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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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Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement

Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement

(p.221) 14 Mandating Consent for Future Research with Biospecimens: A Call for Enhanced Community Engagement
Human Subjects Research Regulation

Carol Weil

Hilary Shutak

Benjamin Fombonne

Nicole Lockhart

The MIT Press

The use of human biological samples in medical research has the potential to transform our understanding of health and disease in the age of the genome, but the collection and banking of samples for currently unknowable future research purposes presents both ethical and legal challenges. Given the primacy of biospecimens in genomic research, it is critical to develop regulatory policies that appropriately balance public preferences about privacy and consent with the scientific imperatives of investigator access and broad data sharing. The Advanced Notice of Proposed Rulemaking (ANPRM) proposes a requirement for written informed consent for research uses of previously collected human biological samples. This chapter explores the impact of that regulatory proposal with respect to the ethics and operations of research involving biospecimens. It describes specific shortcomings of the current federal regulations protecting human biospecimens and associated data used in research, explains how proposed changes to consent procedures in the ANPRM could address these limitations while at the same time pose new challenges for health care institutions, and finally, sets forth the thesis that enhanced education and collaboration with participant communities would greatly improve implementation of the ANPRM’s written consent requirement for secondary uses of biospecimens in research.

Keywords:   Informed consent, Biobanking, Genomics research, Community engagement, Secondary research with tissue

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