MENTAL CAPACITY ACT 2005

Five key principles

The Mental Capacity Act 2005 is underpinned by a set of five key principles:

  1. A presumption of capacity – every adult has the right to make his or her own decisions and must be assumed to have capacity to do so unless it is proved otherwise;
  2. The right for individuals to be supported to make their own decisions – people must be given all appropriate help before it is concluded that they cannot make their own decisions;
  3. That individuals must retain the right to make what might be seen as eccentric or unwise decisions;
  4. Best interests – anything done for or on behalf of people without capacity must be in their best interests; and
  5. Least restrictive intervention – anything done for or on behalf of people without capacity should be the least restrictive of their basic rights and freedoms.

Assessing lack of capacity

The Act sets out a test for assessing whether a person lacks capacity to take a particular decision at a particular time.It is a ‘decision-specific’ test. No one can be labelled ‘incapable’ as a result of a particular medical condition or diagnosis. A lack of capacity cannot be established merely by reference to a person’s age, appearance, or any condition or aspect of a person’s behaviour which might lead others to make unjustified assumptions about capacity.

The test is ‘functional’, looking at the decision-making process itself. It sets out four reasons why a person may be unable to make a decision.

To make a decision a person must first be able to understand the information relevant to the decision. A determination of incapacity may not be reached without the relevant information having been presented to the person in a way that is appropriate to his / her circumstances

The person must be able to retain this information for long enough to make the decision

He / she must be able to use and weigh the information to arrive at a choice.

If the person cannot undertake one of these three aspects of the decision-making process then s/he is unable to make the decision.

The fourth situation in which a person is deemed to be unable to make a decision is where s/he is unable to communicate in any way. This is likely to affect only a small number of people, in particular some of those with the very rare condition of ‘locked-in syndrome’. Any residual ability to communicate, such as blinking an eye, would exclude a person from this category.

Best interests

Everything that is done for or on behalf of a person who lacks capacity must be in that person’s best interests. The Act provides a non-exhaustive checklist of factors that decision-makers must work through in deciding what is in a person’s best interests. A person can put his / her wishes and feelings into a written statement if they so wish, that the person making the determination must consider. Also, carers and family members have a right to be consulted.

Application of the Mental Capacity Act to research

Researchers are encouraged to consider issues relating to incapacity during the original consenting process (or when gaining further consent to an existing consent to an existing long-term study). It is good practice to ensure that consent clearly anticipates the possible onset of incapacity.

  • The Mental Capacity Act (MCA) applies to England and Wales only
  • In general, the provisions of the MCA apply only to persons aged 16 or over (referred to in this guidance as ‘adults’)
  • The research provisions of the MCA (sections 30-34) apply to the conduct of ‘intrusive research’ involving adults who lack capacity to consent for themselves. ‘Intrusive research’ is defined in section 30(2) of the MCA as:

‘[research] of a kind that would be unlawful if it was carried out -

(a)on or in relation to a person who had capacity to consent to it, but,

(b)without his consent.’

  • Therefore, intrusive research is research that normally requires consent in order to be lawful. Intrusive research is not limited to medical and biomedical research, health-related research or research taking place within the NHS. It could be research undertaken in the context of social care or in any other context where consent is normally a legal requirement
  • In some cases, consent may not be a legal requirement, for example where the research is limited to use of the following:

Data that has been completely and irrevocably anonymised and is no longer personal data within the meaning of the Data Protection Act

Personal data where approval has been given by the Patient Information Advisory Group (PIAG) for processing of the data without consent under section 60 of the Health and Social Care Act 2001 (see for further guidance)

‘Existing holdings’ of tissue under the Human Tissue Act 2004, i.e. ‘relevant material’ which was already held prior to 1 September 2006

Tissue from the living, which is not identifiable by the researcher and where the research is ethically approved by a NHS REC under section 1(9) of the Human Tissue Act

  • A clinical trial which is subject to the provision of clinical trials regulations is not subject to this Act
  • Research involving, or in relation to, a person lacking capacity may be lawfully carried out if an ‘appropriate body’ (normally a Research Ethics Committee) agrees that the research is safe, relates to the person’s condition and cannot be done as effectively using people who have mental capacity. The research must produce a benefit to the person that outweighs any risk or burden. Alternatively, if it is to derive new scientific knowledge it must be of minimal risk to the person and be carried out with minimal intrusion or interference with their rights
  • Carers or nominated third parties must be consulted and agree that the person would want to join an approved research project. If the person shows any signs of resistance or indicates in any way that he or she does not wish to take part, the person must be withdrawn from the project immediately.

Loss of Capacity Regulations

  • The Mental Capacity Act(Loss of Capacity during Research Project) (England) Regulations 2006 are made under section 34 of the Act. They provide in certain circumstances for continuation of research involving data or material which has been taken with consent from a person who subsequently loses capacity before the research ends. The Regulations apply only where the research started before 1 October 2007 and the person concerned initially consented to participate before 30 March 2008.

Code of Practice

  • The Mental Capacity Act (MCA) Code of Practice is published at:
  • Under section 42(4) of the MCA, researchers carrying out research approved under the Act are legally required to have regard to the Code of Practice
  • Any researcher who believes their project could be affected by the Act is strongly recommended to consult the following chapters of the Code of Practice before finalising their protocol and applying for ethical review:

Chapter 2, setting out the underlying principles of the Act

Chapter 3, on helping people make decisions for themselves

Chapter 4, dealing with the assessment of capacity to consent

Chapter 11, describing the criteria for approval of research.

Sources

Mental Capacity Act 2005, Office of Public Sector Information:

Research involving adults unable to consent for themselves. National Patient Safety Agency, 2007

Mental Capacity Act 2005 – summary. Department of Constitutional Affairs:

Guidance on nominating a consultee for research involving adults who lack capacity to consent. Department of Health, 2008

Explanatory notes to Mental Capacity Act, The Stationery Office, 2005:

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