The requirements for ethical review by NHS Research Ethics Committees (RECs) are set out in section 2.3 of the harmonised UK-wide edition of the Governance Arrangements for Research Ethics Committees (GAfREC), published by the UK Health Departments in May 2011. These include both:
- Requirements for ethical review of research under legislation applying to the UK as a whole or particular countries of the UK
- Requirements for ethical review under the policy of the UK Health Departments, where research relates to the services for which they are responsible.
Determining whether your research requires NHS REC review:
In the first instance you should refer to the Do I Need NHS REC review decision tool.
For further and detailed guidance please refer to the NRES algorithm ‘Does my project require review by a Research Ethics Committee?’
If after referring to these resources you remain uncertain then please contact your local R&D office. Further advice may also be sought from the HRA.
Application for ethical review to a NHS REC may also be made on a voluntary basis for:
- research tissue banks / biobanks; and
- research databases.
Frequently asked questions:
Do pilot studies need NHS REC review?
Yes, if the pilot study falls under the categories listed in the Governance Arrangements for Research Ethics Committees (GAfREC).
Can NHS RECs review research studies not listed in GAfREC?
If requested to do so, and capacity permitting, a NHS Research Ethics Committee (REC) may agree to consider applications in respect of activities preparatory to research (such as the establishment of research databases or tissues banks) and research proposals which fall outside the normal scope described in Governance Arrangements for NHS Research Ethics Committees (GAfREC). (Review is always available to applicants in respect of research funded by any of the UK Health Departments.) If in doubt, a brief outline of the project should be submitted in writing to the REC manager for consideration by the chair.
I have already carried out my research, but am told that I need ethical approval. Can I apply?
Under the National Research Ethics Service (NRES) Standard Operating Procedures for NHS RECs (SOPs), an ethical opinion cannot be given retrospectively. If the research has already started within the NHS, without first obtaining a favourable ethical opinion, this is a breach of research governance and, in the case of a CTIMP (clinical trial of an investigational medicinal product), a criminal offence may also have been committed. You should always seek an ethical opinion prior to the start of the research.
Does student research require NHS REC review?
Yes, if the research falls under the categories listed in the Governance Arrangements for Research Ethics Committees (GAfREC).
Do advertisements aimed at recruiting participants need ethical approval?
The NHS REC undertaking the ethical review of the research will need to approve the generic wording of any advertisements specifically used to recruit to that research, as well as the type of places they will be placed (for example, local/national press, GPs’ surgeries, and so on).
Where a clinical unit or organisation is involved only in the identification of potential participants and/or facilitating recruitment – but is not responsible for informed consent or any other protocol procedures (‘participant identification centres’) – it would not be considered to be a research site. However, agreement from the relevant NHS R&D office to facilitate identification of potential participants must be obtained.