Peer Review Report For: Co-production of guidance and resources to implement principled participant information leaflets (PrinciPILs) [version 1; peer review: 1 approved, 2 approved with reservations]

Abstract

Background: The way information about potential benefits and harms of trial is presented within participant information leaflets (PILs) varies widely and may cause unnecessary ‘nocebo’ effects. The Medical Research Council (MRC) funded a project that developed seven principles to reduce this variation. However, guidance has not been produced to facilitate the implementation of the principles. Stakeholder involvement is recommended to optimise the way these principles are disseminated and explained. To co-produce recommendations for developing: (1) user-friendly guidance for users of the principles; and (2) resources that support the implementation of the principles. Methods: We held a co-production workshop with representation from the following professional groups: the Health Research Authority (HRA), research ethics committee members, and trial managers. Two rounds of discussions focused on generating recommendations for guidance and resources that support the implementation of the seven principles. Extensive low inference style ethnographic notes were taken, and the data were analysed thematically using deductive codes. The data was collected on October 14, 2022. Results: 25 participants attended a hybrid workshop. Participants recommended that both researchers designing PILs and research ethics committee members should use the principles, and that that they should be simple, mention both benefits and harms explicitly, include examples of visual representations, and provide the evidence base for the principles. Conclusions: We were able to co-produce recommendations for developing and implementing the seven principles within PILs. These recommendations can now be implemented to reduce unexplained variation in the way potential benefits and harms are shared within PILs.

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