Ten years of the HRA - a blog by Jennifer Bostock and Professor Chris Butler

Over the past decade, the Health Research Authority (HRA) has transformed the process and governance of health and social care research – and must now react, respond and re-energise for the next 10 years.

Ask anyone who was involved in health research pre-2010 what it was like to get approval for studies and they will likely roll their eyes and sigh. They might point to three-year PhD projects where two and a half years were spent obtaining approvals. Or a single study needing 117 separate approvals at different sites. Sadly, these were not isolated examples!

In 2011, Sir Michael Rawlins led an Academy of Medical Sciences review into the regulation of health research. This report highlighted numerous shortcomings that were stifling research, without offering much in the way of additional protection to participants. What’s more, this situation was actually causing harm, by holding back research, leading to delays in results getting out there to improve care.

The report triggered sweeping changes, including the creation of the HRA. This new authority was charged with overseeing health and social care research in the UK by providing effective but proportionate protection for research participants while also working to create an environment supportive of high-quality and ethically sound research. It’s now widely accepted that the HRA has done a pretty good job at achieving these aims – and the absence of any significant dramas over the past decade is surely a sign of success. Research can now get off the ground much quicker, while still maintaining the highest ethical standards. This is good for researchers, good for finances and, most importantly, good for patients.

In 2020, the COVID-19 pandemic presented a new challenge to the HRA and other regulatory authorities. With many unknowns, research was urgently needed – for example, to distinguish ineffective from effective treatments and to test new vaccines. And results were needed fast. It is testament to the HRA’s processes and responsiveness that research was launched at high speed and delivered actionable results without cutting any corners, and especially without compromising participant safety. And, of course, while maintaining public trust (some vaccine hesitancy aside).

To mark the tenth anniversary of the founding of the HRA, the Academy of Medical Sciences and the HRA got together to hold a ‘birthday party’ – over Zoom, alas with no cake, but with the serious aim of identifying what the HRA had got right over the past decade, what emerging challenges were on the horizon, and what the HRA could do to address them. Invites went out to researchers, patient and public representatives, members of other regulatory authorities, funders, industry/pharma representatives and a host of other illustrious folk, who convened for friendly and stimulating discussions on the afternoon of Thursday 17 February 2022.

The event was packed with ideas for the HRA as it plots a course for the next ten years. Here are some of the themes that emerged:

• Embedding research in care (including social care): The formation of the HRA was part of a wider drive to ensure that every NHS patient and service user has the opportunity to take part in research. Despite much progress, we’re still some way from ensuring that research is as embedded in the NHS as, say, teaching. Research should be governed, resourced, mandated and just assumed to be a normal part of NHS care. We need to continue lowering the barriers to participation and ensuring that everyone, including health service managers, are bought into the concept – and, more importantly, take action to achieve it.

• Embedding patient and public involvement in research: The drop in public involvement in the development and implementation of research early in the COVID-19 pandemic suggests that it is not as embedded as was assumed. We need to continue pushing for earlier, deeper and wider involvement, with the HRA acting as facilitator as well as enforcer, helping to build capacity for public involvement and focusing on its quality as well as quantity.

• Thinking about ethics earlier: Researchers need to get used to considering the ethical implications of their projects at earlier stages. This means considering and mitigating against ethical issues prior to applying for research funding, to avoid nasty surprises at research ethics committee meetings. Perhaps ethicists and philosophers should be more routinely involved in grant writing, and we may even see a few philosophers as co-applicants. It may seem an unorthodox suggestion, but think back to the days before public involvement, when qualitative research raised eyebrows, yet it doesn’t seem so strange now.

• Overseeingmore complex and distributed clinical trials and encouraging innovative design: Clinical trial design is becoming more innovative, with, for example, adaptive/platform trials. In addition, there are more opportunities for self-testing and remote data gathering from participants at home. These trends could make it easier for people to be involved in research but raise a host of issues that the HRA will need to consider.

• Looking beyond trials: Research is not all about clinical trials: much of the health and social care research conducted in the UK is not a clinical trial. Research in social care and public health, qualitative studies, economic evaluations, secondary data analyses and meta studies are equally important. These all build into a holistic picture of a rich, diverse and progressive research landscape.

• Focusing on equity, diversity and inclusion: Health inequalities are high in the UK and are mirrored in low rates of participation in research in certain populations. With other bodies, the HRA needs to consider how under-represented groups can be encouraged both to take part in research and get involved in activities to shape that research, taking into account the many different factors that may create barriers to participation – including ethnicity, sex and gender, economic circumstances, and geographic location.

• Dealing with a more complex data environment: Data sharing has long been a thorny issue in health and social care research, there are a range of challenges including technical, regulatory and operational. As well as the usual issues with health data sharing, real-world evidence and data harvested from everyday activities have enormous potential to provide insights into impact on patients. Finding better and proportionate ways to ensure smooth, timely data sharing, that earn public approval, will be a key future priority. Central to this will be earning public trust to encourage patients to be the advocates for the sharing of data.

• Maintaining a whole-pathway perspective: For translational pathways to operate smoothly, so that patients benefit from medical innovations as rapidly as possible, an end-to-end perspective is needed. This can ensure there are no unnecessary ‘roadblocks’ and that activities at one step mesh smoothly with those at the next. The HRA needs to continue examining not just its own practices but also its interactions with other bodies, on the national stage and internationally, to help create an ecosystem that supports the speedy development, evaluation and implementation of medical innovations while protecting research participants.

• Ensuring that dissemination leads to impact: Communication needs to be at the heart of the HRA’s work – with the public to encourage participation and promote the benefits of research, with researchers to promote greater consideration of public and patient involvement and ethical issues, and with stakeholders to ensure more joined up approaches. And researchers need to think earlier and more creatively about how to disseminate their findings to maximise the impact of their work. Why not help the patients involved in the research to become the champions of the results?

The HRA and other regulators face a difficult balancing act. On the one hand, they need to protect research participants and ensure that research is driven by their needs. On the other hand, they are required to stimulate research and make it as seamless as possible to carry out.

Without question, the HRA has achieved this balance, maintaining trust in research and ensuring good take up of medical innovations, even given the challenges presented by the COVID-19 pandemic. By continuing to listen to patients, carers and the public, and working closely with researchers and other stakeholders, the HRA now has the chance to build on this solid foundation to address emerging challenges and exploit new opportunities to accelerate the development of innovations that truly meet patient needs.

The next ten years will surely require one more small step, or perhaps many small steps, for regulators; but imagine the giant leap that will be taken if we all work together towards the common goal of high-quality, ethical and timely research.