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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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Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

Chapter:
(p.207) 13 Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?
Source:
Human Subjects Research Regulation
Author(s):

Brett A. Williams

Leslie E. Wolf

Publisher:
The MIT Press
DOI:10.7551/mitpress/9780262027465.003.0018

Certificates of Confidentiality, a legal tool for protecting sensitive, identifiable research data, are recommended for genetic, genomics, and other biospecimen research. The proposed changes to the US federal regulations governing human subjects research under the Advance Notice of Proposed Rule Making may make it more difficult for researchers to obtain a Certificate protections for this type of research. This chapter explores the potentially conflicting requirements of the ANPRM proposals and Certificates and makes recommendations to achieve the dual goals of appropriate consent and adequate confidentiality protections.

Keywords:   Genetics, Genomics, Biospecimen, Research, Confidentiality, Certificate of Confidentiality

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