The report of a workshop informed by the Infected Blood Inquiry has been published this week.
The Inquiry, which reported in 2024, found that over the course of decades, 30,000 adults and children across the UK who were treated by the NHS with blood and blood products had been infected with viruses. Over 3,000 have already died and many more are very unwell.
Medical research was one of the areas examined in the Inquiry. Some victims of the infected blood scandal were subjected to unethical research practices in the 1970s and until the early 90s. This includes participants in research studies who were not told that they were part of research, were not asked for their consent, and could not give it.
The UK's regulatory landscape is much different today, meaning that this could not happen. However, these findings risk undermining trust in today's clinical research if we do not earn and maintain people's confidence in the system of checks and balances that protect them. There may also be opportunities to further improve our regulatory landscape to ensure it continues to be robust and informed by what matters to people the research is for and about going forward.
Last year, Sir Jonathan Montgomery, Chair of the Infected Blood Inquiry Response Expert Group, and Professor Caroline Moore, an NIHR Research Professor, were commissioned to review the Inquiry’s conclusions on medical research. Their implications were considered at a workshop convened by Professor Lucy Chappell, Chief Scientific Advisor at the Department of Health and Social Care. The HRA has been part of that workshop and review.
Chief Executive Matt Westmore reflects on the outcomes.
Matt Westmore, Chief Executive, Health Research Authority‘The infected blood scandal was a tragedy the likes of which must never be repeated. Whilst a lot has changed since, we must not be complacent, and the failings then still risk undermining trust in clinical research today. It’s crucial that the HRA and the wider research community continue to earn and maintain trust so that everyone can be confident to take part in research and use its findings.
‘The report published this week reminds us we are beholden to the public, to those who have been let down in the past, and to those may participate in research in the future. We must continually improve the regulation and oversight of research, to make sure that everyone can understand what to expect if they’re invited to take part in research, that taking part in research is a matter of individual choice, and how to raise concerns if they have them. This month we’ve begun a project to help understand how to do this most effectively. We will share the outcomes and our progress later this year.
The report includes two recommendations specifically relating to the HRA.
The first asks us to work with the National Institute of Health and Care Research (NIHR) and research participants and potential participants to update the 2014 framework on sharing health related findings with people who have been involved in studies. There has been monumental change in individual access to health information and data over the last decade, and we’re keen to explore how our guidance keeps pace with modern expectations. We’ll report on our progress as we do this and will the people this is for and about.
The second is to develop a user-friendly explanation of rights and responsibilities that enables patients and participants to know what to expect when they take part in health and social care research. This should also include how to raise concerns and how they would be responded to.
We accept both these recommendations unreservedly.’