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Rethinking the Regulatory Triggers for Prospective Ethics Review.

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  • 1Carl H. Coleman, J.D., is Professor of Law and Academic Director of the Division of Online Learning at Seton Hall University School of Law. He is a former member of the Secretary's Advisory Committee on Human Research Protections (SACHRP).

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The current standard for ethics review of federally-supported human participant activities is ambiguous. This article proposes a new standard focusing on risk to participants for the benefit of others, rather than generalizable knowledge.

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Area of Science:

  • Bioethics
  • Research Ethics
  • Human Subject Protection

Background:

  • Federally-supported human participant activities require prospective ethics review under the Common Rule if they "develop or contribute to generalizable knowledge."
  • The "generalizable knowledge" standard is ambiguous and can be over- or under-inclusive for determining the need for ethical oversight.

Purpose of the Study:

  • To propose a revised standard for prospective ethics review of federally-supported human participant activities.
  • To address the limitations of the current "generalizable knowledge" standard.

Main Methods:

  • Conceptual analysis of the Common Rule's "generalizable knowledge" standard.
  • Proposal of an alternative criterion for ethics review based on risk exposure and potential benefit to others.

Main Results:

  • The "generalizable knowledge" standard is ethically irrelevant for determining the necessity of prospective ethics review.
  • An alternative standard is proposed: prior ethics review should be required when individuals face greater-than-minimal risks for the potential benefit of others.

Conclusions:

  • The determination of whether an activity constitutes research should be neither necessary nor sufficient for triggering prospective ethical oversight.
  • A revised standard focusing on risk and benefit offers a more ethically relevant framework for human participant protection in federally-supported activities.