OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX, ILE-IFE, NIGERIA.

ETHICS AND RESEARCH COMMITTEE

APPLICATION TO THE ETHICS AND RESEARCH COMMITTEE FOR CLEARANCE OF

RESEARCH INVOLVING HUMAN SUBJECTS, OR PATIENT RECORDS.

All applications to the Committee will only be considered if:

(a) Response to this application is typed.
(b) The form is completed in full with the information requested. Where a question is not applicable, it is important to
make this clear and not to leave it blank.
(c) The application is signed by the applicant, applicants supervisor (where appropriate), the Head of Department
and the Head of Department/Unit where the research will be carried out.
(d) Seventeen collated sets of application forms and accompanying documents are attached.
(e) The language used in the application is clear and simple to understand to lay members.
(g) All abbreviations should first be written in full.

Applicants Checklist
Please indicate if the following have been enclosed, by ticking the relevant box:
Research Proposal/Dissertation (Three copies) Yes No
Application Form (Seventeen copies only) Yes No
Informed consent form Yes No Not applicable
Subject information sheet Yes No Not applicable
Questionnaire form Yes No Not applicable
Proforma Form Yes No Not applicable
Interview form Yes No Not applicable
Advertisement for research subjects Yes No Not applicable
Medical/Dental Practitioners/consultant information sheet/letter Yes No Not applicable
Data sheet for all drugs (one copy only) Yes No Not applicable
Statement regarding compensation arrangements one copy only) Yes No Not applicable
Clearance for use of isotopes and/or radiation Yes No Not applicable

All applications and enquiries should be directed to:

Mrs. A. F. Obisanya
Secretary, Ethics and Research Committee
OAUTHC, Ile-Ife. 08034046787
Or
Mrs. O. G. Akanbi 08155017692
Desk Officer, Ethics and Research Committee
Or
Mrs. A. R. Akinwole 07036841417
Assistant Desk Officer, Ethics and Research Committee

Note: The first twenty applications will be considered and subsequent ones will be carried over to the next month.
The committee meets every last Thursday of the Month.
 OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX,

ILE-IFE, NIGERIA.

ETHICS AND RESEARCH COMMITTEE

APPLICATION TO THE ETHICS AND RESEARCH COMMITTEE FOR CLEARANCE OF

RESEARCH INVOLVING HUMAN SUBJECTS, OR PATIENT RECORDS

PROTOCOL NUMBER (for office use only ____________________

Please note: (a) Response to this application must be typed.

(b) The form must be completed in full or it will not be reviewed.

(c) It must be signed by the applicant, applicants supervisor (where appropriate), the Head
of Department and the Head of Department/Unit where the research will be carried out.

NAME: Prof/Dr/Mr/Mrs/Miss/Ms

Are you the PRINCIPAL INVESTIGATOR or SUB-INVESTIGATOR?

PROFESSIONAL STATUS (if student, what level)

DEPARTMENTAL ADDRESS:

HOSPITAL/INSTITUTION WHERE EMPLOYED:

FULL-TIME OR PART-TIME WORKER?

E-MAIL ADDRESS:

TELEPHONE AND EXTENSION:

TITLE OF RESEARCH PROJECT: (Use no abbreviations)

WHERE WILL THE RESEARCH BE CARRIED OUT? (Please furnish name of particular department (s),
hospital/institution)
All the following sections must be completed. Please tick all relevant boxes.

1. PURPOSE OF THE RESEARCH:

Postgraduate: Degree/Diploma/Fellowship (state the name)

Undergraduate: Degree/Diploma (state which)

Not for degree purposes

2.1 AIM(S) OF THE RESEARCH

2.2 OBJECTIVES OF THE RESEARCH

3. SUMMARY OF THE RESEARCH (give a brief outline of the research plan including

methodology and data analysis):

4. ANTICIPATED START DATE (month & year):

5. STUDY DURATION, UP TO THE COMPLETION OF REPORT (in months):

6. POTENTIAL VALUE OF THE RESEARCH RESULTS:

7. REQUIREMENTS

7.1 Are you using radiation or isotopes in this study Yes No NA

If yes, have you obtained written approval from the Department of Radiology?

Yes No NA (The written approval must be attached, if not, the

application cannot be considered).

7.2 Is Subject Information Sheet attached? (For written and verbal consent) Yes No NA

7.3 Is Informed Consent Form attached? (For written consent). Yes No NA

7.4 Will Consent be verbal Yes No NA

7.5 Are you using questionnaire for the research Yes No NA

7.6 Are you using Proforma Yes No NA

7.7 Are you using Interview guide Yes No NA

(If your answer to any question above is yes, kindly attach the tool to the application, if not
attached, your application will not be considered).
8. SUBJECTS FOR THE STUDY

8.1 Will patients participate in this study Yes No NA

Explain exactly where and how the patients are to be recruited:

8.2 Where the subjects are not patients: Will they be asked to volunteer? Yes No NA

If yes, state who the volunteers are and how they will be selected:

8.3 Will control subjects be used? Yes No NA

If yes, explain who they are and how they will be recruited:

8.4 Are the subjects subordinate to the person doing the recruiting? Yes No

If yes, justify the selection of subordinate subjects:

8.5 Subject records: Do you need information from the patients Medical Records. Yes No NA

If yes, explain how you intend to obtain them

8.6 Age range of Patients............................. Volunteers................................ Controls.......................

If under 18 years, from who will consent be obtained?......................................................

If under 18 years, is a patient assent form attached? Yes No

8.7 Sex: Male Female

8.8 Number of patients .. ; Number of Volunteers .; Number of Controls

8.9 Benefit to participants: will the research benefit the patient(s), volunteer(s) or control(s) in any direct
way? Yes No

If yes, explain in what way and who will benefit:

8.10 Disadvantages to patienties/volunteers/control. Will participation or non-participation disadvantage
them in any way? Yes No

If yes, explain who and in what way:

8.11 Will patients/volunteers/controls be given any payment or inducement to participate in the study?
Yes No

If yes, please give details of who will be given inducement and what

8.12 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 NA

9. PROCEDURES

9.1 Tick research procedure(s) that will be used:

Record review

Interview form (must be attached)

Questionnaire (must be attached)

Proforma (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 the procedure(s) ticked above:

9.2 (a) Is/are procedure(s) ticked above routine for diagnosis/management of the patients?

Yes No

(b) Is/ are the procedure(s) specific to your research? Yes No

9.3 State name(s) and position(s) of the people who will carry out the procedure(s) in 9.1 above

10. RISKS OF THE PROCEDURE(S) Patients/ Volunteers/ Controls 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 here:

11. CONFIDENTIALITY AND DATA SECURITY

11.1 Confidentiality: how will confidentiality be maintained so that patients/subjects/controls are not
identifiable to persons not involved in the research?

11.2 Results: Who will have access to information from study? (List job titles where
specific individuals cannot be identified):

11.3 Please give details of procedures to protect individual data held on computer(s)

11.4 Will photographs, audio recording or video material of people taking part in the study be taken
Yes No NA

If yes, what specific arrangements have been made for these and does this include consent?
11.5 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 participants medical/dental practitioner?

(b) Communication of a breach of health and safety to an employer?

(c) Counselling of participants, where study results may have health implication?

12. GENERAL

12.1 Has permission of relevant authority/ies been obtained? Yes No N/A

State name of authority/ies:

12.2 Finances. Will there be financial costs to:

Patient/ volunteer/control? Yes No

Hospital Management? Yes No

Yourself? Yes No

Explain any box marked "yes" above

12.3 How will the research be funded? (Please give the name of any sponsoring organisation):

12.4 Do you have research grant (apart from OAUTHC Managementgrants) Yes No NA

If yes kindly state name(s)

12.5 Is this research being conducted by, or involve collaboration with an organisation external to OAUTHC?
Yes No NA

If yes, has the study been referred to or agreed by any other Ethics Committee? Yes No

If yes, attach the clearance to the application

12.6 Please provide any other information which may assist the committee to reach its decision:
13. 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:

Signature: Date:

Head of Department of Applicant

Name: Department/Unit:

Signature: Date:

Head of Department/ Unit in which study will be conducted:

Name: Department/Unit:

Signature: Date:
 OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX, ILE-IFE.

Kindly indicate your topic boldly

SUBJECT INFORMATION SHEET

Principal Investigator: Telephone No:-

E-mail

Institution/Department

Co Investigators:

Sponsor (If any):

- Some general things to know about the study:

- What is the purpose of this study:

- Procedures:

- Benefits:

- Costs of Participation:

- Risks:

- Compensation:

- Confidentiality:

- Respondents Rights:

- Conflict of Interest:

- For the Records:

 OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX, ILE-IFE.

(INDICATE YOUR TOPIC IN BOLD FORM)

Subjects Agreement/Consent Form:

I have read the information provided in the Subject Information Sheet, or it has been read to me.

I have had the opportunity to ask questions about the research and all questions I have asked have been answered to
my satisfaction. I consent voluntarily to participate in this study and understand that (insert the procedure(s) to be
carried out) and I have the right to withdraw from the study at any time.

Yes No

------------------------------------------------------------------------------------------------------

Signature/Thumb print of Research Respondent. Date:

If participants cannot read: Signature of Mother or Legal Guardian.

Signature/thumb print of Person Obtaining Consent. Date:

Name of witness Signature Date

Printed Name of Person Obtaining Consent.

 OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX, ILE-IFE.

ASSENT FORM

(PLEASE INDICATE YOUR TOPIC IN BOLD FORM)

Parent/Guardian Consent Form:

I have read the information provided in the Subject information Sheet, or it has been read 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 consent voluntarily to allow my child/ward participate in this study and understand that (Insert the
procedures to be carried out) he/she has the right to withdraw from the study at any time.

Yes No

------------------------------------------------------------------------------------------------------

Signature/Thumb print of Research Respondents Mother or Legal Guardian. Date:

Signature/thumb print of Person Obtaining Consent Date:

Name of witness& Signature

Printed Name of Person Obtaining Consent.

U

Child/Ward Agreement (Verbal)

Although I am not yet 18 years old but I have had the opportunity to ask questions about this research and any
questions I have asked have been answered to my satisfaction. I consent voluntarily to participate in this study and
understand that I have the right to withdraw from the study at any time.
I