Health Research Ethics

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 country’s 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 the National Health Research Ethics Sub-Committee (NatHREC) established in 2002. NatHREC is responsible for ensuring health research proposals are reviewed to safeguard the dignity, rights, safety and well being of research participants. Institutions carrying out/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 whole process of receiving, reviewing and approving the proposals takes 4-6 weeks depending on the responses from the reviewers and the Principal Investigator (PI). NatHREC carries research monitoring by on-site visits in collaboration with district and regional medical authorities. In this regards, 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 and Social Welfare.

 Members of the NatHREC include physicians, lawyers, biomedical scientists, bioethicists, molecular biologists, sociologist/anthropologists and representatives from faith-based organizations. The current members of NatHREC come from the following institutions:

  1. National Institute for Medical Research
  2. Muhimbili University of Health and Allied Sciences
  3. Ministry of Health and Social Welfare
  4. Christian Social Services Commission
  5. Muslim Council of Tanzania
  6. Legal and Human Rights Centre
  7. Medical Association of Tanzania
  8. University of Dar es Salaam
  9. Tanzania Commission for Science and Technology

 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 whereas the Secretary is affiliated to the National Institute for Medical Research.

The Sub-Committee has developed 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:

  1. Brochure for Investigators
  2. Standard Operating Procedures for the National Ethics Committee for use by Other Institutional Research Ethics Committees
  3. Guidelines for Insuring Health Research Participants in Clinical Trials
  4. Application Form
  5. Principal Investigators and Reviewers Guide
  6. Oversight Monitoring Tools for Researchers and Participants
  7. Material Transfer Agreements
  8. Data Transfer Agreements

 Approval to conduct health research in Tanzania

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 researches 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 Tanzania Commission for Science and Technology.

 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. Usually, clinical trial protocols are reviewed at the NatHREC level by the Clinical Trials Sub-Committee. However, clinical trials involving registration of new drugs or devices have in addition, to get a Clinical Trials Certificate from Tanzania Food and Drug Authority before the commencement of the study.

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Standard Operating Procedures (SOPs)

The Standard Operating Procedures for health research ethics review have been articulated to give guidance to health research review committees in the protection and furtherance of the rights of research participants while taking cognizant of the key roles of relevant health research in improving the welfare of humankind.

Click here to download The Standard Operating Procedures

Click here to download  Application form for ethics approval

Click here to download  Checklist for ethical Clearance Application Submission

Click here to download  Data transfer agreement for Researchers/organizations

Click here to download Material transfer agreement for Researchers/organizations

Click here to download NatHREC Bank Details

Click here to download Client Service Charter for NatHREC