What counts as research for the DoH Research Governance Framework?
RGF research governance approvals – permission from an NRES ethics committee and PCT R&D approval – are only required if the activity is counted as research, and not as evaluation or audit. The National Research Ethics Service provides guidance on the differences between research, audit and evaluation. The key discriminating factors are defined as follows:
- Intent: The primary aim of research is to derive new knowledge; audit and service evaluation measure level of care. Research is to find out what we should be doing; audit is to find out if we are doing. Nevertheless, a project may have more than one intent; in such a case, a judgement is needed as to what the primary aim is.
- Treatment: Neither audit nor service evaluation uses a treatment without a firm basis of support in the clinical community.
- Allocation: Neither audit nor service evaluation allocate treatment by protocol. It is by decision of clinician and patient.
- Randomisation: If randomisation is used, it is research.
(From Defining Research; National Research Ethics Service 2008)
We would recommend you write a thorough explanation of what the project is about. Explain why you think it is evaluation, or audit, and not research, using the headings in the NRES guidance (which are more detailed than those above) to make your argument. That should make it easier for them to judge quickly whether it fits their criteria. The more information and explanation you can provide at this stage, the better.
NRES will then give you a written response, stating whether or not you need to apply for research ethics approval within their system. If your work is not counted as research (i.e., if it is audit or evaluation), you do not need to apply for NRES research ethics approval – but bear in mind the following:
- You may still need to apply for ethics approval within your institution. Institutional ethics approval policies may not make the NRES distinction between research, evaluation, and audit, and may well apply to all forms of funded research or research-like activity – your project may still be classed as research by your institution. If you are unsure whether this applies to you, check with your institution’s research office. Remember too that it may help you in getting other permission (e.g. from gatekeepers) if you can show your project’s ethics have been reviewed.
- You may still need permission from other bodies before you can go ahead with your research. If you are working in an NHS Primary Care Trust, you may still need to get permission from the R&D (Research and Development) department in the PCT . Phone the R&D department to check, and see our section on R&D approval.