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September 18, 2025

Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review

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Authors

SFSaba FaisalJWJulia WadeJSJhulia dos Santos

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Overview

This systematic review identifies and evaluates tools measuring participant understanding of informed consent, highlighting issues of reliability and validity.

Key Points

  • This review reveals significant gaps in participant understanding of informed consent processes in clinical trials.
  • Out of 6526 records screened, 148 studies were included, with 103 being quantitative and 20 qualitative.
  • Tools like the Deaconess Informed Consent Comprehension Questionnaire demonstrated high validity and reliability.
  • Findings call for standardised approaches to measuring informed consent understanding among clinical trial participants.

Cite This Study

Faisal et al. (2025) studied this question.

synapsesocial.com/papers/68d461cb31b076d99fa610dbhttps://doi.org/10.21203/rs.3.rs-7375295/v1
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