Health researchers are 'missing a trick' by not demonstrating how patients and the public have contributed to the design and conduct of research, the HRA has said.
Good public involvement can help smooth the process through ethical review, lead to better designed research and improve participant recruitment. But a new study has shown that researchers applying for approvals to start their projects rarely describe their public involvement in enough detail for those reviewing their application to know what involvement has happened and what difference this has made.
Anyone wanting to carry out NHS research involving people, their data or tissue has to gain approval from an independent NHS Research Ethics Committee (REC). The ethics committee looks at what public involvement there has been in the research, but committees often find that applicants don’t provide sufficient detail for the REC to understand clearly what involvement has been carried out.
Jim Elliott, Public Involvement Lead at the Health Research Authority, said:
Jim Elliott, Public Involvement Lead, HRA“Researchers want to see their projects up-and-running, but by failing to properly explain the public involvement they’ve carried out, many are missing a trick that would make getting ethical approval more straightforward.
“We have looked at the responses REC applicants give about public involvement and it seems thatresearchers rarely provide enough detail about the involvement of patients and the public to know what was done and what difference it made to their study. It also seems there is a lot of misunderstanding among researchers about what involvement means, and its purpose at different stages of a project.
“Public involvement is about making sure that research is done with input from relevant patients, carers or members of the public. For example, public involvement is not about taking part as a research participant or subject, but being actively involved in shaping the research question and helping to design the study and what it is for.”
Dr Sheila Fisher chairs an ethics committee in Leeds, and says that public involvement is one of the core elements of a good research project that committees look for.
Dr Sheila Fisher, Chair, Leeds West Research Ethics Committee“RECs are all about protecting the safety and rights of people taking part in research. If you involve patients and the public from the start, it is a clear way of demonstrating that you will be treating them with dignity and courtesy – essentially in an ethical manner. We want to know that the research genuinely reflects the interests of the people who will potentially benefit, that the design is acceptable to participants, that the process of gaining consent is informative and that the findings are going to be communicated to participants and more widely.
“My committee sees a large number of projects every year. There are a good proportion who are carrying out good public involvement but don’t understand the question in the application that asks them to describe it. This makes it difficult to judge whether public involvement shaped the research to make it more ethically acceptable. We also see many applications that say they will be involving the public but are waiting for an opinion from our committee to start to do so. This is frankly not good enough. These plans for future involvement are often not clear enough for us to make a proper assessment of whether this involvement will be meaningful, or whether potential ethical concerns raised by involvement have been addressed.”
“A good place to start with public involvement is in creating public facing documentation, particularly the Participant Information Sheet. These documents often do not appear to have had input from people who will be approached as potential participants, and can often require time- and effort-consuming rewrites. Make sure your involvement starts at the planning stage and is not just a cursory read through of something already written by the research team.”
Analysing patient involvement – study findings
Reports of prior public involvement rarely describe it in sufficient detail to understand precisely what took place and what difference the involvement made:
63% of applicants claimed to have involved the public, but analysis revealed that only 36% of applications reflected the accepted definition of public involvement
For example, researchers often make simple statements along the lines of ‘Patients and carers were involved in the design of this study’. This makes it difficult to judge whether the involvement has shaped the study design in any way that would make it more ethically acceptable.
When researchers do provide some detail, most often they describe the method used, for example ‘We have discussed this study with X Advisory Group’ or the taskcarried out, for example‘An early draft of the study protocol was reviewed by the patient panel’.
Based on this information alone, it is impossible to assess whether such involvement was tokenistic or meaningful, and whether and how it influenced the researchers’ plans.
18% of researchers who described involvement in the design of their study were planning to do this after REC review. Good practice would be to include involvement before REC review, to improve the ethical acceptability of research and inform the ethical review process.
So that public involvement can more usefully inform REC review in future, the HRA is running a project that aims to understand what information RECs need about involvement, and what changes need to be made to the application form to make it easier for applicants to use. It will also offer guidance and training for REC members and the wider research community about how public involvement can support ethical review.
Jim ElliottWe want to help applicants provide more useful and relevant information, specifically around how involvement has helped to address ethical issues or concerns.
“We will also be working with RECs to ensure they know what information we will be asking applicants to provide and that they look for and use it consistently to inform their review of applications.
“Crucially, we need to show researchers, funders and sponsors that there’s an advantage in involving the public. It’s a good thing: it can lead to better designed studies, improve recruitment to studies and can help to smooth the process through ethical review, ultimately leading to higher quality health research. These are huge benefits."
Download the report
Public involvement in applications to the Health Research Authority Research Ethics Service: Comparative analysis of data.
This is the third report of a joint INVOLVE and Health Research Authority (HRA) project to analyse the extent of public involvement reported in applications to the HRA Research Ethics Service (RES) and the form it takes. This report compares responses to the public involvement question in the ethics application form from 2010, 2012 and 2014. Non-commercial and commercially funded studies are analysed separately.