GAfREC and Research Ethics Service SOPs
Published on 21 March 2012
The National Research Ethics Service is releasing, on 16 March, an updated version of its guidance on the requirements for Research Ethics Committee review under the Governance Arrangements for Research Ethics Committees (GAfREC).
Governance Arrangements for Research Ethics Committees (GAfREC)
A harmonised UK-wide edition of GAfREC was published by the UK Health Departments in May 2011 and came into effect on 1 September 2011.
In February 2012, a corrected edition of GAfREC was placed on the DH website, incorporating paragraph 2.3.8A, which was omitted in error from the edition published last year. This paragraph provides for an exception from the normal requirement for review by a REC within the UK Health Departments’ Research Ethics Service where the research is reviewed by another committee operating in accordance with the Economic and Social Research Council’s Framework for Research Ethics, unless any of the following apply:
(a) the research involves withdrawing standard care;
(b) the research involves NHS patients / service users as research participants;
(c) the research is a social care research project funded by the Department of Health in England; or
(d) there is a legal requirement for REC review of the research.
The effect of this exception is that some social care research does not require REC review, provided that it is reviewed by a committee operating in accordance with the ESRC Framework (for example, a university REC).
Further guidance is available within an updated version of the NRES algorithm on requirements for REC review. This also includes additional guidance on the exceptions from REC review relating to research involving NHS staff and to certain types of research project involving human tissue or other biological material. A tracked version of the algorithm is available showing the changes and additions from the previous version.
GAfREC and the Research Governance Framework
The Health Research Authority has received queries about how to interpret the respective requirements for ethical review set out in the harmonised GAfREC and the Department of Health’s Research Governance Framework for Health and Social Care (RGF). As there has been some misunderstanding about this, we are taking this opportunity to clarify the position.
The current version of the RGF (2nd edition, issued April 2005), requires care organisations to obtain evidence of a favourable opinion from a REC before giving permission for research involving human subjects which affects their duty of care, including any research involving NHS patients, service users, care professionals or other staff (or their organs, tissue or data).
The UK Health Departments have confirmed to the Health Research Authority that this general requirement should now be interpreted in the light of the specific requirements for REC review set out in the harmonised GAfREC. Where GAfREC no longer requires review by a REC within the UK Health Departments’ Research Ethics Service, e.g. for research involving staff, care organisations are not required to ensure that review by another REC is obtained before giving permission.
Nonetheless, in some cases there may be another readily available source of review, e.g. research undertaken for educational purposes can normally be reviewed by the university REC as an alternative. It is a matter for responsible R&D offices to determine whether evidence of independent scrutiny is appropriate before giving permission in such cases, and researchers are encouraged to seek their advice at an early stage.
Standard Operating Procedures (SOPs)
Version 7.0 of the Standard Operating Procedures (SOPs) for Research Ethics Committees in the UK comes into effect from 1st September 2016.
To access and download version 7.0 of the SOPs, please go to our SOPs page. You can also see a summary of the changes from version 6.1
The Research Ethics Service SOPs are kept under continuous review in the light of feedback and suggestions from stakeholders. Any feedback or queries about the revised SOPs may be sent to firstname.lastname@example.org