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STANDARD OPERATING PROCEDURE (SOP’s).

INTRODUCTION:

This document shall be cited as the Standard Operating Procedure (SOP’s) of the University of Ilorin Teaching Hospital ERB and...Read more

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OVERVIEW:

The University of Ilorin Teaching Hospital’s (UITH) Ethical Review Committee (ERC) was set up in 1995. Over the years, the Committee has not only grown in size, ramification, scope and functionality but also in the quantum and quality of reviews carried out by it. The Committee, otherwise known as the Ethical Review Board is registered with the National Human Research and Ethics Committee (NHREC) domiciled in the Federal Ministry of Health and other similar international organizations.

The ERC reviews hundreds of proposals brought before it on a yearly basis in the most scientific, professional and rancor-free manner with value addition to such proposals at the end of the exercise. Furthermore, there has been improved level of awareness among the research community, both in the hospital and other adjoining research institutions on the existence and mandate of the committee. As a result of this, the committee now receives proposals from the Teaching Hospital community, the University of Ilorin community, the Kwara State Government health facilities and the University of Ibadan, Oyo state in instances where the researcher elects to recruit participants in Ilorin.

The hospital and its ERC subscribe to Nuremberg code of 1947, the Helsinki declaration as amended in 1993, the Council for International Organizations of Medical Sciences (CIOMS) guidelines of 1993, the Nuffield report of 2002, the Belmont report of 2003, the UNESCO declaration on bioethics and human rights of 2005, the WHO handbook on Good Clinical Practice of 2004, the National code for health research ethics and other similar local and international guidelines on bioethics and medical research. In order to bring these guidelines to the awareness of the membership of the ERC and indeed, the entire Hospital community, the Committee organizes training workshops and seminars regularly, the most recent of which was done in collaboration with Nigerian Institute of Medical Research and sponsored by European and Developing Countries Clinical Trial Partnership (EDCTP).

FUNCTIONS:

1. To review all proposed research in the hospital and affiliated University prior to its commencement in order to ensure protection and safety of research participants and compliance with international best practices.

2. To safeguard the standard of care of research participants using evidence-based medicine, particularly in the setting of placebo-controlled randomized trials.

3.  To exercise oversight and/or monitoring function on all approved protocols to ensure compliance with what has been approved.

4.   To organize periodic training programs on bioethics as a way of raising awareness and engendering compliance.

5.   To liaise with the National Human Research Ethics Committee (NHREC) on behalf of the hospital on matters that border on bioethics. 

6.  To advise the hospital management on any other matter bordering on medical ethics that may be brought before it from time to time.   

MEMBERSHIP:

The ERB is composed of fifteen (15) members, appointed by the Chief Medical Director (CMD) of the University of Ilorin Teaching Hospital and strictly on their personal merit as follows;

1.   The Chairman, who shall be a distinguished clinical scientist with proven integrity and track record of experience in biomedical research.

2.  One representative each of four major clinical departments of Medicine, Surgery, Paediatrics, Obstetrics and Gynaecology provided no department shall have dual representation on the board.

3.   One Clinical Psychologist or Specialist Psychiatrist.

4.   One clinician with vast experience in research representing other departments.

5.   One representative of the laboratory departments.

6.   One representative of nursing services department of the hospital.

7.   One representative of pharmacy department.

8.   One statistician from the planning unit of the hospital.

9.   One representative of the legal unit.

10. One community representative.

11.    One representative of the Clinical services and training directorate of the hospital.

12.  One Recording Secretary.

13.   Secretary and member.

14. At least a third of the membership of the ERB shall be females for the purpose of gender balancing.

TENURE:

A member shall serve a tenure of two (2) years which is renewable to a maximum of six (6) years provided any member with alleged misconduct may have his tenure terminated by the Chief Medical Director of the hospital at any time. The appointment of members shall be through a system of rotation that guarantees maintenance of expertise, continuity and injection of fresh ideas and approaches in the board at any point in time. 

MEETINGS:

The meeting of the ERB shall be convened every two (2) months on the authority of the Chairman and provided that notice of such meetings shall be served in both hard and electronic format at least two (2) weeks before the meeting. The ERB may however meet more frequently as the need arises from time to time.

PROTOCOL SUBMISSION:

Every protocol to be reviewed shall be submitted in both hard and electronic format to the ERB secretariat. The hard copy, including all the supporting documents which shall be listed hereunder shall be in four (4) copies and recorded in the ERB register in the secretariat and a fixed identifier number (ID No) assigned. The electronic submissions shall include both the full protocol and the completed abridged protocol review form which can be downloaded from this website.

MINIMUM COMPONENTS OF A PROTOCOL:  The following shall be the minimum components of a submitted protocol;

•       Introduction

•       Objective(s)

•       Study design

•       Study products

•       Study procedure

•       Assessment and management of safety

•       Statistical consideration

•       Data handling

•       Study monitoring

•       Human subject protection

•       Publication plan and result dissemination

SUPPORTING DOCUMENTS:

Every research protocol must be accompanied by the following documents without which such a submission shall be considered incomplete and to that extent, invalid for further processing;

1.         Information sheet for research participants

2.     Consent form

3.     Sample of Questionnaire where applicable

4.     Sample of research proforma where applicable

5.     Any previous ethical approval letter(s)

6.     Proposed budget where applicable.

7.     Any previous letter of registration or patency pertaining to the study material.

8.     Any insurance coverage policy for research participants.

9.     Any letter of indemnity

10.    A statement describing any compensation to be paid to research participants 

PROTOCOL ADMINISTRATIVE FEES:

The following applicable protocol administrative fees shall be paid into the bank account of the ERB and duly receipted prior to the processing of any application;

I.Five thousand Naira only for dissertation or thesis proposals for residency fellowship and higher degree

 II.Seven thousand and Five hundred Naira only for proposals by Medical Consultants that are personally funded.

III.10% of total budget for all externally funded research proposals.

Undergraduate degree research applicants and other similar certificate courses are however exempted from any administrative fees.

TYPES OF REVIEW:

Following the receipt of applications from the secretariat, the Chairman shall decide on one of the following types of review as may be applicable to the protocol;

           I.   Expedited review:

           II.  Emergency review:

           III. Regular review:

CONCLUSION:

UITH’s ERC has maintained a leading status in the entire North Central geopolitical zone but would continue to strive to be the best nationwide in not too distant a future.

Professor Olanrewaju Timothy Adedoyin MB, BS (ILORIN),  FWACP (Paed), FISN.

Chairman, Ethics and Research Board  (Click to view profile).  E-mail: ooadedoyin@yahoo.com               E-mail us: erc@uith.org                         

                                      

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