NHREC, established in 2005 and backed by the National Health Act (2014) serves as the national authority responsible for ethical oversight of all research involving human participants. NHREC’s activities are guided by the National Code of Health Research Ethics (2007). Its mandate includes protocol review, continuing oversight, suspension of unethical research, and ensuring compliance with national and international standards, including WHO guidelines.

NAFDAC provides regulatory approval for clinical trials only after NHREC has granted ethical clearance, ensuring a sequential and complementary review process. This agency was officially established in 1992 and is backed by the Nigerian Constitution.

Together, the two bodies provide the core regulatory structure for clinical and health-related research in the country.

Strengths of the Current System

• Clear legal provisions requiring ethical review for all human research.
• NHREC has the authority to suspend or terminate unethical studies.
• Multidisciplinary and gender-balanced committee membership.
• Existing SOPs for submissions, expedited reviews, emergency reviews, and screening processes.
• Publicly available information on RECs and national ethics guidelines.
• Active participation in regional platforms such as AVAREF.
• Digitalization of protocol submissions and review

These strengths provide an important baseline for accountability and participant protection.

Nigeria has made significant progress and shows a strong commitment to ethical research oversight. With government dedication and partner support, Nigeria has achieved

substantial advancements in strengthening its health research ethics landscape.