Public involvement (sometimes called patient and public involvement or PPI) in research enables patients, relatives and members of the public to have an active role in studies taking place within the NHS.
What can public involvement do for a clinical trial?
For a researcher, the thought of introducing members of the public – also known as a lay representative or expert by experience – to a concept or proposal in a field that they don’t work in might seem strange at first. More and more research is finding that involving the public has considerable benefits, and especially with that most tricky part of research – recruitment.
Experts by experience can provide researchers with vital life experience perspectives. If they or a member of their family has a certain condition which requires specific interventional treatment, they will be able to advise on things like:
- Aspects of the research that are off-putting and may decrease chances of recruitment
- Delivering research in a way that is accessible to people living with a condition
- Patient enthusiasm (or otherwise) for the intervention you are proposing
- Barriers and opportunities to implementation of your intervention in real life, especially lifestyle interventions
They can also review some of your documents, such as the Plain English Summary or Patient Information Sheet (PIS). If they have knowledge of a condition but still find the content difficult to understand then it is likely that other people will too.
There are lots of ways researchers can work with the public. One of the easiest is by running a discussion group or focus group with people affected by the condition you are researching. Often called PPI groups or patient advisory groups, these may come from mailing lists of people interested in public involvement or by inviting people through clinic lists or research databases.
Lay representatives
Identifying who you want to collaborate with, as part of your research, is a key determinant in the quality of your public involvement and therefore it’s of benefit to you as a researcher. It is often better to speak to a smaller number of the people with real insight into the area, rather than larger numbers of people with less relevant insight. Consider, therefore, where you might find the people you want to talk to. This may be outside the hospital structure.
There are PPI groups within the hospital and university structures who may be both relevant and easily accessible, for example those in the NIHR Leicester Biomedical Research Centre, Leicester Diabetes Centre, NIHR Leicester Clinical Research Facility and Hope Cancer Trials Centre.
As a researcher, you are expected to demonstrate a duty of care for these individuals if they are involved as colleagues within your study, and provide funding for their activities and expenses. At Leicester’s Hospitals we look to ensure these individuals are provided with proper support, such as training and a description of their intended role. We would also recommend that if they are a co-applicant with specific responsibilities within a study, they sign an agreement with the Volunteer Service. This will ensure that they are protected by our organisation.
Contributions from lay representatives
A lay representative can fulfil several roles in a research study.
- Co-applicant: This is when a member of the public helps to create a study with a researcher. This individual is also referred to as the ‘lay member’
- Lay Member on a Board or Executive Committee: This role brings a vital outside perspective to the groups responsible for clinical research
- Focus group, discussion group or PPI Group participant: This means that a member of the public can be part of a group which shares its views on a proposed study or existing and new processes within clinical research
Research participants are patients or members of the public who volunteer to be in a clinical trial. This role on its own is not classed as public involvement.
Public involvement in clinical trials
Public involvement is strongly encouraged and ethics committees will look for evidence of it. Many funders require public involvement, most notably the NIHR.
We recognise that public involvement may not always be purposeful and may depend on what the trial involves. Phase I trials often will not involve patients as research participants. Also, small trials that are individual research projects are also unlikely to require public involvement.
However, it is a requirement of all studies which go on to the NIHR Portfolio that they have evidence of public involvement within them.
As a matter of course, at Leicester’s Hospitals we encourage all researchers to consider accessing and incorporating public involvement when creating and developing protocols.
Support for public involvement
The Research Design Service East Midlands is a great resource. It provides courses and advice for researchers about PPI and how to access and use it appropriately.
If your study relates to the NIHR Leicester BRC or Leicester Diabetes Centre, you can contact Rebecca Pritchard on 0116 204 4731.
If your research relates to the NIHR Leicester CRF you may contact Aidan Dunphy, PPI Lead, on 0116 258 6499.
