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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

1

1

1

Please
R

N/A

1

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 Investigator’s 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

1

com Postal Address: PO Box SE 699. Dept of Emergency Medicine. KCCR 1. Accident and Emergency Centre. Kumasi. Ghana Telephone: Postal Address: p o box up825 knust kumasi 0207287618 Email: wakris2001@yahoo.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.com 2 . degrees. Acting Head of Department. Head of Department.com 1. Komfo Anokye Teaching Hospital Rockefeller A. Email: chrpe. Komfo Anokye Teaching Hospital Telephone: 0208336769 Email: sheenapo80@yahoo.knust. Dr Edward Amoah Boateng. Dept of Emergency Medicine Dr Ellis Owusu Dabo. ______________ 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. KATH Dept of Emergency Medicine.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 University of Michigan School of Medicine. departments and institutions). KATH. Suame. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. Ghana.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.5 Name Principal Investigator Nana Afia Nsua Boateng. KATH List all other co-investigators below (names.kath@gmail. Ghana 1. Dept of Surgery.7 Co-Investigator (II) Name and Signature Degree(s) Title: Prof/Dr/Mr/Miss/Ms Institution & Department Telephone:     0242235595 Email:       neelumsingh13@gmail. 2010) 1. Dept of Emergency Medicine Dr G Oduro.com Neelum Singh MBchB Physician (Dr) Accident and Emergency Centre. Komfo Anokye Teaching Hospital Dr Paa Kow Forson.8.APPLICATION FOR REVIEW FORM (2009) (UPDATED March 1. Resident Accident and Emergency Department. Accident and Emergency Department.8 1. Kumasi. Oteng. MB ChB (Co-Principal Investigator) Degree(s) MB ChB Title: Prof/Dr/Mr/Miss/Ms Institution & Department Physician (Dr).

kath@gmail. or developing theory. including research development. surveys. program evaluation. testing a specific hypothesis(es). Yes (my work is research) 1. 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.9 Where was the Research carried out (site)? (Provide name of Hospital/Institution and specific Department or Town/District/Village etc.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. where applicable): No but my work (please consult us. e If 1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator. test development.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. venipuncture) and manipulations of living individuals or the living individuals’ environments. specimen collection (e. c Both physical procedures (e.com 3 . Ghana. testing and evaluation. Examples: observational studies. as well as. designed to develop or contribute to generalizable knowledgeb. or environment. d Communication or interpersonal contact between the investigator (or research team) and the living individual.APPLICATION FOR REVIEW FORM (2009) (UPDATED March 1. 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. 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. group comparison studies. answering a specific question(s). ___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. Komfo Anokye Teaching Hospital *Please submit proof of notification or written approval/permission on official letterhead from proposed research site/facility 1. employee or student records). where will the samples be kept? a Typically a predetermined method for studying a specific topic.g. do you have Food and Drugs Board Approval? Yes 1. 2010) 1. 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. questionnaires. medical record. diet. blood tissue). physical measurements. Email: chrpe.g. 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. observations. interview or survey studies. administration of experimental drugs or devices. or 2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.knust. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785.) Accident and Emergency Department. Examples: interviews. Committee on Human Research Publication and Ethics Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital Kumasi. manipulations of subject behaviour.g. theses or dissertation projects conducted to meet the requirements of a graduate degree. My work will involve using records already gathered on people. My work will involve a living individual about whom an investigator conducting research obtains identifiable e private informationf.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.11 If this is a new drug trial.

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.APPLICATION FOR REVIEW FORM (2009) (UPDATED March 1. electrocardiograms (ECG) and intravenous medications). ACLS also refers to the skills and training necessary to use the protocol safely and properly. This results in alarming delays and deviations in components of ACLS treatment procedures for adult resuscitation and in many cases lead to fatalities.kath@gmail. if for clinical or interventional research) Educational Study – No funding necessary. The chain of survival concept states that the survival of patients can be improved by early access. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. the health care provider will have to respond to an unconscious person. However. analyze the cause of the emergency. in which the Airway of the patient is secured (airway management). 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. and early advanced care. 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. Results found to be interesting and course directors would like to publish findings.14 1. 2. 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. Under ACLS. treat cardiac arrest. as well as the administration of pharmaceuticals intended to assist with resuscitation. No funding of study required. early defibrillation. ACLS interventions aimed at preventing cardiac arrest much like CPR. ACLS principles are basically expansion of the Basic Life Support (BLS) systems.com 4 . Medical interventions such as intubation to open the airway and shocking with a defibrillator to regulate the heart rhythm are parts of ACLS.0 2. which includes Cardiopulmonary Resuscitation (CPR) and other simple measures to stabilize a patient until he or she can receive more experienced medical care. early CPR. with references) Advanced Cardiac Life Support (ACLS) is a protocol for handling patients who are experiencing serious medical emergencies such as cardiac arrest. All data collected as routine for trauma course to be used to improve the quality of the course. Data to be published from retrospective vantage point.knust.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. Residents and house officers are often the primary participants in the codes that occur in a hospital setting. levels of expertise and comfort as leaders of ACLS teams vary widely. determine the treatment(s) needed and take more advanced clinical steps to restore breathing and heartbeat (using tools such as intubation. Breathing is assessed and stabilized (ventilation support) and Circulation is closely monitored (treatment of bradyarrhythmias and tachyarrhythmias). Medical doctors especially residents are often responsible for leading and performing CPR. ACLS impacts multiple key links that includes interventions to prevent cardiac arrest. 1. In addition to resuscitation.1 INFORMATION ABOUT YOUR PROPOSED RESEARCH Study Background (including relevant African and/or Ghanaian Literature. Ghana. Email: chrpe. and improve outcomes of patients who achieve return of spontaneous circulation (ROSC) after cardiac arrest. 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. relies on basic first aid (often referred to as ABC of ACLS).

Tel: 233 51 22301-4 ext 1098 or 233 20 5453785.000 in 1996 showing a 10 percent rise (International Classification of Diseases[ICD]/9 codes 390-398.2 • Study Aim and Objectives To assess the knowledge of doctors on current ACLS protocol guidelines in KATH 2. In the field of resuscitation. If no bystander CPR is provided.org) SCAs accounts for 10. victim’s chances of survival are reduced by 7 to 10 percent with every minute of delay until defibrillation. 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. It is estimated that about 95 percent of sudden cardiac arrest victims die before reaching the hospital or other source of emergency help.kath@gmail. Committee on Human Research Publication and Ethics Kwame Nkrumah University of Science and Technology and Komfo Anokye Teaching Hospital Kumasi.460 (75. Performing effective CPR immediately after SCA can double or even triple a victim’s chance of survival (Guidelines 2000). The field of resuscitation has been evolving for more than two centuries (Debard ML. the use of the knowledge to identify the presented problem of the patient and to identify if the related crises needs an intervention. ACLS protocols are designed to treat adults suffering compromised circulation. Early CPR and rapid defibrillation combined with early advanced care can produce high long term survival rates for witnessed cardiac arrest victims. This generally involves administration of CPR. 1/3 is saved from death by CPR. Qualitative elements will be employed to elicit responses for the variables. SCA is a medical emergency. Ghana. 2010). Of those. In other words.4 Study Design This study shall be an observational study which will employ a cross-sectional survey design. Survival is directly linked to the amount of time between the onset of sudden cardiac arrest and defibrillation. shock treatment to the chest to reset the heart’s rhythm (defibrillation) and advanced cardiac life support (ACLS). Due to the ever evolving nature of ACLS. 404-429). knowledge and adherence of recent ACLS treatment methods by medical personnel could be as critical as saving the life of the patient.com 5 . 2010) knowledge one has on ACLS.knust. (AmericanHeart.000 people are saved by CPR in the US. Sudden Cardiac arrest(SCA) is an unexpected failure of heart functions occurring due to fast fluttering action of the ventricles. 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. 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. year?).APPLICATION FOR REVIEW FORM (2009) (UPDATED March 1. Approximately 280. approximately 92. The American Heart Association (AHA) has developed the most recent ACLS guidelines in 2010 (http://circ. If defibrillation is provided within 5 to 7 minutes.(americanheart.000 people in the US have a cardiac arrest each 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.873 cardiac cases deaths in persons aged 35-44 years in the United States. Death rates were also higher among young African Americans than among Caucasians. Email: chrpe. 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). which may result in lack of oxygen delivered to the body. which does not allow enough blood to be pumped out to other organs which include the brain and the heart itself.org/content/vol122/18_suppl_3/) using the comprehensive review of resuscitation literature performed by the International Liaison Committee on Resuscitation (ILCOR) (Hazinski. ACLS guidelines have evolved over the past several decades based on combination of scientific evidence of variable strength and expert consensus. 402. 2. 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. World Health Organization (WHO) census statistics on mortality due to cardiac causes has overtaken mortality due to all cancers put together.719 in 1989 to 3. Cardiac arrest is reversible if the victim is administered CPR promptly and given appropriate emergency care. the survival rate from sudden cardiac arrest can be as high as 30-45 percent.4 percent) of all 13. Death may be prevented if the SCA victim receives immediate bystander CPR and defibrillation within a few minutes after collapse.org). The practice of ACLS protocol amongst doctors of KATH is inadequate 2. which can be fatal if not treated immediately.3 • • Study Hypothesis or Conceptual framework There is very little knowledge of doctors of KATH concerning ACLS. 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 patient’s condition.ahajournals.

com 6 . Further. 2. explain how participants’ identities will be protected N/A. 2. 2. 2.kath@gmail. 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. 2. All data was de-identified and primarily used to enhance and improve course educational materials. 2.15 Potential benefits to study population.10 How long.6 Inclusion and Exclusion criteria for the Study Population (Please list and explain where necessary) • Specialists. 2. No data linking participant performance within the trauma course was maintained. delays in service delivery Risk is minimal. No further follow-up is necessary.7 Please describe how you will contact and maintain same with participants Not applicable.e. This is an observational study that doesn’t involve patients and without any specific intervention other than training and education. 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.12 Risks to participants (including possible loss of confidentiality.8 Please describe how you will undertake the consent process and its documentation Not applicable. 2.knust. 2010) 2. 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. Residents and House Officers who perform emergency duties at some period in time at the Accident and Emergency Unit of KATH.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. the patient population being treated at KATH will receive better treatment. by having better trained physicians at KATH. Email: chrpe.11 Who will have access to the Study Data? Only members of the study team will have access to the data. as much as possible. • Specialists. science and/or society (relevance of proposed study to society) Participants improved their personal knowledge about ACLS.9 Will participants be completely anonymous? Yes No If no. etc) Risk should. arterial Please summarise all procedures/processes to be involved in the study (maximum of 1 page): Explained above. 2. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785. discomfort to participants.APPLICATION FOR REVIEW FORM (2009) (UPDATED March 1. Residents and House Officers who are willing to participate in the study (N=56) 2. be minimal i.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 .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. Ghana.16 Sample size (please justify statistically.

APPLICATION FOR REVIEW FORM (2009) (UPDATED March 1. Ghana.kath@gmail.knust. 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. Tel: 233 51 22301-4 ext 1098 or 233 20 5453785.com 7 . Email: chrpe.