1. Determine Whether JSP536 Applies to Your Research Project
The responsibility for deciding whether a protocol requires review rests with the Research Sponsor, working together with the Chief Investigator. Every research project has a sponsor—the organisation that assumes ultimate legal accountability for the study, frequently the employer of the Chief Investigator. Both the Sponsor and Chief Investigator should review JSP536 and then follow the checklist below to ascertain whether the project falls within JSP536’s scope. If there is any uncertainty about the need for review, please contact the MODREC Secretariat for further advice.
If your study may require a Clinical Trials Authorisation or involves a non‑CE‑marked medical device, please reach out to the MODREC Secretariat before submitting your application for additional guidance.
For more details, consult JSP536 Part 2, Annex 1A.
The Sponsor’s Checklist must be completed prior to submitting a study to MODREC for ethical review.
A Scientific Advisory Committee (SAC) review is a distinct step that takes place before MODREC review. SAC approval is necessary to finish the Sponsor’s Checklist; please identify the appropriate SAC and contact them for information about their review procedure.
The checklist is located in JSP536 Part 2, Annex 1B.
Applications to MODREC must be submitted using the prescribed form.
Please email your completed Sponsor’s Checklist, application form, and any supporting documents (such as participant information sheets and consent forms) to the MODREC Secretariat. All materials should be combined into a single Microsoft Word document, with each section numbered sequentially.
4. Receipt of Application Form
The MODREC Secretariat will triage and formally register the incoming application, then decide whether it qualifies for a “Proportionate Review” (see JSP536 Part 2, Chapter 4) or requires a full committee review.
5. MODREC Review
If the project is deemed suitable for a proportionate review, MODREC will issue a decision within 20 working days of receiving a validated application. Researchers are not required to attend a MODREC meeting; all communication will be conducted via email through the secretariat.
When a full MODREC review is necessary, the committee convenes monthly, typically on the first Tuesday of each month. The Chief Investigator will be invited to attend the meeting to respond to any questions or concerns raised by MODREC members.
MODREC will provide a formal decision on the application as soon as practicable, followed by detailed feedback within 10 working days after the meeting’s deliberations.
6. Commencing the Research
Upon receiving a favourable opinion from MODREC—whether through proportionate or full committee review—the Research Sponsor may grant permission to begin the study.
7. Reporting and Monitoring Requirements
Research Sponsors and Chief Investigators must acquaint themselves with the monitoring and reporting obligations outlined in JSP536 Part 2, Chapter 9.
8. Final Report
A summary of the final report must be submitted to MODREC within one year of the study’s completion. A template for final reports is provided in JSP536 Part 2, Annex 9A. At minimum, MODREC should receive information on whether the study met its objectives, the principal findings, and plans for publishing or disseminating the results, including any feedback to participants.
