Incapacity

People with mental health challenges, like any other person, have rights like any other person to participate in research and contribute to new understandings within mental health. CPFT is committed to supporting researchers to ensure that their studies are inclusive whilst ensuring that the participants’ dignity and rights are respected.

Legislation

Particular legislation governs Clinical Trials of Investigational Medicinal Products (CTIMPs) that include participants who lack capacity. Under the Medicines for Human Use (Clinical Trials) Regulations 2004, researchers must obtain informed consent form a personal legal representative, or if no such person exists, a professional legal representative.

In 2007, new legislation introduced in the Mental Capacity Act came into force that provides a framework for adults who lack capacity to consent to participate in research other than (CTIMPs). Researchers carrying out research with participants who may lack capacity to consent have a legal duty to comply with the act and code of practice. The act also provides a framework for adults with capacity to make advance decisions and statements that reflect their wishes should they lose capacity in the future. In non-CTIMPs, researchers must appoint a consultee and these arrangements must be specified within ethical review. 

For more advice about including people who lack capacity to consent in a research study, please contact r&d@cpft.nhs.uk

The page was last updated on 27 March 2018 by aient.

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Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House, Fulbourn Hospital
Cambridge, CB21 5EF

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