Applying for approval for MOD research involving humans

This guidance sets out the process for determining whether governance approval and ethics review is required for research undertaken, funded or sponsored by MOD.

1. Decide if JSP536 applies to a research project

The decision as to whether a protocol requires review lies with the Research Sponsor in collaboration with the Chief Investigator. All research has a research sponsor. This is the organisation that takes final, legal responsibility for a piece of research, and is often the employer of the Chief Investigator. The Sponsor and Chief Investigator should familiarise themselves with JSP536, and then work through the following checklist to determine whether the research project falls under the remit of JSP536. If you are in any doubt as to whether review is necessary please contact the MODREC Secretariat for additional advice.

If you think your study requires a Clinical Trials Authorisation, or is studying a non-CE marked medical device, please contact the MODREC Secretariat prior to submitting your application to receive further guidance.

Read JSP536 part 2 annex 1A for more information.

2. Complete Sponsors Checklist and Scientific Assessment Committee (SAC) review

The Sponsors Checklist must be completed before a study is submitted to MODREC for ethics review.

A SAC review is a separate process that occurs prior to MODREC review. SAC approval is required to complete the Sponsors checklist. Please identify a relevant SAC and contact them for details of their review process.

The checklist can be found in JSP536 part 2 annex 1B.

3. Submit Sponsors Checklist and MODREC application form to MODREC secretariat

Applications to MODREC must be made on the application form template (MS Word Document, 134 KB).