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

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.

Citation:
Symons TJ, Straiton N, Gagnon R, Littleford R, Campbell AJ, Bowen AC, Stewart AG, et al. Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial. Trials. 2022;23(1)

Keywords:
Consumer perspectives; Informed consent; Low-risk trials; Participant information sheet. Consumer perspectives; Informed consent; Low-risk trials; Participant information sheet

Abstract:
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.