In our new HRA strategy, we make a commitment to ‘include’ and make sure health and social care research is done with and for everyone. We want to see more diverse groups of people with relevant lived experience involved in all stages of research and able to take part, with the findings shared publicly so that they can be used to improve care.
But taking part in research means making your own decisions which can be challenging for adults with capacity-affecting conditions like dementia, stroke survivors, learning disabilities, acquired brain injury, autism and/or those with communication difficulties. This can lead to ethical questions about whether it is appropriate to include such people in research? Do people err on the side of caution and exclude people who seem unable to give informed consent? And, if so, what are the implications in terms of under-representation in research?
We spoke to Dr Karen Bunning, Associate Professor in development and learning disabilities at the University of East Anglia, who runs Project ASSENT examining this important issue. Dr Bunning is currently talking to members of our Research Ethics Committees about this topic at our REC Development days taking place up and down the country.
‘Research involving human beings is essential for developing new knowledge. Seeking informed consent is one of the prerequisites of such research. As people live longer, so the number of people who have dementia or who have had strokes rises. Improved neonatal care means that premature babies are also surviving in greater numbers, with an associated risk of developmental disability. All this means that the number of vulnerable people, who require some kind of support in decision-making, is increasing.
The big ethical question is whether it is appropriate to include such people in research. We have legal, ethical and regulatory frameworks governing capacity and consent that are provided for under the Mental Capacity Act (MCA: 2005). However, the process becomes complicated when there are questions about a person’s ability to give informed consent. It may even lead to the exclusion of certain individuals and groups, meaning they are under-represented in research. This in turn may negatively impact the development of medical, educational and social interventions.
For the last four years, Project ASSENT has looked at research practices in the context of the Mental Capacity Act (MCA, 2005) for England and Wales. This has involved analysis of the research provisions in the MCA, surveying the ethics review process, and exploring the views and opinions of: researchers; members of Research Ethics Committees; people providing care and support; and people with capacity-affecting conditions and communication difficulties.
Everyone we spoke to, regardless of their role (for example reviewer or developer of research proposals, potential participant or collaborator), gave unanimous support for the inclusion of people, regardless of capacity and communicative ability, in research. For people with capacity-affecting conditions, it was about ‘having a voice’ and not being excluded on the grounds of a lack of assessed capacity or because of communication difficulties.
If, as a research community, we are to balance the protection and empowerment of such individuals, we need to recognise personal autonomy in all its gradations. We need to ensure that individuals have opportunities to express their own views about research participation and have these views recognised, regardless of their assessed capacity and any communication difficulties.
Moving forward, Project ASSENT has come up with three key recommendations
We need to:
- Promote researcher-participant cooperation: The system for developing, reviewing and conducting ethically-sound research that includes adults who may lack capacity and have communication difficulties would benefit from redefining. This requires promotion of cooperation between a researcher and a participant such that empowerment is addressed positively within a system that protects. For those deemed to lack capacity, a renewed emphasis on seeking positive assent from a participant, may be a more desirable method of ensuring they have a voice in research.
- Support participant autonomy: There is a strong and enduring need for guidance on the different ways participant autonomy can be supported, regardless of their assessed capacity. Even where a consultee is involved to advise on the likely wishes and feelings of the potential participant, we need to pay deliberate attention to how we involve individuals in any decisions about their participation in research.
- Use a full range of adjustments and supports: As a community interested in research, we need to be better informed about the options that are available to support people who may lack capacity and have communication difficulties. We need to make sure that the conditions are right for a person to use their available skills as far as possible, to understand information, to retain and weight it up, and finally, to communicate in whatever way they can – their decisions or responses to the prospects of participation.
We have developed some online guidance to support inclusive practices around research. This has been formally evaluated by representatives of the research community and is now undergoing revisions. Watch this space for more news on the guidance!’
Dr Karen Bunning, Associate Professor in development and learning disabilities at the University of East Anglia