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March 1, 2022BMJ OpenOpen Access

Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices

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Authors

AWAnne WisgallaJHJoerg Hasford

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Overview

Critical analysis reveals widespread deficits undermining informed consent comprehension in prospective trial participants, highlighting an urgent need to reform consent practices.

Key Points

  • Identify core procedural deficits in informed consent practices that prevent adequate participant understanding and invalidate consent in clinical research.
  • Critical ethical and normative review examining the translation of informed consent principles into contemporary clinical trial procedures.
  • Approximately 45% of clinical research participants are unable to name even a single risk associated with trial participation.
  • Identified four structural failures: unmanageable document length, low readability affecting individuals with limited literacy, therapeutic misconception masking research intent, and imbalanced risk-benefit framing that impairs rational decision-making.

Cite This Study

Wisgalla et al. (2022) studied this question.

synapsesocial.com/papers/6a188fcd1ca866914fc9caf5https://doi.org/10.1136/bmjopen-2021-050543
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