This UK policy document describes how NHS/HSC Research Ethics Committees function and specifies when review by an NHS/HSC Research Ethics Committee is required.
This policy was last updated on 20 July 2021.
Governance Arrangements for Research Ethics Committees (published 20 July 2021 and valid from 20 July 2021)
Working with the Devolved Administrations a revision of the Governance Arrangements for Research Ethics Committees was released on 26th March 2020. This revision was a technical update to take account of changes in hyperlinks, references, organisations’ names and branding, as well as legal, policy and operational developments since the previous version was issued in September 2018.
Statement regarding research projects involving the UK Health Security Agency staff accessing previously collected, identifiable patient information with the research participant’s consent
The following statement applies to the ethics review of research studies undertaken by the UK Health Security Agency (UKHSA):
The Governance Arrangements for Research Ethics Committees (GAfREC) stipulate that research involving the use of previously collected information from which individual past or present users of the NHS/HSC are likely to be identified by the researchers either directly from information in, or likely to come into, their possession requires an ethics review by an NHS/HSC Research Ethics Committee (REC).
However, to take a proportionate approach, it has been agreed by the HRA and devolved administrations (Scotland, Wales, and Northern Ireland) that where research studies involve UKHSA researchers accessing previously collected, identifiable patient information with the participant’s consent in place for research purposes, no separate NHS/HSC REC review is required if the following criteria are met:
- consent has been given by the participants for their identifiable information to be accessed by UKHSA researchers for research purposes and the proposed research is within the terms of such consent
- the research study has been reviewed by the UKHSA Research Ethics and Governance Group
- the research study is solely related to accessing previously collected information and there would be no other legal or policy requirement for the study to be reviewed by an NHS/HSC REC under GAfREC
The UKHSA researcher must have a valid reason to access the NHS databases with access governed by data protection arrangements and relevant safeguards in place.