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  1. Public Health Data Collection and Implementation of the Revised Common Rule.Lisa M. Lee - 2019 - Journal of Law, Medicine and Ethics 47 (2):232-237.
    For the first time, the revised Common Rule specifies that public health surveillance activities are not research. This article reviews the historical development of the public health surveillance exclusion and implications for other foundational public health practices.
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  • Rethinking the Regulatory Triggers for Prospective Ethics Review.Carl H. Coleman - 2019 - Journal of Law, Medicine and Ethics 47 (2):247-253.
    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 (...)
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  • Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018.Zachary M. Schrag - 2019 - Journal of Law, Medicine and Ethics 47 (2):254-263.
    In revising the Federal Policy for the Protection of Human Subjects between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The result (...)
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  • Reducing Regulatory Burdens on Research with Human Subjects: A Case Study of the Transition to the Final Common Rule at Boston Medical Center and Boston University Medical Campus.Fanny K. Ennever - 2018 - Journal of Law, Medicine and Ethics 46 (1):164-179.
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