Journal of Law, Medicine and Ethics 41 (2):440-453 (2013)
AbstractThe U.S. Department of Health and Human Services has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking, 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.
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References found in this work
Identifiability of DNA Data: The Need for Consistent Federal Policy.Amy L. McGuire - 2008 - American Journal of Bioethics 8 (10):75-76.
Balancing Privacy Protections with Efficient Research: Institutional Review Boards and the Use of Certificates of Confidentiality.Peter M. Currie - 2005 - IRB: Ethics & Human Research 27 (5):7.
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Citations of this work
IRB Practices and Policies Regarding the Secondary Research Use of Biospecimens.Aaron J. Goldenberg, Karen J. Maschke, Steven Joffe, Jeffrey R. Botkin, Erin Rothwell, Thomas H. Murray, Rebecca Anderson, Nicole Deming, Beth F. Rosenthal & Suzanne M. Rivera - 2015 - BMC Medical Ethics 16 (1):32.
Biobanking Research and Privacy Laws in the United States.Heather L. Harrell & Mark A. Rothstein - 2016 - Journal of Law, Medicine and Ethics 44 (1):106-127.
The Devil is in the Details: Confidentiality Challenges in the Age of Genetics.Barbara J. Daly, Ashley Rosko, Shulin Zhang & Hillard M. Lazarus - 2015 - HEC Forum 27 (1):79-86.
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