What is the Mental Capacity Act about?
The Mental Capacity Act (MCA) 2005 applies to everyone involved in the care, treatment and support of people aged 16 and over living in England and Wales who are unable to make all or some decisions for themselves. The MCA is designed to protect and restore power to those vulnerable people who lack capacity.
All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research.
The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Researchers and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.
What are the core principle of the Act?
Section 1 of the Act sets out a number of core principles. These are rooted in the common law, ethical guidelines and best practice and are designed to be fully compliant with the relevant sections of the Human Rights Act. These principles are:
- A person must be assumed to have capacity unless established otherwise
- Individuals should be helped to make their own decisions as far as practicable
- A person is not to be treated as unable to make a decision merely because he makes an unwise decision
- All decisions and actions must be in the best interests of the person lacking capacity
- All decisions and actions must be the least restrictive of the person’s rights and freedom of action
What is Capacity?
Capacity refers to the everyday ability that individuals possess to make decisions or to take actions that affect them. A person lacks capacity if he or she is unable to make or communicate a decision about a particular matter because of an impairment of, or disturbance in the mind or brain. This may be due to a variety of conditions, including:
• Mental illness/Learning disabilities
• brain damage
• Emergency situations – cardiac arrest/stroke/loss of consciousness/drowsiness/epileptic fit etc.
What type of research does this apply to?
The Act applies to “intrusive research” in England and Wales (except for CTIMPs.)
“Intrusive research” is not limited to trials or clinical interventions. It includes non-interventional research where consent is required such as using personal data, the administration of questionnaires, interviews or observations.
“Non- Intrusive” research includes the processing of non-identifiable data, processing of identifiable data with CAG approval, use of tissue samples collected pre Human Tissue Act 2004.
People must be assumed to have capacity unless established otherwise- see Chapter 4 of the Mental Capacity Act 2005, Code of Practice for guidelines on assessing capacity.
The Act does not cover CTIMPs as separate provision is made for including adults lacking capacity in CTIMPs in Schedule 1 of the Medicines for Human Use (ClinicalTrials) Regulations 2004.
Any Research that falls under the remit of the Mental Capacity Act must be reviewed by an appropraite body. It must be satisfied that all the criteria in Section 31 of the Act are met, including that arrangements are in place to satisfy the requirements of Sections 32 and 33.
An appropriate body is a Research Ethics Committee recognised by the Secretary of State or Welsh Ministers. All NHS RECs in England and Wales are recognised. RECs in Scotland and Northern Ireland are not recognised for the purposes of the Mental Capacity Act.
Applications under the Mental Capacity Act relating to research outside the NHS will be accepted for review by NHS RECs. All applications should be booked with the NRES Central Booking Service for review by a flagged REC.
The REC can only approve the research if it meets the following criteria:
- the research must relate to the condition causing the mind or brain impairment, or to a condition resulting from or attributed to the mind or brain impairment
- the research cannot be performed effectively on people who have mental capacity; and
- the research must produce results relevant to the condition (or a similar condition) affecting the person and have little risk or low adverse impact on the person, or it must have potential benefits to the person without disproportionate risk.
Useful links for further information:
Guidance from the Medical Research Council (MRC)- Medical research involving adults who cannot consent