Rwanda National Research Ethics Committee
RNEC - Submission Platform

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Before submitting your research protocol for RNEC review, please check the following:

Review the submission calendar

Ensure that your protocol is submitted according to the Review Calendar Late submissions will automatically be considered for the next available review meeting.

Prepare all required documents

The required documents depend on the type of submission—whether it is a Clinical Trial, Nonclinical Research, a Protocol Amendment, or a Continued Review (Annual Renewal). Typical documents include:

  • Submission Forms - mandatory for all submission types
  • Study Protocol - complete and following the appropriate template
  • Consent Forms and Assent Forms - including all required versions
  • Data Collection Tools and Questionnaires
  • Translated Documents - if applicable
  • CVs of Investigators - aligned to RNEC CV Template and signed
  • Proof of Payment - as required (see Fee Structure)

The complete list of required documents is provided in the relevant SOPs and in the corresponding submission forms.

Submission SOP.

Initial Submission - Clinical Trial

Before submitting your Clinical Trial Protocol for Initial Ethical Review, check that your submission package is aligned to RNEC requirements as mentioned in Submission SOP (REV01), Protocol Template and Forms:

The steps of review are elaborated in the Standard Full Committee Review of Research Protocols SOP (REV03).

Initial Submission - Non-Clinical Trial

Before submitting your Study Protocol for Initial Ethical Review, check that your submission package is aligned to RNEC requirements as mentioned in Submission SOP (REV01), Protocol Template and Forms:

The steps of review are elaborated in the Standard Full Committee Review of Research Protocols SOP (REV03).

Protocol Amendments

Before submitting a Request for Protocol Amendments, ensure your submission complies with the Amendment SOP (PAC02) and includes:

Amendments are categorized as Administrative, Minor, or Major. Review timelines and applicable fees vary by amendment level and study type. Incomplete or incorrectly prepared submissions will be returned to the Principal Investigator, potentially delaying the review.

Annual Renewal - Continuing Review

Before submitting your Protocl for Continuing Review (Annual Renewal), check that your submission package is aligned to RNEC requirements as mentioned in Annual Renewal SOP (PAC01), Submission Form and Progress Report Template:

Investigators are strongly advised to review the SOP carefully before submission.

Incomplete submissions or submissions using incorrect forms will be returned to the Principal Investigator, which may delay the review process.

RNEC Review Categories

RNEC offers several types of ethical review depending on the level of risk and the nature of the research. The submission requirements for each review type are detailed in the corresponding SOPs:

For guidance on which review type applies to your study, please consult the RNEC Eligibility Criteria. If you require further clarification, you may contact the RNEC Secretariat.

Who we are

The Rwanda National Research Ethics Committee (RNEC) was established in May 2002 under the auspices of the Ministry of Health of Rwanda. Our foundation was formally confirmed through Ministerial Instruction No 20/37 of the 30th of October 2008 and amended by Ministerial Instruction No 20/39 of 26th of February, 2009. RNEC is currentrly regulated bt the Law N° 015/2022 of 29/06/2022 relating to research on a human being and the Ministerial Order nº 002/MoH/2023 of 21/03/2023 relating to Rwanda National Research Ethics Committee on a human being. his evolution reflects our commitment to enhancing the ethical oversight and governance of research activities in Rwanda..

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