Uganda has a centralized registration process for ethics committees (ECs), the majority of which are based at academic institutions or hospitals (institutional ECs are referred to as research ethics committees (RECs) in Uganda). As per UGA-30, the Uganda National Council for Science and Technology (UNCST) was established by the UNCST-Act and operates under the Ministry of Science, Technology, and Innovation. According to the G-RECs and the NGHRP, the UNCST oversees and coordinates research and development in Uganda as well as EC registration and accreditation.
Per the G-RECs and the NGHRP, an EC is accredited for a three (3)-year period and is not permitted to commence its activities until authorization is received from the UNCST. For multicenter or collaborative trials using the same clinical protocol, the participating institutions may enter into a joint EC review arrangement. See Section 4.2 of the NGHRP for details on EC establishment requirements.
Ethics Committee Composition
The NGHRP states that an EC must have at least five (5) members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial.
Specifically, the composition should include:
- Individuals of varying backgrounds, including consideration of gender, cultural backgrounds, and sensitivity to social issues in the community in which research participants are drawn
- At least one (1) individual whose primary concern is scientific, and at least one (1) whose primary concern is non-scientific
- At least one (1) individual who is unaffiliated with the institution
- At least one (1) lay person from the community, whose primary background is not in scientific research involving human participants, and who is capable of sharing his/her insights about the community from which participants are likely to be drawn
Additional criteria for EC membership are available in Sections 4.3 and 4.4 of the NGHRP.
Terms of Reference, Review Procedures, and Meeting Schedule
As set forth in the NGHRP, each EC must have written procedures, including a process to be followed for conducting reviews. The following minimum requirements must be met:
- Meet at least once every three (3) months
- At least 50% of members, including one (1) member representing community interests, must be present to conduct reviews
- Project approval requires a simple majority of those members present at the meeting
- Conduct initial and periodic reviews of research projects, including site visits, at intervals corresponding to the degree of risk, but not less than once a year
- Respond to any allegations of ethical violations in approved or rejected research projects
- Liaise with other ECs within and outside the country to better carry out its functions
- Submit annual performance reports to the UNCST
See Sections 4.5.1 and 4.9 of the NGHRP for additional review requirements.
As per the NGHRP, an EC must also prepare and maintain the following:
- Detailed written procedures
- Copies of reviewed proposals and corresponding documentation (e.g., scientific evaluations, progress reports, correspondence with investigators)
- Meeting minutes
- Records of continuing review activities