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Loss of capacity during a study
Participants who provide consent to participate at the outset may lose capacity to provide their ongoing consent during the duration of the study. The legal status of their original consent on their continued participation depends on the type of study and where in the UK it is being conducted. For more information see the Legal Frameworks page of this website, including the table of differences, and the Health Research Authority website.
All studies should consider what steps would be taken in the event of a participant losing capacity to consent during the study, and this question features in the IRAS form. In particular, researchers should consider whether these participants would remain in the study or be withdrawn.
If there is a significant risk of participants' losing capacity during the study, information about options should be provided and discussed at the time of consent and this should be included in the the Participant Information Sheet. Even where the potential for losing capacity was discussed as part of the original consent you should still review how best to proceed if the participant does subsequently lose capacity, as the original consent is not automatically considered valid.
For clinical trials governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (CTIMPs), consent is considered to survive the loss of capacity, provided there are no significant changes to the protocol.
For other intrusive research that is not a clinical trial (non-CTIMPs), under common law in England and Wales consent is not generally considered to endure a loss of capacity. If the participant is to remain in the study and undergo further interventions and procedures in accordance with the protocol, then under the Mental Capacity Act 2005 (MCA) the study requires approval by an appropriate research ethics committee as an MCA study. A consultee should be identified and their advice sought regarding the person's continued participation.
If there are changes to the protocol during the study, or further consent is needed from participants, consent must be sought from the legal representative of participants who lack capacity or advice sought from the consultee. Any request made by a consultee or legal representative to withdraw someone from a study, or if the participant themselves raises any objections, their withdrawal must be considered.
All studies should consider what steps would be taken in the event of a participant losing capacity to consent during the study, and this question features in the IRAS form. In particular, researchers should consider whether these participants would remain in the study or be withdrawn.
If there is a significant risk of participants' losing capacity during the study, information about options should be provided and discussed at the time of consent and this should be included in the the Participant Information Sheet. Even where the potential for losing capacity was discussed as part of the original consent you should still review how best to proceed if the participant does subsequently lose capacity, as the original consent is not automatically considered valid.
For clinical trials governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (CTIMPs), consent is considered to survive the loss of capacity, provided there are no significant changes to the protocol.
For other intrusive research that is not a clinical trial (non-CTIMPs), under common law in England and Wales consent is not generally considered to endure a loss of capacity. If the participant is to remain in the study and undergo further interventions and procedures in accordance with the protocol, then under the Mental Capacity Act 2005 (MCA) the study requires approval by an appropriate research ethics committee as an MCA study. A consultee should be identified and their advice sought regarding the person's continued participation.
If there are changes to the protocol during the study, or further consent is needed from participants, consent must be sought from the legal representative of participants who lack capacity or advice sought from the consultee. Any request made by a consultee or legal representative to withdraw someone from a study, or if the participant themselves raises any objections, their withdrawal must be considered.
Planning ahead
For some people taking part in a research study it may be helpful to plan ahead for a time when they may lack capacity, including making their future wishes and preferences known. This might include discussing their wishes about remaining in the study or being withdrawn with researchers and family members/carers, and identifying who should be consulted about remaining in the study or requesting their withdrawal.
Even if not currently participating in a study, it may be helpful for people to discuss their future wishes about research participation with family members/carers. Making decisions as a consultee or legal representative may be challenging, particularly when the person's wishes and preferences are unknown.
Even if not currently participating in a study, it may be helpful for people to discuss their future wishes about research participation with family members/carers. Making decisions as a consultee or legal representative may be challenging, particularly when the person's wishes and preferences are unknown.
Regaining capacity during a study
As with participants who might lose capacity during a study, some participants might regain capacity during the course of a study. This must be planned for, including how participant withdrawals at each stage will be handled. More information is available on the Health Research Authority website.
The usual process is to inform participants who regain capacity that have been enrolled in a study, provide them with information about the study when they are able to understand it, and ask for their consent to remain in the study. This will require appropriate documents for this stage in the (re)consent process that explains what has happened, what participants can expect, and what they are being asked to consent to.
Legal representatives and consultees should be informed at the outset if participants who regain capacity will be approached for their for their consent to remain in the study.
For emergency research studies where the participant has been enrolled without prior consent or consultation (deferred consent), participants who regain capacity should be approached to provide consent to remain in the study as as soon as they are able. If they lack capacity, then a consultee or legal representative should be identified and approached as soon as is practicable. Their advice or consent should be sought. Further information about emergency research can be found on the Health Research Authority website.
The usual process is to inform participants who regain capacity that have been enrolled in a study, provide them with information about the study when they are able to understand it, and ask for their consent to remain in the study. This will require appropriate documents for this stage in the (re)consent process that explains what has happened, what participants can expect, and what they are being asked to consent to.
Legal representatives and consultees should be informed at the outset if participants who regain capacity will be approached for their for their consent to remain in the study.
For emergency research studies where the participant has been enrolled without prior consent or consultation (deferred consent), participants who regain capacity should be approached to provide consent to remain in the study as as soon as they are able. If they lack capacity, then a consultee or legal representative should be identified and approached as soon as is practicable. Their advice or consent should be sought. Further information about emergency research can be found on the Health Research Authority website.
Fluctuating capacity
Some people's capacity to make decisions may fluctuate and some may experience a temporary loss of capacity due to, for example, to severe pain or the effect of medication. Some peoples' fluctuations in capacity may be more predictable, for example someone living with dementia who becomes tired and less able to understand and retain information later on in the day, or someone with a mental health condition. Guidance on factors that may indicate that a person may regain or develop capacity, and how to support someone with fluctuating or temporary capacity to make a decision, can be found in the Mental Capacity Act Code of Practice in Chapter 5 paragraph 5.28 and Chapter 3 paragraphs 3.12–3.16.
Where someone experiences a fluctuating or temporary loss of capacity it may be possible for some decisions about research to be delayed until the person has the capacity to make it. In other situations where a timely decision about a study does need to be made, it may be possible to maximise someone's ability to make their own decision by, for example, choosing the time of day at which they are most alert. Family members and carers may be able to advise researchers about the best time and environment to approach the person and provide them with information and support them to be involved in making decisions.
For people with fluctuating capacity who are already taking part in research, ongoing decisions and the requirement to revisit consent (how often and when) will depend on the nature of the study and associated research activities.
For some people with fluctuating capacity it may be helpful to plan ahead for a time when they may lack capacity (see previous section).
Where someone experiences a fluctuating or temporary loss of capacity it may be possible for some decisions about research to be delayed until the person has the capacity to make it. In other situations where a timely decision about a study does need to be made, it may be possible to maximise someone's ability to make their own decision by, for example, choosing the time of day at which they are most alert. Family members and carers may be able to advise researchers about the best time and environment to approach the person and provide them with information and support them to be involved in making decisions.
For people with fluctuating capacity who are already taking part in research, ongoing decisions and the requirement to revisit consent (how often and when) will depend on the nature of the study and associated research activities.
For some people with fluctuating capacity it may be helpful to plan ahead for a time when they may lack capacity (see previous section).
Research involving human tissue
How the provisions of the Mental Capacity Act 2005 apply to activities under the Human Tissue Act is covered in paragraphs 114-127 of the Human Tissue Authority Guidance on the principle of consent (Code A).
Storage or use of tissue from adults who lack capacity to consent is permitted in certain circumstances specified in the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
If an adult lacks capacity to consent, the Human Tissue Act 2004 says that tissue can be stored or used without seeking permission if the storage or use is:
- To get information relevant to the health of another individual (for example, before conducting a transplant), as long as the researcher or healthcare professional storing or using the human tissue believes they are doing it in the best interests of the person who lacks capacity to consent
- For a clinical trial approved and carried out under the Medicines for Human Use (Clinical Trials) Regulations 2004, or
- For intrusive research that meets the MCA requirements and has ethical approval
Tissue samples that were obtained before 31 August 2006 are existing holdings under the Human Tissue Act. Researchers can work with these tissues without seeking permission but will need to get ethical approval. Guidance is available in the Human Tissue Authority Code of Practice on consent (Code A).
Storage or use of tissue from adults who lack capacity to consent is permitted in certain circumstances specified in the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
If an adult lacks capacity to consent, the Human Tissue Act 2004 says that tissue can be stored or used without seeking permission if the storage or use is:
- To get information relevant to the health of another individual (for example, before conducting a transplant), as long as the researcher or healthcare professional storing or using the human tissue believes they are doing it in the best interests of the person who lacks capacity to consent
- For a clinical trial approved and carried out under the Medicines for Human Use (Clinical Trials) Regulations 2004, or
- For intrusive research that meets the MCA requirements and has ethical approval
Tissue samples that were obtained before 31 August 2006 are existing holdings under the Human Tissue Act. Researchers can work with these tissues without seeking permission but will need to get ethical approval. Guidance is available in the Human Tissue Authority Code of Practice on consent (Code A).
When consent is not required
Chapter 11 of the MCA Code of Practice states that the circumstances where no consent is needed to lawfully involve a person in research apply to all people whether they have capacity or not. These include:
- Research that only involves data that has been anonymised (it cannot be traced back to individuals). Confidentiality and data protection laws do not apply in this case
- Under the Human Tissue Act 2004, research that deals only with human tissue that has been anonymised does not require consent (see also MCA Code of Practice sections 11.37–11.40). This applies to both those who have capacity and those who do not, but the tissue must come from a living person and the research must have ethical approval
- Human tissue samples collected before 31 August 2006 which do not need a person’s consent for use by researchers, but normally will need to have ethical approval
- Section 251 arrangements that allow the use of confidential patient information by applying to the Confidentiality Advisory Group (CAG) for approval
- Research that only involves data that has been anonymised (it cannot be traced back to individuals). Confidentiality and data protection laws do not apply in this case
- Under the Human Tissue Act 2004, research that deals only with human tissue that has been anonymised does not require consent (see also MCA Code of Practice sections 11.37–11.40). This applies to both those who have capacity and those who do not, but the tissue must come from a living person and the research must have ethical approval
- Human tissue samples collected before 31 August 2006 which do not need a person’s consent for use by researchers, but normally will need to have ethical approval
- Section 251 arrangements that allow the use of confidential patient information by applying to the Confidentiality Advisory Group (CAG) for approval
At the end of the study
Consideration should be given to how the findings of studies involving adults who lack capacity will be provided to those involved. This might include participants, consultees and legal representatives. Researchers should consider issues such as the accessibility of the summary provided, the timing of the feedback, who and how the findings will be shared, and what should happen in the event of the death of the participant. Public involvement may be especially important when planning these processes.
In the event of the death of the participant
Consent given prior to death, is believed to extend beyond death. However, communicating with families about research following the death of a participant and ongoing use of their data after death is a sensitive issue. The Health Research Authority has more information about this and about the collection/use of tissue for research after death.
In legal terms, the General Data Protection Regulation (GDPR) and the Data Protection Act no longer applies to identifiable data that relate to a person once they have died.
In legal terms, the General Data Protection Regulation (GDPR) and the Data Protection Act no longer applies to identifiable data that relate to a person once they have died.
Research conduct resources
These resources are intended to support the conduct of research including ongoing consent processes, retention, withdrawal and dissemination of results.
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Seminal paper on 'process consent', an inclusionary consent approach developed by Dewing for including people with dementia in research. It highlights that people may lack capacity to consent, but are often able to make their preferences about participating in research known.
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Older but useful summary of MCA provisions and other legislation relating to research involving personal health information, anonymised data and anonymised material for adults who lack capacity to consent
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A guide to help researchers to produce a video abstract for people with aphasia. It contains practical support in terms of technical tips, slide/video templates, software and technology suggestions, reflections on video production and examples of aphasia-friendly video abstracts.
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The guidelines explain how organisations should include people with intellectual disabilities in different parts of their work. This includes a series of 'how-to-guides' on communication, conducting meetings, surveys and focus groups, and supporting participation.
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Scottish Learning Disabilities Observatory website where you can see examples of animations, infographics and podcasts co-created by people with learning disabilities and researchers at the University of Glasgow to help make complex health research easier to understand.
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