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Related Experiment Videos

The common rule's 'reasonable person' standard for informed consent.

Jake Greenblum1, Ryan Hubbard2

  • 1University Health System, San Antonio, Texas, United States.

Bioethics
|November 27, 2018
PubMed
Summary

This study proposes an ordinary, not ideal, person standard for informed consent in research. It suggests a flexible "liberal constraint" to ensure inclusivity and consistent application across review boards.

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Area of Science:

  • Bioethics
  • Research Ethics
  • Informed Consent Law

Background:

  • The revised Common Rule introduces a "reasonable person standard" for informed consent in research.
  • This standard requires providing information a reasonable person would need to decide on study participation.
  • Challenges exist regarding consistent application and potential stigmatization of marginal groups.

Purpose of the Study:

  • To respond to challenges posed by Odwazny and Berkman regarding the reasonable person standard.
  • To propose a refined interpretation of the reasonable person standard for informed consent.
  • To ensure the standard is consistently applicable and inclusive.

Main Methods:

  • Conceptual analysis of the reasonable person standard in research ethics.
Keywords:
Common Rulebioethicsinformed consentinstitutional review boardreasonable personresearch subjects

Related Experiment Videos

  • Development of an "ordinary person" conception of reasonableness.
  • Introduction of a "liberal constraint" for the standard's application.

    • Main Results:

    • Advocates for an "ordinary person" standard over an "ideal person" standard.
    • Proposes a "liberal constraint" to ensure the standard accommodates diverse value systems.
    • Suggests this approach enhances consistency and reduces stigmatization.

    Conclusions:

    • The proposed ordinary person standard with a liberal constraint offers a more equitable and practical approach to informed consent.
    • This framework can improve the consistency of institutional review board decisions.
    • Adoption of this standard may mitigate the stigmatization of vulnerable populations in research participation.