What is research and capacity to consent
Research is essential in order to deliver the best treatment and care for people. Everyone should have the opportunity to take part in health and social care research for the benefit of themselves and for others.
Before taking part in research, a person should be given information about the study in order to make an informed decision about whether to participate. However, people with impaired decision making may not be able to consent to take part. This might be due to injury, a learning disability, a mental health problem or a condition such as dementia. It is important that people with impaired capacity are not excluded from taking part in research.
There are provisions in the Mental Capacity Act for research involving adults who lack capacity to consent, but it can be quite complex. It is important that carers and researchers understand these arrangements in order to make research inclusive for all.
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Decision-making and mental capacity
Mental capacity is the ability to make decisions for yourself, and people who cannot do this are said to ‘lack capacity’. It is estimated that over 2 million people in the UK have significantly impaired decision making capacity. The Mental Capacity Act covers important decision making relating to a person’s financial affairs and health and social care in England and Wales. It is underpinned by 5 principles, including that it is assumed that someone has capacity to make their own decisions unless proven otherwise.
This short video by the National Mental Capacity Forum describes the Mental Capacity Act and the five principles that underpin it.
It is important that people should be supported to make their own decisions and communicate those decisions, and they must be given all practicable help before anyone treats them as not being able to make their own decisions. This video describes how this principle includes both ensuring that people receive and understand information, as well as supporting them to make a decision.
There are a number of resources available to help with inclusive communication.
Assessing capacity to consent to research
An assessment about whether someone has capacity to consent to research follows the same process as for all other decisions covered by the Mental Capacity Act. It is the responsibility of the researcher, with appropriate consultation with others, to decide whether someone has the capacity to consent. Capacity should be assessed at the time a decision is required, and it may change over time. A person may also have the capacity to make some decisions and not others, as some decisions require the person to understand more complex information, or weigh up more options than others. If it is established that someone lacks capacity, it is still important that you involve them as far as possible in making decisions. People who have impaired capacity may still be able to communicate their preference about taking part in research and should be supported to do so.
Research involving adults lacking capacity
Health and social care research is important in order to develop better treatments, as well as improve diagnosis, prevention, care and quality of life. People take part in research for lots of different reasons. People affected by conditions such as dementia describe how participating in research leads to them feeling valued, and having an opportunity to change the future, giving hope to them and their children.
It is important that we maximise the inclusion of individuals with impaired capacity in high quality research, whilst ensuring that their rights are protected. To help achieve this, a meeting was held in Wales with UK research leaders and other key stakeholders to look at facilitating access to health and social care research for adults with impaired capacity to consent. Guidance was produced on research and impaired mental capacity in adults.
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Supporting inclusion in research
There is a growing recognition that people with cognitive and communication disabilities should not be excluded from research, in the same way that they should not be excluded from accessing services and treatment. For example, the Dementia Action Plan for Wales gives people living with dementia the right to know about and decide if they want to be involved in research and be supported to take part. Across the UK, the Prime Minister’s Challenge on Dementia 2020 included commitments to provide more opportunities for people living with dementia and their carers to get involved in research. NICE guidelines also highlight the importance of providing people living with dementia the opportunity to participate in research studies at all stages of the condition.
One of the areas where research is very important is in care homes which provide complex care for people with the highest care needs, and where around 70% of residents may lack capacity to consent. A number of initiatives for increasing the ability to conduct research in care homes have been developed. This includes the ENRICH online toolkit which has a huge amount of evidence-based resources for care homes, researchers, residents and their families. In Wales, ENRICH Cymru has created a summary for care home staff about involving residents with limited capacity in research.
Involvement of alternative decision-makers
When someone lacks capacity to make a decision for themselves, other people who know them well are involved in making the decision. For adults who are assessed as lacking capacity to consent to a study, the researcher must seek advice from a consultee (often a family member or close friend) on whether the person should take part in the project, and what their wishes might be if they had capacity to decide. If, at any time, the consultee advises that the person would decline to take part in the study (or would wish to withdraw from it) the advice must be respected. The responsibility to decide whether the person should take part in the study lies with the researcher, unless it is a clinical trial of a medicine where the family member does provide consent as a legal representative.
Unlike other decisions about health and care, the Mental Capacity Act Code of Practice states that decisions made about research are not necessarily based on what would be in the person’s ‘best interests’.
This means that it is possible for research to be carried out which doesn’t actually directly benefit the person taking part, as long as it aims to provide knowledge about the causes, treatment or care of people with the same impairing condition, or a similar condition and presents a negligible risk and is not unduly restrictive. ‘Care’ and ‘treatment’ are not limited to medical care and treatment. For example, research could examine how day-to-day life in prison affects prisoners with mental health conditions (Mental Capacity Act, 2005).
Our survey of health and social care professionals found that the majority were unaware about the legal arrangements enabling people lacking capacity in their care to participate in research. Some thought they could only take part if it was in their ‘best interests’ to do so, and many thought a decision could only be made by the multi-disciplinary team caring for them and not by their families or close friends. This impacts on people with impaired capacity having the opportunity to participate in research and being supported to do so by those who provide their care.
Supporting family members
Decisions about research should be based on what the consultee or legal representative thinks the person’s feelings and wishes would be about taking part. However, it is not always easy to know what someone else’s wishes would be, and people rarely talk about their future research preferences. This can worry family members and lead them to decline participation, even when the person with impaired capacity would have wanted to take part. Our study which explored how family members had made a decision about research for someone else found that they experienced both an emotional and decisional burden and felt that more support is needed. The findings have been made into a short animation.
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Inequalities and exclusion from research
The Welsh Government’s ‘A Healthier Wales’ sets out the vision for everyone in Wales to have longer, healthier and happier lives and aims to reduce health inequalities and achieve equal health outcomes for all. However, there is evidence that people who lack capacity in the UK are frequently excluded from research, which has an impact on the quality of the care they receive. Exclusion from research leads to a disproportionate amount of research with populations that are able to provide consent and denies these populations the opportunity to contribute to, and benefit from, evidence-based care.
For example, people with learning and intellectual disabilities are often excluded from research and so denied the opportunities to benefit from improvements in health and care provision that are available to those without such disabilities. In one international study, over 90% of research studies were designed in ways that would automatically exclude people with intellectual disabilities from participating. However, research studies involving adults with learning disabilities who lack capacity to consent can be harder to conduct. This is partly due to the difficulties of identifying appropriate consultees and legal representatives, as found in this Welsh-led trial (ANDREA-LD) which explored the safety of a reduction of antipsychotic medication by adults with behaviour that challenges. They also found that the care teams and support staff were apprehensive about the legal arrangements around consent.
Ethical issues in research involving adults lacking capacity to consent
Many of the challenges of involving people with impaired capacity in research arise from ethical concerns about potentially exposing ‘vulnerable groups’ to the harms of research. However, an overemphasis on the possible harm may itself lead to harm, and the potential benefits of participation in research may be overlooked. Some of the ethical issues, and the safeguards that are in place, are discussed in a report by the Nuffield Council on Bioethics in the context of dementia.
Practical challenges of conducting research with adults with impaired capacity
There are also a number of practical challenges when conducting research involving people with impaired capacity, including the processes for ethical approval, conducting mental capacity assessments and consulting others. A guide from the British Psychological Society provides practical information on these, including some case studies. A few studies have explored the challenges encountered when setting up a study in care homes that will include residents who lack capacity, and also the views of residents, their families and care staff about providing consent.
Using participatory approaches to consent and research
Alternative approaches, such as ‘process consent’ which focuses on building relationships and inclusion, are increasingly being used which enable more people living with dementia to participate in research. Similar approaches are also used in methods of data collection involving people living in care homes, and the use of research findings to develop evidence-enriched practice as described in this report published by the Joseph Rowntree Foundation.