The Health Research Authority plays an important role in driving patient engagement in the UK. We asked Jim Elliott, Public Involvement Lead at the Health Research Authority & a newly-appointed PFMD Board Member, how the HRA sees the future role of patients in research. He discusses the role of research ethics committees and how he sees PFMD’s role in patient engagement.
What is the role of the NHS Health Research Authority and how does it promote patient involvement?
The Health Research Authority (HRA) is responsible for making sure all new research which involves NHS patients (or their clinical samples or health data) in England is ethically reviewed. In a nutshell, we protect and promote the interests of patients and the public in health and social care research. As a part of this, we work hard to involve patients in how we make decisions throughout the organisation, and we encourage and support researchers who apply to us for approval to work with relevant patients, carers, service users, and other members of the public in their work.
Describe the Authority’s key patient involvement initiatives?
When researchers apply to the HRA for an ethics review we ask them to describe how they are working with patients or other members of the public who have lived experience which is relevant to the proposed research. Our Research Ethics Committees (RECs) evaluate how well patients have been included in planning the research and what impact this has had when they evaluate the ethical acceptability of the study.
In 2018 we integrated guidance into our application form to explain exactly what RECs want to know about public involvement.
RECs want to know how the involvement has helped shape the research. Did talking to people with the health condition the research is tackling help to confirm that the research question addresses something that is likely to make a difference to the quality of life of people living with the condition?
How do you promote best practice?
Last year we launched new webpages which capture this in four best practice principles, developed in partnership with ethics committee members, patients, and other regulators: Involve the right people; Involve enough people; Involve those people in the right ways; Tell us how it helps.
What challenges do you face in advocating greater and earlier involvement?
Managing change. Peer-led change is really important, which is why it’s interesting to see what different organisations who come to us for approvals are doing. When we come across good examples from pharmaceutical companies, such as where the staff have developed a network of patient involvement champions across the organisation, we look into how we can support and encourage others to take similar approaches.
Part of the challenge for the HRA is that as a regulator we interact with researchers and study sponsors quite late in the research process. Because the HRA doesn’t commission or fund research, everything we receive for review has already been planned and funded. That’s why a lot of our focus is on trying to communicate clearly and consistently to researchers and sponsors about how working well with relevant patients can make it easier to get a favourable ethical opinion for their research (and the disadvantages of not working with people at all).
What tools are needed to make it easier for researchers to involve patients and patient advocates?
There’s so much fantastic guidance already out there, and so one of the most important things we can do is to signpost people to existing resources. Over the past year what we’ve most commonly heard are calls for support in preparing information using plain language to write participant information, and an emphasis on the importance of making it easier for people to learn from one another by sharing best practice and practical examples of how different people have approached common questions and issues. We think it’s really important that patients and the public should be offered payment for their time, so guidance which helps organisations to budget for meaningful involvement makes it easier for them to work well together.
Are there key steps in the research process where researchers should work more closely with patients?
Really what we need is involvement running all the way through the research process; for people to plan and budget for involvement before they even start planning the research. Working with relevant patients to develop participant-facing information can be hugely effective and is something in which our research ethics committees are particularly interested.
What have you planned for 2020 and beyond?
We’re going to be working with our ethics committees to make the way information about the involvement of patients and the public is used simpler and more effective. Within the HRA we host a network of patients, carers, service users, and other members of the public who work with us to ensure that the HRA is an effective ‘involving’ organisation – to make sure patient and public voices are listened to and acted upon in the work that we do as an organisation. This year we’d like to work with the network to review our work so far and to explore how we can continue to improve it.
We also plan to work more closely with sponsors and funders in the commercial sector to support and encourage more of them to work with patients and the public. We think that the HRA’s membership of PFMD will be mutually beneficial and help to persuade more of the commercial sector that working with patients is good for them and good for patients.