Details of risk-benefit communication in informed consent documents for phase I/II trials.

ABSTRACT:

Background

Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk-benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.

Method

We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk-bene

SUBMITTER: Kahrass H 

PROVIDER: S-EPMC7876653 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature