Under the UK Health Departments Governance Arrangements for Research Ethics Committees (GAfREC), each Research Ethics Committee (REC) within the Research Ethics Service, is required to adopt Standard Operating Procedures (SOPs) approved by or on behalf of its appointing authority. The REC is required to act in accordance with its SOPs and is ultimately accountable to its appointing authority for its governance in this respect.
7.5.1 of the Standard Operating Procedures for Research Ethics Committees came into effect from 2 August 2021.
The document is more than 200 pages long. We therefore recommend that you use the guide below to make sure you can find the section of interest. Comments and enquiries regarding the SOPs can be emailed to email@example.com.
The Summary of Changes document has been produced to set out the changes included in SOPs version 7.4 and 7.5. This is a comprehensive document and is best used in accordance with the revised SOPs in order to verify whether the wording of a particular paragraph has been updated since the previous version.
Deletions from the previous wording are marked with a strikethrough in the left hand column and the new wording is in the right hand column with additional wording highlighted by underlining.
Summary of the various sections within the SOPs
When you open the SOPs document, please click on the relevant heading in the index to go straight to the section you require.
- Section 1: New applications for ethical review
- Section 2: Full meetings of a Research Ethics Committee
- Section 3: Giving an ethical opinion
- Section 4: Proportionate Review
- Section 5: Assessment of site suitability
- Section 6: Amendments to research given a favourable opinion
- Section 7: Sub-committees
- Section 8: Further review of research given an unfavourable opinion
- Section 9: Expedited and proportionate review
- Section 10: Monitoring of research given a favourable opinion
- Section 11: Research databases
- Section 12: Research involving human tissue
- Section 13: Research involving adults unable to consent for themselves
- Section 14: Communication with other regulators and review bodies
- Section 15: Storage and retention of documentation
- ANNEX A: Index to standard letters and forms
- ANNEX B: Definition of a Clinical Trial of an Investigational Medicinal Product (CTIMP)
- ANNEX C: Notification of substantial amendments to CTIMPs
- ANNEX D: Corrective procedures following a legally invalid ethical opinion on a CTIMP
- ANNEX E: Notification of reasons for unfavourable opinion to the MHRA
- ANNEX F: Insurance, indemnity and compensation
- ANNEX G: Statutory requirements relating to research involving human tissue
- ANNEX H: The Gene Therapy Advisory Committee
- ANNEX I: The Social Care Research Ethics Committee