Projects that may not require approval via the Research Governance Framework
There is a series of very useful leaflets produced by the National Patient Safety Agency at:
http://www.nres.npsa.nhs.uk/applications/is-your-project-research/
“Defining Research”, Issue 3, is particularly helpful and is also available on WebCT for registered students.
The key words in this heading are “may not”: you still need to check as it is not yet clear whether or not local conditions will need to be met for the types of study shown below.
Recent advice is that you may not need Ethical and Research and Development approval if your project is:
- genuinely an evaluation of a service activity or innovation
- testing practice against a gold standard (audit)
- the analysis of an existing anonymised dataset, such as the over 5000 made available through the ESRC on the UK data archive http://www.data-archive.ac.uk : these don't fall under Research Governance provided that they are accessed according to the terms and agreements outlined on the UK data archive website, and bearing in mind that special agreements apply to certain datasets, or
- you may be able to key into a research project that already has approval that covers what you want to do.
In any event, as a minimum, you need to discuss the issue with your supervisor and those responsible for the protection of the data concerned. Get their decision in writing and, if in doubt, ask your local NHS Research and Development staff – see links above.