Governance Arrangements for Research Ethics Committees (GAfREC): a harmonised edition (DH, 2011) outlines the policy of the UK Health Departments, describing what is expected from the research ethics committees that review research proposals relating to areas of the departments’ responsibility. An updated edition of the policy has been published and was implemented in July 2021.
Standard Operating Procedures for Research Ethics Committees (SOPs)
There are Standard Operating Procedures (SOPs) for Research Ethics Committees (RECs) within the UK Health Departments’ Research Ethics Service. RECs are required to act in accordance with the SOPs.
The SOPs are divided into 15 chapters, which each cover a different aspect of the ethical review process from booking and submitting applications, giving an ethical opinion, and reviewing amendments to studies which have previously been issued an ethical opinion.
It is helpful for all REC members (and essential for REC Officers) to have an awareness of the SOPs and what the expected processes are. A copy of the SOPs is available for you to have a look at and to refer to when you need to.
If you have questions or require any further help using the SOPs, please contact your REC Manager in the first instance.
Peer/Scientific review and the role of RECs
A framework of questions (and considerations that would arise) RECs might ask when satisfying themselves of the adequacy of peer review of applications.
Ethics Review form
There is a lead reviewer form for use when undertaking an ethical review. There is also a separate lead reviewer form for studies requiring approval under the Mental Capacity Act. Additionally, there are also separate forms for Research Tissue Banks and Research Databases. REC Members should use these documents when ethically reviewing applications to support and lead the discussions about the application at the meeting. The forms can also be used when REC members cannot attend a meeting and wish to provide comments in support to the ethical review of an application, in this situation the forms should be sent to the REC support staff in advance of the meeting to be shared with the Chair. Alternatively, members can also complete the ethics review form directly in the HARP Member Portal.
HARP Member Portal
The HARP Member Portal is available for all members to access. This allows full applications, proportionate review applications and substantial amendments to be accessed electronically through the portal. All REC members need to use the HARP Member Portal to access the applications and amendments which have been submitted for an ethics review.
There is a YouTube video which provides a demonstration of the HARP member portal:
We recommend that you read both the HARP member portal user manual and our frequently asked questions document, which can both be accessed from the ‘Help’ section of the Member Portal’
National Research Ethics Advisors’ Panel (NREAP)
NREAP was established by the Research Ethics Service (RES) under Governance Arrangements for Research Ethics Committees (GAfREC) as a resource to the RES and the appointing authorities of RECs within that service to help optimise research ethics review and so improve the research environment in the UK.
NREAP provides advice and support to RECs and appointing authorities in exercising their responsibilities under GAfREC and SOPs.
Terms of reference, minutes of NREAP meetings, Panel members’ biographies and a library of NREAP guidance may be found within the NREAP area on our website.