Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network's PeRSEVERE project.

ABSTRACT:

Background/aims

Existing regulatory and ethical guidance does not address real-life complexities in how clinical trial participants' level of participation may change. If these complexities are inappropriately managed, there may be negative consequences for trial participants and the integrity of trials they participate in. These concerns have been highlighted over many years, but there remains no single, comprehensive guidance for managing participation changes in ways that address real-life complexities while maximally promoting participant interests and trial integrity. Motivated by the lack of agreed standards, and observed variability in practice, representatives from academic clinical trials units and linked organisations in the United Kingdom initiated the PeRSEVERE project

SUBMITTER: Cragg WJ 

PROVIDER: S-EPMC12476473 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature