MENTAL CAPACITY ACT 2005
The Mental Capacity Act supports and protects people who may be unable to make some decisions. Research projects involving individuals aged 16 or over and requiring the consent of participants could potentially fall under the Mental Capacity Act (MCA) if a participant lacks or loses mental capacity during the course of the study. The research does not need to be related to the health of the participants.
All research involving adults (16+) who do not have capacity to consent (or who have lost capacity) requires approval from a recognised research ethics committee under the MCA.
Recognised ethics committees are predominantly NHS RECs, although there are also a number of other committees such as the Social Science REC and the Ministry of Defence REC. University ethics committees are not recognised committees under the MCA and, therefore, cannot approve studies falling under the act.
If a study is not approved by a recognised REC and a participant in the study loses capacity then they cannot continue in the study and must be withdrawn from the study.
Section 2 of the MCA says: "…a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain". The impairment or disturbance can be permanent or temporary.
Section 3 says that a person is unable to make a decision if he or she is unable to do one or more of the following things:
- understand the information relevant to the decision;
- retain the information for long enough to be able to make a decision;
- use or weigh up the information as part of the process of making the decision;
- communicate the decision by any possible method, such as talking, using sign language, squeezing someone’s hand and so on.
Further information about the Mental Capacity Act can be found on the websites of the Department of Health and the Public Guardianship Office. There is practical guidance in the MCA Code of Practice (Chapter 11 – How does the Act affect research projects involving a person who lacks capacity?), available at direct.gov.uk
King’s College, London, also has a useful fact sheet for Social Scientists:innovation/research/support/ethics