I keep hearing about Patient and Public Involvement (PPI), but what is it?
PPI is the involvement of the public within the NHS. The NHS Constitution states that members of the public have the right to be informed of and have access to clinical research studies. 99% of NHS organisations conduct clinical research and the individuals that work within those trusts are obliged to ensure that this occurs.
What can PPI do for a clinical trial?
For a researcher, the thought of introducing a member of the public – also known as a Lay Representative – to a concept or proposal in a field that they don’t work in, might seem strange at first. But the effect of what PPI can do for a study is invaluable.
Lay representatives can provide researchers with vital life experience perspectives. If they or a member of their family have a certain condition which requires specific interventional treatment, they will be able to advise what will be off-putting to patients and therefore, what may affect recruitment to a trial.
They can also review your documents such as the Plain English Summary or Patient Information Sheet, for example. If they have knowledge of a condition but still find the content difficult to digest, then others will too.
Patient Advisory Groups (PAGs) are also a great resource for a researcher, as they will have a practical perspective of what clinical need or gaps currently exist for the local population.
Who can be a lay representative?
Any member of the public can become a lay representative. The most common requirement is that the individual has knowledge of what specialty they are particularly interested, be it from a patient, family member or carer perspective. The term ‘Lay Representative’ implies that the individual must be able to represent the wider group or section of people.
For a PAG, this may not necessarily be the case if the purpose of the group is to review or be involved with a range of specialties throughout an organisation.
As a researcher however, 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 that these individuals are provided with proper support such as training and a description of their intended role. We would also recommend that they if they are a co-applicant with specific responsibilities within a study, that they sign an agreement with the Volunteer service. This will ensure that they are protected by our organisation.
What can a lay representative do in a research study?
A lay representative can fulfil several roles for 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
- Patient advisory group (PAG) member. 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 participant. This is a patient or member of the public who volunteers to be in a clinical trial
Having provided the forth example, this role on its own would not be classed as PPI for a study. The term ‘involvement’ suggests incorporated lay representative views and actions within the whole study pathway which a participant alone would not be able to provide.
Is PPI mandatory for clinical trials?
No. It very much depends on what the trial is. Stage I trials have very different requirements and will not involve patients as research participants. Also, small trials that are individual research projects are also unlikely to require PPI.
However, it is a requirement of all studies which go on to the NIHR Portfolio, that they have evidence of patient and public involvement (PPI) within them.
As a matter of course, at Leicester’s Hospitals we encourage all researchers to consider accessing and incorporating PPI when creating and developing protocols.
Where can I go to get more information?
The Research and Innovation team are in the process of developing a PPI work-stream and developing resources which will guide you.
In the meantime, the Research Design Service East Midlands are a great resource. They provide courses and advice for researchers about PPI and how to access and use it appropriately.
The Research and Innovation team also have a PPI Lead. Please complete the form below with your query or request and our team will get back to you.