Institutionalizing Research Administration in Africa

1. Institutionalizing Research Administration in Africa IRB ethical approval challenges withsolutions in resource limited settings Paul Kutyabami BpharmM.a.

2. Introduction • History of research is replete with unethical research and systematic atrocities committed in the name of medical research. • While some may have been deliberate, many of the atrocities were unintended consequence of research activities • Public concern about the safety of individuals and communities involved in research

3. Introduction • Nuremberg code; the first legal attempt to deal with human participant protection • Ethical review is one of the attempts to ensure protection of research participants enshrined in several international guidelines • Ethical review has been largely reactive response to abuses and scandals that have marred the history of research • An effective system for ethical review is a crucial safeguard for participants

4. Some of the international guidelines provide for ethical review process • World Medical Association ‘Declaration of Helsinki’ …...protocol should be submitted for consideration, comment, guidance, and where appropriate, approval, to a specially appointed ethical review committee…’ • Council for International Organizations of Medical Sciences (CIOMS) 1991 principle 33; ……... Sponsors and investigators are expected to submit their proposals to ethical review…… • World Health Organization (WHO) ‘Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products’ (1995) The protocol, appendices and other relevant documentation should be reviewed from a scientific and ethical standpoint by one or more review bodies…constituted appropriately for this purpose and independent of the investigator(s) and sponsor’. • International Conference on Harmonization (ICH) ‘Harmonized Tripartite Guideline. Guideline for Good Clinical Practice’ (1996) A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion

5. Requirements for effective ethical review of research • Stake holders’ support; government officials, senior members of universities and research institutions, or local researchers • Supportive policies to ensure autonomy and smooth operation of the committees • Supportive infrastructure; office space and equipment, secretarial services • Financial resources • Availability of competent and committed staff to man and sit on Ethical review committees • Trained staff in research ethics • Motivated staff

6. Characteristic of an ineffective ethical review system • Process failure • Long turn around time • Committee decisions may ignored or overridden • Ethical review may be seen just as a formality

7. Ethical review process in action

8. Challenges Limited training in ethics • Few training program in ethics and most of them emphasize the western style of ethics • Small pool of trained people to take up roles in IRBs • Members may not appreciate their roles or may misunderstand the roles of an IRB • The few people who volunteer to take up roles may become fatigues when they overstay on the IRB

9. Ethical review Vs Scientific review • Scientifically unsound research is unethical and it is not permissible to undertake unethical research for the purpose of yielding good scientific knowledge • Ethics committees tend to concentrate more on science than on the ethics

10. Independence of IRBs • It improves the likelihood that decisions made free are from inappropriate influences that could distort their task of evaluating risks and potential benefits • Sometime members may be subjected to indirect institutional “pressure” to facilitate the acceptance of internationally sponsored research projects that bring with them substantial resources for the institution • Members may feel constrained because they are examining the work of their colleagues or their supervisors • It is advisable that in such situation, such members should not participate in protocol review unless they are able to separate these concerns from their task

11. Resource constraints • Ethical review activities require resources both financial and non financial to sustain them. • Ethical review committees may not have clear cut sources of funding • Rely on the goodwill of investigators or institution • Limited funding constrains on the activities of the committee • Failure to conduct meeting • Delays in communicating to investigator • Failure to recruit secretariat staffs

12. Recruitment and retention • Members of IRC are often expected to undertake ethical review activities in addition to own duties with inadequate or no compensation for time and efforts. • reduces the numbers of people willing to devote time and effort in the process • Difficulty in attracting community members

13. Limited community representation and participation • Guidelines require that community representatives in IRB meeting. • Members chosen • May not necessarily represent the actual research participants • Not guarantee that participants’ aspirations are considered during the review process

14. Variation in IRB decision making • IRBs are required to demonstrate autonomy in the interpretation of regulations. • IRBs must apply their own discretion when deciding how research proposals will be evaluated to meet the ethical criteria • Therefore there is always a wide variation in the standard applied to the review and approval of protocols between different IRB

15. Lack of institutional guidelines and SOPs • Guidelines exist at international and national level • Present broad ethical principles and may not be effectively applied directly at the local setting • Members are often left to resolve issues on the basis of personal knowledge • Looking at the ever increasing complex nature of research specific areas of science may require specific guidelines

16. Tension between IRB and investigators • There is always a natural tension between IRB and other stake holder of research • IRBs tend to operate on the presumption that investigators are intent on exploiting disadvantaged and poorly educated subjects Vs • Investigators’ concerned that IRB's impose impractical demands that will impede the researcher's ability to meet standards of good scientific practice

17. IRB credibility • Effectiveness of the ethical review process lies in the credibility of the IRB both within the institution and the surrounding community. • Credibility depends upon the • Competence and actions of IRB members, • The degree of cooperation between the investigator and the IRB, • The importance granted the IRB by the institutional administration, and • The extent to which IRB decisions reflect sensitivity to participant and community perspectives

18. Remedies to the Challenges • Establishing more training programs in ethics within countries to generate a pool of staff to take up roles on IRCs • Developing appropriate IRB policies and guidelines at institutions to support the independence and integrity of ethical committees • Institutional commitment to support ethical review activities in terms of both finance and infrastructure • Development of SOP for IRB operation to promote consistence of operations of ethical committees

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