79C3C34C52B45572883A05D425EB0F82
Mental Capacity Act
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/
http://leaux.net/URLS/ConvertAPI Text Files/FEE6D374E6F6472F9BCE3FF16B702931.en.txt
Examining the file media/Synopses/FEE6D374E6F6472F9BCE3FF16B702931.html:
This file was generated: 2020-12-01 07:17:42
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
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p.(None): statutory Code of Practice.
p.(None):
p.(None): Whose responsibility is it to decide whether a potential participant has the capacity to consent for
p.(None): themselves to research?
p.(None):
p.(None): This is the responsibility of the researcher, consulting as appropriate with other care professionals.
p.(None):
p.(None):
p.(None):
p.(None): Scope of the research provisions
p.(None):
p.(None): Does the Mental Capacity Act apply to my research?
p.(None): The Act applies to any intrusive research within England and Wales, wherever it takes place, except
p.(None): for clinical trials of investigational medicinal products. This may include research in healthcare, social
p.(None): care, criminal justice and other settings. It is not limited to research undertaken within NHS
p.(None): organisations or other public bodies.
p.(None):
p.(None):
p.(None): Which parts of the Act apply to research?
p.(None): Sections 30-33 of the Act provide lawful authority for intrusive research to be carried out involving
p.(None): people without capacity provided that the research has been approved by an appropriate body.
p.(None): Section 34 makes transitional provisions relating to the loss of capacity in research which started
p.(None): before 1 October 2007.
p.(None):
p.(None):
p.(None): What is “intrusive research”?
p.(None): Under Section 30 of the Act, research is intrusive if it is of a kind that would be unlawful if it was
p.(None): carried out “on or in relation to a person who had capacity to consent to it, but without this
p.(None): consent”. Therefore intrusive research means research that would legally require consent if it
p.(None): involved people with capacity. Intrusive research is not limited to trials of clinical interventions.
p.(None):
p.(None): It includes non- interventional research where consent is legally required, for example involving the
p.(None): processing of personal data or the administration of questionnaires, interviews or observations.
p.(None): Intrusive research involving a person who lacks capacity is unlawful unless it is approved by an
p.(None): appropriate body.
p.(None):
p.(None):
p.(None): What research is not intrusive?
p.(None): Consent is not a legal requirement, and therefore the research is not intrusive, if it is limited to one
p.(None): or more of the following:
p.(None):
p.(None): processing of non-identifiable data
p.(None): processing of identifiable patient data with the approval under Section 251 of the NHS Act
p.(None): 2006 (or formerly under Section 60 of the Health and Social Care Act 2001)
p.(None): use of tissue samples (cellular material) held prior to the coming into force of the Human
p.(None): Tissue Act on 1 September 2006 (“existing holdings”)
p.(None): use of tissue samples (cellular material) taken from a living person, provided that the
p.(None): person is not identifiable to the researcher and the research project has ethical approval
p.(None): use of the results of the analysis of DNA in material taken from a living person, provided
p.(None): that the person is not identifiable to the researcher and the research project has ethical
p.(None): approval.
p.(None):
p.(None):
p.(None): Does the Mental Capacity Act apply to clinical trials of investigational
p.(None): medicinal products (CTIMPs)?
p.(None): No. Under Section 30 of the MCA, CTIMPS are specifically excluded from the research provisions of
p.(None): the Act. This is because separate provision is made for including adults lacking capacity in CTIMPs in
p.(None): Schedule 1 of the Medicines for Human Use (ClinicalTrials) Regulations 2004.
p.(None):
p.(None): Further information about these provisions is available in our information paper on informed
p.(None): consent in CTIMPs.
p.(None):
...
Political / criminal
Searching for indicator criminal:
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p.(None): decision needs to be made, and should not assume that a person cannot make any decision. A
p.(None): person’s loss of capacity may be temporary, and capacity may fluctuate.
p.(None):
p.(None): Some people may lack capacity to make a complex decision but retain the capacity to make other
p.(None): decisions. The duty to assess capacity also applies to researchers when recruiting participants into,
p.(None): and conducting, intrusive research. For further guidance on assessing capacity, see Chapter 4 of the
p.(None): statutory Code of Practice.
p.(None):
p.(None): Whose responsibility is it to decide whether a potential participant has the capacity to consent for
p.(None): themselves to research?
p.(None):
p.(None): This is the responsibility of the researcher, consulting as appropriate with other care professionals.
p.(None):
p.(None):
p.(None):
p.(None): Scope of the research provisions
p.(None):
p.(None): Does the Mental Capacity Act apply to my research?
p.(None): The Act applies to any intrusive research within England and Wales, wherever it takes place, except
p.(None): for clinical trials of investigational medicinal products. This may include research in healthcare, social
p.(None): care, criminal justice and other settings. It is not limited to research undertaken within NHS
p.(None): organisations or other public bodies.
p.(None):
p.(None):
p.(None): Which parts of the Act apply to research?
p.(None): Sections 30-33 of the Act provide lawful authority for intrusive research to be carried out involving
p.(None): people without capacity provided that the research has been approved by an appropriate body.
p.(None): Section 34 makes transitional provisions relating to the loss of capacity in research which started
p.(None): before 1 October 2007.
p.(None):
p.(None):
p.(None): What is “intrusive research”?
p.(None): Under Section 30 of the Act, research is intrusive if it is of a kind that would be unlawful if it was
p.(None): carried out “on or in relation to a person who had capacity to consent to it, but without this
p.(None): consent”. Therefore intrusive research means research that would legally require consent if it
p.(None): involved people with capacity. Intrusive research is not limited to trials of clinical interventions.
p.(None):
p.(None): It includes non- interventional research where consent is legally required, for example involving the
p.(None): processing of personal data or the administration of questionnaires, interviews or observations.
...
Political / stateless persons
Searching for indicator nation:
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p.(None): specific questions about compliance with the Act in Part B Section 6 of the form.
p.(None):
p.(None): The study protocol should describe the procedures for recruiting people lacking capacity, including
p.(None): arrangements for identifying and consulting consultees.
p.(None):
p.(None): If appropriate, procedures should be described for seeking consent from participants who may
p.(None): regain capacity during the study.
p.(None):
p.(None):
p.(None): What happens where research is conducted in Scotland as well as England or
p.(None): Wales?
p.(None): Research conducted in England/Wales and Scotland requires separate approvals under the Mental
p.(None): Capacity Act and the Adults with Incapacity (Scotland) Act 2000 respectively.
p.(None):
p.(None): Separate applications should be made to recognised RECs in each jurisdiction. In Scotland, the
p.(None): application must be made to the Scotland A REC and should include a consent form for the
p.(None): guardian, welfare attorney or adult’s nearest relative. Guidance on documentation to be used in
p.(None): recruiting participants lacking capacity in Scotland is available in our guidance on information sheets
p.(None): and consent forms.
p.(None):
p.(None):
p.(None): What happens where research is conducted in Northern Ireland as well as
p.(None): another UK nation?
p.(None): If the research is taking place in England or Wales as well as Northern Ireland, only one application is
p.(None): needed. This should be made to a recognised REC in England and Wales.
p.(None):
p.(None): The main REC (England and Wales) will liaise with a Health and Social Care REC in Northern Ireland
p.(None): in reviewing the documentation to be used in Northern Ireland.
p.(None):
p.(None): Further guidance is available in our guidance on information sheets and consent forms.
p.(None):
p.(None):
p.(None): What is the position for research that started before the Act came into
p.(None): force?
p.(None): Any intrusive research involving adults lacking capacity, that started prior to 1 October 2007,
p.(None): required further approval from a recognised REC under Section 30 of the Act by 1 October 2008.
p.(None):
p.(None): If such approval has not been obtained, it is no longer lawful to undertake any intrusive research
p.(None): procedures on or in relation to adults lacking capacity.
p.(None):
p.(None):
p.(None):
p.(None): Approval criteria
p.(None):
p.(None): What are the requirements for approval?
p.(None): The approval criteria are set out in Section 31 of the Act:
p.(None):
p.(None): 1. The research must be connected with an impairing condition affecting the participant or
p.(None): its treatment.
p.(None): 2. Research of equal effectiveness could not be carried out if confined to participants with
p.(None): capacity.
p.(None): 3. The research must either: (a) have the potential to benefit the participant without
p.(None): imposing a disproportionate burden, or (b) provide knowledge of the causes of, or
...
Health / Cognitive Impairment
Searching for indicator impairment:
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p.(None): involving participants lacking mental capacity.
p.(None):
p.(None):
p.(None):
p.(None): What are the core principles of the Act?
p.(None): Section 1 of the Act sets out a number of core principles. These are rooted in the common law,
p.(None): ethical guidelines and best practice and are designed to be fully compliant with the relevant sections
p.(None): of the Human Rights Act.
p.(None):
p.(None): These principles are:
p.(None):
p.(None): a person must be assumed to have capacity unless established otherwise
p.(None): individuals should be helped to make their own decisions as far as practicable
p.(None): a person is not to be treated as unable to make a decision merely because he makes an
p.(None): unwise decision
p.(None): all decisions and actions must be in the best interests of the person lacking capacity
p.(None): all decisions and actions must be the least restrictive of the person’s rights and freedom of
p.(None): action.
p.(None):
p.(None):
p.(None):
p.(None): What is capacity?
p.(None): Capacity refers to the everyday ability that individuals possess to make decisions or to take actions
p.(None): that affect them, from simple decisions such as what to have for breakfast to far-reaching decisions
p.(None): about serious medical treatment or financial affairs.
p.(None):
p.(None): A person lacks capacity if he or she is unable to make or communicate a decision about a particular
p.(None): matter because of an impairment of, or a disturbance in, the mind or the brain.
p.(None): This may be the result of a variety of conditions, including:
p.(None):
p.(None): dementia
p.(None): mental illness
p.(None): learning disability
p.(None): brain damage
p.(None): intoxication
p.(None): any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion,
p.(None): stroke, heart attack, epileptic fit, serious accident, delirium).
p.(None):
p.(None):
p.(None):
p.(None): How is capacity assessed?
p.(None): The Act contains a two-stage test of capacity:
p.(None):
p.(None): Is there an impairment of, or disturbance to, the functioning of the mind or brain?
p.(None):
p.(None): And if so;
p.(None):
p.(None): Is the impairment or disturbance sufficient that the person is unable to make that
p.(None): particular decision?
p.(None):
p.(None):
p.(None): The Act says that a person is unable to make a decision if unable to:
p.(None):
p.(None): understand the information relevant to the decision
p.(None): retain the information
p.(None): use or weigh the information
p.(None): communicate his or her decision (by any means).
p.(None):
p.(None): A person with a duty of care must assess capacity to make a particular decision at the time the
p.(None): decision needs to be made, and should not assume that a person cannot make any decision. A
p.(None): person’s loss of capacity may be temporary, and capacity may fluctuate.
p.(None):
p.(None): Some people may lack capacity to make a complex decision but retain the capacity to make other
p.(None): decisions. The duty to assess capacity also applies to researchers when recruiting participants into,
p.(None): and conducting, intrusive research. For further guidance on assessing capacity, see Chapter 4 of the
p.(None): statutory Code of Practice.
p.(None):
p.(None): Whose responsibility is it to decide whether a potential participant has the capacity to consent for
p.(None): themselves to research?
p.(None):
p.(None): This is the responsibility of the researcher, consulting as appropriate with other care professionals.
p.(None):
p.(None):
p.(None):
p.(None): Scope of the research provisions
...
Health / Intoxication
Searching for indicator intoxication:
(return to top)
p.(None): of the Human Rights Act.
p.(None):
p.(None): These principles are:
p.(None):
p.(None): a person must be assumed to have capacity unless established otherwise
p.(None): individuals should be helped to make their own decisions as far as practicable
p.(None): a person is not to be treated as unable to make a decision merely because he makes an
p.(None): unwise decision
p.(None): all decisions and actions must be in the best interests of the person lacking capacity
p.(None): all decisions and actions must be the least restrictive of the person’s rights and freedom of
p.(None): action.
p.(None):
p.(None):
p.(None):
p.(None): What is capacity?
p.(None): Capacity refers to the everyday ability that individuals possess to make decisions or to take actions
p.(None): that affect them, from simple decisions such as what to have for breakfast to far-reaching decisions
p.(None): about serious medical treatment or financial affairs.
p.(None):
p.(None): A person lacks capacity if he or she is unable to make or communicate a decision about a particular
p.(None): matter because of an impairment of, or a disturbance in, the mind or the brain.
p.(None): This may be the result of a variety of conditions, including:
p.(None):
p.(None): dementia
p.(None): mental illness
p.(None): learning disability
p.(None): brain damage
p.(None): intoxication
p.(None): any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion,
p.(None): stroke, heart attack, epileptic fit, serious accident, delirium).
p.(None):
p.(None):
p.(None):
p.(None): How is capacity assessed?
p.(None): The Act contains a two-stage test of capacity:
p.(None):
p.(None): Is there an impairment of, or disturbance to, the functioning of the mind or brain?
p.(None):
p.(None): And if so;
p.(None):
p.(None): Is the impairment or disturbance sufficient that the person is unable to make that
p.(None): particular decision?
p.(None):
p.(None):
p.(None): The Act says that a person is unable to make a decision if unable to:
p.(None):
p.(None): understand the information relevant to the decision
p.(None): retain the information
p.(None): use or weigh the information
p.(None): communicate his or her decision (by any means).
p.(None):
p.(None): A person with a duty of care must assess capacity to make a particular decision at the time the
p.(None): decision needs to be made, and should not assume that a person cannot make any decision. A
p.(None): person’s loss of capacity may be temporary, and capacity may fluctuate.
p.(None):
p.(None): Some people may lack capacity to make a complex decision but retain the capacity to make other
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.(None): ethical guidelines and best practice and are designed to be fully compliant with the relevant sections
p.(None): of the Human Rights Act.
p.(None):
p.(None): These principles are:
p.(None):
p.(None): a person must be assumed to have capacity unless established otherwise
p.(None): individuals should be helped to make their own decisions as far as practicable
p.(None): a person is not to be treated as unable to make a decision merely because he makes an
p.(None): unwise decision
p.(None): all decisions and actions must be in the best interests of the person lacking capacity
p.(None): all decisions and actions must be the least restrictive of the person’s rights and freedom of
p.(None): action.
p.(None):
p.(None):
p.(None):
p.(None): What is capacity?
p.(None): Capacity refers to the everyday ability that individuals possess to make decisions or to take actions
p.(None): that affect them, from simple decisions such as what to have for breakfast to far-reaching decisions
p.(None): about serious medical treatment or financial affairs.
p.(None):
p.(None): A person lacks capacity if he or she is unable to make or communicate a decision about a particular
p.(None): matter because of an impairment of, or a disturbance in, the mind or the brain.
p.(None): This may be the result of a variety of conditions, including:
p.(None):
p.(None): dementia
p.(None): mental illness
p.(None): learning disability
p.(None): brain damage
p.(None): intoxication
p.(None): any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion,
p.(None): stroke, heart attack, epileptic fit, serious accident, delirium).
p.(None):
p.(None):
p.(None):
p.(None): How is capacity assessed?
p.(None): The Act contains a two-stage test of capacity:
p.(None):
p.(None): Is there an impairment of, or disturbance to, the functioning of the mind or brain?
p.(None):
p.(None): And if so;
p.(None):
p.(None): Is the impairment or disturbance sufficient that the person is unable to make that
p.(None): particular decision?
p.(None):
p.(None):
p.(None): The Act says that a person is unable to make a decision if unable to:
p.(None):
p.(None): understand the information relevant to the decision
p.(None): retain the information
p.(None): use or weigh the information
p.(None): communicate his or her decision (by any means).
p.(None):
p.(None): A person with a duty of care must assess capacity to make a particular decision at the time the
p.(None): decision needs to be made, and should not assume that a person cannot make any decision. A
p.(None): person’s loss of capacity may be temporary, and capacity may fluctuate.
p.(None):
p.(None): Some people may lack capacity to make a complex decision but retain the capacity to make other
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.(None): What are the core principles of the Act?
p.(None): Section 1 of the Act sets out a number of core principles. These are rooted in the common law,
p.(None): ethical guidelines and best practice and are designed to be fully compliant with the relevant sections
p.(None): of the Human Rights Act.
p.(None):
p.(None): These principles are:
p.(None):
p.(None): a person must be assumed to have capacity unless established otherwise
p.(None): individuals should be helped to make their own decisions as far as practicable
p.(None): a person is not to be treated as unable to make a decision merely because he makes an
p.(None): unwise decision
p.(None): all decisions and actions must be in the best interests of the person lacking capacity
p.(None): all decisions and actions must be the least restrictive of the person’s rights and freedom of
p.(None): action.
p.(None):
p.(None):
p.(None):
p.(None): What is capacity?
p.(None): Capacity refers to the everyday ability that individuals possess to make decisions or to take actions
p.(None): that affect them, from simple decisions such as what to have for breakfast to far-reaching decisions
p.(None): about serious medical treatment or financial affairs.
p.(None):
p.(None): A person lacks capacity if he or she is unable to make or communicate a decision about a particular
p.(None): matter because of an impairment of, or a disturbance in, the mind or the brain.
p.(None): This may be the result of a variety of conditions, including:
p.(None):
p.(None): dementia
p.(None): mental illness
p.(None): learning disability
p.(None): brain damage
p.(None): intoxication
p.(None): any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion,
p.(None): stroke, heart attack, epileptic fit, serious accident, delirium).
p.(None):
p.(None):
p.(None):
p.(None): How is capacity assessed?
p.(None): The Act contains a two-stage test of capacity:
p.(None):
p.(None): Is there an impairment of, or disturbance to, the functioning of the mind or brain?
p.(None):
p.(None): And if so;
p.(None):
p.(None): Is the impairment or disturbance sufficient that the person is unable to make that
p.(None): particular decision?
p.(None):
p.(None):
p.(None): The Act says that a person is unable to make a decision if unable to:
p.(None):
p.(None): understand the information relevant to the decision
p.(None): retain the information
p.(None): use or weigh the information
p.(None): communicate his or her decision (by any means).
p.(None):
p.(None): A person with a duty of care must assess capacity to make a particular decision at the time the
p.(None): decision needs to be made, and should not assume that a person cannot make any decision. A
p.(None): person’s loss of capacity may be temporary, and capacity may fluctuate.
p.(None):
...
Health / patients in emergency situations
Searching for indicator emergency situation:
(return to top)
p.(None): sheets and consent forms.
p.(None):
p.(None):
p.(None): Should the consultee continue to be involved during the study?
p.(None): Yes. If the study involves a series of procedures, it is good practice for the researcher to keep the
p.(None): consultee fully informed, for example by attending any research procedures and providing support
p.(None): to the participant.
p.(None):
p.(None): If the consultee advises that the participant should be withdrawn, the researcher must withdraw
p.(None): them unless this would produce a significant risk to their health.
p.(None):
p.(None):
p.(None): What should I do if the personal consultee becomes unavailable during the
p.(None): study, or is no longer willing to undertake the role?
p.(None): The researcher should take steps to identify another personal consultee to take on the role. If no
p.(None): other appropriate person can be identified, a nominated consultee should be approached.
p.(None):
p.(None):
p.(None): What if the treatment to be given as part of the research is urgent and there
p.(None): is no time to approach a consultee?
p.(None): Section 32(8) of the Act allows exceptionally for a person lacking capacity to be entered into
p.(None): research prior to a consultee being consulted.
p.(None):
p.(None): There are strict conditions:
p.(None):
p.(None): urgent treatment is to be provided and it is not possible to separate this from inclusion in
p.(None): the research
p.(None): it is not practicable to identify and consult a consultee before providing the treatment.
p.(None):
p.(None): This exception only applies during the emergency situation. As soon as time allows, the researcher
p.(None): must then consult a consultee or seek the participant’s consent (if capacity has been recovered)
p.(None): about their continued inclusion in the research and use of any samples or data already collected.
p.(None):
p.(None):
p.(None):
p.(None): Consent
p.(None):
p.(None): Who do I seek consent from if a participant lacks capacity?
p.(None): Under the Mental Capacity Act, no-one gives consent on behalf of a person lacking capacity. Instead,
p.(None): the researcher is required to seek advice from a consultee on what the wishes and feelings of the
p.(None): person might be and whether or not they should take part.
p.(None):
p.(None): The consultee gives advice, not consent in law. Responsibility to decide whether the person should
p.(None): be entered into the research lies with ultimately with the researcher.
p.(None):
p.(None):
p.(None): Can researchers seek advance consent anticipating the loss of capacity,
p.(None): without needing approval under the Act?
p.(None): No. Consent does not survive the loss of capacity under common law. A person with capacity may
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): approval.
p.(None):
p.(None):
p.(None): Does the Mental Capacity Act apply to clinical trials of investigational
p.(None): medicinal products (CTIMPs)?
p.(None): No. Under Section 30 of the MCA, CTIMPS are specifically excluded from the research provisions of
p.(None): the Act. This is because separate provision is made for including adults lacking capacity in CTIMPs in
p.(None): Schedule 1 of the Medicines for Human Use (ClinicalTrials) Regulations 2004.
p.(None):
p.(None): Further information about these provisions is available in our information paper on informed
p.(None): consent in CTIMPs.
p.(None):
p.(None):
p.(None): Do the research provisions apply in Scotland and Northern Ireland?
p.(None): No. The Mental Capacity Act only applies to England and Wales. In Scotland, the inclusion of adults
p.(None): lacking capacity in research is governed by the provisions of Section 51 of the Adults with Incapacity
p.(None): (Scotland) Act 2000. In Northern Ireland, it is currently governed by the provisions of the Mental
p.(None): Capacity Act (Northern Ireland) 2016.
p.(None):
p.(None):
p.(None): Do the research provisions apply to children?
p.(None): In general the Act applies only to people aged 16 and over. There are a few exceptions, which are
p.(None): explained in Chapter 12 of the Code of Practice. For projects involving children under the age of 16,
p.(None): researchers and research ethics committees are advised to follow existing guidance, such as that
p.(None): provided by the Medical Research Council.
p.(None):
p.(None):
p.(None): Do projects not classified as research require approval under the Mental
p.(None): Capacity Act?
p.(None): No. The provisions of Sections 30-34 of the Act apply only to intrusive research.
p.(None): Appropriate body
p.(None):
p.(None): What is the role of the appropriate body?
p.(None): The appropriate body is responsible for approving intrusive research involving adults lacking
p.(None): capacity. It must be satisfied that all the criteria in Section 31 of the Act are met, including that
p.(None): arrangements are in place to satisfy the requirements of Sections 32 and 33.
p.(None):
p.(None):
p.(None): Who can act as the appropriate body?
p.(None): An appropriate body is a Research Ethics Committee recognised by the Secretary of State or Welsh
p.(None): Ministers.
p.(None):
p.(None): All NHS RECs in England and Wales are recognised. RECs in Scotland and Northern Ireland are not
p.(None): recognised for the purposes of the Mental Capacity Act.
p.(None):
p.(None): In addition, there is a national Social Care REC (SCREC) which is recognised as an appropriate body
p.(None): under the Mental Capacity Act. University ethics committees are not recognised by the Secretary of
p.(None): State or Welsh Ministers and are not appropriate bodies under the Act.
p.(None):
...
Social / Child
Searching for indicator children:
(return to top)
p.(None): person is not identifiable to the researcher and the research project has ethical approval
p.(None): use of the results of the analysis of DNA in material taken from a living person, provided
p.(None): that the person is not identifiable to the researcher and the research project has ethical
p.(None): approval.
p.(None):
p.(None):
p.(None): Does the Mental Capacity Act apply to clinical trials of investigational
p.(None): medicinal products (CTIMPs)?
p.(None): No. Under Section 30 of the MCA, CTIMPS are specifically excluded from the research provisions of
p.(None): the Act. This is because separate provision is made for including adults lacking capacity in CTIMPs in
p.(None): Schedule 1 of the Medicines for Human Use (ClinicalTrials) Regulations 2004.
p.(None):
p.(None): Further information about these provisions is available in our information paper on informed
p.(None): consent in CTIMPs.
p.(None):
p.(None):
p.(None): Do the research provisions apply in Scotland and Northern Ireland?
p.(None): No. The Mental Capacity Act only applies to England and Wales. In Scotland, the inclusion of adults
p.(None): lacking capacity in research is governed by the provisions of Section 51 of the Adults with Incapacity
p.(None): (Scotland) Act 2000. In Northern Ireland, it is currently governed by the provisions of the Mental
p.(None): Capacity Act (Northern Ireland) 2016.
p.(None):
p.(None):
p.(None): Do the research provisions apply to children?
p.(None): In general the Act applies only to people aged 16 and over. There are a few exceptions, which are
p.(None): explained in Chapter 12 of the Code of Practice. For projects involving children under the age of 16,
p.(None): researchers and research ethics committees are advised to follow existing guidance, such as that
p.(None): provided by the Medical Research Council.
p.(None):
p.(None):
p.(None): Do projects not classified as research require approval under the Mental
p.(None): Capacity Act?
p.(None): No. The provisions of Sections 30-34 of the Act apply only to intrusive research.
p.(None): Appropriate body
p.(None):
p.(None): What is the role of the appropriate body?
p.(None): The appropriate body is responsible for approving intrusive research involving adults lacking
p.(None): capacity. It must be satisfied that all the criteria in Section 31 of the Act are met, including that
p.(None): arrangements are in place to satisfy the requirements of Sections 32 and 33.
p.(None):
p.(None):
p.(None): Who can act as the appropriate body?
p.(None): An appropriate body is a Research Ethics Committee recognised by the Secretary of State or Welsh
p.(None): Ministers.
p.(None):
p.(None): All NHS RECs in England and Wales are recognised. RECs in Scotland and Northern Ireland are not
p.(None): recognised for the purposes of the Mental Capacity Act.
p.(None):
p.(None): In addition, there is a national Social Care REC (SCREC) which is recognised as an appropriate body
p.(None): under the Mental Capacity Act. University ethics committees are not recognised by the Secretary of
p.(None): State or Welsh Ministers and are not appropriate bodies under the Act.
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.(None): 2006 (or formerly under Section 60 of the Health and Social Care Act 2001)
p.(None): use of tissue samples (cellular material) held prior to the coming into force of the Human
p.(None): Tissue Act on 1 September 2006 (“existing holdings”)
p.(None): use of tissue samples (cellular material) taken from a living person, provided that the
p.(None): person is not identifiable to the researcher and the research project has ethical approval
p.(None): use of the results of the analysis of DNA in material taken from a living person, provided
p.(None): that the person is not identifiable to the researcher and the research project has ethical
p.(None): approval.
p.(None):
p.(None):
p.(None): Does the Mental Capacity Act apply to clinical trials of investigational
p.(None): medicinal products (CTIMPs)?
p.(None): No. Under Section 30 of the MCA, CTIMPS are specifically excluded from the research provisions of
p.(None): the Act. This is because separate provision is made for including adults lacking capacity in CTIMPs in
p.(None): Schedule 1 of the Medicines for Human Use (ClinicalTrials) Regulations 2004.
p.(None):
p.(None): Further information about these provisions is available in our information paper on informed
p.(None): consent in CTIMPs.
p.(None):
p.(None):
p.(None): Do the research provisions apply in Scotland and Northern Ireland?
p.(None): No. The Mental Capacity Act only applies to England and Wales. In Scotland, the inclusion of adults
p.(None): lacking capacity in research is governed by the provisions of Section 51 of the Adults with Incapacity
p.(None): (Scotland) Act 2000. In Northern Ireland, it is currently governed by the provisions of the Mental
p.(None): Capacity Act (Northern Ireland) 2016.
p.(None):
p.(None):
p.(None): Do the research provisions apply to children?
p.(None): In general the Act applies only to people aged 16 and over. There are a few exceptions, which are
p.(None): explained in Chapter 12 of the Code of Practice. For projects involving children under the age of 16,
p.(None): researchers and research ethics committees are advised to follow existing guidance, such as that
p.(None): provided by the Medical Research Council.
p.(None):
p.(None):
p.(None): Do projects not classified as research require approval under the Mental
p.(None): Capacity Act?
p.(None): No. The provisions of Sections 30-34 of the Act apply only to intrusive research.
p.(None): Appropriate body
p.(None):
p.(None): What is the role of the appropriate body?
p.(None): The appropriate body is responsible for approving intrusive research involving adults lacking
p.(None): capacity. It must be satisfied that all the criteria in Section 31 of the Act are met, including that
p.(None): arrangements are in place to satisfy the requirements of Sections 32 and 33.
p.(None):
p.(None):
p.(None): Who can act as the appropriate body?
p.(None): An appropriate body is a Research Ethics Committee recognised by the Secretary of State or Welsh
p.(None): Ministers.
p.(None):
...
p.(None):
p.(None):
p.(None):
p.(None): Applying for approval under the Act
p.(None):
p.(None): Which REC should I apply to?
p.(None): The Research Ethics Service has flagged a number of NHS RECs in England and Wales to review new
p.(None): applications for approval under the Mental Capacity Act. Members of these RECs have had
p.(None): additional training in issues relating to the MCA.
p.(None):
p.(None): Applications should be booked with our Online Booking Service so they can be allocated to an
p.(None): appropriate REC.
p.(None):
p.(None):
p.(None): Are there any specific requirements for applications under the Act?
p.(None): The application form, available via the Integrated Research Application System (IRAS) , incorporates
p.(None): specific questions about compliance with the Act in Part B Section 6 of the form.
p.(None):
p.(None): The study protocol should describe the procedures for recruiting people lacking capacity, including
p.(None): arrangements for identifying and consulting consultees.
p.(None):
p.(None): If appropriate, procedures should be described for seeking consent from participants who may
p.(None): regain capacity during the study.
p.(None):
p.(None):
p.(None): What happens where research is conducted in Scotland as well as England or
p.(None): Wales?
p.(None): Research conducted in England/Wales and Scotland requires separate approvals under the Mental
p.(None): Capacity Act and the Adults with Incapacity (Scotland) Act 2000 respectively.
p.(None):
p.(None): Separate applications should be made to recognised RECs in each jurisdiction. In Scotland, the
p.(None): application must be made to the Scotland A REC and should include a consent form for the
p.(None): guardian, welfare attorney or adult’s nearest relative. Guidance on documentation to be used in
p.(None): recruiting participants lacking capacity in Scotland is available in our guidance on information sheets
p.(None): and consent forms.
p.(None):
p.(None):
p.(None): What happens where research is conducted in Northern Ireland as well as
p.(None): another UK nation?
p.(None): If the research is taking place in England or Wales as well as Northern Ireland, only one application is
p.(None): needed. This should be made to a recognised REC in England and Wales.
p.(None):
p.(None): The main REC (England and Wales) will liaise with a Health and Social Care REC in Northern Ireland
p.(None): in reviewing the documentation to be used in Northern Ireland.
p.(None):
p.(None): Further guidance is available in our guidance on information sheets and consent forms.
p.(None):
p.(None):
p.(None): What is the position for research that started before the Act came into
p.(None): force?
p.(None): Any intrusive research involving adults lacking capacity, that started prior to 1 October 2007,
p.(None): required further approval from a recognised REC under Section 30 of the Act by 1 October 2008.
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None):
p.(None): Some people may lack capacity to make a complex decision but retain the capacity to make other
p.(None): decisions. The duty to assess capacity also applies to researchers when recruiting participants into,
p.(None): and conducting, intrusive research. For further guidance on assessing capacity, see Chapter 4 of the
p.(None): statutory Code of Practice.
p.(None):
p.(None): Whose responsibility is it to decide whether a potential participant has the capacity to consent for
p.(None): themselves to research?
p.(None):
p.(None): This is the responsibility of the researcher, consulting as appropriate with other care professionals.
p.(None):
p.(None):
p.(None):
p.(None): Scope of the research provisions
p.(None):
p.(None): Does the Mental Capacity Act apply to my research?
p.(None): The Act applies to any intrusive research within England and Wales, wherever it takes place, except
p.(None): for clinical trials of investigational medicinal products. This may include research in healthcare, social
p.(None): care, criminal justice and other settings. It is not limited to research undertaken within NHS
p.(None): organisations or other public bodies.
p.(None):
p.(None):
p.(None): Which parts of the Act apply to research?
p.(None): Sections 30-33 of the Act provide lawful authority for intrusive research to be carried out involving
p.(None): people without capacity provided that the research has been approved by an appropriate body.
p.(None): Section 34 makes transitional provisions relating to the loss of capacity in research which started
p.(None): before 1 October 2007.
p.(None):
p.(None):
p.(None): What is “intrusive research”?
p.(None): Under Section 30 of the Act, research is intrusive if it is of a kind that would be unlawful if it was
p.(None): carried out “on or in relation to a person who had capacity to consent to it, but without this
p.(None): consent”. Therefore intrusive research means research that would legally require consent if it
p.(None): involved people with capacity. Intrusive research is not limited to trials of clinical interventions.
p.(None):
p.(None): It includes non- interventional research where consent is legally required, for example involving the
p.(None): processing of personal data or the administration of questionnaires, interviews or observations.
p.(None): Intrusive research involving a person who lacks capacity is unlawful unless it is approved by an
p.(None): appropriate body.
p.(None):
p.(None):
p.(None): What research is not intrusive?
...
p.(None):
p.(None): Stay up to date with latest news, updates to regulations and upcoming
p.(None): learning events
p.(None): Sign up to our newsletter
p.(None):
p.(None): First Name
p.(None):
p.(None):
p.(None): Last Name
p.(None):
p.(None):
p.(None):
p.(None): Email Address
p.(None):
p.(None):
p.(None): Sign up
p.(None): Planning and improving research
p.(None): Research planning
p.(None):
p.(None):
p.(None): Best Practice
p.(None):
p.(None): Policies, Standards & Legislation
p.(None):
p.(None):
p.(None): Learning
p.(None):
p.(None):
p.(None): Confidentiality Advisory Group registers
p.(None):
p.(None): Research summaries
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Approvals and amendments
p.(None): What approvals and decisions do I need?
p.(None):
p.(None):
p.(None): Amending an approval
p.(None):
p.(None): Managing your approval
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): About the HRA
p.(None): What we do
p.(None):
p.(None): Who we are
p.(None):
p.(None):
p.(None): Committees and services
p.(None):
p.(None):
p.(None): Consultations
p.(None):
p.(None):
p.(None): Partnerships
p.(None):
p.(None): Governance
p.(None):
p.(None):
p.(None): News & updates
p.(None):
p.(None):
p.(None): HRA Latest
p.(None):
p.(None): Vacancies
p.(None):
p.(None):
p.(None): Glossary
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research Ethics Committees
p.(None): RES and RECs
p.(None):
p.(None):
p.(None): Search for a REC
p.(None):
p.(None):
p.(None): REC Standard Operating Procedures
p.(None):
p.(None):
p.(None): REC members area
p.(None):
p.(None):
p.(None): Become a REC member
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Follow us
p.(None):
p.(None): Health Research Authority
p.(None): Skipton House, 80 London Road, London SE1 6LH
p.(None): © Copyright HRA 2017
p.(None):
p.(None):
p.(None): Contact us Privacy notice Terms & conditions Accessibility statement for HRA website Feedback or concerns
p.(None):
p.(None):
p.(None): Site by Torchbox
...
Orphaned Trigger Words
p.(None): matter because of an impairment of, or a disturbance in, the mind or the brain.
p.(None): This may be the result of a variety of conditions, including:
p.(None):
p.(None): dementia
p.(None): mental illness
p.(None): learning disability
p.(None): brain damage
p.(None): intoxication
p.(None): any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion,
p.(None): stroke, heart attack, epileptic fit, serious accident, delirium).
p.(None):
p.(None):
p.(None):
p.(None): How is capacity assessed?
p.(None): The Act contains a two-stage test of capacity:
p.(None):
p.(None): Is there an impairment of, or disturbance to, the functioning of the mind or brain?
p.(None):
p.(None): And if so;
p.(None):
p.(None): Is the impairment or disturbance sufficient that the person is unable to make that
p.(None): particular decision?
p.(None):
p.(None):
p.(None): The Act says that a person is unable to make a decision if unable to:
p.(None):
p.(None): understand the information relevant to the decision
p.(None): retain the information
p.(None): use or weigh the information
p.(None): communicate his or her decision (by any means).
p.(None):
p.(None): A person with a duty of care must assess capacity to make a particular decision at the time the
p.(None): decision needs to be made, and should not assume that a person cannot make any decision. A
p.(None): person’s loss of capacity may be temporary, and capacity may fluctuate.
p.(None):
p.(None): Some people may lack capacity to make a complex decision but retain the capacity to make other
p.(None): decisions. The duty to assess capacity also applies to researchers when recruiting participants into,
p.(None): and conducting, intrusive research. For further guidance on assessing capacity, see Chapter 4 of the
p.(None): statutory Code of Practice.
p.(None):
p.(None): Whose responsibility is it to decide whether a potential participant has the capacity to consent for
p.(None): themselves to research?
p.(None):
p.(None): This is the responsibility of the researcher, consulting as appropriate with other care professionals.
p.(None):
p.(None):
p.(None):
p.(None): Scope of the research provisions
p.(None):
p.(None): Does the Mental Capacity Act apply to my research?
p.(None): The Act applies to any intrusive research within England and Wales, wherever it takes place, except
p.(None): for clinical trials of investigational medicinal products. This may include research in healthcare, social
p.(None): care, criminal justice and other settings. It is not limited to research undertaken within NHS
p.(None): organisations or other public bodies.
p.(None):
p.(None):
p.(None): Which parts of the Act apply to research?
p.(None): Sections 30-33 of the Act provide lawful authority for intrusive research to be carried out involving
p.(None): people without capacity provided that the research has been approved by an appropriate body.
p.(None): Section 34 makes transitional provisions relating to the loss of capacity in research which started
p.(None): before 1 October 2007.
p.(None):
p.(None):
p.(None): What is “intrusive research”?
p.(None): Under Section 30 of the Act, research is intrusive if it is of a kind that would be unlawful if it was
p.(None): carried out “on or in relation to a person who had capacity to consent to it, but without this
p.(None): consent”. Therefore intrusive research means research that would legally require consent if it
p.(None): involved people with capacity. Intrusive research is not limited to trials of clinical interventions.
p.(None):
p.(None): It includes non- interventional research where consent is legally required, for example involving the
p.(None): processing of personal data or the administration of questionnaires, interviews or observations.
p.(None): Intrusive research involving a person who lacks capacity is unlawful unless it is approved by an
p.(None): appropriate body.
p.(None):
p.(None):
p.(None): What research is not intrusive?
p.(None): Consent is not a legal requirement, and therefore the research is not intrusive, if it is limited to one
p.(None): or more of the following:
p.(None):
p.(None): processing of non-identifiable data
p.(None): processing of identifiable patient data with the approval under Section 251 of the NHS Act
p.(None): 2006 (or formerly under Section 60 of the Health and Social Care Act 2001)
p.(None): use of tissue samples (cellular material) held prior to the coming into force of the Human
p.(None): Tissue Act on 1 September 2006 (“existing holdings”)
p.(None): use of tissue samples (cellular material) taken from a living person, provided that the
p.(None): person is not identifiable to the researcher and the research project has ethical approval
p.(None): use of the results of the analysis of DNA in material taken from a living person, provided
p.(None): that the person is not identifiable to the researcher and the research project has ethical
p.(None): approval.
p.(None):
p.(None):
p.(None): Does the Mental Capacity Act apply to clinical trials of investigational
p.(None): medicinal products (CTIMPs)?
p.(None): No. Under Section 30 of the MCA, CTIMPS are specifically excluded from the research provisions of
p.(None): the Act. This is because separate provision is made for including adults lacking capacity in CTIMPs in
p.(None): Schedule 1 of the Medicines for Human Use (ClinicalTrials) Regulations 2004.
p.(None):
p.(None): Further information about these provisions is available in our information paper on informed
p.(None): consent in CTIMPs.
p.(None):
p.(None):
p.(None): Do the research provisions apply in Scotland and Northern Ireland?
p.(None): No. The Mental Capacity Act only applies to England and Wales. In Scotland, the inclusion of adults
p.(None): lacking capacity in research is governed by the provisions of Section 51 of the Adults with Incapacity
p.(None): (Scotland) Act 2000. In Northern Ireland, it is currently governed by the provisions of the Mental
p.(None): Capacity Act (Northern Ireland) 2016.
p.(None):
p.(None):
p.(None): Do the research provisions apply to children?
p.(None): In general the Act applies only to people aged 16 and over. There are a few exceptions, which are
p.(None): explained in Chapter 12 of the Code of Practice. For projects involving children under the age of 16,
...
p.(None):
p.(None): Separate applications should be made to recognised RECs in each jurisdiction. In Scotland, the
p.(None): application must be made to the Scotland A REC and should include a consent form for the
p.(None): guardian, welfare attorney or adult’s nearest relative. Guidance on documentation to be used in
p.(None): recruiting participants lacking capacity in Scotland is available in our guidance on information sheets
p.(None): and consent forms.
p.(None):
p.(None):
p.(None): What happens where research is conducted in Northern Ireland as well as
p.(None): another UK nation?
...
p.(None):
p.(None): This exception only applies during the emergencyXsituation. As soon as time allows, the researcher
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| children | Child |
| criminal | criminal |
| disability | Mentally Disabled |
| emergency situation | patients in emergency situations |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| incapacity | Incapacitated |
| intoxication | Intoxication |
| nation | stateless persons |
| unlawful | Illegal Activity |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
justice
protect
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input