Mental Capacity Act 2005
The Mental Capacity Act 2005 for England and Wales received Royal Assent on 7 April 2005 and came fully into force on 1 October 2007. Sections 30-34 specifically concern the approval and conduct of research involving participants who lack the capacity to consent for themselves.
Researchers involved in projects that envisage the use of participants aged 16 and over whose capacity to consent is in doubt should apply to NRES for ethical approval within the terms of the Act. The Code of Practice and the Standard Operating Procedures for Research Ethics Committees in the United Kingdom provide guidance to researchers on the form and content of their applications.
For those research projects involving participants under 16 who lack capacity, the IDRECs will continue to be able to provide ethical approval as before.
What research does the Act cover?
The Act applies to research that:
- is ‘intrusive’ (if a person taking part had capacity, the researcher would need to get their consent to involve them); and
- involves people aged 16 and over who lack capacity to consent; and
- started on or after 1 October 2007, or was in progress on that date; and
- is being carried out in England or Wales ; and
- is not a clinical trial covered under the Medicines for Human Use (Clinical Trials) Regulations 2004.
Research covered by the Act must have the approval of an appropriate body and follow the other requirements of the Act, namely to:
(i) consider the views of carers and other relevant people;
(ii) respect any objections a person who lacks capacity makes during research; and
(iii) treat the person’s interests as more important than those of science and society. In order to establish (iii), the research must either:
(a) have some chance of benefiting the person who lacks capacity, and the benefit must be in proportion to any burden caused by taking part; or
(b) the aim of the research must be to provide knowledge about the cause of, or treatment or care of people with, the same impairing condition or a similar condition. If researchers are relying on (b), the risk to the person must be negligible, there must be no significant interference with that person’s freedom of action or privacy, and nothing must be done to or in relation to the person which is unduly invasive or restrictive.
Research: The Act does not define the meaning of the term ‘research’, but the Code of Practice refers to a definition used in the Department of Health’s Research governance framework for health and social care: ‘the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’.
Intrusive: Although little further guidance on the interpretation of this term in the context of the Act is available, it is clear that its scope is wider than invasive acts and that health and social care research is intended to be caught by it. The other requirements of the Mental Capacity Act 2005 indicate that there must be no interference with the participant’s freedom of action or privacy.
People aged 16 and over: With the exception of Sections 2(6) (relating to property and financial affairs) and 44 (relating to ill treatment and wilful neglect), the Act does not apply to people under 16. All qualifying research involving those aged 16-18 is understood to fall within the remit of the Act and therefore should be referred to NRES for review.
Capacity to consent: The Act introduces an assumption of capacity and a two-stage test for those wishing to prove incapacity on the balance of probabilities.
Incapacity is broadly defined and can include those who lack capacity to consent because they are unconscious or barely conscious or whose decision-making is impaired by the influence of drugs or alcohol, as well as people with dementia, learning disabilities, mental health problems, stroke or head injuries.
Research starting on or after 1 October 2007: Projects that already have ethical approval will need to obtain approval from an appropriate body under sections 30 and 31 of the Mental Capacity Act and to comply with the requirements of sections 32 and 33 of that Act by 1 October 2008. If the research is expected to conclude prior to 1 October 2008, the researcher may opt not to apply for approval under section 30 (REC SOPs, section 12.37). Research that does not have ethical approval must have received approval from an appropriate body by 1 October 2007 to continue lawfully.
Exclusions: The Act does not apply to research involving clinical trials, nor to the circumstances where lawfully no consent is needed to involve a person in research, whether a person has capacity or not, e.g. research involving only anonymous data.
Appropriate body: All research ethics committees established under the Governance Arrangements for NHS Research Ethics Committees (GAfREC) in England and Wales are recognised for this purpose by the Secretary of State for Health and Welsh Ministers and are therefore ‘appropriate bodies’ within the terms of the Act. The National Research Ethics Service (NRES) will refer researchers to those committees which have been designated for approval of research falling within the terms of the Act.
 The Code of Practice indicates that the Act applies to "everyone it concerns who is habitually resident or present in England and Wales". The NRES website provides further information on the 'appropriate body' for research conducted in Scotland and Northern Ireland.