Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

摘要

In this paper, ‘capacity’ refers to mental capacity to make an informed decision regarding research participation. ‘The spectrum of capacity’ of individuals ranges from potentially impaired, and anticipated to have impaired capacity, to lacking capacity. The legislation governing involvement of adults lacking capacity in research and terminology is jurisdiction specific. In this paper, the term ‘consultee’ (someone who has capacity) is used to encompass the different terms used in respective jurisdictions including but not limited to proxy-decision maker, personal consultee and nominated consultee. A distinction is made between a personal consultee (e.g. family member) and a nominated consultee (e.g. health professional) [29]. ‘The process of consent’ refers to the steps taken to ensure that an eligible research participant is sufficiently informed about the purposes, content, affiliations of the study, and their right to withdraw from the study at any point, enabling them or their consultee to decide freely about research participation [30].