As indicated in the G-AppConductCT, all clinical trials require national ethics committee (EC) approval for each trial site. Per the G-TMRCC and TZA-50, the national EC in Tanzania is the National Health Research Ethics Committee (NatHREC), which focuses on the ethical issues surrounding submitted research proposals. As delineated in the G-TMRCC and TZA-18, NatHREC is a subcommittee of the Medical Research Coordination Committee (MRCC), which serves as the national health research coordinating body, and is responsible for supervising health research in Tanzania. The MRCC, which is part of the National Institute for Medical Research (NIMR), delegates the registration, review, approval, and monitoring of clinical research to NatHREC.
Per the G-AppConductCT, TZA-18, TZA-5, and TZA-1, proposed health research in Tanzania must also get institutional EC approval at the host institution where the research will be based. If there is no institutional EC, the approval must still be obtained from NatHREC. For all health research involving foreign collaborators, the applicant must get both the institutional EC and NatHREC’s ethical approval.
Ethics Committee Composition
National Health Research Ethics Committee
As per the G-TMRCC and TZA-5, NatHREC is composed of 15 members—scientists and non-scientists with varying backgrounds—to promote a complete and adequate review of health research proposals commonly received by NIMR. NatHREC members are appointed by their respective institutions based on knowledge, qualifications, and experience in reviewing and evaluating the scientific, medical, and ethical aspects of research protocols. The chairperson is to be non-affiliated with the NIMR, and the Secretary is to be affiliated with the NIMR. According to TZA-5, committee members must include medical scientists; biomedical scientists; social scientists; a legal representative; unaffiliated community representatives (e.g., teacher or nurse); and representatives of religious/faith-based organizations. As per the G-TMRCC, NatHREC is represented by the following organizations:
- Muhimbili University of Health and Allied Sciences (MUHAS)) (formerly known as Muhimbili University College of Health Science (MUCHS))
- Christian Social Services Commission (CSSC)
- The National Muslim Council of Tanzania (BAKWATA)
- Economic and Social Research Foundation (ESRF)
- Tanzania Gender Networking Programme (TGNP)
- Legal and Human Rights Centre (LHRC)
- University of Dar es Salaam (UDSM)
- Ministry of Education (MoE)
Institutional Ethics Committees
As per the G-EthicsHR, the composition and qualification requirements for the institutionally based ECs vary by host institution. A committee consisting of up to 12 members is considered to be appropriate. See section 1.2.1 for detailed information on composition requirements, and TZA-23 for links to specific institutions.
Terms of Reference, Review Procedures, and Meeting Schedule
The G-TMRCC and TZA-5 state that NatHREC must operate within written standard operating procedures (SOPs), including a process to be followed for conducting reviews. The SOPs should include information on NatHREC composition, meeting schedules, frequency of reviews, requirements for initial and ongoing evaluation of the research study, and requirements for notifying the investigator and the institution of results related to the study’s initial and ongoing evaluation.
Committee members should agree to disclose their names, occupations, and affiliations, and to sign the confidentiality and conflict of interest agreements. The appointment of committee members is valid for four (4) years. The majority of committee members must be involved in the review and approval process.
According to TZA-5, the Secretary and Secretariat of NatHREC are responsible for providing training and educational programs to new and continuing committee members, and the scientific community in Tanzania on issues related to health research ethics. The training must include programs about the basic principles of human subject protection, current literature, and regulations and guidelines affecting NatHREC and NIMR. Additional functions of the Secretariat are as follows:
- Organizing an effective and efficient tracking procedure for each proposal received
- Prepare, maintain, and distribute proposals and meeting materials for review
- Organize committee meetings, including preparation and maintenance of meeting agenda and minutes
- Maintain the committee’s documentation and archive, including designing and maintaining a system for collecting and filing all committee documents, including meeting minutes, member qualifications, proposal submission versions, deviations from approved proposals, and periodic and final reports
- Communicate with the committee members and applicants
- Organize the preparation, review, revision, and distribution of SOPs and guidelines
- Provide the necessary administrative support for the committee-related activities to the chairperson of the committee, such as communicating a decision to the applicant
- Provide updates on relevant and contemporary issues related to ethics in health research, as well as relevant contemporary literature to committee members
- Perform a pre-review of each submission of the committee to ensure adherence to administrative submission requirements
- Design and disseminate templates for committee submission documents, including research proposals, informed consent materials, agreements, and periodic and final reports
- Communicate with all submitting researchers at all times throughout the submission and review process, while remaining independent of the researcher’s proposal operations; advise submitting investigators on preparing and submitting proposals for review
- Assist the Chairperson with the conduct of committee meetings
- Nominate consultant reviewers
The committee must meet once a month unless stated otherwise and in such a case, an alternate meeting time, date, and venue must be provided by the Secretary. A quorum of at least half the number of committee members, including at least one (1) member whose primary concern is in non-scientific areas and one (1) medical scientist is required for NatHREC to conduct business. The Secretariat will keep a record of attendance, indicating which members were present for the discussion of each proposal application review. The Secretary must notify all committee members of an upcoming meeting at least two (2) weeks in advance and include a meeting agenda. The agenda must outline all proposal and related research submissions for consideration in the meeting, and must include all related materials, including copies of proposals, informed consent materials, continuing and final reviews, safety reports, etc.
TZA-5 also states that, for all active study files, NatHREC must send the closed or completed study files to an off-site storage facility and store them for at least 15 years after the study’s conclusion. For all prematurely terminated studies, the relevant records must be stored and “inactivated.” The principal investigator must keep the original versions of NatHREC’s termination memorandum and the Continuing Review Application Form in the proposal file. The proposal file should be stored and archived indefinitely.
For detailed NatHREC procedures and information on other administrative processes, see TZA-5.
Note that because each institutional EC has its own terms and procedures, sponsors check with their relevant institutional EC.