Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial.

ABSTRACT:

Background

For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers' views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers' views on the optimal content and la

SUBMITTER: Symons TJ 

PROVIDER: S-EPMC9795139 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature