Ethics Approval & Institutional Review Boards (IRBs) in Nigeria: A Guide for Sponsors & CROs

Maryam Yakubu
2 days ago
4 min read

Any researcher or institution conducting research that involves human participants needs to adhere to strict ethical standards to ensure the protection and safety of everyone involved. This is where IRBs come into place. The Institutional Review Boards (IRBs) play a vital role in safeguarding these standards by reviewing, monitoring, and approving these studies before they start.

These boards rigorously review research protocols, scrutinise consent processes, and monitor studies from start to finish. Their goal? To ensure every project aligns with Nigeria’s laws, cultural values, and global ethical benchmarks. Without IRB approval, research involving humans can’t legally proceed, making these committees indispensable for ethical integrity.

The Role of IRBs in Nigeria

Nigeria’s IRBs operate under the National Health Research Ethics Committee (NHREC), established in 2005. This body enforces compliance with key regulations like the National Code for Health Research Ethics and the National Health Act (NHA). In fact, Section 34 of the NHA clearly specifies that every institution conducting health research must have or partner with a registered ethics committee. So, what exactly do these committees do? Let’s break it down:

Review research proposals and protocols in order to ensure that research conducted by the relevant institution, agency or establishment will promote health, contribute to the prevention of communicable or non-communicable diseases or disability or result in cures for communicable or non-communicable diseases.
Grant approval for research by the relevant institution, agency or establishment in instances where research proposals and protocols meet the ethical standards of that health research ethics committee.
Perform other functions that may be referred to by the Minister of Health.

The NHREC (the central IRB) or HRECs (local IRBs) ensure that research is carried out in line with local laws, cultural considerations, and international ethical standards. Their approval is mandatory for any research involving human participants, as it:

Safeguards participant rights and well-being.
Provides a legal and ethical basis for conducting research.
Enhances the credibility of the study’s findings.

Key HRECs (IRBs) in Nigeria

Nigeria’s IRB landscape is as diverse as its research fields. Here are a few of the major HRECs:

Nigerian Institute of Medical Research (NIMR): One of the biggest institutes of biomedical research, NIMR tackles everything from malaria to diabetes. Its IRB is a go-to for studies aiming to translate lab discoveries into real-world health solutions.
Institute of Human Virology Nigeria (IHVN): Focused on HIV and infectious diseases, this board ensures trials meet international standards like Good Clinical Practice (GCP), making Nigeria a trusted partner in global health research.
National Orthopaedic Hospital, Enugu, Ethics Committee: Specializing in trauma and rehabilitation, this committee ensures orthopaedic innovations like prosthetics or surgical techniques are tested ethically, prioritizing patient safety.
APIN: With a focus on HIV/AIDS, APIN collaborates with NGOs and government bodies to fast-track research that aligns with public health priorities.
National Hospital Abuja Ethics Committee: As a centre for multidisciplinary research, this committee oversees cutting-edge clinical trials and health policy studies, often involving partnerships with international agencies.
Covenant Health Research Ethics Committee (CHREC): Based at Covenant University, CHREC stands out for its cross-disciplinary approach, evaluating projects in tech, social sciences, and health. This IRB emphasizes the integration of ethical principles in academic research.
College of Medicine, University of Ibadan Ethics Committee: This is one of Nigeria’s oldest and most respected IRBs. Renowned for its rigorous review processes, it oversees medical and health sciences research conducted within and beyond the university.

How to Get HREC Approval: A Step-by-Step Guide

Securing HREC approval might seem daunting, but with the right guidance, it’s manageable. Here’s how to streamline the process:

Step 1: Draft a Research Proposal

Your research proposal is your first impression, so it needs to be straightforward and clear. It usually includes:

Study Protocol: Spell out your methods, recruitment strategies, and risk mitigation plans. Avoid jargon; clarity is very important.
Informed Consent Forms: These aren’t just paperwork; they play a vital role in clinical trials. Use plain language to explain risks, benefits, and the participant’s right to withdraw.
Investigator Credentials: Highlight GCP certifications and practising licence to show your team’s competency along with their credentials.
One-Page Summary: Simplify and summarise the study protocol in layman’s terms to make it accessible to non-technical reviewers.
Additional Documents (if applicable): Material Transfer Agreements, recruitment advertisements, or patient information leaflets may also be required.

Step 2: Pick the Right HREC

Match your study’s focus to the HREC’s expertise and jurisdiction. For example, if you are conducting Orthopaedic research at the National Orthopaedic Hospital, Enugu, Ethics Committee is a great fit. Or if you are conducting your research in Abuja, then the NIMR ethics committee is perfect.

Step 3: Gather Your Documents

While requirements vary, most HRECs ask for:

Cover letter
Study protocol
Consent forms
CVs and GCP certificate/Practise license
Recruitment materials (ads, flyers)
Material Transfer Agreements (for shared samples/data)

Step 4: Submit Strategically

Many HRECs now accept online submissions, but some still prefer hard copies. Confirm their preferences upfront before making any submissions.

Step 5: Wait for Feedback

HRECs prioritise participant safety, so expect tough questions. Respond promptly to queries about risks or methodology. Minimal-risk studies may clear in 2–4 weeks, while complex projects can take over 5 weeks.

Step 6: Stay Compliant Post-Approval

Approval isn’t the finish line. You’ll need to:

Submit annual progress reports.
Report any protocol changes (e.g., adjusting sample size).
Report serious adverse events within 72 hours.

Our Recommendation: Partner with a Local Expert

While understanding the HREC landscape is vital, navigating it requires time and local expertise. Bispharm Clinical provides end-to-end regulatory support and site management for international and local sponsors. From initial protocol review to final NAFDAC and HREC approval, we ensure your Nigerian clinical trials start on time and stay compliant.

References

Clinical Trial FAQs - NAFDAC. (2024, January 30). NAFDAC. https://nafdac.gov.ng/regulatory-resources/clinical-trial-faqs/

IHVN Institutional Review Board (IRB), Guidelines, and Required Documents. (n.d.). Retrieved December 4, 2024, from https://ihvnigeria.org/wp-content/uploads/2023/08/IHVN_IRB_REQUIREMENTS_FOR_ETHICAL_SUBMISSION_FOR_RESEARCH.pdf

IRB Information Leaflet. (2015). Retrieved December 4, 2024, from https://nimr.gov.ng/nimr/wp-content/uploads/2015/06/IRB-Information-Leaflet.pdf

IRB Frequently Asked Questions | IPA. (2023, January 30). Poverty-Action.org. https://poverty-action.org/irb-frequently-asked-questions

National Code of Health Research Ethics Federal Ministry of Health. (2007). https://www.nhrec.net/nhrec/NCHRE_Aug%2007.pdf

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