UK MOD guidance: ethics approval (MODREC/JSP536) for 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
)
.
Send your Sponsors Checklist and application form, along with any supporting documentation (participant information sheets, consent forms etc.) by email to the
MODREC
Secretariat
. Applications should be sent as a single MS Word document with all parts having unique sequential page numbers.
4. Receipt of application form
The
MODREC
Secretariat will triage and formally register the submitted application and determine whether the application requires “Proportionate Review” (see
JSP536 part 2 chapter 4
) or a full committee review.
5.
MODREC
review
If a project is suitable for a proportionate review by
MODREC
, researchers will receive a decision within 20 working days of a validated application. Researchers will not be required to attend a
MODREC
meeting, all correspondence will be via email from the secretariat.
If a full
MODREC
review is required,
MODREC
aims to meet on a monthly basis, usually on the first Tuesday of each month. The Chief Investigator will be invited to attend the review to address any queries and/or concerns raised by
MODREC
.
MODREC
will provide a formal decision on the application as soon as practicable, and will provide formal feedback within 10 working days of it being considered at the meeting.
6. Commencing the research
Once a favourable opinion has been received from
MODREC
(through either proportionate or full committee review) permission to commence the research can be provided by the Research Sponsor.
7. Reporting and Monitoring Requirements
Research Sponsors and Chief Investigators must familiarise themselves with the monitoring 
and reporting requirements laid out in JSP536 part 2 chapter 9.
8. Final Report
A summary of the final report on the research must be submitted to
MODREC
within one year of the conclusion of the research. A template for final reports is included in JSP536 part 2 Annex 9A. As a minimum,
MODREC
should receive information on whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research including any feedback to participants.
Who to contact
MOD Research Ethics Committee (MODREC)
MODREC Secretariat
Office of the Chief Scientific Adviser, Dstl Portsdown West
Fareham
PO17 6AD
Email
DOS-OCSA-MODRECTeam@mod.gov.uk
See also the
full list of contacts
for each of the scientific advisory committees.