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Human Biospecimens Come from People

dc.contributor.authorTomlinson, Tom
dc.contributor.authorDe Vries, Raymond G.
dc.date.accessioned2019-04-02T18:10:55Z
dc.date.available2020-05-01T18:03:25Zen
dc.date.issued2019-03
dc.identifier.citationTomlinson, Tom; De Vries, Raymond G. (2019). "Human Biospecimens Come from People." Ethics & Human Research 41(2): 22-28.
dc.identifier.issn2578-2355
dc.identifier.issn2578-2363
dc.identifier.urihttps://hdl.handle.net/2027.42/148374
dc.description.abstractContrary to the revised Common Rule, and contrary to the views of many bioethicists and researchers, we argue that broad consent should be sought for anticipated later research uses of deidentified biospecimens and health information collected during medical care. Individuals differ in the kinds of risk they find concerning and in their willingness to permit use of their biospecimens for future research. For this reason, asking their permission for unspecified research uses is a fundamental expression of respect for them as persons and should be done absent some compelling moral consideration to the contrary. We examine three moral considerations and argue that each of them fails: that there is a duty of easy rescue binding on all, that seeking consent creates a selection bias that undermines the validity of biospecimen research, and that seeking and documenting consent will be prohibitively expensive.
dc.publisherWiley Periodicals, Inc.
dc.publisherBroadway Books
dc.subject.otherdeidentified biospecimens
dc.subject.otherhuman research ethics
dc.subject.otherCommon Rule
dc.subject.otherinformed consent
dc.subject.otherbroad consent
dc.subject.otherrespect for persons
dc.titleHuman Biospecimens Come from People
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelPhilosophy
dc.subject.hlbsecondlevelMedicine (General)
dc.subject.hlbtoplevelHumanities
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/148374/1/eahr500009.pdf
dc.identifier.doi10.1002/eahr.500009
dc.identifier.sourceEthics & Human Research
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dc.identifier.citedreferenceGiven the position we argue for, it’s difficult to settle on the right term for referring to those whose materials are being used. “Sources” is ambiguous between human and nonhuman sources and so obscures the person from whom materials were obtained. “Participants” is misleading, since after the data and specimens are generated, there is no more participation. “Donor” may subtly beg the question by suggesting that the person chose to provide materials. But since we think that is what should happen, “donor” is the term we will employ.
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dc.identifier.citedreferenceDe Vries, R. G., et al., “ The Moral Concerns of Biobank Donors: The Effect of Non-welfare Interests on Willingness to Donate,” Life Sciences, Society and Policy 12 ( 2016 ): doi: 10.1186/s40504-016-0036-4.
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dc.identifier.citedreferenceFor example, see Lynch and Meyer, “ Regulating Research with Biospecimens under the Revised Common Rule,” 4.
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dc.identifier.citedreferenceCohn et al., “ Self-Reported Race and Ethnicity of US Biobank Participants Compared to the US Census,” 229.
dc.identifier.citedreferenceRivera et al., “ CTSA Institution Responses to Proposed Common Rule Changes,” 82.
dc.identifier.citedreferenceGlimcher, L. H., “How Not to End Cancer in Our Lifetimes,” Wall Street Journal, April 4, 2016; Secretary’s Advisory Committee on Human Research Protections, “Extensive Resources Necessary to Obtain and Track Consent for De-identified Biospecimens,” section in “Attachment A: Recommendations NPRM,” Office for Human Research Protections, content last reviewed March 9, 2016, https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2016-january-5-recommendation-nprm-attachment-a.
dc.identifier.citedreference“ BioVu Consent Form,” Vanderbilt University Medical Center, Institute for Clinical and Translational Research, January 14, 2019, https://victr.vanderbilt.edu/pub/biovu/?sid=220.
dc.identifier.citedreferenceBioIVT, https://www.bioivt.com/.
dc.identifier.citedreference“ Federal Policy for the Protection of Human Subjects,” Fed. Reg. (January 19, 2017 ), https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects#h-3.
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dc.identifier.citedreferenceCouncil on Governmental Relations, “ Analysis of Public Comments on the Common Rule NPRM,” 2016, https://tinyurl.com/ydddtxkj.
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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