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

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.
• 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.