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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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In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data

In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data

(p.265) 17 In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data
Human Subjects Research Regulation

Barbara J. Evans

The MIT Press

This chapter discusses informational (observational) studies that use pre-existing data or biospecimens. It summarizes existing regulatory pathways for gaining research or public health access to data and specimens under the Common Rule and HIPAA Privacy Rule and explores their defects. Non-consensual (unconsented) access to identifiable data and specimens is occasionally necessary to support socially beneficial public health and research studies where consent is impracticable or would introduce unacceptable biases into the study finding. The existing Common Rule waiver provisions, which allow IRBs to approve nonconsensual access, fail to meet the needs of modern informational research while also failing to provide adequate protection to people whose data and specimens are used. The recent ANPRM neglected this problem, and this chapter identifies needed substantive reforms and examines the appropriate processes and procedures for modernizing the Common Rule’s waiver provisions.

Keywords:   Waiver provisions, Consent waiver, Data, Biospecimens, Informational research, Observational studies, Waiver reform

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