HEALTH RESEARCH REGULATIONS
MEDICAL RESEARCH COORDINATING COMMITTEE
Health research coordination in Tanzania is under the Medical Research Coordinating Committee (MRCC). MRCC is the national health research coordinating body that ensures all health research follows the national health ethics requirements. The Committee functions include coordination of health research conducted in Tanzania. The MRCC has delegated functions of registering, ethical review, approving and monitoring of research to be carried in Tanzania to the National Health Research Ethics Review Sub-Committee (NatHREC).
NATIONAL HEALTH RESEARCH ETHICS COMMITTEE
The day-to-day activities of the MRCC are carried out by theNational Health Research Ethics Sub-Committee (NatHREC) established in 2002. NatHREC isresponsible for ensuring health research proposals are reviewed to safeguard the dignity, rights, safety and well being of research participants. Institutions carrying out or hosting health research are encouraged to have institutional review committees to safeguard their image by ascertaining the quality of the research output. The Sub-committee is also responsible for overseeing all issues pertaining to health research data and material transfers. Over the years, the Sub Committee has supported a number of research institutions in Tanzania to establish their own Institutional Ethics Review Committees (IREC) or Institutional Review Boards (IRBs).
The Committee consists of up to 15 members who collectively have the relevant qualification and experience to review and evaluate the science, medical aspects, and ethics of health research proposals. It is composed of both scientists and non-scientists with varying backgrounds to promote a complete and adequate review of health research proposals commonly received by NIMR. The NatHREC includes the following category members:
- Clinical scientists;
- Biomedical scientists;
- Social scientists;
- Legal representative
- Unaffiliated community representatives;
- Representatives of religious/Faith-Based Organizations
The Committee members are appointed by their respective institutions. Members are appointed based on knowledge, qualification and interest on matters of health research and research ethics. The NatHREC chairperson is non-affiliated to the National Institute for Medical Research whereas the Secretary is affiliated.
The Sub-Committee has guidelines, regulations and standard operating procedures for ethics review, as well as evaluating, monitoring and controlling new, ongoing and approved health research. These documents include:
- Brochure for Investigators
- Standard Operating Procedures for the National Ethics Committee for use by Other Institutional Research Ethics Committees
- Guidelines for Insuring Health Research Participants in Clinical Trials
- Application Form
- Principal Investigators and Reviewers Guide
- Oversight Monitoring Tools for Researchers and Participants
- Material Transfer Agreement
- Data Transfer Agreement
APPROVAL TO CONDUCT HEALTH RESEARCH IN TANZANIA
The whole process of receiving, reviewing and approving the protocolstakes a maximum of 6 weeks. NatHREC carries research monitoring by on-site visits in collaboration with district and regional medical authorities. In this regard, copies of certificates of cleared research proposals are sent to respective District and Regional Medical Officers where research is to be carried out. Research certificate approval is renewed annually and PIs are required to submit progress reports biannually. To publish the findings, the principal investigator will have to seek permission from the National Institute for Medical Research. Copies of the final publications must be made available to NIMR and the Ministry of Health, Community Development, Gender, Elderly and Children.
All proposed health research in Tanzania must get an Institutional Ethical approval at the host institution where the research will be based. In case there is no any Institutional Ethics Committee, the approval will be sought from the NatHREC. For all health research involving external collaborators (non-Tanzanians), the researchers must apply for the Institutional Ethical Clearance as well as the National Ethics Clearance. Non-Tanzanian researchers are required by law to get Research Clearance and Research Permit from the Tanzania Commission for Science and Technology (COSTECH) (www.costech.or.tz).
Protocols for Clinical trials to be conducted in Tanzania are reviewed by another specialized sub-committee, Clinical Trials Sub-Committee. This sub-committee has nine members, and meets monthly and reports to the NatHREC. Clinical trials are required to also obtain a Clinical Trials Certificate from Tanzania Food and Drug Authority (www.tfda.or.tz) before the commencement of the study.
GUIDING DOCUMENTS AND TEMPLATES
National Institute for Medical Research, 3 Barack Obama Drive, 11101 Dar es Salaam, Tanzania
Tel: +255 22 2121400 | Mobile: +255 758 587885