Hostname: page-component-586b7cd67f-t7fkt Total loading time: 0 Render date: 2024-11-26T05:55:00.775Z Has data issue: false hasContentIssue false
  • English
  • Français

Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles

Published online by Cambridge University Press:  01 January 2021

Laura M. Beskow  and
P. Pearl O'Rourke
Get access Rights & Permissions [Opens in a new window]

Extract

Whether or not to offer individual genetic results to research participants has been the subject of considerable debate, yet consensus regarding what, when, and how to return remains elusive. Despite this lack of clarity, the discussion has moved to the offer of research results to family members of participants, including when the participant is deceased. Given the familial implications of genetic information, this extension is perhaps logical. But it raises concerns throughout the research process, including, for example, questions about disclosures and choices on consent forms, procedures for identifying and contacting family members, and how any such obligations might apply to secondary users of biospecimens and data.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 3 , Autumn 2015 , pp. 502 - 513
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

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

Eckstein, L. Garrett, J. R. Berkman, B. E., “A Framework for Analyzing the Ethics of Disclosing Genetic Research Findings,” Journal of Law, Medicine & Ethics 42, no. 2 (2014): 190–207; Johnson, L. M. Church, C. L. Walsh, M. F. Baker, J. N., “Clinically Significant? Depends on Whom You Ask,” American Journal of Bioethics 12, no. 10 (2012): 18–20; Bredenoord, A. L. Kroes, H. Y. Cuppen, E. Parker, M. Van Delden, J. J., “Disclosure of Individual Genetic Data to Research Participants: The Debate Reconsidered,” Trends in Genetics 27, no. 2 (2011): 41–47; Forsberg, J. S. Hansson, M. G. Eriksson, S., “Changing Perspectives in Biobank Research: From Individual Rights to Concerns about Public Health Regarding the Return of Results,” European Journal of Human Genetics 17, no. 12 (2009): 1544–1549; Miller, F. A. Christensen, R. Giacomini, M. Robert, J. S., “Duty to Disclose What? Querying the Putative Obligation to Return Research Results to Participants,” Journal of Medical Ethics 34, no. 3 (2008): 210–213; Shalowitz, D. I. Miller, F. G., “The Search for Clarity in Communicating Research Results to Study Participants,” Journal of Medical Ethics 34, no. 9 (2008): E17.CrossRefGoogle Scholar
Milner, L. C. Liu, E. Y. Garrison, N. A., “Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects,” American Journal of Bioethics 13, no. 10 (2013): 66–67; Rothstein, M. A., “Should Researchers Disclose Results to Descendants?” American Journal of Bioethics 13, no. 10 (2013): 64–65; Chan, B. Facio, F. M. Eidem, H. Hull, S. C. Biesecker, L. G. Berkman, B. E., “Genomic Inheritances: Disclosing Individual Research Results From Whole-Exome Sequencing to Deceased Participants' Relatives,” American Journal of Bioethics 12, no. 10 (2012): 1–8; Ormondroyd, E. Moynihan, C. Watson, M. Foster, C. Davolls, S. Ardern-Jones, A. Eeles, R., “Disclosure of Genetics Research Results After the Death of the Patient Participant: A Qualitative Study of the Impact on Relatives,” Journal of Genetic Counseling 16, no. 4 (2007): 527–538; Ormondroyd, E. Moynihan, C. Ardern-Jones, A. Eeles, R. Foster, C. Davolls, S. Watson, M., “Communicating Genetics Research Results to Families: Problems Arising When the Patient Participant is Deceased,” Psychooncology 17, no. 8 (2008): 804–811; Tassé, A. M., “The Return of Results of Deceased Research Participants,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 621–630; Tassé, A. M., “Biobanking and Deceased Persons,” Human Genetics 130, no. 3 (2011): 415–423.CrossRefGoogle Scholar
L. G. Dressler, S. Smolek, R. Ponsaran, J. M. Markey, H. Starks, N. Gerson, S. Lewis, N. Press, E. Juengst, and G. L. Wiesner for the GRRIP Consortium, “IRB Perspectives on the Return of Individual Results from Genomic Research,” Genetics in Medicine 14, no. 2 (2012): 215–222; Collins, C.K. Fernandez, C. V., “Offering Results to Research Subjects: U.S. Institutional Review Board Policy,” Accountability in Research 14, no. 4 (2007): 255–267; Simon, C. Shinkunas, L. A. Brandt, D. Williams, J. K., “Individual Genetic and Genomic Research Results and the Tradition of Informed Consent: Exploring US Review Board Guidance,” Journal of Medical Ethics 38, no. 7 (2012): 417–422; Simon, C. M. Williams, J. K. Shinkunas, L. Brandt, D. Daack-Hirsch, S. Driessnack, M., “Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives,” Journal of Empirical Research on Human Research Ethics 6, no. 4 (2011): 53–67.Google Scholar
McWilliams, R. R. Wieben, E. D. Rabe, K. G. Pedersen, K. S. Wu, Y. Sicotte, H. Petersen, G. M., “Prevalence of CDKN2A Mutations in Pancreatic Cancer Patients: Implications for Genetic Counseling,” European Journal of Human Genetics 19, no. 4 (2011): 472–478.CrossRefGoogle Scholar
Gordon, E. J. Philpott, S., “The Convergence of Research and Clinical Practice: Institutional Review Board Review of Humanitarian Use Device Applications,” Journal of Empirical Research on Human Research Ethics 3, no. 4 (2008): 81–98; Ripley, E. Macrina, F. Markowitz, M. Gennings, C., “Why Do We Pay? A National Survey of Investigators and IRB Chairpersons,” Journal of Empirical Research on Human Research Ethics 5, no. 3 (2010): 43–56; Wagner, T. H. Murray, C. Goldberg, J. Adler, J. M. Abrams, J., “Costs and Benefits of the National Cancer Institute Central Institutional Review Board,” Journal of Clinical Oncology 28, no. 4 (2010): 662–666; Largent, E. A. Grady, C. Miller, F. G. Wertheimer, A., “Money, Coercion, and Undue Inducement: Attitudes About Payments to Research Participants,” IRB 34, no. 1 (2012): 1–8; Beskow, L. M. Namey, E. E. Miller, P. R. Nelson, D. K. Cooper, A., “IRB Chairs' Perspectives on Genotype-Driven Research Recruitment,” IRB 34, no. 3 (2012): 1–10 [hereinafter Beskow, et al. 2012A]; Beskow, L. M. Check, D. K. Namey, E. E. Dame, L. A. Lin, L. Cooper, A. Weinfurt, K. P. Wolf, L. E., “Institutional Review Boards' Use and Understanding of Certificates of Confidentiality,” PLoS One 7, no. 9 (2012): E44050; Crites, J. S. Harter, T. D. Furman, L. M. Daly, B. J., “Payment to Participants in Pediatric Research: Variation in IRB Members' Attitudes,” IRB 35, no. 5 (2013): 9–13.CrossRefGoogle Scholar
Broad Institute, Creating A Global Alliance to Enable Responsible Sharing of Genomic and Clinical Data, available at <http://www.broadinstitute.org/files/news/pdfs/gawhitepaperjune3.pdf> (last visited August 3, 2015).+(last+visited+August+3,+2015).>Google Scholar
Shalowitz, D. I. Miller, F. G., “Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions,” PLoS Medicine 5, no. 5 (2008): E91.CrossRefGoogle Scholar
Beskow, L. M. Burke, W. Fullerton, S. M. Sharp, R. R., “Offering Aggregate Results to Participants in Genomic Research: Opportunities and Challenges,” Genetics in Medicine 14, no. 4 (2012): 490–496.CrossRefGoogle Scholar
Wolf, S. M., “Return of Individual Research Results and Incidental Findings: Facing the Challenges of Translational Science,” Annual Review of Genomics and Human Genetics 14, no. 4 (2013): 557–577.Google Scholar
Bledsoe, M. J. Clayton, E. W. McGuire, A. L. Grizzle, W. E. O'Rourke, P. P. Zeps, N., “Return of Research Results from Genomic Biobanks: Cost Matters,” Genetics in Medicine 15, no. 2 (2013): 103–105; Black, L. Avard, D. Zawati, M. H. Knoppers, B. M. Hebert, J. Sauvageau, G., “Funding Considerations for the Disclosure of Genetic Incidental Findings in Biobank Research,” Clinical Genetics 84, no. 5 (2013): 397–406.CrossRefGoogle Scholar
Wolf, S. M. Lawrenz, F. P. Nelson, C. A. Kahn, J. P. Cho, M. K. Clayton, E. W. Fletcher, J. G. Georgieff, M. K. Hammerschmidt, D. Hudson, K. Illes, J. Kapur, V. Keane, M. A. Koenig, B. A. Leroy, B. S. McFarland, E. G. Paradise, J. Parker, L. S. Terry, S. F. Van Ness, B. Wilfond, B. S., “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219–248; Fabsitz, R. R. McGuire, A. Sharp, R. R. Puggal, M. Beskow, L. M. Biesecker, L. G. Bookman, E. Burke, W. Burchard, E. G. Church, G. Clayton, E. W. Eckfeldt, J. H. Fernandez, C. V. Fisher, R. Fullerton, S. M. Gabriel, S. Gachupin, F. James, C. Jarvik, G. P. Kittles, R. Leib, J. R. O'Donnell, C. O'Rourke, P. P. Rodriguez, L. L. Schully, S. D. Shuldiner, A. R. Sze, R. K. Thakuria, J. V. Wolf, S. M. Burke, G. L., “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from A National Heart, Lung, and Blood Institute Working Group,” Circulation: Cardiovascular Genetics 3, no. 6 (2010): 574–580; Wolf, S. M. Crock, B. N. Van Ness, B. Lawrenz, F. Kahn, J. P. Beskow, L. M. Cho, M. K. Christman, M. F. Green, R. C. Hall, R. Illes, J. Keane, M. Knoppers, B. M. Koenig, B. A. Kohane, I. S. Leroy, B. Maschke, K. J. McGeveran, W. Ossorio, P. Parker, L. S. Petersen, G. M. Richardson, H. S. Scott, J. A. Terry, S. F. Wilfond, B. S. Wolf, W. A., “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361–384; Bookman, E. B. Din-Lovinescu, C. Worrall, B. B. Manolio, T. A. Bennett, S. N. Laurie, C. Mirel, D. B. Doheny, K. F. Anderson, G. L. Wehr, K. Weinshilboum, R. Chen, D. T., “Incidental Genetic Findings in Randomized Clinical Trials: Recommendations from the Genomics and Randomized Trials Network (GARNET),” Genome Medicine 5, no. 1 (2013): 7; Presidential Commission for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing (2012), available at <http://bioethics.gov/node/764> (last visited August 3, 2015); Knoppers, B. M. Deschenes, M. Zawati, M. H. Tassé, A. M., “Population Studies: Return of Research Results and Incidental Findings Policy Statement,” European Journal of Human Genetics 21, no. 3 (2013): 245–247; Wellcome Trust and Medical Research Council, Framework on the Feedback of Health-Related Findings in Research, available at <http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtp056059.pdf> (last visited August 2, 2015); Jarvik, G. P. Amendola, L. M. Berg, J. S. Brothers, K. Clayton, E. W. Chung, W. Evans, B. J. Evans, J. P. Fullerton, S. M. Gallego, C. J. Garrison, N. A. Gray, S. W. Holm, I. A. Kullo, I. J. Lehmann, L. S. McCarty, C. Prows, C. A. Rehm, H. L. Sharp, R. R. Salama, J. Sanderson, S. Van Driest, S. L. Williams, M. S. Wolf, S. M. Wolf, W. A. Burke, W., “Return of Genomic Results to Research Participants: The Floor, the Ceiling, and the Choices in Between,” American Journal of Human Genetics 94, no. 6 (2014): 818–826.CrossRefGoogle Scholar
See Dressler, et al. , supra note 3; Beskow, et al. 2012A, supra note 5.Google Scholar
See Wolf, et al. , supra note 11; Fabsitz, et al. , supra note 11; Wolf, et al. , supra note 11; Bookman, et al. , supra note 11; Knoppers, et al. , supra note 11; Wellcome Trust and Medical Research Council, supra note 11; Jarvik, et al. , supra note 11; Presidential Commission for the Study of Bioethical Issues, “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-To-Consumer Contexts” (2013), available at <http://bioethics.gov/node/3183> (last visited September 25, 2015).+(last+visited+September+25,+2015).>Google Scholar
See Dressler, et al. , supra note 3.Google Scholar
Id.; Keane, M. A., “Institutional Review Board Approaches to the Incidental Findings Problem,” Journal of Law, Medicine, & Ethics 36, no. 2 (2008): 352–355; Wolf, S. M. Kahn, J. P. Lawrenz, F. P. Nelson, C. A., “The Incidentalome,” JAMA 296, no. 23 (2006): 2800–2801; Author Reply 2801–2802; Beskow, L. M., “Considering the Nature of Individual Research Results,” American Journal of Bioethics 6, no. 6 (2006): 38–40; Author Reply W10–32.CrossRefGoogle Scholar
Wolf, S. M. Burke, W. Koenig, B. A., “Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 486–501.CrossRefGoogle Scholar
Fernandez, C. V. O'Rourke, P. P. Beskow, L. M., “Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 514–522.Google Scholar
Radecki Breitkopf, C. Petersen, G. M. Wolf, S. M. Chaffee, K. G. Robinson, M. E. Gordon, D. R. Lindor, N. M. Koenig, B. A., “Preferences Regarding Return of Genomic Results to Relatives of Research Participants, Including After Participant Death: Empirical Results from a Cancer Biobank,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 464–475.CrossRefGoogle Scholar
Wolf, S. M. et al. , “Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 440–463.CrossRefGoogle Scholar