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 2018 edition of the policy has been published and was implemented on 17 September 2018
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.
Study Review sheet for REC members
There is a lead reviewer form for use when undertaking a full ethical review. There is also a separate lead reviewer form for studies requiring approval under the Mental Capacity Act. Use when reviewing the application to ensure all aspects of the ethical review are considered. It can also be used when members cannot attend a meeting to guide comments to be sent to the REC Manager.
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.
We encourage as many members as possible to use the HARP Member Portal as it allows you to view applications as soon as they are valid, which is often earlier in the month than when paper copies are sent, and it allows you to download and read applications at a time which is convenient for you. Additionally, reviewing Proportionate Review applications and substantial amendments saves you from receiving large numbers of attachments to your email inbox. It also saves the NHS money and is better for the environment.
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’
In 2016 the Research Ethics Service commenced a large programme of work to look at consistency. The programme involved various pieces of work to look at different areas of the service which are included in the Consistency Improvement Plan.
As part of the consistency programme a piece of work was undertaken to look at provisional opinions. One of the reasons for this is because the annual reports indicated significant variations between REC in terms of the percentage of provisional opinion issued and the percentage of favourable opinions with additional conditions issued. The work involved looking at a sample of provisional opinions for each REC across the UK. The Provisional Opinion Audit contains additional information about this work.
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.