We are pleased to share the updated version of Governance Arrangements for Research Ethics Committees (GAfREC), which has been renamed the UK Research Ethics Committee (REC) Policy Document.
The REC Policy Document is a joint document developed by the HRA, Northern Ireland, Scotland and Wales. It sets the principles, requirements and standards that apply to RECs across the UK established by the HRA and the devolved administrations to review health and social care research applications.
Whilst 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.
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 UK REC Policy Document stipulates 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 the UK REC Policy Document
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.