Are you planning to conduct health research in Cameroon? Will the study take place in multiple regions or in a region without a regional ethics committee? Will your study involve international collaboration and funding? If so, you’ll need to submit your research protocol, to the Cameroon National Ethics Committee of Research for Human Health or Comite National d’Ethique pour la Recherche en Sante Humaine (CNERSH). This is an essential step for anyone involved in health research studies in the country. The Committee has specific rules and requirements you should follow, including certain procedures, documents, and fees. This guide will break down the process into easy-to-follow steps, so you can make sure your submission meets all the necessary criteria.

According to the Law Governing Medical Research in Cameroon: “A research protocol is defined as a dated document, approved by the sponsor and the investigator, which incorporates, inter alia, successive amendments and describes the rationale, objectives, design, methodology, statistical aspects, organization of the research, as well as ethical issues, funding and institutional affiliations.”

Read our blog on Navigating the Ethics Review Landscape in Cameroon: A Comprehensive Guide for Researchers to have an overview of ethics review in Cameroon.

Criteria and Requirements for Submitting a Protocol to the Cameroon National Ethics Committee

To ensure that your submission is accepted by the Cameroon National Ethics Committee, you should carefully follow these requirements:

1. Complete Documentation: Your protocol must include all necessary parts, which are detailed further in this guide.
2. Physical Copies: Prepare four printed copies of the protocol. This enables the Committee to thoroughly review the document and maintain proper records.
3. Digital Copy: In addition to the printed versions, provide a PDF copy of the protocol on a USB flash drive to be shared with the committee.
4. Proof of Payment: Bring the original receipt for the submission fees, and remember to keep a scanned or photocopied copy for your records.
5. Discharge Sheet: Sign two copies of the discharge sheet. One will be kept by the ethics committee, confirming your submission, and the other should be retained by you as a personal record.

By meticulously adhering to these prerequisites, you ensure a smoother submission and review process, demonstrating your commitment to ethical research standards in Cameroon.

Essential Parts of a Study Protocol for Submission to the Cameroon National Ethics Committee

Below are the most important parts expected in a study protocol when submitting to the National Ethics Committee

1. Cover page:
   • Title of the research protocol
   • Names and addresses of principal investigators (PIs) and co-investigators
   • Sponsor’s name and address
   • Signature of Principal Investigator/Co-Investigators
2. A letter of request for ethical clearance: addressed to the Chairman of the Committee and signed by the Principal Investigator (or Sponsor).
3. Summary/Table of contents
4. List of abbreviations
5. Summary of the study in English and French
6. Introduction: provides the background and context for the study.
7. Research question (if appropriate)
8. Research hypotheses (if appropriate)
9. Objectives: general and specific
10. Literature review: summarizes existing research on the topic, highlighting key findings and identifying gaps or areas where the new study contributes.
11. Methodology:
    • Type of study/ study design
    • Study location
    • Study period
    • Study population
    • Selection criteria: inclusion criteria, exclusion criteria
    • Study population recruitment strategies
    • Sample size and rationale
    • Sample collection procedure
    • Data analysis and management
12. Ethical considerations: potential risks, benefits, measures taken for data confidentiality and participant privacy.
13. Information leaflet in English and French: A document that provides essential information about the research study to potential participants. It is an essential tool for informed consent.
14. Informed consent forms in English and French (The structure is explained in the blog on: Preparing Informed Consents for Health Research in Cameroon. A step-by-step Guide.
15. Datasheets: questionnaires, case report forms, etc. Documents or templates used to collect, organize, and record data during the study.
16. Chronograms of activities: the timeline for various stages of the research, such as planning, data collection, analysis, reporting, and other essential tasks.
17. Detailed budget and source of funding (Include the sponsor’s name and address).
18. References
19. Other documents (Appendices)
    • Updated CVs of investigators
    • Previous ethical clearances (if resubmission)
    • Study site authorizations
    • Biological Material Transfer Agreement (MTA) (if applicable)
    • Data Sharing Agreement (DSA) (if applicable)
    • Photocopies of receipt for payment of evaluation fees

NB: All documents must be paginated and bound.

Timeline for Protocol Evaluation

1. Evaluation Meetings: Protocol evaluation meetings are held once every two months, on the fourth Thursday.
2. Submission Deadline: Research protocols must be submitted to the committee secretariat no later than 10 days before the scheduled meeting to be considered for that session.
   • Example: If the meeting is on April 27, 2023, the submission deadline is April 17, 2023.
3. Deliberation Period: After the meeting date, the committee will deliberate, and a final decision will be reached within about a month.
4. Late Submissions: If a protocol is submitted less than 10 days before the meeting, it will be considered for the next session. This will extend the waiting time for evaluation. Occasionally, if there are fewer protocols for a session and a submission is slightly late, it may still be considered. However, this is not guaranteed.
5. Decision Timeline: In general, submitting a protocol on time will lead to a decision within a month to a month and a half. Late submissions may result in a waiting time of over two months.

Always contact the committee secretary for accurate session dates and other details before submitting.

Fees for Protocol Submission

The submission of a research protocol to the Cameroon National Ethics Committee involves certain fees, depending on the source of funding for the research. These fees are essential for processing the submission and vary based on the applicant’s status and funding source. The table below outlines the specific amounts:

Follow-up and expected outcomes

The table below states the possible outcomes expected and what the researcher will need to do in each case.

Amendments

If you need to make changes to your project, you will need to amend your ethical approval. Please note that any proposed changes should not be initiated without prior review and approval by the approving Research Ethics Committee (REC). The only exception would be if urgent changes are necessary to address immediate hazards to researchers and/or participants; the REC must always be notified at the earliest possible opportunity in these instances.

Major modifications (like change in study objectives, or change in important parts of the methodology or changes where the ethical issues are vastly increased) require a new application to be submitted, making it clear what the changes are.

For further information

For any challenges or inquiries, contact the committee.

References

1. SOPs for a document or protocol to be presentable to the National Ethics Committee dossier_clairance_ethique.pdf (minsante.cm)
2. Fomboh, Richard N. “Review of Research and Research Ethics in Cameroon,” 2017.
3. Law No. 2022/008 of April 27, 2022, relating to Medical Research Involving Human Subjects in Cameroon, LOI Nº 2022/008 DU 27 AVRIL 2022 RELATIVE A LA RECHERCHE MEDICALE IMPLIQUANT LA PERSONNE HUMAINE AU CAMEROUN | Centre de Documentation Numérique du Secteur Santé (minsante.cm)
4. London UC. Do I need ethical approval? | UCL Research Ethics – UCL – University College London [Internet]. 2023. Available from: https://www.ucl.ac.uk/research-ethics/ethical-approval/do-i-need-ucl-ethical-approval