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Rethinking the Regulatory Triggers for Prospective Ethics Review

Published online by Cambridge University Press:  01 January 2021

Carl H. Coleman
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Abstract

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 2: Human Subject Protection , Summer 2019 , pp. 247 - 253
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

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