Is my study research or audit?
If you are not sure whether your study is research or audit, see Is your project research? and
Ethical review requirements
Can NHS RECs review research studies not listed in GAfREC?
If requested to do so, an 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), capacity permitting. (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 co-ordinator for consideration by the chair.
Where can I get advice on ethical research issues?
For advice on ethical research issues you could do the following:
through the REC co-ordinator raise the issue with the chair of the local REC; a brief outline of the project/ethical issue should be submitted in writing to the REC co-ordinator for consideration by the chair
consult our Ethics Research Information Catalogue (ERIC);
email your question to firstname.lastname@example.org;
do a literature search;
debate with your colleagues what might be fair and ethical;
seek the advice of an ethicist (for example, at a local university), who would probably be glad to help you;
consult the research ethics manuals produced by universities and Royal Colleges; or
see the section on ethical principles on the Medical Research Council's website, and the requirements for conducting medical research with people as participants or with animals;
discuss with your R&D department.
I have already carried out my research, but am told that I need ethical approval. Can I apply?
Under our Standard Operating Procedures for NHS RECs (SOPs), an ethical opinion cannot be given retrospectively (see paras 1.88-1.90).
If the research has already started without first obtaining a favourable ethical opinion, within the NHS 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 it falls under the categories listed in GAfREC. For more information see Ethical review requirements.
Who should be the chief investigator / principal investigator for my research; me or my academic supervisor?
For all doctoral research, the student should be named as the chief investigator (CI).
For research projects below doctoral level, the named CI should be a senior person who is able to undertake all the responsibilities set out in the Research Governance Framework for Health and Social Care. For projects conducted mainly for educational reasons, the academic supervisor should normally be named as the CI. The supervisor should sign both the CI and supervisor declarations and should provide a current CV. The student should also provide a CV.
Where the student is participating in a project that is not purely educational, the CI may be another experienced researcher such as a health professional or academic researcher.
While non-doctoral students should not normally be named as the CI, it is expected that the student will complete the application form on behalf of the CI as part of their training.
The student’s details should be given in the application and a copy of the student's CV included. The REC will invite the student to attend a meeting to answer questions about the study. The academic supervisor is also encouraged to attend. Once a favourable opinion is given by the REC, it is expected that the student will actually undertake the research under supervision by the CI.
Further advice may be sought from the NHS R&D Office at the lead site for the research if necessary. Students are encouraged to discuss their research with the R&D Office at an early stage and seek support in principle.
Do pilot studies need REC review?
Yes, if the pilot study falls under the categories listed in Governance Arrangements for NHS 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, 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.