Public involvement could usefully inform ethical review, but rarely does: What are the implications?

Abstract

Background Researchers conducting research in the NHS in England are required to submit their study for approval by an NHS Research Ethics Committee (REC). Public involvement in research prior to REC review helps to ensure studies are ethically acceptable to participants, thus informing the review process. The Integrated Research Application System (IRAS) used by RECs, asks researchers to describe any involvement in the development of their project, and in its delivery and dissemination. We analysed researchers’ reports of involvement to assess how well current approaches to involvement are supporting REC review. Methods We used a mixed methods approach. The anonymised free-text data from all 2748 non-educational applications submitted to RECs in 2014 were analysed using NVivo. Themes were developed from the data and used to summarise and categorise the different types of reports of involvement. The frequency of common types of report was analysed using simple statistics. Results In general, researchers rarely describe any prior involvement in sufficient detail to know what was done and what difference this made. This makes it difficult to judge whether the involvement shaped the research design in any way to make it more ethically acceptable. Similarly, researchers’ plans for future involvement are not clear enough to enable RECs to make a proper assessment of whether this involvement will be meaningful, or whether potential ethical concerns raised by involvement have been addressed. This analysis also shows there is still considerable misunderstanding amongst researchers around what involvement means, and its purpose at different stages of a project. This may be severely limiting the potential for impact. Conclusions So that public involvement can usefully inform REC review in future, the HRA is undertaking a collaborative exercise to understand what information RECS need about involvement, and what changes need to be made to the IRAS form. At the same time it will develop guidance and training for REC members and the wider research community about how public involvement can support ethical review. Researchers may also benefit from guidance on the value and purpose of involvement at the research stages: design, data collection and dissemination of results.