQGLWVGLUHFWLRQ
6HOHFWLRQELDV$V\VWHPDWLFGLIIHUHQFHEHWZHHQSHRSOHZKRDUHVHOHFWHGIRUDVWXG\DQGWKRVH
ZKRDUHQRWVHOHFWHG
Glossary 225
6HQVLWLYLW\RIDGLDJQRVWLFWHVWLVWKHSURSRUWLRQRISHRSOHZKRWHVWDVSRVLWLYHWRDGLVHDVHZKR
UHDOO\KDYHWKHGLVHDVHLHWKH\DUHWUXHSRVLWLYH
6NHZHGGLVWULEXWLRQ$IUHTXHQF\GLVWULEXWLRQFXUYHZKLFKLVDV\PPHWULFDOZLWKRQHVLGHRIWKH
FXUYHH[WHQGLQJLQDQHORQJDWHGIDVKLRQ
6SHFLILFLW\7KHSURSRUWLRQRISHRSOHZKRWHVWQHJDWLYHO\IRUDGLVHDVH
6WDQGDUGGHYLDWLRQ$PHDVXUHRIWKHGLVSHUVLRQRUYDULDELOLW\RIDJURXSRIVFRUHV
6WDQGDUGHUURU$VWDWLVWLFDOPHDVXUHRIWKHSUREDELOLW\WKDWWKHILQGLQJLQWKHVDPSOHZLOOUHIOHFW
WKHILQGLQJLQWKHSRSXODWLRQIURPZKLFKWKHVDPSOHZDVGUDZQ
6WDWLVWLFDOVLJQLILFDQFH$VWDWLVWLFLQGLFDWLQJWKDWWKHUHVXOWREWDLQHGLVSUREDEO\QRWGXHWR
FKDQFHEXWLVUHDO$VWDWLVWLFDOO\VLJQLILFDQWUHVXOWGRHVQRWQHFHVVDULO\PHDQWKDWLWLVLPSRUWDQW
RULQWHUHVWLQJ
6WDWLVWLFDOVLJQLILFDQFHWHVW$WHVWWRHVWLPDWHWKHOLNHOLKRRGWKDWDQREVHUYHGVWXG\UHVXOWIRU
H[DPSOHDGLIIHUHQFHEHWZHHQWZRJURXSVRUDQDVVRFLDWLRQFDQEHGXHWRFKDQFH
6WUDWLILHGUDQGRPVDPSOLQJ$VDPSOLQJSURFHGXUHLQZKLFKWKHUHVHDUFKHUWULHVWRHQVXUHWKDW
LPSRUWDQWVXEJURXSVLQWKHSRSXODWLRQDUHDGHTXDWHO\UHSUHVHQWHG
6WUXFWXUHGLQWHUYLHZ$QLQWHUYLHZLQZKLFKWKHTXHVWLRQVDUHJHQHUDOO\SUHGHILQHGDVNHGLQD
IL[HGRUGHUDQGUHFRUGHGLQZULWLQJ
6XEMHFWLYHPHDVXUHV0HDVXUHVLQYROYLQJDVXEVWDQWLDOGHJUHHRIKXPDQLQWHUSUHWDWLRQIRU
H[DPSOHUDWLQJVRISDLQ
6XEMHFWV3DUWLFLSDQWVLQDVWXG\7KH\VKRXOGQRWEHFDOOHGPDWHULDOIRUWKHVWXG\
6XUURJDWHHQGSRLQW$YDULDEOHWKDWLVUHODWLYHO\HDVLO\PHDVXUHGDQGWKDWSUHGLFWVDUDUHRUGLVWDQW
RXWFRPHEXWZKLFKLVQRWLWVHOIDGLUHFWPHDVXUHRIHLWKHUKDUPRUFOLQLFDOEHQHILW
6\VWHPDWLFVDPSOLQJ$VDPSOLQJSURFHGXUHLQZKLFKVXEMHFWVDUHVHOHFWHGE\DVLPSOHSHULRGLF
SURFHVVIRUH[DPSOHVHOHFWLQJHYHU\VHFRQGRUWKLUGSDWLHQW
WWHVW6WDWLVWLFDOWHVWXVHGIRUQXPHULFDOGDWDWRGHWHUPLQHZKHWKHUDQREVHUYHGGLIIHUHQFHEHWZHHQ
WKHPHDQVRIWZRJURXSVFDQEHFRQVLGHUHGVWDWLVWLFDOO\VLJQLILFDQWLHXQOLNHO\WREHGXHWR
FKDQFH
7KHJDS:KLOHRIWKHJOREDOEXUGHQRIGLVHDVHLVLQGHYHORSLQJFRXQWULHVRQO\DQ
HVWLPDWHGRIWKHJOREDOUHVRXUFHVDUHVSHQWRQGLVHDVHSUREOHPVRIGHYHORSLQJFRXQWULHV
7UDQVFULSW$YHUEDWLPZULWWHQYHUVLRQRIDQLQWHUYLHZ
7UXHQHJDWLYH$GLDJQRVWLFWHVWFRUUHFWO\LQGLFDWLQJWKDWDSHUVRQGRHVQRWKDYHWKHGLVHDVH
7UXHSRVLWLYH$GLDJQRVWLFWHVWFRUUHFWO\LQGLFDWLQJWKDWDSHUVRQKDVWKHGLVHDVH
7ZRWDLOHGWHVW$VWDWLVWLFDOWHVWZKHUHDGLIIHUHQFHEHWZHHQWZRJURXSVLVWHVWHGZLWKRXW
UHIHUHQFHWRWKHH[SHFWHGGLUHFWLRQRIWKHGLIIHUHQFHIRUH[DPSOHZKHWKHUDULVNIDFWRUVXFKDV
XVHRIKRUPRQDOFRQWUDFHSWLRQZLOOLQFUHDVHRUGHFUHDVHWKHLQFLGHQFHRIDFRQGLWLRQ$WZRWDLOHG
WHVWZLOOQHHGDODUJHUVDPSOHVL]HWKDQDRQHWDLOHGWHVW
7\SH,HUURU7KHHUURUFRPPLWWHGZKHQRQWKHEDVLVRIDVWDWLVWLFDOWHVWDSSOLHGWRWKHVDPSOH
RIGDWDDFRQFOXVLRQLVPDGHWKDWWKHUHLVHYLGHQFHRIDQDVVRFLDWLRQEHWZHHQYDULDEOHVRU
GLIIHUHQFHEHWZHHQJURXSVLQWKHSRSXODWLRQZKHQLQIDFWWKHUHLVQRGLIIHUHQFHRUDVVRFLDWLRQ
7KHSUREDELOLW\RIW\SH,HUURULVUHSUHVHQWHGE\WKHV\PERODOSKDĮ$QRWKHUQDPHIRUDOSKDLV
WKHOHYHORIVWDWLVWLFDOVLJQLILFDQFH
7\SH,,HUURU$³PLVV´ZKHQRQWKHEDVLVRIDVWDWLVWLFDOWHVWDSSOLHGWRWKHVDPSOHRIGDWD
DFRQFOXVLRQLVPDGHWKDWWKHUHLVQRHYLGHQFHRIDQDVVRFLDWLRQEHWZHHQYDULDEOHVRUGLIIHUHQFH
EHWZHHQJURXSVLQWKHSRSXODWLRQZKHQLQIDFWWKHUHLVDGLIIHUHQFHRUDVVRFLDWLRQ7KHSUREDELOLW\
RIW\SH,HUURULVUHSUHVHQWHGE\WKHV\PEROEHWDȕ
8QOLQNHGLQIRUPDWLRQ,QIRUPDWLRQZKLFKFDQQRWEHOLQNHGDVVRFLDWHGRUFRQQHFWHGZLWKWKH
SHUVRQWRZKRPLWUHIHUVFRQILGHQWLDOLW\KHUHLVQRWDWVWDNH
8QLYDULDWH DQDO\VLV $ VHW RI PDWKHPDWLFDO WRROV WR DVVHVV WKH UHODWLRQVKLS EHWZHHQ RQH
LQGHSHQGHQWYDULDEOHDQGRQHGHSHQGHQWYDULDEOH
9DOLGLW\7KHH[WHQWWRZKLFKDWHVWPHDVXUHVZKDWLWLVLQWHQGHGWRPHDVXUH
9DULDELOLW\7KHH[WHQWWRZKLFKDJURXSRIVFRUHVYDULHVRULVVSUHDGRXW7KLVLVXVXDOO\GHVFULEHG
E\DGHVFULSWLYHVWDWLVWLFVXFKDVWKHUDQJHRUVWDQGDUGGHYLDWLRQ
9DULDEOH6WDWLVWLFDOWHUPIRUWKHVFRUHLQGDWD
9DULDQFH$PHDVXUHRIWKHGLVSHUVLRQRUYDULDELOLW\RIDJURXSRIVFRUHV
Index
$
$EVROXWHULVN
$EVWUDFW
6WUXFWXUHG
$FFHVVLEOHSRSXODWLRQ
$FNQRZOHGJHPHQWV
:ULWLQJRI
$FWLRQUHVHDUFK
$GMXVWHGUDWH
$OSKD
$OWHUQDWLYHK\SRWKHVLV
$QDO\WLFDOVWXG\
$WWULEXWDEOHULVN
$WWULWLRQ
$WWULWLRQELDV
$XGLW
7UDLO
$XWKRUVKLS
%
%DQJNRNGHFODUDWLRQ
%DVLFYHUVXVDSSOLHGUHVHDUFK
%HIRUHDQGDIWHUVWXG\
%HOOVKDSHGFXUYH
%HQHILFHQFH
%HWD
%LDV
%LJVFLHQFH
%LRORJLFDOJUDGLHQW
%LRORJLFDOSODXVLELOLW\
%LR0HG&HQWUDO
%OLQGLQJ
%OREERJUDP
%RROHDQRSHUDWRUV
%XGJHWRIUHVHDUFKSURSRVDO
,WHPL]DWLRQ
-XVWLILFDWLRQ
&
&DVH±FRQWUROVWXGLHV
&DVHUHSRUW
&DWHJRULFDOYDULDEOHV
&DXVDWLRQPDNLQJWKHFDVHIRU
&HQWUDOWHQGHQF\
&KLVTXDUHWHVW
&,206
&OLQLFDOSUDFWLFHJXLGHOLQHV
&OLQLFDOWULDOVSKDVHVRI
&OXVWHUVDPSOLQJ
&RFKUDQH&ROODERUDWLRQ
&RFKUDQH/LEUDU\
&RGLQJRIWKHGDWD
&RGLQJVRUW
&RKRUWVWXG\
&ROODERUDWLRQEHWZHHQLQGXVWU\DQGDFDGHPLD
&RPSXWHUDVVLVWHGSUHVHQWDWLRQ
&RQILGHQFHLQWHUYDOV
&RQILGHQWLDOLW\
&RQIOLFWRILQWHUHVW
&RQIRXQGLQJ
&RQVHFXWLYHVDPSOLQJ
&RQWLQXRXVYDULDEOHV
&RQWUROOHGWULDOV
&RQWUROVKLVWRULF
&RS\ULJKW
&RUUHODWLRQ
&RHIILFLHQW
&RVWEHQHILWDQDO\VLV
&RVWHIIHFWLYHQHVVDQDO\VLV
&URVVVHFWLRQDOVWXG\
&URVVRYHUVWXG\
&URVVWDEXODWLRQV
'
'DWD
'LVWULEXWLRQ
0DQDJHPHQWDQGDQDO\VLVRI
0LVVLQJ
7\SHV
'DWDLPPHUVLRQ
'HJUHHVRIIUHHGRP
'HSHQGHQWYDULDEOHV
'HVFULSWLYHVWXG\
Index 229
'HVFULSWLYHVWDWLVWLFV
'HVLJQRIUHVHDUFK
7\SHV
6HOHFWLRQ
'LDJQRVWLFVXVSLFLRQELDV
'LDJQRVWLFWHVWV
,QWHUSUHWLQJVWXGLHVRI
'LVFUHWHYDULDEOHV
'LVVHUWDWLRQ
'LVWULEXWLYHMXVWLFH
'RVHUHVSRQVHUHODWLRQ
'RXEOHEOLQGVWXGLHV
'XPP\WDEOHV
'XSOLFDWHSXEOLFDWLRQ
(
(FRQRPLFVKHDOWKUHVHDUFKLQ
(IIHFWVL]H
(IILFLHQF\LQGLDJQRVWLFWHVWV
(OHFWURQLFLQGH[
(SKHPHUDOOLWHUDWXUH
(VVHQWLDOQDWLRQDOKHDOWKUHVHDUFK
(WKLFVFRPPLWWHHV
(WKLFDOUHYLHZRIH[WHUQDOO\VSRQVRUHGUHVHDUFK
(WKLFV
*HQHUDOSULQFLSOHV
,QWHUQDWLRQDOJXLGHOLQHV
5HVSRQVLELOLW\IRU
(WKLFVLQ
(SLGHPLRORJLFDOILHOGDQGTXDOLWDWLYHVWXGLHV
([SHULPHQWDWLRQRQKXPDQVXEMHFWV
([SHULPHQWDWLRQRQDQLPDOV
,PSOHPHQWDWLRQRIWKHVWXG\
5HVHDUFKFRPELQHGZLWKPHGLFDOFDUH
5HVHDUFKGHVLJQ
5HVHDUFKLQYROYLQJFKLOGUHQ
5HVHDUFKSURWRFRO
5HVHDUFKSURSRVDO
5HVHDUFKLQYROYLQJSUHJQDQWZRPHQ
6FLHQWLILFSXEOLFDWLRQ
6HOHFWLRQRIUHVHDUFKWRSLF
:ULWLQJDVFLHQWLILFSDSHU
(YLGHQFHEDVHGUHYLHZV
([SHULPHQWDOVWXG\
([WHUQDOYDOLGLW\
)
)RFXVJURXSGLVFXVVLRQ
)LJXUHV
)LVFDOKRQHVW\
)ORZFKDUWV
)UDXGVFLHQWLILF
)UHTXHQF\GLVWULEXWLRQFXUYH
)UHTXHQF\GLVWULEXWLRQWDEOHV
)XQGLQJ
$YDLODELOLW\
6RXUFHV
*
*DXVVLDQGLVWULEXWLRQ
*HQGHULVVXHV
*HQHUDOL]DELOLW\
*RRGFOLQLFDOSUDFWLFH*&3
*UDSKV
+
+HOVLQNLGHFODUDWLRQ
+,1$5,
,
,OOXVWUDWLRQV
,PSDFWIDFWRU
,05$'
,QGHSHQGHQWYDULDEOHV
,QGH[0HGLFXV
(DVWHUQ0HGLWHUUDQHDQ5HJLRQ
,QGXVWU\VSRQVRUHGUHVHDUFK
&RQFHUQVDERXWSDUWLFLSDWLRQ
,QIHUHQFH
,QIHUHQWLDOVWDWLVWLFV
,QIRUPDWLRQELDV
,QIRUPHGFRQVHQW
,QIRUPHGGHFLVLRQPDNLQJ
,QWHOOHFWXDOSURSHUW\
,QWHUREVHUYHUUHOLDELOLW\
,QWHUQDOYDOLGLW\
,QWHUQDWLRQDO&RPPLWWHHRI0HGLFDO-RXUQDO(GLWRUV
,QWHUQDWLRQDOKHDOWKUHVHDUFK
0RGHOVIRUSDUWLFLSDWLRQ
&RQFHUQVLQGHYHORSLQJFRXQWULHV
(WKLFDOFRQFHUQV
Index 231
,QWHUQHW
6HDUFKLQJ
,QWHUYHQWLRQVWXGLHV
,QWHUYLHZV
,QWHUTXDUWLOHUDQJH
,QWUDREVHUYHUUHOLDELOLW\
.
.H\ZRUGV
/
/HYHOVRIHYLGHQFH
/LQNHGLQIRUPDWLRQ
/RQJLWXGLQDOVWXG\
0
0DWFKLQJ
0HDVXUHPHQWELDV
0HDQ
0HGLDQ
0('/,1(
0('/,1(SOXV
0H6+
0HWDDQDO\VLV
0RGH
0RQLWRULQJRIWKHVWXG\
0XOWLFHQWUHFOLQLFDOWULDOV
0XOWLGLVFLSOLQDU\UHVHDUFK
0XOWLYDULDWHDQDO\VLV
1
1DUUDWLYHUHYLHZ
1DWLRQDO/LEUDU\RI0HGLFLQH
1HZSKDUPDFHXWLFDOSURGXFWV
5HVHDUFKRQ
1RQPDOHILFHQFH
1RQSDUDPHWULF
1RUPDOGLVWULEXWLRQ
1XOOK\SRWKHVLV
1XPEHUQHHGHGWRWUHDW
2
2EVHUYDWLRQDOVWXGLHV
2GGVUDWLR
2QOLQHVHDUFKLQJ
2SSRUWXQLW\FRVW
2XWFRPHYDULDEOHV
2YHUKHDGSURMHFWRU
3
3YDOXH
3DUDPHWULFWHVWV
3DWHQWVDQGSXEOLFDWLRQ
3HHUUHYLHZ
3HUFHQWDJHVDQGSURSRUWLRQV
3KDUPDFHXWLFDOFRPSDQ\UHVHDUFK
3DUWLFLSDWLRQLQ
3LORWVWXG\
3ODFHERFRQWUROOHGWULDO
3RVWPDUNHWLQJUHVHDUFK
3UHGLFWLYHYDOXHLQGLDJQRVWLFWHVW
3UHWHVWLQJWKHSURWRFRO
3ULYDF\ULJKWWR
3URVSHFWLYHVWXG\
3URWRFRO
)RUPDWIRUWKH
3XEOLFOLEUDU\RIVFLHQFH
3XEOLFPHGLD
3XE0HG
3XE0HG&HQWUDO
4
4XDOLWDWLYHUHVHDUFK
'HVFULSWLRQDQGDQDO\VLVRIUHVXOWV
(WKLFVLQ
,QWHUSUHWLQJUHVXOWVRI
3ODQQLQJRI
4XDQWLWDWLYHYHUVXV
9DOLGDWLRQRIUHVXOW
:ULWLQJDSDSHURQ
4XDOLW\DVVXUDQFHDQGTXDOLW\FRQWURO
4XHVWLRQQDLUHGHVLJQ
5
5DQGRPVDPSOLQJ
5DQGRPL]HGFRQWUROOHGWULDOV
5DQGRPL]DWLRQ
5DQJH
5DWHV
5DWLRV
5HFDOOELDV
Index 233
5HFHLYHURSHUDWRUFKDUDFWHULVWLF
5HGXQGDQWSXEOLFDWLRQ
5HODWLYHULVN
5HOLDELOLW\
5HIHUHQFHV
&LWDWLRQRI
*XLGHOLQHVRQKRZWRZULWH
+RZWRRUGHU
5HJUHVVLRQHTXDWLRQ
5HVHDUFKTXHVWLRQ
5HVHDUFKGHVLJQ
7\SHVRI
6HOHFWLQJ
5HVHDUFKSURSRVDO
5HVHDUFKWRSLF
5HVHDUFKK\SRWKHVLV
*HQHUDWLQJWKH
7HVWLQJRI
5HVSRQVHELDV
5HWURVSHFWLYHVWXG\
5LVNIDFWRUV
,QWHUSUHWLQJUHVXOWVRI
5RVHQWKDOHIIHFW
5XQQLQJWLWOH
6
6DPSOHVL]H
6DPSOLQJ
7\SHVRI
6FDWWHUGLDJUDP
6FLHQFHFLWDWLRQLQGH[
6FLHQWLILFKRQHVW\
6FLHQWLILFULJRXU
6HDUFKHQJLQHV
6HDUFKLQJWKHOLWHUDWXUH
6HFRQGDU\VFLHQWLILFSDSHUVZULWLQJRI
6HOHFWLRQELDV
6HQVLWLYLW\LQGLDJQRVWLFWHVWV
6NHZHGGLVWULEXWLRQ
6OLGHV
6SHFLILFLW\LQGLDJQRVWLFWHVWV
6WDQGDUGGHYLDWLRQ
6WDQGDUGHUURU
6WDWLVWLFDOSRZHU
6WDWLVWLFDOVLJQLILFDQFH
,QWHUSUHWLQJ
6WDWLVWLFDOWHVWV
([DPSOHVRI
6HOHFWLRQRI
6WDWLVWLFV
,QDVFLHQWLILFSDSHU
6WUDWLILHGUDQGRPVDPSOLQJ
6XEPLVVLRQRIPDQXVFULSW
7HFKQLFDOLQVWUXFWLRQV
8QLIRUPUHTXLUHPHQWV
6XUURJDWHHQGSRLQW
6\VWHPDWLFUHYLHZ
6\VWHPDWLFVDPSOLQJ
7
WWHVW
7DEOHV
,QVFLHQWLILFSDSHU
7HUPLQDWLRQRIWKHVWXG\
7LPHDQGPRWLRQVWXG\
7LWOH
2IVFLHQWLILFSDSHU
5XQQLQJWLWOH
7UDQVIHUDELOLW\
7KHVLV
7\SH,HUURU
7\SH,,HUURU
8
8QOLQNHGLQIRUPDWLRQ
8QLIRUPUHTXLUHPHQWVIRUPDQXVFULSWVVXEPLWWHGWRELRPHGLFDOMRXUQDOV
8QLYDULDWHDQDO\VLV
9
9DOLGLW\
9DQFRXYHU*URXS
6\VWHPIRUFLWDWLRQRIUHIHUHQFHV
9DULDEOHV

EMRO

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

EMRO

Uploaded by

Copyright:

Available Formats

WHO Regional Publications Eastern Mediterranean Series 30

Chapter 1. Introduction and overview .......................................................................... 11

Chapter 2. Ethics in health research ........................................................................... 20

Chapter 3. What research to do? ................................................................................ 25

Chapter 4. Planning the research ................................................................................ 43

Chapter 6. Submitting a research proposal ................................................................. 72

Chapter 7. Implementing the research project ............................................................ 79

Chapter 8. Describing and analysing research results ................................................ 87

Chapter 9. Interpreting research results .................................................................... 106

Chapter 10. Communicating research ....................................................................... 119

Chapter 11. Writing a scientific paper........................................................................ 130

Chapter 12. Publishing a scientific paper .................................................................. 151

Chapter 13. Making a scientific presentation............................................................. 162

Chapter 14. Assessment and evaluation of research ................................................ 172

Annex 1. World Medical Association Declaration of Helsinki Ethical

Annex 2. International ethical guidelines for biomedical research involving

Annex 3. Searching the literature ........................................................................... 201

Annex 5. Bangkok Declaration on Health Research for Development ................... 214

Glossary of terms in health research ........................................................................ 216

References and additional sources of information

2.2 General ethical principles

2.3 Responsibility for ethics in health research

2.4 Ethics committees

7KH:RUOG +HDOWK 2UJDQL]DWLRQ KDV LVVXHG RSHUDWLRQDO JXLGHOLQHV IRU HWKLFV

2.5 Ethical considerations throughout the research process

References and additional sources of information

3.2 Selection of a field for research

3.2.2 Multidisciplinary research

3.2.3 Basic versus applied research

3.2.4 Quantitative versus qualitative research

3.2.5 Action research

3.2.6 Research in health economics

3.2.7 Big science

3.3 Drivers for health research

3.3.2 Needs-driven research

3.3.3 Profit-driven research

3.3.4 Opportunity-driven research

3.4 Participation in collaborative international research

Participation in multi-centre clinical trials

3.4.2 Concerns in developing countries about international health

3.5 Participation in pharmaceutical company research

3.5.2 Concerns about participation in industry-sponsored

3.6 Where do research ideas come from?

3.6.2 New initiatives for expanding access to the scientific

Health InterNetwork Access to Research Initiative (HINARI)

ILYHOHDGLQJSXEOLVKHUV²%ODFNZHOO(OVHYLHU LQFOXGLQJ+DUFRXUW 6SULQJHU9HUODJ

Eastern Mediterranean Region Virtual Health Sciences Library

Eastern Mediterranean Region Index Medicus

3.7 Criteria for a good research topic

References and additional sources of information

4.2 Types of research design

Experimental or intervention studies

4.3 Selecting a research design

4.4 Defining and refining the research question

4.5 Generating the research hypothesis

4.6 Study sample

4.6.2 Types of sampling

4.7 Sample size

4.9 Planning qualitative research

4.10 A note on questionnaire design

4.11 A note on research in health economics

4.12 Ethics in research design

4.12.2 Ethics in research design involving experimentation

4.12.3 Epidemiological, field and qualitative studies

ILYHOHDGLQJSXEOLVKHUV²%ODFNZHOO(OVHYLHULQFOXGLQJ+DUFRXUW6SULQJHU9HUODJ

3KDVH,,,FOLQLFDOWULDOV3KDVH,,,WULDOVLQFOXGHODUJHUDQGSRVVLEO\YDULHGSDWLHQW