We are pleased to share the updated version of the Governance Arrangements for Research Ethics Committees (GAfREC), which has been renamed the UK Research Ethics Committee (REC) Policy Document.
The REC Policy Document sets the principles, requirements and standards that apply to RECs established by the HRA and the devolved administrations to review health and social care research applications.
While this document is intended to be a guide for REC members, alongside more operational detail which is set out in the UK Research Ethics Service (RES) Standard Operating Procedures (SOPs), members of the research community may also find this document helpful.
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 modifications 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 approvals team 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 an Ethics Review Form for use when undertaking an ethical review. There is also a separate Ethics Review 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.
Recommendations have been developed on how best to use the Ethics Review Form to aid and focus discussions, reduce meeting length, and help staff ensure that REC outcomes are clear when communicated to the applicant.
HARP Member Portal
The HARP Member Portal is available for all members to access. This allows full applications, proportionate review applications and substantial modifications to be accessed electronically through the portal. All REC members need to use the HARP Member Portal to access the applications and modifications which have been submitted for an ethics review.
There is a YouTube video which provides a demonstration of the HARP member portal:
Download a transcript of the HARP Member Portal Demonstration video.
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 provided advice and support to RECs and appointing authorities in exercising their responsibilities under GAfREC and SOPs. Under the revised terms of reference introduced in 2017, the NREAP no longer hold formal meetings, but their 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.