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
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