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APPLICATION FOR REVIEW FORM (2009)

(UPDATED March 1, 2010)

COMMITTEE ON HUMAN RESEARCH, PUBLICATIONS AND


ETHICS
KWAME NKRUMAH UNIVERSITY OF SCIENCE AND
TECHNOLOGY,
SCHOOL OF MEDICAL SCIENCES &

APPLICATION FOR ETHICAL REVIEW OF RESEARCH PROTOCOL


Submission forms may be obtained from the CHRPE Office, Room 8 Block J, Anatomy Block 3, Komfo Anokye Teaching Hospital or
chrpe.knust.kath@gmail.com. Completed forms must be returned, collated and stapled/clipped, to the CHRPE Office, KATH.
The following documents should be enclosed to make a submission complete:
General
Research
A

For all research:


Personalised Covering letter from the Investigator
Completed CHRPE Application Form
Copies of the research protocol
Participant Information Leaflet and Consent Form
Summary of protocol (Maximum of 3 pages)
Data capturing sheet(s)/questionnaires/interview guide
Proof of notification or written approval or permission from research
site/facility (where study is to be conducted)
Soft Copies of all submitted documents (on CD)
Where applicable:
For sponsored research, proof of payment of CHRPE Fees

B.

NUMBER OF COPIES
Student
Research

1
10
10
10
10
10
10

1
5
5
5
N/A
5
5

Please
R

N/A

1
1
For all Clinical and Field trials, abridged Curriculum Vitae of Principal
Investigator showing research experience
N/A
1
Written approval or permission on official letterhead from Supervisor
(Research for Academic Purposes)
10
5
Other (Please specify) e.g. copy of diary cards
Please note that ethics review is conditional upon submission of all the required documents in A above and B, where applicable

1.0

GENERAL INFORMATION

1.1
Title of Study
Advanced Emergency Trauma Course Utilizing Open Educational Resources and Low-Cost Simulation Models
1.2

Principal Investigators Status

SMS Staff
1.3

KATH Staff

Other

Please specify

Purpose of Research

Non Degree Purposes


1.4

Student

Diploma

1st Degree

2nd Degree

PhD

Nationality of Principal Investigator

Ghanaian

Non- Ghanaian (Resident)

Non-Ghanaian (Non-Resident)

Committee on Human Research Publication and Ethics


Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com

APPLICATION FOR REVIEW FORM (2009)


(UPDATED March 1, 2010)

1.5
Name

Principal Investigator
Nana Afia Nsua Boateng, MB ChB (Co-Principal Investigator)

Degree(s)

MB ChB

Title: Prof/Dr/Mr/Miss/Ms
Institution & Department

Physician (Dr), Resident


Accident and Emergency Department, Komfo Anokye Teaching Hospital

Telephone:
0208336769
Email: sheenapo80@yahoo.com

Postal Address:
PO Box SE 699, Suame, Kumasi, Ghana

1.6
Co-Principal Investigator (I)
Name and Signature
Chris Oppong (Co Principal Investigator)
Degree(s)
MBchB
Title: Prof/Dr/Mr/Miss/Ms
Physician (Dr)
Institution & Department
Department of Emergency Medicine
ED Faculty, KATH, Accident and Emergency Department, Kumasi, Ghana
Telephone:
Postal Address: p o box up825 knust kumasi
0207287618
Email: wakris2001@yahoo.com
1.7
Co-Investigator (II)
Name and Signature
Degree(s)
Title: Prof/Dr/Mr/Miss/Ms
Institution & Department
Telephone:0242235595
Email:
neelumsingh13@gmail.com

Neelum Singh
MBchB
Physician (Dr)
Accident and Emergency Centre, KATH
Dept of Emergency Medicine. KATH

List all other co-investigators below (names, degrees, departments and institutions).
Dr Edward Amoah Boateng, Dept of Surgery, Komfo Anokye Teaching Hospital
Dr Paa Kow Forson, Dept of Emergency Medicine, Komfo Anokye Teaching Hospital
Rockefeller A. Oteng, Acting Head of Department, Accident and Emergency Centre, KATH
University of Michigan School of Medicine, Dept of Emergency Medicine
Dr G Oduro, Head of Department, Dept of Emergency Medicine
Dr Ellis Owusu Dabo, KCCR
1.8
1.8.1

If this is a student project: Not Applicable


For which degree/diploma is the study being conducted? (Please state specific degree and Institution)

__Not Applicable__________________________________________________________________________
1.8.2

Who will be the supervisor? (Check where Applicable)


Principal Investigator
Other (fill in details below)

__Both Principle Investigors will have primary responsibility for supervision of project. ______________
Name and Signature of
Supervisor (If different from PI)
Department
Telephone: N/A
Email:N/A

Not Applicable
Not Applicable
Postal Address: Not Applicable

Committee on Human Research Publication and Ethics


Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com

APPLICATION FOR REVIEW FORM (2009)


(UPDATED March 1, 2010)

1.9

Where was the Research carried out (site)? (Provide name of Hospital/Institution and specific Department or
Town/District/Village etc.)
Accident and Emergency Department, Komfo Anokye Teaching Hospital

*Please submit proof of notification or written approval/permission on official letterhead from proposed research site/facility
1.10

Have you had Good Clinical Practice (GCP) or Good Laboratory Practice (GLP) training in the past three years?
Yes
No
N/A
Please state the name of the place and year of training.
___Nana Afia Nsua Boateng KATH A&E Research Lecture Series & UM PEERS Training
___ Chris Oppong KATH A&E Research Lecture Series & UM PEERS Training

1.11

If this is a new drug trial, do you have Food and Drugs Board Approval? Yes

1.12

Can your work be classified as research? (Read the following statements and check where applicable): The activity I wish
to undertake is a systematic investigation a, including research development, testing and evaluation, designed to develop or
contribute to generalizable knowledgeb.
Yes (my work is research)

1.13

No

N/A

(Educational Research) No (my work is not research)

Does your work involve human participants? Yes


involves identifiable human tissue/records
No

(Check below, where applicable):


No
but my work
(please consult us, your proposal may not require ethics review)

My work will involve a living individual about whom an investigator conducting research obtains data through interraction c
with the individual
My work will involve a living individual about whom an investigator conducting research obtains data through interaction d
with the individual.
My work will involve a living individual about whom an investigator conducting research obtains identifiable e private
informationf.
My work will involve using records already gathered on people.
My work has earlier been approved by CHRPE (please submit letter of approval or quote CHRPE Reference Number)
My work will involve using human samples.

If so, where will the samples be kept?

Typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific
hypothesis(es), or developing theory. Examples: observational studies, interview or survey studies, group comparison
studies, program evaluation, test development, interventional research.
b

Typically requires that results (or conclusions) of the activity are intended to be extended beyond a single individual or
an internal program. Examples: activities where there is an intent to publish the results in a peer-reviewed journal or to
present at a regional or national meeting, as well as, theses or dissertation projects conducted to meet the requirements
of a graduate degree.
c

Both physical procedures (e.g. venipuncture) and manipulations of living individuals or the living individuals
environments.
d

Communication or interpersonal contact between the investigator (or research team) and the living individual.
Examples: interviews, questionnaires, surveys, observations, manipulations of subject behaviour, diet, or environment,
physical measurements, specimen collection (e.g. blood tissue), administration of experimental drugs or devices.
e

If 1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained
by the investigator; or 2) the identity of the individual from whom the information was obtained is associated or may be
readily associated with the information.
f

Private Information: information about behaviour that occurs in a context in which the individual can reasonably expect
that no observation or recording is taking place or information that has been provided for specific purposes that the
individual can reasonably expect will not be made public (e.g. medical record, employee or student records).
Committee on Human Research Publication and Ethics
Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com

APPLICATION FOR REVIEW FORM (2009)


(UPDATED March 1, 2010)

______________________
Note: Ethical issues surrounding the storage of blood and/or tissue samples internationally stipulate that if blood specimens are to be stored for
future analysis and it is planned that such analysis will be done outside the facility/country where research is to be conducted, then the blood must be
stored in the facility with release of sub-samples only conditional on approval of such a project by authorities of the facility as well as CHRPE.

1.14

1.15

Work Plan
Project Start date:
Project End date:
Recruitment Start Date:
Recruitment End Date:

01/06/2012
31/08/2012

(dd/mm/yr)
(dd/mm/yr)
(dd/mm/yr)
(dd/mm/yr)

How do you intend to fund the study?


Donor/Grant
(please name sponsor)
KNUST/KATH

(please specify fund)

Ghana Government
Other

(please name agency)

(please name agency)

Self (please explain how you can guarantee this, if for clinical or interventional research) Educational Study No funding
necessary. All data collected as routine for trauma course to be used to improve the quality of the course. Results found to
be interesting and course directors would like to publish findings. No funding of study required. Data to be published from
retrospective vantage point.

2.0
2.1

INFORMATION ABOUT YOUR PROPOSED RESEARCH

Study Background (including relevant African and/or Ghanaian Literature, with references)
Advanced Cardiac Life Support (ACLS) is a protocol for handling patients who are experiencing serious
medical emergencies such as cardiac arrest. ACLS also refers to the skills and training necessary to use the
protocol safely and properly. Under ACLS, the health care provider will have to respond to an unconscious
person, analyze the cause of the emergency, determine the treatment(s) needed and take more advanced clinical
steps to restore breathing and heartbeat (using tools such as intubation, electrocardiograms (ECG) and
intravenous medications). ACLS impacts multiple key links that includes interventions to prevent cardiac arrest,
treat cardiac arrest, and improve outcomes of patients who achieve return of spontaneous circulation (ROSC)
after cardiac arrest. The chain of survival concept states that the survival of patients can be improved by early
access, early CPR, early defibrillation, and early advanced care.
ACLS principles are basically expansion of the Basic Life Support (BLS) systems, which includes
Cardiopulmonary Resuscitation (CPR) and other simple measures to stabilize a patient until he or she can
receive more experienced medical care. ACLS interventions aimed at preventing cardiac arrest much like CPR,
relies on basic first aid (often referred to as ABC of ACLS), in which the Airway of the patient is secured
(airway management), Breathing is assessed and stabilized (ventilation support) and Circulation is closely
monitored (treatment of bradyarrhythmias and tachyarrhythmias). Medical interventions such as intubation to
open the airway and shocking with a defibrillator to regulate the heart rhythm are parts of ACLS, as well as the
administration of pharmaceuticals intended to assist with resuscitation. In addition to resuscitation, the goal of
ACLS is to begin to identify what is chronically wrong with the patient so that long term treatment plan can be
prescribed and advised
Knowledge and adherence to ACLS guidelines and protocols must be a requirement for hospital-based doctors
working at KATH as part of the privilege procedures for most Teaching Hospitals. Residents and house officers
are often the primary participants in the codes that occur in a hospital setting, yet there is paucity of data on how
much knowledge they possess in the management of these medical emergencies as most of them may not
perform patient resuscitation on a regular basis. This results in alarming delays and deviations in components of
ACLS treatment procedures for adult resuscitation and in many cases lead to fatalities.
Medical doctors especially residents are often responsible for leading and performing CPR. However, levels of
expertise and comfort as leaders of ACLS teams vary widely. These varieties may be associated with the level of
Committee on Human Research Publication and Ethics
Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com

APPLICATION FOR REVIEW FORM (2009)


(UPDATED March 1, 2010)

knowledge one has on ACLS, the use of the knowledge to identify the presented problem of the patient and to
identify if the related crises needs an intervention.
World Health Organization (WHO) census statistics on mortality due to cardiac causes has overtaken mortality
due to all cancers put together.
Approximately 280,000 people in the US have a cardiac arrest each year. Of those, 1/3 is saved from death by
CPR. In other words, approximately 92,000 people are saved by CPR in the US.(americanheart.org).
Sudden Cardiac arrest(SCA) is an unexpected failure of heart functions occurring due to fast fluttering action of
the ventricles, which does not allow enough blood to be pumped out to other organs which include the brain and
the heart itself. SCA is a medical emergency, which can be fatal if not treated immediately. Cardiac arrest is
reversible if the victim is administered CPR promptly and given appropriate emergency care. This generally
involves administration of CPR, shock treatment to the chest to reset the hearts rhythm (defibrillation) and
advanced cardiac life support (ACLS).
Death may be prevented if the SCA victim receives immediate bystander CPR and defibrillation within a few
minutes after collapse. Performing effective CPR immediately after SCA can double or even triple a victims
chance of survival (Guidelines 2000). Early CPR and rapid defibrillation combined with early advanced care
can produce high long term survival rates for witnessed cardiac arrest victims.
It is estimated that about 95 percent of sudden cardiac arrest victims die before reaching the hospital or other
source of emergency help. Survival is directly linked to the amount of time between the onset of sudden cardiac
arrest and defibrillation. If no bystander CPR is provided, victims chances of survival are reduced by 7 to 10
percent with every minute of delay until defibrillation. If defibrillation is provided within 5 to 7 minutes, the
survival rate from sudden cardiac arrest can be as high as 30-45 percent. (AmericanHeart.org)
SCAs accounts for 10,460 (75.4 percent) of all 13,873 cardiac cases deaths in persons aged 35-44 years in the
United States. African Americans are reported as having the highest proportion of cardiac arrests in an
Emergency Department or dead on arrival (Morbidity and Mortality Weekly Report [MMWR] weekly). Yearly
data for unexpected deaths that occurred out-of-hospital or in an emergency room from diseases of the heart in
people with ages 15 to 34 rose from 2,719 in 1989 to 3,000 in 1996 showing a 10 percent rise (International
Classification of Diseases[ICD]/9 codes 390-398, 402, 404-429). Death rates were also higher among young
African Americans than among Caucasians.
The field of resuscitation has been evolving for more than two centuries (Debard ML, year?). From
recommended mouth-to-mouth ventilation for drowning victims through formally endorsed cardiopulmonary
resuscitation (CPR) to standardized CPR guidelines as instructions to medical personnel.
ACLS guidelines have evolved over the past several decades based on combination of scientific evidence of
variable strength and expert consensus. The American Heart Association (AHA) has developed the most recent
ACLS guidelines in 2010 (http://circ.ahajournals.org/content/vol122/18_suppl_3/) using the comprehensive
review of resuscitation literature performed by the International Liaison Committee on Resuscitation (ILCOR)
(Hazinski, 2010).
ACLS protocols are designed to treat adults suffering compromised circulation, which may result in lack of
oxygen delivered to the body. Due to the ever evolving nature of ACLS, doctors as well as other health care
professionals need to keep abreast with new ACLS guidelines and apply same to the nature and treatment
protocols on the ACLS. In the field of resuscitation, knowledge and adherence of recent ACLS treatment
methods by medical personnel could be as critical as saving the life of the patient. Recognizing that a critically
ill patient may need ACLS and knowing what to do generally serve as the basis for the health care provider to
either direct or participate in the resuscitation of a patient in either the pre-hospital or hospital setting when
encountered.
2.2

Study Aim and Objectives


To assess the knowledge of doctors on current ACLS protocol guidelines in KATH

2.3

Study Hypothesis or Conceptual framework


There is very little knowledge of doctors of KATH concerning ACLS.
The practice of ACLS protocol amongst doctors of KATH is inadequate

2.4
Study Design
This study shall be an observational study which will employ a cross-sectional survey design. Qualitative elements will be
employed to elicit responses for the variables. It seeks to assess knowledge and attitudes of the medical doctors working at
the accident and emergency area of the KATH towards resuscitation of patients using the ACLS protocol. It also seeks to
assess whether prior knowledge to ACLS changes one attitude towards resuscitating a patient and how one is able to
assess the critical nature of a patients condition.
Committee on Human Research Publication and Ethics
Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com

APPLICATION FOR REVIEW FORM (2009)


(UPDATED March 1, 2010)

2.5

Procedures to be undertaken

Please mark

all research procedure(s) that will be employed:

Record review

Interview schedule or guide (must be attached)

Questionnaire (must be attached)

Physical Examination

Drug or other substance administration

X-rays

Biopsy

Isotope administration

Blood sampling: venous

; arterial

Please summarise all procedures/processes to be involved in the study (maximum of 1 page):


Explained above.
2.6
Inclusion and Exclusion criteria for the Study Population (Please list and explain where necessary)

Specialists, Residents and House Officers who perform emergency duties at some period in time at the Accident and
Emergency Unit of KATH.

Specialists, Residents and House Officers who are willing to participate in the study (N=56)
2.7
Please describe how you will contact and maintain same with participants
Not applicable. No further follow-up is necessary.
2.8
Please describe how you will undertake the consent process and its documentation
Not applicable. This is an observational study that doesnt involve patients and without any specific intervention other than training and
education.
2.9

Will participants be completely anonymous? Yes


No
If no, explain how participants identities will be protected
N/A. No data linking participant performance within the trauma course was maintained. All data was de-identified and primarily used to
enhance and improve course educational materials.
2.10
How long, and in what way will records be retained?
Records will be kept for a minimum of one year past when manuscripts have been accepted for publication.
2.11
Who will have access to the Study Data?
Only members of the study team will have access to the data.
2.12
Risks to participants (including possible loss of confidentiality, discomfort to participants, delays in service delivery
Risk is minimal.

etc)

Risk should, as much as possible, be minimal i.e. the probability and magnitude of harm or discomfort anticipated in the research should not be
greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exam or
test.

2.13
Methods of minimising risks of participation in the study
All data is de-identified and will not be used outside of the study team.
2.14
Potential direct benefits to participants (benefits that only research participants hope to gain as a result of participating in this study)
Not applicable
2.15
Potential benefits to study population, science and/or society (relevance of proposed study to society)
Participants improved their personal knowledge about ACLS. Further, by having better trained physicians at KATH, the patient
population being treated at KATH will receive better treatment.
2.16

Sample size (please justify statistically, the selected number in your proposal)
Committee on Human Research Publication and Ethics
Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com

APPLICATION FOR REVIEW FORM (2009)


(UPDATED March 1, 2010)

Number of participants enrolled

56

Total number of study participants

56

______________________________
Co-Principal Investigator's Signature

(dd/mm/yr)

____________________________________________________
Name of Investigator

______________________________
Co-Principal Investigator's Signature

(dd/mm/yr)

____________________________________________________
Name of Investigator

REFERENCES:

Committee on Human Research Publication and Ethics


Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital
Kumasi, Ghana. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Email: chrpe.knust.kath@gmail.com