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. To address these systemic pressures and align with international best practices, NHREC initiated the second revision of the National Code of Health Research Ethics, which has now been submitted to the NHREC leadership for consideration and adoption.

While the existing framework facilitated significant progress, the increasing volume of research proposals highlighted gaps in digital processes, reviewer capacity, and post-approval monitoring. Furthermore, a World Health Organisation benchmarking assessment identified persistent issues such as duplicate ethics approvals, weak enforcement standards, and the need for harmonised procedures.

The rapid advancement of health technology also necessitated a modernised regulatory approach. The previous guidelines required updates to explicitly address the complexities of digital health technologies, artificial intelligence, machine learning, wearable devices, and remote data collection. Supported by the TRACE project, this revision aims to transition the ethics system into a digital, data-driven, and highly institutionalised regulatory body.

To ensure a comprehensive and technically sound update that responds to the needs of the current research landscape, the NCHRE (2007)  underwent a rigorous evaluation by three independent reviewers. These experts provided complementary perspectives, focusing on strategic implementation risks, technical clarity, and the integration of emerging technologies. Their feedback generated 43 distinct themes for assessment, culminating in 29 confirmed Code amendments across various operational clusters.

The updated Code introduces several transformative principles designed to optimize ethical oversight in Nigeria. To summarize the most significant shifts in the regulatory framework, the following structural improvements were adopted:

• Risk-Proportionate Oversight: The Code establishes a foundational principle of risk-proportionate oversight, ensuring that review pathways, monitoring, and enforcement are scaled appropriately to the risk level of the research.

• Emerging Technologies: Methodologies involving artificial intelligence, machine learning, digital health technologies, and electronic informed consent are now explicitly governed within the scope of the Code.

• Participant Protection: The revision introduces the concept of contextual and layered vulnerability, meaning vulnerability arises from specific situational circumstances rather than an inherent trait of a population group. It also clarifies that pregnancy alone is not a valid reason for research exclusion without scientific justification.

• Data and Emergency Governance: A new data stewardship principle frames investigators and sponsors as responsible stewards of research data throughout its lifecycle. Additionally, the Code establishes a standing Emergency Ethics Review Panel for rapid activation during public health emergencies and a Technical Advisory Panel on Data Governance.

  
  

By shifting from a compliance-heavy approach to a developmental framework, the revised Code reframes Health Research Ethics Committee categorization as a capacity-strengthening tool rather than a punitive classification. This comprehensive revision embeds ethical rigor, contextual sensitivity, and technological agility directly into the core of modern clinical research oversight in Nigeria and it is expected to be published at the end of October 2026.

Cross-section of stakeholders during the January 2026 face-to-face meeting, where members of the National Health Research Ethics Committee deliberated on inputs to the draft NCHRE process.