Authors: Victoria Shepherd, Richard Griffith, Mark Sheehan, Fiona Wood, Kerenza Hood
People who lack capacity to provide informed consent are often excluded from medical research, leading to concerns that there is an evidence-bias in the quality of healthcare received by such groups. Recent campaigns have called for an increase in the amount of UK research into conditions associated with cognitive impairment, such as the Dementia 2020 strategy, the Ministerial Advisory Group looking at the under-representation of care home residents in research, and strategies seeking greater social inclusion of people with learning disabilities which includes their participation in research. These calls form part of a growing recognition that adults who lack capacity should not be excluded from research in the same way that they should not be excluded from accessing services and treatment. However, the challenges of involving adults with cognitive impairments in research are manifold, not least the ethical and legal issues surrounding informed consent, and the need to balance their appropriate inclusion in research with ensuring that their welfare and interests are protected.
Health and social care professionals act as gatekeepers to research by virtue of their role in identifying potential participants, informing them about research opportunities, and seeking informed consent and other research activities. This is particularly the case for those with cognitive impairment where involvement in research occurs in the context of relationships of care and support, and where health and social care professionals may also be responsible for acting as the patient’s representative in situations where family members are unavailable. Their confidence and competence in both recruiting and representing those who lack capacity is essential in order for their patients or clients to have access to research. A lack of knowledge and understanding of the legal provisions for those who lack capacity may act as a barrier to their inclusion in research. As researchers, we have often encountered this challenge when conducting clinical trials and other studies with populations who may lack decision-making capacity. In light of this, we carried out a survey to explore health care professionals and social care practitioners’ knowledge and understanding of the legislation governing research involving adults lacking capacity in England and Wales.
Our study involved a wide range of professionals from community learning disability practitioners to consultant psychiatrists, including specialities ranging from palliative care to critical care. Many were active in research, including people who were leading studies. However, when asked, few were able to identify who was legally authorised to decide about research on behalf of a person who lacked capacity to consent. This was seen across five different scenarios. Of those who did correctly identify the decision-maker, very few could provide any details about how the law described the decision-maker’s role, or the basis for their decision.
Whilst the health and social care professionals’ lack of knowledge and understanding about the legislation was perhaps unsurprising given the complexity of the regulatory framework in England and Wales, the study also revealed a deeper issue about their attitudes towards the inclusion of people with impaired decision-making capacity in medical research. A number of those who responded stated that people who lack capacity should never be included in research, both from an ethical and a legal perspective, and some voiced concerns that only the person’s medical practitioner or an appointed judge should have the authority to decide about research participation, and only when it is determined to be in their best interests to take part. There was a widespread lack of understanding that the decision about research participation should be based on what the person’s wishes and feelings about taking part would be, if they had capacity, which can only be determined through consulting with those that know them well.
The findings reflect some of the wider concerns surrounding decision-making on behalf of those who lack capacity, highlighting tensions arising from the stark binary divide between capacity and incapacity, and associated binaries of autonomy and welfare approaches, which underpins much of the debate in this area. The study may also contribute to the debate surrounding the need to transform thinking about disability and decision-making in the UK with the advent of the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD). Addressing the role of mental (in)capacity as a gatekeeper to inclusion may constitute a step towards realising the rights of people with disabilities to be treated as full and equal citizens.
Our study highlights a considerable need for education and training in this area across all health and social care professions, and at all levels of training and practice. It also suggests that there is a need for a much broader sea change in attitudes towards the inclusion of adults who lack capacity in research. Greater understanding is needed that people with cognitive impairments should have equitable opportunities to be able to access research studies and to contribute to scientific knowledge, in order for them to receive evidence-based care. We hope that this study, together with our ongoing work into the ethical, legal, and practical dimensions of research involving adults who lack capacity, can raise awareness about this issue, and perhaps serve as a driver towards greater inclusiveness of under-researched populations.
Competing Interests: None declared