Research Ethics - Clinical / NHS
Where research is clinical, and will involve any of the following categories then researchers must contact the NHS Research Ethics Committee under the Department of Health/NHS framework.
- patients and users of the NHS. This is intended to mean all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS (for example where a subject is recruited due to an NHS diagnosed condition). It includes NHS patients treated under contracts with private sector institutions
- individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above
- access to data, organs or other bodily material of past and present NHS patients
- foetal material and IVF involving NHS patients
- the recently dead in NHS premises
- the use of, or potential access to, NHS premises or facilities
- individuals under the care of social or community care professionals, local authorities or prisons
No research study within the NHS involving individuals, their organs, tissue or data may begin until it has a favourable opinion from a NHS Research Ethics Committee.
NOTE - From 1 September 2011, a revised version of the National Research Ethics Service Standard Operating Procedures (SOPs) for NHS Research Ethics Committees in the UK is in operation. There have been changes to the remit of NHS RECs and revised requirements for ethical review of research by NHS RECs. To check whether this affects the need to apply for ethical review for your research under either legislation or the policy of the UK Health Departments, please see the following link:
http://www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/
and in particular the following guidance from the link:
- Guidance on changes to the remit of RECs; and
- Algorithm - does your project require REC review?
If you approach a NHS Research Ethics Committee and are advised that the research does not require approval from the NHS Research Ethics Committee, then you must submit an ethics application to your College Ethics Committee.