Now you would think that the NHS Ethics process might have been the most difficult of these approvals. But actually there is so much support for this process and information available that this wasn’t really the case. The support pages (see link below) are really useful and there is also face-to-face training which goes through an application form, what it looks like, the different forms of review and the decision making process of the Research Ethics Committees (RECs) (again see link below).
I think the big piece of intelligence I can share is that some of the RECs are flagged as being specialists in qualitative research. This was great because there’s always a worry that you might get reviewers who don’t understand the methodology and therefore you spend more time explaining what qualitative research is rather than defending your approach. We went to one of these committees, which was NRES Committee Yorkshire & The Humber – Leeds West.
The application was through IRAS and you also need telephone and book an appointment with the committee at the same time as sending through the application. There was only two weeks between me booking the appointment at the actual committee date which was great. One thing to note is to make sure all your documents have version numbers and dates on them. We had these on everything except our protocol – because the study was small we were just using our original project proposal to the funders but that didn’t have a version on it.
In the meeting itself the panel were very welcoming and asked good questions about the plan for the research. They were also complimentary of our topic guides which had been drafted based on our training at NatCen. Following the meeting we were given a provisional decision which included requiring further information and clarification on:
- Confirmation that audio recordings would be deleted once transcribed
- Rewrite of the participant invitation letter to use more suitable language
- Confirmation that consent would not be assumed if a patient did not contact the research team after invitation
- Within the Participant Information Sheet, the following revisions should be made:
- a) Definition of unlicensed medication in lay language
- b) The information sheet for Patient Participants should be rewritten in more appropriate language
The patient participation information materials have been particularly difficult for this research project, as anyone who has tried explaining to a patient what an unlicensed medicine is will know. There is a fine line between transparency, lay language and scaring patients. Helpfully, I was actually able to talk to the REC manager about this. In the end there was actually only a minor change and our response to the REC was actually about explaining our approach and why we had chosen the language we had. It was also extremely helpful to have a PPI member of the group as someone to reference for being involved in the development of the materials.
We got a return of a favourable opinion from the REC less than two weeks after sending through our response.
HRA Ressearch Ethics Service pages: http://www.hra.nhs.uk/about-the-hra/our-committees/res/
NHS Researcher Training Days for NHS Ethics: http://www.hra.nhs.uk/hra-training/training/