The Department of Health Governance Arrangements for Research Ethics Committees (May 2011) states that ethical advice from the appropriate NHS Research Ethics Committee (NHS REC) is required for any research proposal involving:
- Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user's past or present; treatment by, or use of, the NHS and Social Care services
- NHS patients treated under contracts with private sector institutions, including patients that are cared for in private and voluntary sector nursing homes
- 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
- Fetal material and IVF involving NHS patients
- The recently dead in NHS premises
- Xenotransplantation (i.e. putting living cells, tissues or organs from animals into people), which, as a matter of government policy is recommended to take place in a controlled research context.
- Social care research funded by the Department of Health.
In addition for some research there is a legal requirement for review by an NHS REC, these include:
- People who lack (or lose) the capacity to give informed consent to take part (or to keep taking part) in the research
- Possession of confidential patient information without consent where this would otherwise breach confidentiality.
- Exposure to ionising radiation
- Medical Devices that are not CE marked or CE marked medical devices that have been modified or ae being used for a new purpose
- Investigational medicinal products
- Practicing midwives conducting a clinical trial
- The use of any relevant material as defined by the Human Tissue Act where consent has been obtained for its use in research projects.
If you think that your study involves the NHS then you can use the ethical review decision making tool and the Defining Research leaflet to cross-check your perception of your study and where you should obtain ethics approval from before you begin the application process.
The Health Reseach Authority (HRA) provides useful information about undertaking research in the NHS. Guidance on whether your study is research and requires approval though an NHS REC, can be found by completing the MRC decision making tools: Is my study research? and Do I need NHS Ethics approval? Further guidance on why these approvals are required is explained in the HRA Algorithm.
Sponsorship, Indemnity and insurance NHS Research Studies (NRES)
Sponsorship is mandatory for all studies whether conducted by University staff or students. For research studies conducted in the NHS, or at the specific request of funders and host organisations, the University will normally act as sponsor or co-sponsor. For further information please view Sponsorship.
NHS RECs will also want to see evidence that the University has the necessary insurance and indemnity arrangement in place for staff and students conducting research in the NHS. For further information please see Insurance and Indemnity. Copies of the University's insurance policies can be downloaded from the Insurance Services- key policies webpage.
Informed consent for NHS Research Studies
The stipulation that researchers seek consent after providing appropriate information is a central theme in modern research ethics. For guidance please see our web pages on Consent and informed consent provided by the HRA and use the templates provided.