Human Biospecimens Come from People
dc.contributor.author | Tomlinson, Tom | |
dc.contributor.author | De Vries, Raymond G. | |
dc.date.accessioned | 2019-04-02T18:10:55Z | |
dc.date.available | 2020-05-01T18:03:25Z | en |
dc.date.issued | 2019-03 | |
dc.identifier.citation | Tomlinson, Tom; De Vries, Raymond G. (2019). "Human Biospecimens Come from People." Ethics & Human Research 41(2): 22-28. | |
dc.identifier.issn | 2578-2355 | |
dc.identifier.issn | 2578-2363 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/148374 | |
dc.description.abstract | Contrary 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.publisher | Wiley Periodicals, Inc. | |
dc.publisher | Broadway Books | |
dc.subject.other | deidentified biospecimens | |
dc.subject.other | human research ethics | |
dc.subject.other | Common Rule | |
dc.subject.other | informed consent | |
dc.subject.other | broad consent | |
dc.subject.other | respect for persons | |
dc.title | Human Biospecimens Come from People | |
dc.type | Article | |
dc.rights.robots | IndexNoFollow | |
dc.subject.hlbsecondlevel | Philosophy | |
dc.subject.hlbsecondlevel | Medicine (General) | |
dc.subject.hlbtoplevel | Humanities | |
dc.subject.hlbtoplevel | Health Sciences | |
dc.description.peerreviewed | Peer Reviewed | |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/148374/1/eahr500009.pdf | |
dc.identifier.doi | 10.1002/eahr.500009 | |
dc.identifier.source | Ethics & Human Research | |
dc.identifier.citedreference | Ornstein, C., and K. Thomas, “Sloan Kettering’s Cozy Deal with Start-Up Ignites a New Uproar,” New York Times, September 20, 2018. | |
dc.identifier.citedreference | Lynch, H. F., and M. N. Meyer, “ Regulating Research with Biospecimens under the Revised Common Rule,” Hastings Center Report 47, no. 3 ( 2017 ): 3 – 4; J. Menikoff, J. Kaneshiro, and I. Pritchard, “The Common Rule, Updated,” New England Journal of Medicine 376, no. 7 (2017): 613–15; S. M. Rivera et al., “CTSA Institution Responses to Proposed Common Rule Changes: Did They Get What They Wanted?,” Journal of Empirical Research on Human Research Ethics 12, no. 2 (2017): 79–86. | |
dc.identifier.citedreference | Given 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. | |
dc.identifier.citedreference | Tomlinson, T., “ Respecting Donors to Biobank Research,” Hastings Center Report 43, no. 1 ( 2013 ): 41 – 47. | |
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dc.identifier.citedreference | Platt, J., et al., “ Public Preferences regarding Informed Consent Models for Participation in Population-Based Genomic Research,” Genetics in Medicine 16, no. 1 ( 2014 ): 11 – 18. | |
dc.identifier.citedreference | D’Abramo, F., J. Schildmann, and J. Vollmann, “ Research Participants’ Perceptions and Views on Consent for Biobank Research: A Review of Empirical Data and Ethical Analysis,” BMC Medical Ethics 16 ( 2015 ): 60; Haddow, G., et al., “Tackling Community Concerns about Commercialization and Genetic Research: A Modest Interdisciplinary Proposal,” Social Science and Medicine 64, no. 2 (2007): 272–82. | |
dc.identifier.citedreference | De 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. | |
dc.identifier.citedreference | Simon, C. M., et al., “ Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models,” Genetics in Medicine 13, no. 9 ( 2011 ): 821 – 31. | |
dc.identifier.citedreference | Porsdam-Mann, S., J. Savulescu, and B. J. Sahakian, “ Facilitating the Ethical Use of Health Data for the Benefit of Society: Electronic Health Records, Consent and the Duty of Easy Rescue,” Philosophical Transactions of the Royal Society A 374 ( 2016 ): doi: 10.1098/rsta.2016.0130, p. 5 quoted. | |
dc.identifier.citedreference | Singer, P., “ Famine, Affluence and Morality,” Philosophy and Public Affairs 1 ( 1972 ): 229 – 43. | |
dc.identifier.citedreference | Porsdam-Mann, Savulescu, and Sahakian, “ Facilitating the Ethical Use of Health Data for the Benefit of Society,” 6. | |
dc.identifier.citedreference | Arneson, R. J., “ The Principle of Fairness and Free-Rider Problems,” Ethics 92, no. 4 ( 1982 ): 616 – 33. | |
dc.identifier.citedreference | Cohn, E. G., et al., “ Self-Reported Race and Ethnicity of US Biobank Participants Compared to the US Census,” Journal of Community Genetics 8, no. 3 ( 2017 ): 229 – 38; Hill, E. M., et al., “Let’s Get the Best Quality Research We Can: Public Awareness and Acceptance of Consent to Use Existing Data in Health Research: A Review and Qualitative Study,” BMC Medical Research Methodology 13 (2013): 72. | |
dc.identifier.citedreference | For example, see Lynch and Meyer, “ Regulating Research with Biospecimens under the Revised Common Rule,” 4. | |
dc.identifier.citedreference | Kho, M. E., et al., “ Written Informed Consent and Selection Bias in Observational Studies Using Medical Records: Systematic Review,” BMJ 338 ( 2009 ): doi: 10.1136/bmj.b866, p. 5 quoted. | |
dc.identifier.citedreference | Rothstein, M. A., and A. B. Shoben, “ Does Consent Bias Research?,” American Journal of Bioethics 13, no. 4 ( 2013 ): 27 – 37. | |
dc.identifier.citedreference | Cohn et al., “ Self-Reported Race and Ethnicity of US Biobank Participants Compared to the US Census,” 229. | |
dc.identifier.citedreference | Rivera et al., “ CTSA Institution Responses to Proposed Common Rule Changes,” 82. | |
dc.identifier.citedreference | Glimcher, 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.citedreference | BioIVT, 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. | |
dc.identifier.citedreference | Skloot, R., The Immortal Life of Henrietta Lacks ( New York: Broadway Books, 2011 ). | |
dc.identifier.citedreference | Council on Governmental Relations, “ Analysis of Public Comments on the Common Rule NPRM,” 2016, https://tinyurl.com/ydddtxkj. | |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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