Consent to research: Research involving adults without capacity

1. 23. This section gives guidance about specific issues in research involving adults who lack capacity. It sets out the key elements of the law that governs the involvement of people over 16 who lack capacity to consent. Annex A contains a summary of the law in this area, and annex B explains the key elements of the legislation that governs clinical trials of investigational medicinal products in the UK.
2. 24. You must assess an adult’s capacity to make a particular decision at the time it needs to be made. You must follow the guidance in part 3 of Consent: patients and doctors making decisions together,¹³  which gives advice on maximising a person's ability to make decisions, and on assessing capacity.

Subsections:

• When adults without capacity might be involved in research (paragraphs 25-26)
• Seeking to involve adults without capacity in research (paragraphs 27-29)
• Right to withdraw from research (paragraph 30)
• Loss of capacity during a research project (paragraphs 31-32)
• Research into treatment in emergencies (paragraphs 33-35)