Title Capacity for change: improving the governance of dementia research Media name/outlet Policy@Manchester Country/Territory United Kingdom Date 11/09/23 Description The Mental Capacity Act 2005 (MCA) outlines legal decision-making procedures in England and Wales for people above the age of 16 who have an impairment of, or disturbance in, the functioning of the mind or brain. It specifies that research involving these people must be approved by a research ethics committee (REC) sanctioned by the Secretary of State. In this article, Dr James Fletcher outlines the systematic weaknesses and the bureaucracy inherent to current dementia research legislation and makes policy and practice recommendations for improvement.
The Mental Capacity Act governs dementia research whilst contravening UN legislation – as it removes peoples’ legal right to personal decision-making due to them having a disability.
The current system of procedural ethics contains inadequacies that can lead to capacity-based exclusion and unethical research.
The Mental Capacity Act should be replaced – or amended to comply with international law and uphold ethical standards.
Dementia research – background and bureaucracy
Currently, only Health Research Authority (HRA) research ethics committees comprising a network of regional NHS committees are sanctioned for dementia research. Research involving people with dementia is automatically subject to HRA research ethics committee governance. However, much dementia research covers neither treatment nor care, meaning that the HRA can be poorly suited to review. This discordance generates a cumbersome bureaucracy that can incentivise unethical research.
The number of research ethics committees in the UK has increased by over 75% since 1990, exemplifying three decades of major growth in the procedural ethical governance of university research. At the same time, British dementia research has flourished, and now includes a world-leading social scientific dementia research sector. The MCA governs research in this sector and attempts to systematise the inclusion of people with cognitive impairments in research whilst balancing competing concerns of safeguarding and involvement. It does this by distinguishing two legal statuses for people with cognitive impairments: having capacity to make decisions and lacking capacity to make decisions.
The contention around capacity
Capacity-based legal discrimination is contentious. The United Nations (UN) Convention on the Rights of Persons with Disabilities (UNCRPD) explicitly rejects impairment-based legal discrimination, preferring a rights-based approach granting equality of legal status. Although the UK has ratified this, it continues to implement the MCA’s capacity-based approach in practice. In response, the UN committee overseeing the Convention has written to the British government expressing concern that the MCA contravenes UN recommendations by removing a legal right to personal decision-making from people due to them having a disability. Hence, the MCA requires dementia researchers to contravene international human rights.
The Mental Capacity Act and dementia research
Beyond human rights concerns, MCA governance of dementia research can also be criticised for manifesting several inadequacies of procedural ethics:
Some procedures focus on protecting institutions from potential litigation at the expense of participant welfare – such as requiring extensive legal text in participant-facing documentation that can be disabling for people with cognitive impairments.
NHS research ethics committees lack the requisite technical expertise for the kinds of advanced dementia research that British universities now host, e.g. cutting-edge digital and creative methodologies, or coproduction practices.
The HRA pathway treats dementia research as health research, but as with other disabilities, life with dementia entails far more than health or care, and so much dementia research is dedicated to issues beyond health.
Health-focussed procedural ethics typically require a degree of standardisation and predictability that is at odds with the innovation and naturalism of much contemporary dementia research. For example, research ethics committees require pre-specified sample characteristics but co-research methodologies can entail participants with dementia designing and implementing sampling procedures.
NHS research ethics committees review is also far more administratively burdensome than the internal review processes that other university-based research undergoes, and is untenable for many time-constrained projects. For example, a two-year study cannot feasibly dedicate 10-12 months to negotiating procedural ethics, meaning that dementia researchers must win larger grants than non-dementia researchers, just to be able to do comparable research.
Finally, HRA governance of dementia research is as it extends considerable institutional power over people who, in practice, receive little direct state support because dementia care is mostly unpaid. Hence, diagnosis brings the person under NHS control, but they receive few services in return.
In combination, these problems incentivise ethically dubious research practices. In research relating to ageing, cognition and care, an expedient way of minimising bureaucratic burden is to exclude people with cognitive impairments outright. As a result, people with cognitive impairments are under-represented in research about issues that are highly relevant to them, such as residential care or having their driving licence revoked. Hence, capacity-based legal discrimination leads to capacity-based exclusion.
These cumbersome procedural ethics processes also risk incentivising non-compliance. In instances where research ethics committee stipulate procedures such as the inclusion of complex/legal jargon (which may be difficult for participants with cognitive impairment to understand), the researchers can face a decision whether to conduct research ethically or legally. The historic expansion of procedural ethics has occurred under the guise of increasing ethical standards, but in practice generated a system that risks non-compliance.
At a macro level, there is a case for replacing the MCA. The Acts capacity-based approach contravenes the UNCRPD’s rights-based approach by discriminating legal statuses based on disability. It also undermines ethical and innovative dementia research by imposing inappropriate and sometimes unfeasible administrative requirements. This creates discrepancies between legal and ethical practice, and wastes large portions of valuable research time on bureaucracy. Hence, there is a strong case for replacing a capacity-based approach with a rights-based approach to comply with international law, uphold ethical standards and better support a world-leading British industry. A rights-based approach cannot discriminate legal statuses based on disability. This means notions of capacity should be replaced with assistive procedures to support personal decision-making in social research. People with dementia should be fully involved (not merely consulted) in the development of such an approach, and funding should be dedicated to its implementation and ongoing governance because disability rights cannot exist practically without sufficient resourcing.
At a smaller scale, the MCA could be amended to improve dementia research governance specifically. The universal delegation of dementia research to the HRA is based on misunderstandings of the sector that lead to unsuitable bureaucratic constraints.
The Department of Health and Social Care should consider establishing a more suitable system for dementia research. Given the UK’s prominence in this field, an improved system would be able to draw on impressive national infrastructures. This system should comprise clear technical and experiential expertise, facilitating review by a team of relevant professionals and people with dementia. Following this strategy, there is no reason that the UK could not have the best dementia research review procedures in the world.
URL https://blog.policy.manchester.ac.uk/posts/2023/09/capacity-for-change-improving-the-governance-of-dementia-research/ Persons James Fletcher
Research Beacons, Institutes and Platforms
- mental capacity
- research policy