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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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Biospecimen Exceptionalism in the ANPRM

Biospecimen Exceptionalism in the ANPRM

(p.193) 12 Biospecimen Exceptionalism in the ANPRM
Human Subjects Research Regulation

Ellen Wright Clayton

The MIT Press

The ANPRM defines biospecimens as identifiable per se, apparently viewing genomic information as particularly risky, a proposal that is misguided in two opposing directions. This chapter argues that the risk of re-identification is actually quite low, given the limited availability of the identified samples needed for comparison and the lack of benefit to the attacker. Nor are the consequences of re-identifying an individual clear. Yet given OHRP’s concern, it is striking that it would require only an unspecified “broad general consent” with a presumption in favor of broad data sharing. OHRP also proposes to eliminate IRB oversight of this research, deferring instead to the HIPAA Privacy Rule, which has different thresholds of identifiability. This chapter discusses and analyses these issues.

Keywords:   Biospecimen exceptionalism, ANPRM, Risk, Informed consent

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