Governing Agencies and Ethics Review Structure
The Federal Ministry of Health Department of Health Planning, Research and Statistics Research Unit is responsible for the coordination of issues concerning health research in Nigeria. One function of this department is to serve as the Secretariat of the National Health Research Ethics Committee (NHREC). The Nigerian NHREC is responsible for the review and approval of research that meet all ethical standards.
- Guidance for submitting applications for ethical review of research protocols
- Guidance on the training needed for research studies in Nigeria
- Prototype Consent Form
- Good Clinical Practice Regulations (2009)
- National Code of Health Research Ethics (2007)
- Standard Operating Procedures for Health Research Ethics Committees
- Policy Statement on Storage of Human Samples in Biobanks and Biorepositories in Nigeria (2013)
Points to Consider – Investigators
- Transfer of samples and biological materials out of Nigeria requires a Material Transfer Agreement (MTA) in which the Institutional HREC reviews and grants approval pending receipt of acknowledgement from the NHREC.
- Clinical trials must comply with Good Clinical Practice (GCP), and international standards set forth in The Belmont Report, CIOMS, Declaration of Helsinki, UNESCO and other international guidelines.
- Investigators can submit complaints about their Institutional HREC directly to NHREC, with the possibility of re-allocation of the proposal to another HREC and sanction of the concerned HREC.
- HREC continuing review must occur at least once a year or at least once during the lifetime of the research protocol where the duration of the research is less than a year.
- Justification is required for research protocols involving vulnerable populations. Vulnerable participants include children, women, prisoners, the illiterate and people with limited resources, refugee population and internally displaced persons.
- Under Nigerian law, a child is anyone under the age of 18 years.
Points to Consider – US IRBs
- The Nigerian National Health Research Ethics Committee (NHREC) provides leadership to human and animal research conducted in Nigeria. Specifically, NHREC establishes guidelines for health research ethics committees; registers and audits health research ethics committees; sets norms and standards for conducting research on humans and animals, including clinical trials; and advises Federal Ministry of Health and State Ministries on ethical issues.
Local Research Institutions
- 68 Nigerian Army Reference Hospital
- Irrua Specialist Teaching Hospital (ISTH)
- University of Nigeria Teaching Hospital
- Hearing International Nigeria [HING]
- AIDS Prevention Initiative in Nigeria
- Marie Stopes International Organisation Nigeria