Publication Cover
New Genetics and Society
Critical Studies of Contemporary Biosciences
Volume 41, 2022 - Issue 1
2,010
Views
1
CrossRef citations to date
0
Altmetric
Tracking the Transformation of Novel Sequencing Practices into Clinical Services

“If relatives inherited the gene, they should inherit the data.” Bringing the family into the room where bioethics happens

&
Pages 23-46 | Received 30 Apr 2021, Accepted 05 Nov 2021, Published online: 13 Dec 2021

References

  • “ABC v St George Healthcare NHS Trust.” 2017. https://www.mentalhealthlaw.co.uk/ABC_v_St_George%27s_Healthcare_NHS_Trust_(2017)_EWCA_Civ_336.
  • Allen, Nicole L., Elizabeth W. Karlson, Susan Malspeis, Bing Lu, Christine E. Seidman, and Lisa Soleymani Lehmann. 2014. “Biobank Participants’ Preferences for Disclosure of Genetic Research Results: Perspectives from the OurGenes, OurHealth, OurCommunity Project.” Mayo Clinic Proceedings 89 (6): 738–746. doi:10.1016/j.mayocp.2014.03.015.
  • Amendola, Laura M., Martha Horike-Pyne, Susan B. Trinidad, Stephanie M. Fullerton, Barbara J. Evans, Wylie Burke, and Gail P. Jarvik. 2015. “Patients’ Choices for Return of Exome Sequencing Results to Relatives in the Event of Their Death.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 43 (3): 476–485. doi:10.1111/jlme.12290.
  • Aronowitz, Robert. 2015. Risky Medicine: Our Quest to Cure Fear and Uncertainty. Chicago, IL: University of Chicago Press.
  • ASHG. 1998. “Professional Disclosure of Familial Genetic Information.” The American Journal of Human Genetics 62 (2): 474–483. doi:10.1086/301707.
  • Ballard, Lisa M., Rachel H. Horton, Angela Fenwick, and Anneke M. Lucassen. 2020. “Genome Sequencing in Healthcare: Understanding the UK General Public’s Views and Implications for Clinical Practice.” European Journal of Human Genetics 28 (2): 155–164. doi:10.1038/s41431-019-0504-4.
  • Beskow, Laura M., and P. Pearl O’Rourke. 2015. “Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles.” The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics 43 (3): 502–513. doi:10.1111/jlme.12292.
  • Bombard, Yvonne, Kenneth Offit, and Mark E. Robson. 2012. “Risks to Relatives in Genomic Research: A Duty to Warn?” The American Journal of Bioethics 12 (10): 12–14. doi:10.1080/15265161.2012.699157.
  • Branum, Rebecca, and Susan M. Wolf. 2015. “International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access.” The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics 43 (3): 576–593. doi:10.1111/jlme.12301.
  • Burgess, M. M., and L. d’Agincourt-Canning. 2001. “Genetic Testing for Hereditary Disease: Attending to Relational Responsibility.” The Journal of Clinical Ethics 12 (4): 361–372.
  • Chan, Ben, Flavia M. Facio, Haley Eidem, Sara Chandros Hull, Leslie G. Biesecker, and Benjamin E. Berkman. 2012. “Genomic Inheritances: Disclosing Individual Research Results from Whole-Exome Sequencing to Deceased Participants’ Relatives.” The American Journal of Bioethics: AJOB 12 (10): 1–8. doi:10.1080/15265161.2012.699138.
  • Corrigan, Oonagh. 2003. “Empty Ethics: The Problem with Informed Consent.” Sociology of Health & Illness 25 (7): 768–792. doi:10.1046/j.1467-9566.2003.00369.x.
  • Couzin-Frankel, Jennifer. 2014. “Clinical Research. Divulging DNA Secrets of Dead Stirs Debate.” Science (New York, N.Y.) 343 (6169): 356–357. doi:10.1126/science.343.6169.356.
  • Daly, Mary B. 2015. “A Family-Centered Model for Sharing Genetic Risk.” The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics 43 (3): 545–551. doi:10.1111/jlme.12297.
  • Dheensa, Sandi, Angela Fenwick, and Anneke Lucassen. 2016. “‘Is This Knowledge Mine and Nobody Else’s? I Don’t Feel That.’ Patient Views About Consent, Confidentiality and Information-Sharing in Genetic Medicine.” Journal of Medical Ethics 42 (3): 174–179. doi:10.1136/medethics-2015-102781.
  • Dheensa, Sandi, Angela Fenwick, and Anneke Lucassen. 2017. “Approaching Confidentiality at a Familial Level in Genomic Medicine: A Focus Group Study with Healthcare Professionals.” BMJ Open 7 (2): e012443. doi:10.1136/bmjopen-2016-012443.
  • Dheensa, Sandi, Angela Fenwick, Shiri Shkedi-Rafid, Gillian Crawford, and Anneke Lucassen. 2016. “Health-Care Professionals’ Responsibility to Patients’ Relatives in Genetic Medicine: A Systematic Review and Synthesis of Empirical Research.” Genetics in Medicine: Official Journal of the American College of Medical Genetics 18 (4): 290–301. doi:10.1038/gim.2015.72.
  • Donchin, A. 2001. “Understanding Autonomy Relationally: Toward a Reconfiguration of Bioethical Principles.” The Journal of Medicine and Philosophy 26 (4): 365–386. doi:10.1076/jmep.26.4.365.3012.
  • Doukas, D. J., and J. W. Berg. 2001. “The Family Covenant and Genetic Testing.” The American Journal of Bioethics: AJOB 1 (3): 3–10. doi:10.1162/152651601750417784.
  • Dove, Edward S., Vicky Chico, Michael Fay, Graeme Laurie, Anneke M. Lucassen, and Emily Postan. 2019. “Familial Genetic Risks: How Can We Better Navigate Patient Confidentiality and Appropriate Risk Disclosure to Relatives?” Journal of Medical Ethics 45 (8): 504–507. doi:10.1136/medethics-2018-105229.
  • Dove, Edward S., Susan E. Kelly, Federica Lucivero, Mavis Machirori, Sandi Dheensa, and Barbara Prainsack. 2017. “Beyond Individualism: Is There a Place for Relational Autonomy in Clinical Practice and Research?” Clinical Ethics 12 (3): 150–165. doi:10.1177/1477750917704156.
  • Facio, Flavia M., Stephanie Brooks, Johanna Loewenstein, Susannah Green, Leslie G. Biesecker, and Barbara B. Biesecker. 2011. “Motivators for Participation in a Whole-Genome Sequencing Study: Implications for Translational Genomics Research.” European Journal of Human Genetics 19 (12): 1213–1217. doi:10.1038/ejhg.2011.123.
  • Finkler, Kaja. 2000. Experiencing the New Genetics: Family and Kinship on the Medical Frontier. Philadelphia: University of Pennsylvania Press. https://www.upenn.edu/pennpress/book/13382.html.
  • Foucault, Michel. 1997. “Polemics, Politics, and Problematizations: An Interview with Michel Foucault.” In Ethics: Essential Works of Michel Foucault 1954–1984, Vol. 1, edited by P. Rabinow, 111–119. London: Penguin.
  • Fox, Renée C. 1996. “‘More Than Bioethics.’ In Search of the Good Society: The Work of Daniel Callahan.” The Hastings Center Report 26 (6): 5–7. doi:10.2307/3528743.
  • Fox, Dov, Emily Spencer, and Ali Torkamani. 2018. “Returning Results to Family Members: Professional Duties in Genomics Research in the United States.” The Journal of Legal Medicine 38 (2): 201–219. doi:10.1080/01947648.2017.1417934.
  • Fox, Renée C., and Judith P. Swazey. 1984. “Medical Morality Is Not Bioethics—Medical Ethics in China and the United States.” Perspectives in Biology and Medicine 27 (3): 336–360. doi:10.1353/pbm.1984.0060.
  • Fox, Renée C., and Judith P. Swazey. 2010. “Guest Editorial: Ignoring the Social and Cultural Context of Bioethics Is Unacceptable.” Cambridge Quarterly of Healthcare Ethics 19 (3): 278–281. doi:10.1017/S0963180110000046.
  • Garrison, Nanibaa’ A. 2015. “Considerations for Returning Research Results to Culturally Diverse Participants and Families of Decedents.” The Journal of Law, Medicine & Ethics 43 (3): 569–575. doi:10.1111/jlme.12300.
  • Gert, Bernard, Edward M. Berger, and George F. Cahill. 1996. Morality and the New Genetics : A Guide for Students and Health Care Providers. Jones and Bartlett Series in Philosophy. Boston, MA: Jones and Barlett.
  • Gilbar, Roy. 2007. “Communicating Genetic Information in the Family: The Familial Relationship as the Forgotten Factor.” Journal of Medical Ethics 33 (7): 390–393. doi:10.1136/jme.2006.017467.
  • Gilbar, Roy, and Charles Foster. 2018. “It’s Arrived! Relational Autonomy Comes to Court: ABC v ST George’s Healthcare NHS Trust [2017] EWCA 336.” Medical Law Review 26 (1): 125–133. doi:10.1093/medlaw/fwx044.
  • Goodman, Jessie L., Laura M. Amendola, Martha Horike-Pyne, Susan B. Trinidad, Stephanie M. Fullerton, Wylie Burke, and Gail P. Jarvik. 2017. “Discordance in Selected Designee for Return of Genomic Findings in the Event of Participant Death and Estate Executor.” Molecular Genetics & Genomic Medicine 5 (2): 172–176. doi:10.1002/mgg3.274.
  • Gordon, Deborah R. 1988. “Tenacious Assumptions in Western Medicine.” In Biomedicine Examined, edited by Margaret Lock and Deborah Gordon, 19–56. Dordrecht: Springer. doi:10.1007/978-94-009-2725-4_3.
  • Gordon, Deborah R., Carmen Radecki Breitkopf, Marguerite Robinson, Wesley O. Petersen, Jason S. Egginton, Kari G. Chaffee, Gloria M. Petersen, Susan M. Wolf, and Barbara A. Koenig. 2019. “Should Researchers Offer Results to Family Members of Cancer Biobank Participants? A Mixed-Methods Study of Proband and Family Preferences.” AJOB Empirical Bioethics 10 (1): 1–22. doi:10.1080/23294515.2018.1546241.
  • Gordon, Deborah R., and Eugenio Paci. 1997. “Disclosure Practices and Cultural Narratives: Understanding Concealment and Silence Around Cancer in Tuscany, Italy.” Social Science & Medicine (1982) 44 (10): 1433–1452. doi:10.1016/s0277-9536(96)00198-0.
  • Graves, Kristi D., Pamela S. Sinicrope, Mary Jane Esplen, Susan K. Peterson, Christi A. Patten, Jan Lowery, Frank A. Sinicrope, et al. 2014. “Communication of Genetic Test Results to Family and Health Care Providers Following Disclosure of Research Results.” Genetics in Medicine : Official Journal of the American College of Medical Genetics 16 (4): 294–301. doi:10.1038/gim.2013.137.
  • Hallowell, Nina. 1999. “Doing the Right Thing: Genetic Risk and Responsibility.” Sociology of Health & Illness 21 (5): 597–621. doi:10.1111/1467-9566.00175.
  • Hallowell, Nina, C. Foster, R. Eeles, A. Ardern-Jones, V. Murday, and M. Watson. 2003. “Balancing Autonomy and Responsibility: The Ethics of Generating and Disclosing Genetic Information.” Journal of Medical Ethics 29 (2): 74–79; discussion 80–83. doi:10.1136/jme.29.2.74.
  • Hoeyer, Klaus. 2005. “Studying Ethics as Policy: The Naming and Framing of Moral Problems in Genetic Research.” Current Anthropology 46 (S5): S71–S90. doi:10.1086/432454.
  • Horton, Rachel H., and Anneke M. Lucassen. 2019. “Recent Developments in Genetic/Genomic Medicine.” Clinical Science (London, England : 1979) 133 (5): 697–708. doi:10.1042/CS20180436.
  • Jennings, Bruce. 2016. “Reconceptualizing Autonomy: A Relational Turn in Bioethics.” The Hastings Center Report 46 (3): 11–16. doi:10.1002/hast.544.
  • Kleinman, Arthur. 1997. “Writing at the Margin: Discourse Between Anthropology and Medicine.” Berkeley: University of California Press Eweb:148013. https://repository.library.georgetown.edu/handle/10822/879897.
  • Knoppers, Bartha Maria. 2002. “Genetic Information and the Family: Are We Our Brother’s Keeper?” Trends in Biotechnology 20 (2): 85–86. doi:10.1016/s0167-7799(01)01879-0.
  • Koenig, Barbara A. 2001. “Why Not Grant Primacy to the Family?” American Journal of Bioethics 1 (3): 33–34. doi:10.1162/152651601750417937.
  • Koenig, Barbara A. 2014. “Have We Asked Too Much of Consent?” The Hastings Center Report 44 (4): 33–34. doi:10.1002/hast.329.
  • Konrad, Monica. 2005. Narrating the New Predictive Genetics: Ethics, Ethnography and Science. 1st ed. Cambridge University Press. doi:10.1017/CBO9780511584183.
  • Lucassen, Anneke, and Roy Gilbar. 2018. “Alerting Relatives About Heritable Risks: The Limits of Confidentiality.” BMJ 361 (April): k1409. doi:10.1136/bmj.k1409.
  • Lucassen, Anneke, and Alison Hall. 2012. “Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information.” Clinical Medicine 12 (1): 5–6. doi:10.7861/clinmedicine.12-1-5.
  • Lucassen, Anneke, Jonathan Montgomery, and Michael Parker. 2017. “Chapter 16. Ethics and the Social Contract for Genomics in the NHS.” In Annual Report of the Chief Medical Officer 2016. Department of Health. https://eprints.soton.ac.uk/412776/.
  • Mackenzie, Catriona, and Natalie Stoljar. 2000. Relational Autonomy: Feminist Perspectives on Autonomy, Agency, and the Social Self. Oxford University Press. https://researchers.mq.edu.au/en/publications/relational-autonomy-feminist-perspectives-on-autonomy-agency-and-.
  • Mackley, Michael P., Benjamin Fletcher, Michael Parker, Hugh Watkins, and Elizabeth Ormondroyd. 2017. “Stakeholder Views on Secondary Findings in Whole-Genome and Whole-Exome Sequencing: A Systematic Review of Quantitative and Qualitative Studies.” Genetics in Medicine 19 (3): 283–293. doi:10.1038/gim.2016.109.
  • Montgomery, Sir Jonathan. 2019. “Foreword.” In Consent and Confidentiality in Genomic Medicine: Guidance on the Use of Genetic and Genomic Information in the Clinic. Royal College of Physicians, Royal College of Pathologists and British Society for Genetic Medicine. https://www.rcplondon.ac.uk/projects/outputs/consent-and-confidentiality-genomic-medicine.
  • Parker, Michael, and Anneke M. Lucassen. 2004. “Genetic Information: A Joint Account?” BMJ (Clinical Research Ed.) 329 (7458): 165–167. doi:10.1136/bmj.329.7458.165.
  • Parker, Michael, and Anneke Lucassen. 2018. “Using a Genetic Test Result in the Care of Family Members: How Does the Duty of Confidentiality Apply?” European Journal of Human Genetics 26 (7): 955–959. doi:10.1038/s41431-018-0138-y.
  • Petersen, Gloria M., M. de Andrade, and M. Goggins. 2006. “Pancreatic Cancer Genetic Epidemiology Consortium | Cancer Epidemiology, Biomarkers & Prevention.” Cancer, Epidemiology, Biomarkers and Prevention 15 (4): 704–710.
  • Presidential Commission for the Study of Bioethical Issues. 2013. “Anticipate and Communicate Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.” https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf.
  • Radecki Breitkopf, Carmen, Gloria M. Petersen, Susan M. Wolf, Kari G. Chaffee, Marguerite E. Robinson, Deborah R. Gordon, Noralane M. Lindor, and Barbara A. Koenig. 2015. “Preferences Regarding Return of Genomic Results to Relatives of Research Participants, Including After Participant Death: Empirical Results from a Cancer Biobank.” The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics 43 (3): 464–475. doi:10.1111/jlme.12289.
  • Radecki Breitkopf, Carmen, Susan M. Wolf, Kari G. Chaffee, Marguerite E. Robinson, Noralane M. Lindor, Deborah R. Gordon, Barbara A. Koenig, and Gloria M. Petersen. 2018. “Attitudes Toward Return of Genetic Research Results to Relatives, Including After Death: Comparison of Cancer Probands, Blood Relatives, and Spouse/Partners.” Journal of Empirical Research on Human Research Ethics 13 (3): 295–304. doi:10.1177/1556264618769165.
  • Rothstein, Mark A. 2018. “Reconsidering the Duty to Warn Genetically At-Risk Relatives.” Genetics in Medicine: Official Journal of the American College of Medical Genetics 20 (3): 285–290. doi:10.1038/gim.2017.257.
  • Royal College of Physicians, Royal College of Pathologists and British Society for Genetic Medicine. 2019. Consent and Confidentiality in Genomic Medicine: Guidance on the Use of Genetic and Genomic Information in the Clinic. Report of the Joint Committee on Medical Genetics. London: RCP, RCPath and BSGM. https://www.rcplondon.ac.uk/projects/outputs/consent-and-confidentiality-genomic-medicine.
  • Royal College of Physicians, Royal College of Pathologists, British Society for Human Genetics. 2011. Consent and Confidentiality in Clinical Genetic Practice: Guidance on Genetic Testing and Sharing Genetic Information. Report of the Joint Committee on Medical Genetics. London: RCP, RCPath and BSGM. https://www.rcpath.org/resourceLibrary/consent-and-confidentiality-in-geneticpractice.html.
  • Samuel, Gabrielle Natalie, Sandi Dheensa, Bobbie Farsides, Angela Fenwick, and Anneke Lucassen. 2017. “Healthcare Professionals’ and Patients’ Perspectives on Consent to Clinical Genetic Testing: Moving Towards a More Relational Approach.” BMC Medical Ethics 18 (1): 47. doi:10.1186/s12910-017-0207-8.
  • Strathern, Marilyn. 1995. “Nostalgia and the New Genetics.” In Rhetorics of Self-Making, edited by D. Battaglia. Berkeley: University of California Press. https://publishing.cdlib.org/ucpressebooks/view?docId = ft3z09n8 ( 2;chunk.id=0;doc.view = print.
  • Tabor, Holly K., Benjamin E. Berkman, Sara Chandros Hull, and Michael J. Bamshad. 2011. “Genomics Really Gets Personal: How Exome and Whole Genome Sequencing Challenge the Ethical Framework of Human Genetics Research.” American Journal of Medical Genetics. Part A 155A (12): 2916–2924. doi:10.1002/ajmg.a.34357.
  • Tassé, Anne Marie. 2011. “The Return of Results of Deceased Research Participants.” Journal of Law, Medicine & Ethics 39 (4): 621–630. doi:10.1111/j.1748-720X.2011.00629.x.
  • Ursin, Lars, and Maria Stuifbergen. 2018. “Ethics of Dead Participants: Policy Recommendations for Biobank Research.” Journal of Medical Ethics 44 (10): 695–699. doi:10.1136/medethics-2017-104241.
  • Weaver, Meaghann. 2016. “The Double Helix: Applying an Ethic of Care to the Duty to Warn Genetic Relatives of Genetic Information.” Bioethics 30 (3): 181–187. doi:10.1111/bioe.12176.
  • Wertz, Dorothy C. 2001. “No Consensus Worldwide.” The American Journal of Bioethics 1 (3): 14–15. doi:10.1162/152651601750417801.
  • Wertz, Dorothy C., and John C. Fletcher. 1991. “Privacy and Disclosure in Medical Genetics Examined in an Ethics of Care.” Bioethics 5 (3): 212–232. doi:10.1111/j.1467-8519.1991.tb00161.x.
  • Wertz, Dorothy C., John C. Fletcher, Karen Berg, and WHO Human Genetics Programme. 2003. “Review of Ethical Issues in Medical Genetics: Report of Consultants to WHO/D.C.” World Health Organization. https://apps.who.int/iris/handle/10665/68512.
  • Widdows, Heather. 2009. “Between the Individual and the Community: The Impact of Genetics on Ethical Models.” New Genetics and Society 28 (2): 173–188. doi:10.1080/14636770902901611.
  • Widdows, Heather. 2013. The Connected Self: The Ethics and Governance of the Genetic Individual. Cambridge Bioethics and Law. Cambridge: Cambridge University Press. doi:10.1017/CBO9781139051798.
  • Wolf, Susan M. 2015. “Introduction: Return of Research Results: What About the Family?” The Journal of Law, Medicine & Ethics 43 (3): 437–439. doi:10.1111/jlme.12287.
  • Wolf, Susan M., Rebecca Branum, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, et al. 2015. “Returning a Research Participant’s Genomic Results to Relatives: Analysis and Recommendations.” Journal of Law, Medicine and Ethics 43 (3): 440–463. doi:10.1111/jlme.12288.
  • Zhen, David B., Kari G. Rabe, Steven Gallinger, Sapna Syngal, Ann G. Schwartz, Michael G. Goggins, Ralph H. Hruban, et al. 2015. “BRCA1, BRCA2, PALB2, and CDKN2A Mutations in Familial Pancreatic Cancer: A PACGENE Study.” Genetics in Medicine 17 (7): 569–577. doi:10.1038/gim.2014.153.