Table 2 Key processes in the the design, conduct and delivery of trials involving adults with impaired capacity
Process | Description of process |
|---|---|
Making trial design decisions | Decisions about the design of the trial made prospectively (e.g. eligibility criteria) and during the ongoing conduct of the trial (e.g. adaptations following a feasibility study) |
Navigating ethical approval | Process of seeking review by a Research Ethics Committee and the challenges of obtaining a favourable opinion. May involve multiple approvals process across the UK nations and beyond for multi-centre multi-national trials |
Informing and supporting the participant | Providing information about the trial to a potential participant with a communication disability and/or impaired capacity, and supporting their involvement in making a decision about participation |
Assessment of capacity to consent | Assessment of a person’s mental capacity with respect to their ability to make a decision about participating in a trial, in accordance with the process set out in the Mental Capacity Act 2005 or other devolved legislation |
Involvement of alternative decision-maker | Process of identifying and consulting an alternative decision-maker (e.g. consultee or legal representative) on behalf of a participant who lacks capacity to consent. In accordance with the legal frameworks, this may involve someone acting in either a personal or professional capacity |
Revisiting consent and consultation | Informed consent is an ongoing process which may require revisiting consent and/or consultation with alternative decision-makers due to changes in the participant’s capacity during the trial. This includes in emergency research where a participant may have been recruited without prior consent or consultation |