As per the G-KenyaCT, the G-ECBiomedRes, and KEN-30, Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. KEN-25 provides a list of the accredited institutional ECs.
As delineated in the G-ECAccred, NACOSTI will issue a certificate of accreditation to accredited institutional ECs, which is effective for three (3) years from the date of NACOSTI notification. All accredited ECs must submit annual reports to NACOSTI by July 31st for review and monitoring. Applications for renewal of accreditation should be made six (6) months before expiry of the accreditation period. Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the EC will lapse at the end of the current accreditation period. Accreditation must be terminated if the accredited committee fails to maintain the required standards. See the G-ECAccred for detailed instructions and KEN-10 for the application form required for institutional EC accreditation.
Ethics Committee Composition
As delineated in the G-ECAccred, institutional ECs should consist of at least seven (7) members, or an odd number above seven (7). The G-ECBiomedRes states that these members should be multidisciplinary and multisectoral in composition, collectively encompass relevant scientific expertise, balanced age and gender distribution, and include laypersons representing community interests and concerns. Per the G-ECAccred, the composition should meet the following requirements:
- At least one (1) member with knowledge and understanding of Kenyan law
- At least one-third of the members must be female and one-third must be male
- At least one (1) member who is unaffiliated with the institution
- At least two (2) members must have research expertise and experience, one (1) of whom must be in the health field
- At least one (1) member must be a lay member
- For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research
- Reflect the regional and ethnic diversity of the people of Kenya
The chairperson must also have some basic training and/or experience in bioethics and leadership. All EC appointments are the responsibility of the institution’s administrative head. See the G-ECAccred and the G-ECBiomedRes for detailed institutional EC requirements.
Terms of Reference, Review Procedures, and Meeting Schedule
Per G-ECBiomedRes, ECs need to have independence from political, institutional, professional and market influences. As delineated in the G-ECAccred, the G-ECBiomedRes, and the STI-Regs, institutional ECs must operate within written standard operating procedures (SOPs) which delineate the EC’s process for conducting reviews. Per the G-ECAccred, SOPs should include but are not limited to information on EC scope, responsibility, and objectives, institutions served, committee functions, terms and conditions of member appointment, business procedures including meeting schedules and types of reviews, documentation, recordkeeping, and archiving procedures, quorum requirements, communication procedures, and complaint process and dispute resolution procedures. Per the G-ECAccred and the STI-Regs, these documents must be provided to NACOSTI.
Per the G-ECAccred, the quorum for NACOSTI-accredited EC meetings must be:
- At least 50 percent of the membership must form the quorum;
- A lay person must be present in all meetings; and
- For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research.
The G-ECBiomedRes also defines quorum requirements:
- The minimum number of members required to compose a quorum (e.g., more than half the members)
- The professional qualifications requirements (e.g., physician, lawyer, statistician, paramedical, or layperson) and the distribution of those requirements over the quorum; no quorum should consist entirely of members of one (1) profession or one (1) gender; a quorum should include at least one (1) member whose primary area of expertise is in a non-scientific area, and at least one (1) member who is independent of the institution/research site