Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.

ABSTRACT: Obtaining written informed consent from participants before enrolment in a study is essential. A previous study showed that only 50% of the participants in clinical trials understood the components of informed consent, and the methods of participants' understanding of informed consent were controversial. This updated meta-analysis aimed to estimate the proportion of participants in clinical trials who understand the different informed consent components. PubMed, EMBASE, the Cochrane Library, and Scopus were searched till April 2023. Therapeutic misconception, ability to name one risk, knowing that treatments were being compared, and understanding the nature of the study, the purpose of the study, the risks and side-effects, the direct benefits, placebo, randomization, voluntariness, freedo

SUBMITTER: Wu C 

PROVIDER: S-EPMC10760836 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature