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AHMADU BELLO UNIVERSITY TEACHING HOSPITAL
SHIKA – ZARIA
HEALTH RESEARCH ETHICS COMMITTEE
APPLICATION FORM FOR ETHICAL CLEARANCE
RESEARCH INVOLVING HUMAN SUBJECTS OR PATIENTS/OTHER (SPECIFY)
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PROTOCOL NUMBER (FOR OFFICE USE ONLY)
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Please note:
(a) This application must be typed or handwritten in capital letters in black biro
(b) The form must be completed in full or it will not be reviewed
(c) It must be signed by the applicant, applicant’s supervisor (where appropriate) and
the Head of Department/unit
NAME:
Prof/Dr/Mr/Mrs/Miss/Ms………………………………………………………………………………………
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Are you the PRINCIPAL INVESTIGATOR or SUB INVESTIGATOR?
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PROFESSIONAL STATUS (if Student year of study)
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DEPARTMENTAL ADDRESS:…..
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HOSPITAL/INSTITUTION WHERE EMPLOYED
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FULL TIME OR PART TIME?
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E-MAIL ADDRESS:
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MOBILE TELEPHONE NUMBER
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TITLE OF RESEARCH PROJECT: (No abbreviation please)
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WHERE WILL THE RESEARCH BE CARRIED OUT? (Please furnish name of hospital/institution and
particular department)
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All the following sections must be completed. Please tick all relevant boxes
1. Purpose of research
PG
FNMC
FWACP
MSC
PHD
UNDERGRADUATE
COLLABORATIVE INTERNATIONAL
COLLABORATIVE NATIONAL
OTHERS (Specify) ……………………………………………………
2. AIMS AND OBJECTIVES OF THE RESEARCH
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3. SUMMARY OF THE RESEARCH (gives a brief outline of the research):
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4. ANTICIPATED START DATE (month & year)
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5. STUDY DURATION UP TO THE COMPLETION OF REPORT (In months/years)
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6. POTENTIAL VALUE OF THE RESEARCH RESULTS:
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7. STUDY REQUIREMENTS
7.1 If radiation or isotopes are to used, written approval must be obtained from the
department of radiology, is the attached? Yes NO N.A
(If not approved the application cannot be considered)
7.2 Subject information sheet is attached (for written and verbal consent) Yes NO
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Informed Consent form is Attached (for written Consent) Yes No
Consent will be verbal Yes NO
Informed Consent is not necessary Yes NO
7.3 Is a questionnaire or interview to be use in this research Yes NO
If yes, is the questionnaire attached? Yes NO
(if not attached, the application cannot be considered)
7.4.0 SUBJECT FOR THE STUDY
7.4.1 Explain exactly where and how the subjects are to be recruited:
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7.4.2. Where the subjects are patients, will they be asked to volunteer?
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State how the subject will be selected or who will be asked to volunteer
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Are the subjects subordinate to the person doing the recruiting? Yes No
(if yes, justify the selection of subordinate subject)
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7.4.3 Will control subject be used? Yes No
(If yes, explain how they will be recruited)
7.4.4 Subject records: What records will be used and how will they be selected?
7.4.5 Age range of patients/subjects/controls:
(if under 18 years, from who will consent be obtained?
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(if under 18 years, is a patient assent form attached) Yes No
7.4.6 Sex: Male Female
7.4.7 Number of patients ………………………….non – patient subjects ………………
controls…………………
7.4.8 Benefit to patient or subject will be research benefit the patient (s) or subject (s) is any
direct way
Yes No
If yes, explain in what way
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7.4.9 Disadvantages to patients/subjects/controls. Will participation or non- participation
disadvantage them in any way? Yes No.
7.4.10 Will patient/subject/controls be given any payment or inducement to participate in the
study?
Yes No.
If yes, please give details
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7.4.11 Are there any arrangements for compensation should a participant suffer injury as a
result of the participation, if such an injury results from a non-negligent act? Yes
No
8.0 PROCEDURES
8.1 Mark research procedure(s) that will be used
Record review
Interview form (must be attached)
Questionnaire (must be attached)
Examination (state the nature and frequency of examination)
Substance administration (state the name(s) of substance(s) and dose(s)
and frequency of administration:
X-Rays
Isotope administration (state the name(s) of isotope(s) and frequency)
Blood sampling Venous Arterial (State amount to be taken and the frequency of
blood sampling):
Biopsy
Other procedures (explain):
Use this space to elaborate procedures marked above:
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8.2 Is/are procedure(s) routine for diagnosis/management? Yes No.
Specific to research Yes No
8.3 Who will carry out the procedure(s)? (state name(s) and position(s) held)
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9.0 RISK OF THE PROCEDURE(S) subject/control will suffer:
No risk Discomfort Pain Possible complications Side effects from
agents used
If you have checked any of the above except “No risk” provide details hereunder:
10.0 CONFIDENTIALITY AND DATA SECURITY
10.1 Confidentiality how will confidentiality be maintained so that
patients/subjects/controls are not identifiable to persons not involved in the
research? ………………………………………………..
10.2 Results: Who will have access to information from study volunteers? (List job titles
where specific individuals cannot be identified)
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10.3 Please give details of procedures to protect individual data held on Computer(s)
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10.4 I f photographs or video material of people taking part in the study will be taken,
what specific Arrangements have been made for these?
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Does this include consent? Yes No
10.5 What arrangements are in place to handle specific information of a broader
relevance that may arise during the study such as:
a. Communication of medical information to a participant’s medical/dental
practitioner?
b. Communication of breach of health and safety to an employer?
c. Counseling of subjects/controls, where study results may have implication?
11.0 GENERAL
11.1 Has permission of the relevant authority been obtained? Yes No N/A
State name of authority:
11.2 Finances. Will there be financial cost to:
Patient/subjects? Yes No
Hospital/Institution? Yes No
Others? (If yes, please state the name……………………………) Yes No
Explain any box marked “yes”
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How will the research be funded? (Please give the name of any sponsoring
organization)
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11.3 Is this research being conducted by, or involve collaboration with organization
external to ABU/ABUTH?
Yes No
If yes, has the study been referred to or agreed by any other Ethnics Committee? Yes
No
11.4 Please provide any other information which may assist the Committee to reach its
decision
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12.0 DECLARATION
The information supplied in this form is accurate to the best of my knowledge and belief
Applicant’s Signature ……………………………………………………………
Date…………………………………..
Who will supervise the project?
Name: ………………………………………………………………….Department/Unit
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Signature of Supervisor……………………………………………………
Date………………………………………….
Head of Department/Unit in which the study will be conducted
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Name: ………………………………………………………………….Department/Unit
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Signature of Supervisor……………………………………………………
Date………………………………………….
GUIDELINES INFORMATION REQUIRED IN FILLING THE SUBJECT INFORMATION
SHEET
INDICATE YOUR
TOPIC................................................................................................................
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Principal Investigator
Mobile Telephone Number
E-mail address
Institution
Department
Title of Study
Co-investigators
Sponsor (if any)
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- Some general things to know about the study
- What is the purpose of the study
- Procedures
- Benefits
- Cost of participation
- Risks
- Confidentiality
- Respondents’ rights
- Conflict of interest
- For the records
CONSENT FORM
Title of Research Project:
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I have the read information provided above (if has been adequately explain to me).
I have had the opportunity to ask questions about it and any questions I have asked have
been answered to my satisfaction. I voluntarily accept to participate / allow my ward or
children to participate in this study and understand that I have the right to withdraw from
the study at any time, without compromising the quality of care I deserve.
Yes No
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Signature/thumb print of research respondent Date
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Printed name of Research subject’s legal guardian
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Signature/thumb print of person obtaining consent Date
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Printed name of person obtaining consent
Address
GSM/Telephone Number ………………………………………………………..
