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

Published online by Cambridge University Press:  01 January 2021

Brett A. Williams  and
Leslie E. Wolf
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Extract

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 41 , Issue 2 , Summer 2013 , pp. 440 - 453
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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References

“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Fed. Reg. 44512 (July 26, 2011) [hereinafter ANPRM] (to be codified at 45 C.F.R. pts. 46, 160, and 164 and 21 C.F.R. pts. 50 and 56).Google Scholar
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