The MCA sets out a clear legal framework for many types of research involving people who lack the capacity to consent to taking part in such research. Staff may be asked to become involved in research projects where the people they are providing with care or treatment, and who lack capacity, are taking part in such research.
It is important that research is able to involve people who lack capacity, to provide knowledge about the causes of incapacity and about the diagnosis, treatment, care and needs of people who lack capacity. The Act covers a wide range of research including clinical, health and social care research but not clinical trials, which are covered by separate legislation.
Research covered by the Act could include:
The MCA introduced a number of safeguards to protect people taking part in such research, such as:
The person’s past and present wishes, feelings and values are important in deciding whether they should take part in research or not. Staff providing people who lack capacity with care or treatment may be asked how the people they are providing with care and treatment feel about taking part in research, and may be asked to let researchers know if they seem upset about any aspect of current projects.
Anyone setting up or carrying out such research will need to make sure the research complies with the provisions set out in the Act and Regulations and follow the guidance given in Chapter 11 of the the MCA 2005 Code of Practice.
The Human Tissue Authority Codes of Practice provides information on issues relating to the consent to the use of tissue or organs for research.
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