Dr Kirsty Edwards, Policy Manager
At the Health Research Authority, we review all sorts of research studies. Some last a couple of years, which is a relatively short period of time when it comes to research.
Other longer-term pieces of research can last decades or even a lifetime and you may hear these studies referred to as longitudinal research.
Longitudinal research gives vital insight into how diseases may develop, the impact of treatments and any themes that may emerge.
Taking part in a longitudinal research study can represent a long-term commitment for participants. Whenever we review an application for a longitudinal study, our ethical review always considers the impact on participants and the different factors researchers need to think about.
One of the key things we consider is informed consent to take part in research.
Researchers have an ethical and legal obligation to make sure that people volunteering for research projects have the information they need to help them decide whether to take part or not.
But what happens if participants’ ability to consent changes during the course of a study, perhaps as a result of developing dementia, or following a brain injury? Can, and should, they continue to take part?
Currently, many participants are removed from longitudinal research when it is known that they have lost mental capacity.
Starting the conversation
Working alongside Genomics England and Our Future Health, we decided to start a conversation about this.
Genomics England is a company set up and owned by the United Kingdom Department of Health and Social Care. It enables others to deliver genomic healthcare and conduct genomic research, partnering with leading researchers from academia and the life sciences sector to host a number of pioneering initiatives such as the 100,000 Genomes Project, the National Genomic Research Library and upcoming Generation Study.
Our Future Health is the UK’s largest ever health research programme. Our Future Health is inviting millions of people, from all backgrounds and from right across the UK, to take part. Participants provide information about their health and lifestyles to create a detailed picture that represents the whole of the UK. By developing a more detailed understanding of what makes certain people more likely to develop a disease, the programme has the potential to help to develop more effective approaches to both prevention and treatment.
In September we brought together people with a range of different perspectives to talk about the issue of consent and changing mental capacity for participants in longitudinal research.
The event was part of a key commitment in the HRA’s strategy to create public conversations about research issues that matter to people.
The roundtable was chaired by Vivienne Parry OBE (science writer, broadcaster, and Head of Engagement at Genomics England) who welcomed members of the public, charities, organisations that manage healthcare data, researchers and legal experts from across the UK to contribute to the conversation.
We considered the responsibilities, if any, of researchers and those who manage health research data when mental capacity is affected, examining legal compliance, ethical considerations, and public expectations.
It was fantastic to see so many people come together and talk about an issue that we are all clearly very passionate about.
Everyone agreed that this was an important conversation to have, and that there were lots of different things that must be factored into the discussion.
An important first step in the right direction
We all acknowledged that these are complicated issues and there are no quick fixes.
There was firm agreement on the need to respect people involved in research and the danger of under-researching certain conditions because of the challenges we face. The importance of conducting research in the later stages of illness, despite the difficulties presented by loss of mental capacity, was also emphasised.
Some longitudinal research has thousands, if not millions, of participants involved over many years. Researchers would therefore face huge practical challenges if they were checking in on individuals' mental capacity after initial consent is given.
There was a suggestion that when it is clear that someone has lost mental capacity, this should be followed up and, where appropriate, their consultees should be approached to reconfirm their consent. But what do we do when we are not sure?
Those managing health research data do not usually have direct contact with people involved in research so cannot know the continuing status of someone’s mental capacity. Often, organisations managing health research data do not have a clear flow of information to allow them to identify with complete certainty if a participant has lost mental capacity. In these types of situations, we discussed what we thought the expectations of people involved in research might be.
We also discussed different types of longitudinal research. Some only use participants’ data, while others have more direct contact with participants. Views in the room suggested studies that only collect data might be treated differently in terms of approaches to this issue. However, roundtable attendees also agreed that we need much more evidence about what the public think, perhaps by conducting a public dialogue, to understand these issues better.
Sarah Markham, public contributor
'The HRA roundtable with Our Future Health and Genomics England was an authentically co-produced event aimed at bringing greater clarity to the Gordian knot of intertwined ethical, legal and practical dimensions of managing consent of participation in longitudinal research, in the context of potential loss of mental capacity to consent.
It was a refreshingly considered and frank meeting, with diverse stakeholders contributing knowledge and professionally or experientially informed perspectives, all intent on working through this issue and seeking routes to potential solutions. As a patient and research participant, I was there to champion our rights and to learn from everyone else. We all want the best for people and for research and findings that can translate into better care and treatments. The roundtable was a first positive step on the road to embracing and resolving the important issues at hand.
It was incredibly empowering and enlightening to work alongside colleagues at the HRA to design the roundtable. As public contributors we were treated as peers and colleagues and it was a privilege to have so much trust placed on us, our perspectives and our contributions. I can't recall any other instance of supporting an event where I felt so included and relied upon.'
Ending with more questions than we started with
As the roundtable conversation developed, it became clear that attendees felt longitudinal research participants should be able to continue to be involved in a way that both respects their previously expressed wishes and appropriately protects them as potentially vulnerable individuals.
We all agreed that the next steps should be to find out what the public and people involved in research think, especially those potentially at risk of under-representation, or with conditions that may have less research undertaken because of this issue.
By doing this, we hope to get a more informed understanding of the different scenarios and where we might be able to get greater clarity over the best way to involve people in longitudinal research, so that they can trust what may happen if they lose mental capacity in the future.
We certainly left the conversation with more questions than we came in with, but that’s what we wanted!
It was an important first step towards hopefully making a difference on an issue that is important to a lot of people.
Helen Bates, public contributor
'As a mature student in health and medical sciences at Warwick Medical School, taking part in the roundtable event has been very enriching for my studies, enabling me to gain insight into the guidelines underpinning real world situations. It has been reassuring to hear from so many stakeholders who all have the same important goal, which is to ensure that the rights and welfare of participants are being held paramount above all else in research, as they should be.
Seeing for ourselves that they are going out of their way to ensure they are acting ethically and lawfully in their work at all times, even down to the most gnarly and difficult things to review, is fantastic to witness. The various stakeholders listened genuinely to the public and patient involvement advisors, taking on board all views and, in fact, ultimately deciding that additional patient and public views are needed, which will add further rigour to the work.
It has been a great pleasure to work alongside the team, and I expect there is great work ahead!'