Nigeria

Nigeria’s health research ethics system is built on a solid legal foundation. Oversight of health-related research is carried out by two national bodies: the National Health Research Ethics Committee (NHREC) and the National Agency for Food and Drug Administration and Control (NAFDAC).

NAFDAC| NHREC

COUNTRY BACKGROUND

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.

KPIs and Milestones

Nigeria has prioritized the following key outcomes to be achieved through the TRACE project initiative.

Ethical & Regulatory Framework:

Existence and enforcement of legal provisions requiring ethical review for all human research.
Authority of NHREC to suspend or terminate unethical research

Committee Structure & Governance:

Multidisciplinary and gender-balanced REC membership
Availability and implementation of functional SOPs for core review processes.

Transparency & Public Engagement:

Public availability of REC information and national ethics guidelines
Participation in regional platforms (e.g: AVAREF)

Digitalization of Ethics Review Processes:

Digital protocol submission and review system operational

Overall System Performance:

Demonstrated national commitment to strengthening ethical oversight
Advancement of health research ethics landscape

Why Change: Revision of Nigeria’s National Code of Health Research Ethics (NCHRE) 2007

The National Health Research Ethics Committee (NHREC) is Nigeria's body responsible for safeguarding the rights, safety, and well-being of research participants. With the growing diversity and volume of health research in the country, evidenced by the review of approximately 400 research protocols in 2025 alone, the national regulatory framework faced increasing pressure.

Nigeria: Meeting and Training Workshop to Advance Discussions on Strengthening Research Ethics Governance

A productive meeting was held at Transcorp Hilton Hotel in Abuja -Nigeria during the National Health Research Ethics Committee (NHREC) Meeting and Training Workshop to advance discussions on strengthening research ethics governance in Nigeria and the role of the TRACE Project in supporting national priorities.

Nigeria: Advancing Digital Ethics And Research Governance

Nigeria has reaffirmed its commitment to ethical and transparent clinical research through the TRACE mission held in Abuja. The mission brought together the TRACE team and the NHREC as well as Institutional and local committees to strengthen clinical trial oversight.