Under the UK Health Departments Governance Arrangements for Research Ethics Committees (GAfREC), each REC within the Research Ethics Service is required to adopt 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.
Version 7.0 of the Standard Operating Procedures for Research Ethics Committees came into effect from 1st September 2016. The Standard Operating Procedures for Research Ethics Committees version 7.1 was published on 13th October 2016 to include a revision to section 10. The only paragraphs revised in version 7.1 were paragraphs 10.37 and 10.49 to clarify that annual safety reports do not need to be submitted to the REC if a trial has been declared as ended in the UK but is continuing globally, and to clarify that if the trial has ended in the UK but the end of trial has not been declared (as this is not a requirement until the global trial has ended) then annual safety reports should still continue to be submitted.
The document is over 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 7.0 and 7.1 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: Site-specific assessment
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: Format and content of Annual Safety Reports on CTIMPs
ANNEX G: Insurance, indemnity and compensation
ANNEX H: Statutory requirements relating to research involving human tissue
ANNEX J: The Gene Therapy Advisory Committee
ANNEX K: The Social Care Research Ethics Committee