1. Which government agency or ministry is responsible for human subjects oversight? Is there a national ethical review committee?
The National Council for Science and Technology (NCST) is responsible for coordinating all research in Kenya and advising the government on research-related matters. NCST makes final decisions about protocol applications in Kenya, except in the types of situations described below. (n1, n2, n3) Two other national bodies involved in ethical review are the Kenya HIV/AIDS Vaccine Subcommittee and the Pharmacy and Poisons Board, both of which are affiliated with the Ministry of Health. (n4)
2. Does the country have national regulations or guidelines?
Kenya has three fundamental documents regulating human subjects research:
- NCST promulgated Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya, pursuant to the Science and Technology Act of 1979 (PDF as of 13 June 2006). These guidelines set forth a framework for determining if a research proposal is ethical. The reviewing committee must consider the following factors: value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent and respect for potential and enrolled subjects. (n1)
- In 2005 the Ministry of Health enacted National Guidelines for Research and Development of HIV/AIDS Vaccines (PDF as of 13 June 2006). These guidelines specifically address human subjects research proposals relating to the effort to identify HIV/AIDS vaccines. (n4)
- The Kenya Medical Research Institute (KEMRI) has guidelines for research that will be conducted through that institution. (n1) KEMRI was established under the 1979 Science and Technology (Amendment) Act to be a national body responsible for carrying out health science research. (n2)
3. How does the process of ethical review work on the national and/or local level?
Kenya has a multi-tiered system of human subjects research review. Research proposals must generally go through two or three rounds of review.
Depending upon local requirements, some proposals must first be reviewed by the researcher’s department within the local institution. All proposals must then be reviewed by the ethical review committee at the host institution where a local researcher is based or where a foreign researcher is collaborating. When this review has been completed, a review is performed by NCST. Researchers who are not affiliated with a specific institution or who are affiliated with an institution that lacks an ethical review committee should go directly to NCST for review. (n3, n5)
While researchers typically must seek final approval from NCST, certain institutions have final approval power themselves. Two institutions with committees that can grant final approval are KEMRI and Kenyatta National Hospital. This hospital’s ethical review committee is responsible for reviewing all research proposals from Ministry of Health researchers. (n3)
For HIV/AIDS vaccine research, investigators must submit a concept paper to the Kenya HIV/AIDS Vaccine Subcommittee, which will respond with advice. The investigators must next submit a proposal simultaneously to the Pharmacy and Poisons Board and to NCST or another designated ethical review committee. Both of those bodies must approve the research plan. (n4)
4. What enforcement mechanisms are used to encourage adherence to regulations or guidelines?
All three of the guidelines described in section 1 are legally binding and enforceable as they have been promulgated through acts of Parliament. In addition, KEMRI has a disciplinary committee to ensure that the agency’s research complies with all relevant requirements. (n3)
5. What future changes are possible or likely?
The KEMRI guidelines will soon be updated. Revisions have been completed and are currently awaiting approval by KEMRI’s Board of Chief Officers. (n3)
(n1) Republic of Kenya, National Council for Science and Technology, NCST NO. 45. Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (PDF as of 13 June 2006). 2004.
(n2) Republic of Kenya. The Science and Technology Act. Government Printer 1980.
(n3) Pauline Mwinzi. E-mail from Pauline Mwinzi to Kelly Safreed Harmon. 21 Feb. 2006.
(n5) Pauline Mwinzi. E-mail from Pauline Mwinzi to David Borasky. 6 Feb. 2006.