Guidance

Apply for ethical approval for MOD research involving humans

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

You can download the ethics review process as a flowchart. For detail, click through the numbered items on the left.

MOD ethics review process flowchart

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1. Decide if research requires ethical approval

This checklist will help you decide if ethical approval is necessary. If any of your answers are in column A, then it is likely your research will require ethical approval. The checklist is not comprehensive, so even if all your answers are in Column B, if you are in any doubt as to whether ethics approval is necessary please contact the MODREC Secretariat for advice.

It is your responsibility and that of your MOD line manager to ensure that no research requiring ethics approval is started before MODREC approval has been obtained, including the recruitment of volunteers.

  A B
1. Are the risks to the research participants in any way greater than those to which they are exposed in the course of their normal peacetime duties? YES NO
2. Is there any psychological intrusion, for example personality questionnaires, psychometric tests, or recording of sensitive personal information? YES NO
3. Is there any physical intrusion, for example body fluid sampling or medical examination? YES NO
4. Will the psychological endurance of the research participants be tested beyond the limits inherent in their normal peacetime duties? YES NO
5. Will the physical endurance of the research participants be tested beyond the limits inherent in their normal peacetime duties? YES NO
6. Will any physiological monitoring be used, for example of body temperature, heart rate, ECG, breathing rates, spirometry etc? YES NO
7. Will any drugs or other substances be administered? YES NO
8. If applicable, have all the unmanned tests and safety assessments been completed satisfactorily, to appropriate standards and throughout the ranges of environmental and physiological conditions in which human exposures are planned? NO YES
9. Will the research participants be paid extra for taking part in the study? YES NO
10. Will the research participants be drawn from a group which stands to benefit from the new equipment or technique? NO YES
11. If applicable, are Standard Operating Procedures available for the equipment or system? NO YES
12. Can the information collected be linked to individual participants? YES NO

2. Complete application form

You should ensure that any external funding is agreed in principle before completing the application form (MS Word Document, 126KB) . Short CV templates and guidance can be found on the HRA website

3. Submit application form

Any proposed research on RAF Service or Air Command Civilian personnel must meet the requirements of JSP 536. The application must be submitted with a letter of support from an appropriate sponsor within the RAF chain of command in which the proposed research is to be conducted. The letter must be from an officer of at least one star status. Without this documentation, the protocol will be rejected.

Send your completed application and supporting documentation by email to the Secretariat.

4. Receipt of application form

  • the Secretariat will triage and formally register the submitted application
  • the application will be forwarded to the relevant Scientific Advisory Committee (SAC) for scientific review

5. SAC review

The SAC will review the application to ensure that the purpose, proposed methods and analysis of the data are scientifically robust. The SAC will also ensure that the study will not present an unacceptable risk to either the participants or the researchers. During this process, the SAC will actively engage with the Chief Investigator (CI) to discuss any revisions required. The CI will be expected to participate in any formal review meetings, if necessary by teleconference.

The SAC will provide an initial decision on the application within 20 working days of it being presented to the Committee. This will be reported to the next MODREC meeting.

The possible SAC decisions are:

  1. The application is approved as presented (approved)
  2. The application is approved subject to minor revision (provisional approval)
  3. The application requires major revision and a second review by the same SAC (second SAC review)
  4. The application is rejected (rejected)

Applications referred back to the CI for revision will be monitored by the MODREC Secretariat, which will contact the CI to hasten a response after 30 working days. After 3 hasteners the application will be registered as discontinued. The submission of a revised application after this time period will be registered as a new application.

On receipt of the SAC’s decision, the CI can contact the MODREC Secretariat to formally withdraw an application.

The MODREC Secretariat will only forward applications to MODREC for ethics review which have full SAC approval.

6. MODREC review

MODREC aims to meet on a monthly basis, usually on the first Tuesday of each month, although this can be increased if required. The CI will be required to attend the review of their applications to address any queries and/or concerns raised by MODREC. Only valid applications will be reviewed.

The possible MODREC decisions are:

  1. The application is approved as presented (approved)
  2. The application is approved subject to minor revision (provisional approval)
  3. The application requires major revision and a second SAC review prior to a second MODREC review (second SAC review)
  4. The application requires a major revision and a second MODREC review (second MODREC review)
  5. The application is rejected (rejected)

MODREC will provide a formal decision on the application as soon as practicable and will provide formal feedback within 20 working days of it being considered at the meeting.

MODREC reserves the right to refer an application back to the SAC in light of its risk/benefit analysis.

7. Commence research

Notification is required at the commencement of research under a specific application to ensure that the appropriate MODREC governance and oversight requirements are evoked. If the MODREC Secretariat has not been notified regarding the commencement of research within 6 months of formal MODREC approval, then the CI will be required to provide a note of explanation.

8. Annual report

The first Annual Report is due 12 months after receipt of MODREC approval. If this has not been received by the MODREC Secretariat within 90 days of its due date, the MODREC Chairman will be informed of this by the MODREC Secretariat and the CI will be required to provide a note of explanation in writing and/or in person.

9. Closure report

This will take the form of either a completion report or a termination report.

Completion report

A full report is required on the completion of individual research studies to enable MODREC to determine whether or not the submitted application achieved the desired outcome, together with a report and explanation of unexpected or adverse events and a note of any plans for publication of the results.

This should be submitted to the MODREC Secretariat no later than 90 days after completion of the study. If the report has not been received within 90 days, the MODREC Chairman will be informed and the CI will be required to provide an explanation in writing and/or in person.

Termination report

In the event that a study is not undertaken or is terminated prior to completion, the CI is to submit a report to MODREC detailing the reason(s) why the study has not proceeded as expected, or has been terminated. The format to be used is at Annex F.

The CI is required to notify the MODREC Secretariat of the decision to terminate the study as soon as possible after the decision has been made and to submit a formal termination report to the MODREC Secretariat no later than 30 working days after the decision not to proceed/terminate has been made. If the report has not been submitted to the MODREC Secretariat within 30 days, the MODREC Chair will be informed and the CI will be required to provide an explanation.

Who to contact

MOD Research and Ethics Committees (MODREC)

MODREC Corporate Secretariat
Bldg 005, G02
Dstl Porton Down

Salisbury
Wiltshire
SP4 0JQ

Use for research project enquiries, approvals and appeals

See also the full list of contacts for each of the scientific advisory committees.