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What is capacity?
Capacity refers to peoples' everyday ability to make decisions or to take actions that affect them, which can range from simple decisions such as what to eat to more serious decisions about medical treatment or their financial affairs.
A person may lack capacity if they are unable to make or communicate a decision about a particular matter because of an impairment of, or a disturbance in, the mind or the brain.
This may arise from a variety of conditions, including:
A person may lack capacity if they are unable to make or communicate a decision about a particular matter because of an impairment of, or a disturbance in, the mind or the brain.
This may arise from a variety of conditions, including:
- dementia
- stroke
- mental health condition
- learning disability
- delirium
- at the end of life
- other conditions causing a loss of consciousness (e.g. concussion, heart attack, epileptic fit, serious accident)
Assessment of capacity
In England and Wales, there is a presumption that an adult has capacity under the Mental Capacity Act 2005 (MCA). However, if there are concerns that a person lacks capacity to make a particular decision, then the MCA outlines how to determine whether they have capacity. To apply the test, it can best be broken down into three questions:
(1) Is the person able to make a decision? If they cannot:
(2) Is there an impairment or disturbance in the functioning of the person’s mind or brain? If so:
(3) Is the person’s inability to make the decision because of the identified impairment or disturbance?:
The Act says that a person is unable to make a decision if they are unable to:
Capacity is considered to be time and decision specific. Some people may lack capacity to make a complex decision but retain the capacity to make other decisions, and a person’s loss of capacity may be temporary, or capacity may fluctuate. The Health Research Authority has more information about how the MCA applies to research on its website.
The MCA Code of Practice contains additional information about research in Chapter 11, including that the person whose capacity is in question has the right to make decisions that others might not agree with, and they have the right not to take part in research.
(1) Is the person able to make a decision? If they cannot:
(2) Is there an impairment or disturbance in the functioning of the person’s mind or brain? If so:
(3) Is the person’s inability to make the decision because of the identified impairment or disturbance?:
The Act says that a person is unable to make a decision if they are unable to:
- understand the information relevant to the decision
- retain the information
- use or weigh the information
- communicate their decision (by any means).
Capacity is considered to be time and decision specific. Some people may lack capacity to make a complex decision but retain the capacity to make other decisions, and a person’s loss of capacity may be temporary, or capacity may fluctuate. The Health Research Authority has more information about how the MCA applies to research on its website.
The MCA Code of Practice contains additional information about research in Chapter 11, including that the person whose capacity is in question has the right to make decisions that others might not agree with, and they have the right not to take part in research.
Who assesses capacity to consent to research?
The person who requires the decision to be made must assess capacity to make that particular decision at the time the decision needs to be made. It should not be assumed that a person lacks capacity due to factors such as their age, appearance, diagnosis, or place of residence (e.g a care home).
The duty to assess capacity applies to researchers when recruiting participants into, and conducting, intrusive research including clinical trials. It is the responsibility of the researcher who is seeking consent to assess a potential participant's capacity to consent to the research study if there are concerns. The researcher may need other relevant information to support their assessment, for example, the views of staff involved in the person’s care. A record of the findings should be made in the relevant records and/or study documentation. For further guidance on assessing capacity, see Chapter 4 of the MCA Code of Practice.
The duty to assess capacity applies to researchers when recruiting participants into, and conducting, intrusive research including clinical trials. It is the responsibility of the researcher who is seeking consent to assess a potential participant's capacity to consent to the research study if there are concerns. The researcher may need other relevant information to support their assessment, for example, the views of staff involved in the person’s care. A record of the findings should be made in the relevant records and/or study documentation. For further guidance on assessing capacity, see Chapter 4 of the MCA Code of Practice.
Supported decision-making
It is important to do everything practicable to help a person to make a decision for themselves before concluding that they lack capacity to do so (second principle of MCA). People with an illness or disability affecting their ability to make a decision should receive support to help them make their own decision if they are able to do so. This is also captured in the UN Convention on the Rights of Persons with Disabilities (CRPD).
The kind of support people might need to help them make a decision varies depending on the circumstances and their individual support needs. It might include:
Chapter 3 of MCA Code of Practice has more information on ways to help people make decisions for themselves.
The kind of support people might need to help them make a decision varies depending on the circumstances and their individual support needs. It might include:
- using a different form of communication (e.g non-verbal communication)
- providing information in a more accessible format (e.g photographs, drawings, 'easy read', audio-visual or digital)
- treating a medical condition which may be affecting the person’s capacity (e.g the cause of their delirium)
Chapter 3 of MCA Code of Practice has more information on ways to help people make decisions for themselves.
Resources to support communication and assessment of capacity
These resources are intended to support researchers and health and social care professionals to ensure accessible communication and appropriate assessment of capacity when conducting research involving adults with impaired capacity to consent.
Accessibility guidanceGuidance from the MRC which explains how the Patient Information Sheet template can be adjusted for alternative requirements
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Accessible design'Dos and don'ts' on designing for accessibility, including for people with: low vision, dyslexia, motor disabilities, who are D/deaf and hard of hearing, and users of screen readers
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Talking MatsA picture-based communication tool developed by speech and language therapists which has been used in a number of studies. The website also has a page of resources and templates to assist communication with people with communication disability
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Assessing
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Assessing capacity remotely (1)Webinar and other resources from the National Mental Capacity Forum on conducting remote capacity assessments during the COVID-19 crisis (NOTE: this refers to capacity in relation to decisions about care and treatment rather than research)
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Assessing capacity remotely (2)Mental Capacity Law and Policy guidance on the Mental Capacity Act and COVID-19, including resources on conducting remote capacity assessments such as a downloadable guide by Lorraine Currie, MCA lead at Shropshire Council (NOTE: this refers to capacity in relation to decisions about care and treatment rather than research)
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Research VoicesWebsite of resources from 'Research Voices: Including the voices of people with learning disabilities in health research' project which included a Citizens' Jury of adults with learning disabilities discussing health research
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BPS Assessing capacityBritish Psychological Society's guidelines on 'What Makes a Good Assessment of Capacity?' including a section on increasing capacity (primarily relates to decisions about care rather than research)
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Inclusive ResearchGuidance from Inclusive Research on preparing for inclusive research with people with disabilities. Includes guidance on accessibility and consent (not specific to people who may have impaired capacity to consent)
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Trials for Aphasia resourcesResources for planning and conducting RCTs in aphasia rehabilitation collated by CATs Trials for Aphasia panel. Includes resources on public involvement, accessible information, ethical and governance guidelines, and outcome measurement.
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Aphasia accessible informationGuidelines produced by the Stroke Association for use by people working with people with aphasia. They aim to help people produce written materials, in order to make them more accessible to people with aphasia (generic rather than specific to research)
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Clinical Trials: An easy-read guideGuidance produced by the National Institute for Health Research (NIHR) which provides easy-read information for potential research participants explaining what clinical trials are, why they're carried out, what a research team is, and what's involved when taking part.
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Accessibility by Design (AbD) ToolkitA comprehensive resource to support greater inclusion of people with disabilities (although not people lacking capacity to consent) in clinical research. It was developed by the MRCT Center in collaboration with people with disabilities, family caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
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SCIE webinar on supported decision-makingWebinar focusing practicable steps for people with communication difficulties. Exploring who might need supported decision-making, what supported decision-making for people with communication difficulties might look like in practice, how Speech & Language Therapists can help, and what other professionals can do
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Guidance from ASSENT projectGuidance on including adults who may lack capacity and may have communication difficulties in ethically sound research, and to promote understanding on the research provisions of the Mental Capacity Act 2005. Aimed at researchers, REC members, people who may lack capacity and those who support them.
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Guidance from Innovations in Dementia on accessible writing for people living with dementia - and everyone else! (generic rather than specific to research). This guide was produced with help from the Dementia Diarists DEEP group.
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