Hostname: page-component-586b7cd67f-g8jcs Total loading time: 0 Render date: 2024-11-28T22:41:13.365Z Has data issue: false hasContentIssue false
  • English
  • Français

Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy

Published online by Cambridge University Press:  01 January 2021

Rebecca L. Walker ,
Eric T. Juengst ,
Warren Whipple  and
Arlene M. Davis
Get access Rights & Permissions [Opens in a new window]

Extract

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria (“heart-beating cadavers”), were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression (GTEx) program through the National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue 2 , Summer 2014 , pp. 220 - 231
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Wicclair, M. R., “Ethics and Research with Deceased Patients,” Cambridge Quarterly of Healthcare Ethics 17, no. 1 (2008): 87–97.CrossRefGoogle Scholar
Lonsdale, J. et al., “The Genotype-Tissue Expression (GTEx) Project,” Nature Genetics 45, no. 6 (2013): 580–585.CrossRefGoogle Scholar
U.S. Code of Federal Regulations, Title 45, Part 46, Subpart A, Section 102(f).Google Scholar
McGuire, A. L. et al., “Taking DNA from the Dead,” Nature Reviews Genetics 11, no. 5 (2010): 318–318.CrossRefGoogle Scholar
Carolina Center for Genome Sciences, “CCGS Investigators Receive NC TraCS $50k Pilot Awards,” available at <http://genomics.unc.edu/news/articles/100401-NCtracsPilotAwards.html>(last visited April 24, 2014).(last+visited+April+24,+2014).>Google Scholar
Lieb, J. D. Davis, I. Evans, J., “The UNC Comprehensive Individual Molecular Atlas Project,” The North Carolina Translational and Clinical Sciences Institute, Planning Grant (April 2010): (unpublished grant).Google Scholar
Pentz, R. D. et al., “Ethics Guidelines for Research with the Recently Dead,” Nature Medicine 11, no. 11 (2005): 1145–1149; see Wicclair, , supra note 1.Google Scholar
U.S. National Conference of Commissioners on Uniform State Laws, Revised Uniform Anatomical Gift Act (2006), Section 11(d).Google Scholar
Moore, W., The Knife Man: The Extraordinary Life and Times of John Hunter, Father of Modern Surgery (New York: Roadway, 2005). Cantor, N. L., After We Die: The Life and Times of the Human Cadaver (Washington, D.C.: Georgetown University Press, 2010); Roach, M., Stiff: The Curious Lives of Human Cadavers (New York: W.W. Norton & Company, 2004).Google Scholar
Tilney, N. L., Transplant, from Myth to Reality (New Haven: Yale University Press, 2003): At 46–48.Google Scholar
U.S. National Conference of Commissioners on Uniform State Laws, Uniform Anatomical Gift Act (1968), Section 3.Google Scholar
U.S. National Conference of Commissioners on Uniform State Laws, Uniform Determination of Death Act (1980).Google Scholar
Burkle, C. M. et al., “Brain Death and the Courts,” Neurology 76, no. 9 (2011): 837–841.CrossRefGoogle Scholar
U.S. Code of Federal Regulations, Title 45, Part 46, Subpart A, Section 102(f).Google Scholar
Strong, C., “Specified Principlism: What It Is, and Does It Really Resolve Cases Better Than Casuistry?” Journal of Medicine and Philosophy 25, no. 3 (2000): 323–341.CrossRefGoogle Scholar
See McGuire, et al., supra note 2.Google Scholar
Schmidt, H. Callier, S., “How Anonymous Is ‘Anonymous’? Some Suggestions Towards a Coherent Universal Coding System for Genetic Samples,” Journal of Medical Ethics 38, no. 5 (2012): 304–309; Im, H. K. et al., “On Sharing Quantitative Trait GWAS Results in an Era of Multiple-Omics Data and the Limits of Genomic Privacy,” American Journal of Human Genetics 90, no. 4 (2012): 591–598.CrossRefGoogle Scholar
See Pentz, et al., supra note 7; Wicclair, , supra note 1; McGuire, et al., supra note 2.Google Scholar
U.S. Code of Federal Regulations, Title 45, Part 46, Subpart D.Google Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report,” April 18, 1979, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html>(last visited April 14, 2014); Wendler, D. Prasad, K., “Core Safeguards for Clinical Research with Adults Who Are Unable to Consent,” Annals of Internal Medicine 135, no. 7 (2001): 514–523; Chen, D. T. Miller, F. G. Rosenstein, D. L., “Enrolling Decisionally Impaired Adults in Clinical Research,” Medical Care 40, no. 9 (2002): Supplement V20–V29.Google Scholar
U.S. Code of Federal Regulations, Title 45, 164.512(i)(1)(iii).Google Scholar
Clayton, E. W. et al., “Informed Consent for Genetic Research on Stored Tissue Samples,” Journal of the American Medical Association 274, no. 22 (1995): 1786–1792.CrossRefGoogle Scholar
National Institutes of Health, National Human Genome Research Institute, “The Genotype-Tissue Expression Project: Organ and Tissue Donors FAQ,” August 12, 2012, available at <http://www.genome.gov/27549431>(last visited April 24, 2014).(last+visited+April+24,+2014).>Google Scholar
National Institutes of Health, Office of Strategic Coordination – the Common Fund, “The Genotype-Tissue Expression Project, Updated Informational Brochure,” 2012, available at http://commonfund.nih.gov/sites/default/files/GTEx_trifold_final_2012.pdf>(last visited April 24, 2014) (emphasis added).(last+visited+April+24,+2014)+(emphasis+added).>Google Scholar
Berg, J., “Grave Secrets: Legal and Ethical Analysis of Postmortem Confidentiality,” Connecticut Law Review 34, no. 1 (2001): 81–122.Google Scholar
Aristotle, Nicomachean Ethics, Irwin, Terence, trans. (Indianapolis: Hackett Publishing Company, 1984): At 1100a20.Google Scholar
Nagel, T., “Death,” Nous 4, no. 1 (1970): 73–80; Feinberg, J., “Harm to Others,” in Harm to Others (Oxford University Press, 1984): At 79–95; Feinberg, J., “Harm to Others,” in Harm to Others (Oxford University Press, 1984): At 79–95; Pitcher, G., “The Misfortunes of the Dead,” in American Philosophical Quarterly 21, no. 2 (1984): 217–225.CrossRefGoogle Scholar
U.S. Code of Federal Regulations, Title 45, Part 46, Subpart A.Google Scholar
Personal communication between the U.S. Office for Human Research Protections and Daniel Nelson, K., Director of the University of North Carolina at Chapel Hill Office of Human Research Ethics (August 17, 2012).Google Scholar
U.S. Office for Human Research Protections, “Guidance on Research Involving Coded Private Information or Biological Specimens,” 2004, revised 2008, available at <http://www.hhs.gov/ohrp/policy/cdebiol.html>(last visited May 6, 2014).(last+visited+May+6,+2014).>Google Scholar
Department of Health and Human Services, “Advance Notice of Proposed Rulemaking, 45 CFR Parts 46, 160, and 164,” Federal Register 76, no. 143 (July 26, 2011).Google Scholar
Personal communication between the U.S. Office for Human Research Protections and Daniel Nelson, K., Director of the University of North Carolina at Chapel Hill Office of Human Research Ethics (August 17, 2012).Google Scholar
Halperin, E. C., “The Poor, the Black, and the Marginalized as the Source of Cadavers in United States Anatomical Education,” Clinical Anatomy 20, no. 5 (2007): 489–95.CrossRefGoogle Scholar
Skloot, R., The Immortal Life of Henrietta Lacks (New York: Broadway Paperbacks, 2011).Google Scholar
U.S. Code of Federal Regulations, Title 45, Part 46, Subpart A.Google Scholar
BBC News, “Organ Scandal Background,” January 29, 2001, available at <http://news.bbc.co.uk/2/hi/1136723.stm>(last visited April 24, 2014).(last+visited+April+24,+2014).>Google Scholar
UK Legislature, Human Tissue Act (2004), Part 3, Provision 45.Google Scholar
See Halperin, , supra note 33, at 489.Google Scholar
Id.Google Scholar
Richardson, R., Death, Dissection and the Destitute (Chicago: University of Chicago Press, 2001).Google Scholar
National Institutes of Health, “Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research,” Federal Register 59, no. 46 (March 9, 1994): 11146–11151.Google Scholar
National Institutes of Health, “Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects,” March 6, 1998, available at <http://grants.nih.gov/grants/guide/notice-files/not98–024.html>(last visited April 24, 2014).(last+visited+April+24,+2014).>Google Scholar
See Halperin, , supra note 33, at 494.Google Scholar
U.S. Department of Health and Human Services, Office of Minority Health, “Organ Donation Data/Statistics,” available at <http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=3&vlid=555>(last visited April 24, 2014).(last+visited+April+24,+2014).>Google Scholar
Roach, M., The Curious Lives of Human Cadavers (New York: W.W. Norton and Company, 2003).Google Scholar
Teresi, D., The Undead: Organ Harvesting, the Ice-Water Test, Beating-Heart Cadavers – How Medicine Is Blurring the Line Between Life and Death (New York, Pantheon Books, 2012); Teresi, D., “What You Lose When You Sign That Donor Card,” Wall Street Journal, April 4, 2012; National Public Radio, “Blurring the Line between Life and Death,” March 19, 2004, available at <http://www.npr.org/2012/03/19/148296627/blurring-the-line-between-life-and-death>(last visited April 24, 2014).Google Scholar
See Pentz, et al., supra note 7; Wicclair, , supra note 1.Google Scholar
Id. (Wicclair), at 90.Google Scholar
U.S. National Conference of Commissioners on Uniform State Laws, Revised Uniform Anatomical Gift Act (2006), Section 8(a).Google Scholar
U.S. National Conference of Commissioners on Uniform State Laws, Revised Uniform Anatomical Gift Act (2006), Section 11(f).Google Scholar
Couzin-Frankel, J., “Return of Unexpected DNA Results Urged,” Science 339, no. 29 (March 2013): 1507–1508; Knoppers, B. M. et al., “The Emergence of an Ethical Duty to Disclose Genetic Research Results: International Perspectives,” European Journal of Human Genetics 14, no. 26 (July 2006): 1170–1178; Beskow, L. M. Burke, W., “Offering Individual Genetic Research Results: Context Matters,” Science Translational Medicine 2, no. 38 (2010): 38cm20.CrossRefGoogle Scholar
National Institutes of Health, supra note 23.Google Scholar
See Pentz, et al., supra note 7, at 1149.Google Scholar
Clayton, E. W., “Informed Consent and Biobanks,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 15–21.CrossRefGoogle Scholar
McGuire, A. L. Gibbs, R. A., “No Longer De-Identified,” Science 312, no. 5772 (2006): 370–371.CrossRefGoogle Scholar
Greely, H. T., “The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks,” Annual Review of Genomics and Human Genetics 8 (2007): 343–364; Hansson, M. G. et al., “Should Donors Be Allowed to Give Broad Consent to Future Biobank Research?” The Lancet Oncology 7, no. 3 (2006): 266–269; Caulfield, T., “Biobanks and Blanket Consent: The Proper Place of the Public Good and Public Perception Rationales,” King's Law Journal 18, no. 2 (2007): 209–226.CrossRefGoogle Scholar
National Institutes of Health, National Human Genome Research Institute, “The Genotype-Tissue Expression Project: Surgical Donors FAQ,” August 12, 2012, available at <http://www.genome.gov/27549432>(last visited April 24, 2014).(last+visited+April+24,+2014).>Google Scholar
Wicclair, M. R., “Informed Consent and Research Involving the Newly Dead,” Kennedy Institute of Ethics Journal 12, no. 4 (2002): 351–372.CrossRefGoogle Scholar