Professional Documents
Culture Documents
By
Mulusew Andualem (BSc, MPH):
A research consultant and Research advisor
February 2015
Overview of lecture
1. Introduction
2. Principles of Ethics in Health Research
3. Ethics Codes, guidelines and
regulations
References
1. RichardA.CashandTracyL.Rabin.OverviewofEthicalIssuesinCollectingDatain
Developingcountries,withSpecialReferencetoLongitudinalDesigns.Leveraging
LongitudinalDatainDevelopingCountries:ReportofaWorkshop2002.
2. BonnieSteinbock,AlexJohnLondon,JohnD.Arras.EthicalissuesinModern
Medicine,2008.ISBN:0073407356/9780073407357
3. HirotsuguAiga.Bombardingpeoplewithquestions:areconsiderationofsurveyethics.Bull
WorldHealthOrgan2007;85:823.
4. ZulfiqarAhamedBhutta.EthicsininternationalhealthResearch:aperspectivefromthe
developingworld.BullWorldHealthOrgan2002;80:114-120.
5. EthiopianScienceandTechnologyCommissioninCollaborationwiththeEthiopianPublic
HealthAssociationandRegionalStateHealthBureaus.HealthResearchEthicsTraining
Module4,AddisAbabaEthiopia2005.
6. EthiopianScienceandTechnologyCommission.NationalHealthSciencesandTechnology
council.HealthDepartment.NationalHealthResearchEthicsReviewGuideline.4 thEdition
Revised,AddisAbabaEthiopia2005
7. EthicalPrinciplesandGuidelinesfortheprotectionofhumansubjectsofresearch.The
BelmontReport.TheNationalCommissionfortheProtectionofHunanSubjectsof
BiomedicalandBehavioralResearch1979
Mulusew Andualem; College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
1.Introduction
Therearewideinequalitiesinburdenofdiseaseandhealth
outcomesbetweenthedevelopedanddeveloping
countries
Healthresearchplaysapivotalroleinaddressingthese
inequitiesinhealthandhumandevelopment,buttoachieve
theseobjectivestheresearchmustbebasedonsound
scientificandethicalprinciples
What is Research?
Asystematiccollection,analysisandinterpretationof
datatosolveaproblem
Systematicinvestigationdesignedtoproduce
generalizableknowledge
Canbeappliedtootherpopulations
Publishedanddisseminated
Mulusew Andualem: College of Medicine & Health
Sciences, Bahir Dar University, Ethiopia
What is Research?
Researchhascontributedimmenselytohumanprogress
andtothedevelopmentofmodernsociety
Scientificknowledgegeneratedthroughresearchis
powerfultoolforsolvingchallengeshumanity
FoodsecuritytodiseasessuchasAIDS,
pollutiontotheproliferationofweapons
Recentadvancesininformationtechnology,geneticsand
biotechnologyholdextraordinaryprospectsforindividual
well-beingandhumankindasawhole
Mulusew Andualem: College of Medicine & Health Sciences, Bahir
Dar University, Ethiopia
What is Research?
Indevelopedcountriesresearch:
Searchfornewknowledge
Advancementoftheoreticalformulations
Developmentofnewinventionsandinnovation
Indevelopingcountriesresearchperceived
Luxury
doneonlywhenacountrybecomesmoredevelopedand
hasextraresources
Manyoftheworldsmostseriousproblemshaveaimpacton
developingcountries,suchasinsub-SaharanAfrica
Mulusew Andualem: College of Medicine & Health Sciences, Bahir
Dar University, Ethiopia
Participants of Research
Livingindividualsfromwhomtheresearchermayobtain:
Datathroughinteractionorintervention.
Identifiableprivateinformation
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Informedconsentofthesecondparty:
Isitethicalforamaleheadofhouseholdtoconsentforhis
entirefamilytoparticipateinresearch?
Wouldchoosinghouseholdoverindividualconsentexpress
culturalsensitivityorethicaldoublestandards?
IsitethicalforConsentinghusbandforawomen?
Innocaseacompetentadultwomanbeenrolledinresearch
solelyupontheconsentofanotherperson.
But,IRBmayacceptaconsentprocess:
Ifitisimpossibletoconducttheresearchwithoutobtaining
supplementalpermission
Iffailuretoconducttheresearchwoulddenybenefitstowomen
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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IndividualvsCommunity
Selectivedisclosure
Inducementtoparticipation
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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Confidentiality
Personalidentifiers
IDvariables
Communitiesidentifiers
GeocodingandGISdata
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Beneficence
Personsaretreatednotonlybyrespectingtheirdecisionsand
protectingthemfromharm,butalsobymakingeffortsto
securetheirwell-being(physical,mentalandsocialasrelated
tothestudy)
Beneficenceisanobligationandnotjustasactsofkindness
/charity
Protectionofthewell-beingoftheparticipantistheprimary
responsibilityofthestudyteam.
WeighrisksVsbenefits
Physical,mentalandsocialwell-being
Riskreductiontoaminimum
Mulusew Andualem: College of Medicine & Health Sciences,
Protectionofparticipants
Bahir Dar University, Ethiopia
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Maximizing benefits
Communicationofstudyresults
Provisionofhealthcare
Trainingoflocalhealthstaff
FairBenefitframework
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Minimizing harm
Carefuluseoflocalhealthresourcesandrespectfor
localpriorities
Avoidstigmatization,prejudice,economicloss
Preparelocalresearchstaffforspecialsituations
Proposemeasuresagainsteminentrisksobserved
duringthestudy
Avoidharmfulpublicity
Respectlocalsocialandculturalnorms
Confidentiality
Disclosureofconflictofinterest
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Justice
Distributionofriskandbenefits
Equitablerecruitmentofparticipants
Protectionofvulnerablegroups
Theprincipleofjusticeforbidsplacingonegroupof
peopleatrisksolelyforthebenefitofanother
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Justice: considerations
Equityinselectionofsubjects
Exclusionsmustbejustifiable:itisunjustto
deprivegroupsofpersonsthebenefitofresearch
Ensureaccesstothebenefitsoftheresearchtothe
researchcommunity,particularlywhennosuperioror
equivalentapproachestotherapyareavailable.
Institutionalization:Sustainability
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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Justice(cont.)
Overcrowdingofresearchproject
Overcrowdedcommunity:Communityfatigue
A survey, again? You are the third survey team who
visited us during these couple of months. I am fed
up with ...
Mayresultinduplicationofefforts
Overaccumulationofanalyzeddata
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Nuremberg Code
Emphasizedon:
Informedconsent
Qualifiedresearchers
Appropriatedesign
Weighriskagainstbenefit
Freetostopatanytime
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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Helsinki Declaration
Emphasizedon:
Wellbeingofsubjecttakesprecedenceoverinterestsofscience
andsociety
Consentinwriting
Limiteduseofplacebo
Greateraccesstobenefit
Usecautionifparticipantisindependentrelationshipto
researcher
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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Common Rule
ApprovedbyEthicscommittee
Writteninformedconsentanddocumentation
Equitablerecruitmentofparticipants
Specialprotectionofvulnerablegroups
Continuingreviewofapprovedresearch
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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Emphasison:
Informedconsent
Protectionofvulnerablegroups
Distributionsofburdensandbenefits
RoleofEthicscommittee
Researchindevelopingcountries
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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Common to all
Fundamentalprinciples:respect,Beneficenceand
justice.
Researchisaprivilegenotaright
Wellbeingofparticipantisparamount
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Researchers Responsibilities
Protectionofhumanparticipants
Conductresearchaccordingtoprotocol
CompliancewithEthicsCommitteerequirements
Poststudy:longterminterestofparticipants
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Sponsors Responsibility
Ensureappropriatereview,approvalandsupervision
Monitorresearch
Selectqualifiedresearchers
Providepoliciesandprocedures
Complywithlocalethicalrequirements
Ensurelocalrelevanceofresearch
Provideresearchintegrity
Mulusew Andualem: College of Medicine & Health Sciences,
Bahir Dar University, Ethiopia
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