Rethinking the Regulatory Triggers for Prospective Ethics Review

Journal of Law, Medicine and Ethics 47 (2):247-253 (2019)
  Copy   BIBTEX


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.



    Upload a copy of this work     Papers currently archived: 74,569

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
Limits to Research Risks.F. G. Miller & S. Jofe - 2009 - Journal of Medical Ethics 35 (7):445-449.
Prospective Memory: A New Focus for Research.Peter Graf & Bob Uttl - 2001 - Consciousness and Cognition 10 (4):437-450.
Is Mandatory Research Ethics Reviewing Ethical?Murray Dyck & Gary Allen - 2013 - Journal of Medical Ethics 39 (8):517-520.
Prospective Payment and Medical Ethics.Charles E. Begley - 1987 - Journal of Medicine and Philosophy 12 (2):107-122.
Procreative Beneficence and the Prospective Parent.P. Herissone-Kelly - 2006 - Journal of Medical Ethics 32 (3):166-169.


Added to PP

6 (#1,095,916)

6 months
1 (#418,511)

Historical graph of downloads
How can I increase my downloads?