When you read this, I will have retired from the Health Research Authority (HRA) after nearly eleven and a half years of the best job of my career but one that was accidental.
I responded to a call for input to help with the establishment of the HRA in late 2012 and specifically to scope out whether and how public involvement might be of relevance to the remit and work of the HRA. Well, it was, and one thing led on to another. First to co-develop a strategy for patient and public involvement and then to write an implementation plan. In the process of doing all of that my fixed term contracts took me to over two years’ service which meant I ‘accidentally’ became a permanent fixture at the HRA. That was a very happy accident as it turned out.
To me it was quite obvious that public involvement could and should make an important contribution to the work of the HRA in delivering its mission ‘to protect and promote the interests of patients and the public in health research’. After all you can’t protect someone’s interests if you don’t know what they are. Whilst the core role of [health] Research Ethics Committees (RECs) is to put themselves in the shoes of research participants and reach an opinion about how well research teams have proposed to do that, they can’t really know what each and every population of research participants will think is important and relevant for them in a study they have been asked to take part in and whether the practicalities of taking part will be acceptable. Even with a third of the HRA’s REC members being ‘lay’ they still need those specific insights and that is where good public involvement in designing and carrying out health and social care research helps.
I was aware of what the HRA’s predecessor, the National Research Ethics Service (NRES, then part of the NHS Patient Safety Agency), had done, working with the former INVOLVE, to start the process of building patient and public involvement into the research application process. I was a member of INVOLVE’s advisory group and was part of the work with NRES to develop a question set for the application system (IRAS) and then later to assess what applicants had said in it soon after the question was introduced. I was also involved in the development of a ‘joint statement’ about patient and public involvement and [health] REC review, which made it clear that involving patients and the public in designing health research studies doesn’t in itself need to be reviewed by a REC because public involvement isn’t health research as defined by the Declaration of Helsinki, which is currently being reviewed: the next version will refer to ‘human participants’ rather than ‘human subjects’). The ‘joint statement’ was revised and updated in 2016 by the HRA and INVOLVE and it can still be accessed on the former INVOVLE’s ‘zombie’ website.
That work as an INVOLVE Advisory Group member sparked my interest in [health] research ethics review and the way that can be informed by insights from people with lived experience of what is being investigated. My time at the HRA has allowed me to develop and build that interest into an area of significant experience and expertise, though I say it myself. There are some highlights from my work for the HRA that stem from this and which are really starting to bear fruit.
Key highlights
The analysis of what applicants for REC review said about their involvement of patients and the public in designing their studies that INVOLVE and NRES undertook with data from 2010 was repeated by the HRA working with INVOLVE two more times. First with data from 2012 when the INVOLVE team led the analysis with me and my colleague Andrea Horwood helping. And then with 2014 data I led the work and was able to conduct a much more in-depth analysis using all of the data rather than a [large] sample as in the previous two occasions. I worked with Kristina Staley to undertake a detailed qualitative analysis of what applicants said, from which it was clear that very few of them indeed really understood and appreciated that involving people with lived experience in designing a study can inform how to manage some of the most important potential ethical issues in a study and so inform [health] REC review.
That work really drove home the fact that although we were asking applicants about patient and public involvement, we hadn’t made it clear enough why that was important and how doing it well could help them to improve their studies and get them started sooner. For reasons I won’t go into now we couldn’t just change the question in IRAS then (there will be a new and much better question set in the near future) so we developed much more focused guidance and then co-developed the HRA’s Best Practice Principles for Public Involvement with members and chairs of RECs and ‘public contributors’ as the HRA calls the people who it involves. The impact of all of that has been to steadily increase the proportion of applications that contain information about public involvement that is useful to the HRA’s REC members in reaching their ethical opinion. As part of the checklist we developed for applicants the HRA now advises applicants to take one of their public contributors to the REC meeting with them. REC members like that because they can talk to someone with relevant lived experience of what is to be studied and get a much better feel for how well the potential ethical issues have been thought about and addressed. It is still a small minority of applicants who do that but in time its benefits, which include an increased chance of getting a favourable opinion at first review, will, hopefully, encourage the majority to do it.
There are two further highlights from my time at the HRA I want to reflect on. The first is the Shared Commitment to Public Involvement, the realisation of which is a major career highlight for me. I covered this in my last post, which I wrote to mark the second anniversary of its launch so I won’t say more other than to thank, again, my dedicated and amazing colleague Barbara Molony-Oates. Barbara works phenomenally hard behind the scenes, and increasing now in full public view, to make the partnership work. I am so glad that she joined us to take that on because I never could have delivered the huge amount of high-quality work she has. Thank you so much, Barbara.
The other highlight has been a very slow burning one, but one which I think is as significant as the Shared Commitment in many ways. The HRA’s strategy for public involvement included what turned out to be a far more challenging objective than I, somewhat naively, realised at the time it was co-developed and published in September 2013. As well as setting out our stall for what we wanted to achieve to ‘improve the quality of the research the HRA approves’ by supporting and enabling more and better patient and public involvement, we also set three ambitious objectives of which the first was to ‘Develop the HRA into an effective “involving” organisation’.
I really didn’t appreciate at the time the enormity of that ambition in terms of the cultural change it was going to need across the organisation. We made steady progress in all of the other aspects of the strategy, which is illustrated by my reflections above. However, despite starting well in involving patients and the public in the work of the HRA, such as the co-development of the public involvement strategy itself and in the recruitment of my team, then all director level staff followed by a wider range of staff, the focus was limited to what I and my small team could actually facilitate.
The 'Ronseal' test
The necessary cultural change to make public involvement really part of how the HRA works only actually started to happen as our work changed and developed to respond to the Covid-19 pandemic. The culmination was the HRA’s new overall strategy that was published in 2022 with the highly ambitious aim of ‘Making it easy to do research that people can trust’. Public involvement is at the heart of that and the small but brilliant team I had the honour to lead are now supported by so many colleagues across the HRA from the Board and Executive team down to now work in partnership with people and communities (a term I far prefer to ‘patient and public involvement’ because it passes the ‘Ronseal’ test in doing what it says on the tin) in a growing number of aspects of the HRA’s work. It took ten years from the vision in the public involvement strategy but it has happened and in a more effective way that I could have imagined that had little to do with me in the end, which is very satisfying to see.
Go, you involving organisation you!