IRB ETHICAL APPROVAL CHALLENGES WITHSOLUTIONS IN RESOURCE LIMITED SETTINGS

Institutionalizing Research Administration in Africa

PAUL KUTYABAMI BPHARM M.A.

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

Introduction

Some of the international guidelines provide for ethical review process

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

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

Ethical review process in action

Challenges

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

Limited training in ethics

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

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

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

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

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

Variation in IRB decision making

Lack of institutional guidelines and SOPs

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

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

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

THANK YOU