Rethinking the Regulatory Triggers for Prospective Ethics Review

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.