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

Journal of Law, Medicine and Ethics

Volumn 43, Issue 3, 2015, Pages 502-513

  Beskow, Laura M ^a   O'Rourke, P Pearl ^b,c  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b Partners Community HealthCare   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETHICS; FAMILY; FEMALE; GENETICS; HUMAN; INTERPERSONAL COMMUNICATION; MALE; MIDDLE AGED; PROFESSIONAL STANDARD; QUESTIONNAIRE; RESEARCH SUBJECT;

DISCLOSURE; ETHICS COMMITTEES, RESEARCH; FAMILY; FEMALE; GENETIC RESEARCH; HUMANS; MALE; MIDDLE AGED; RESEARCH SUBJECTS; SURVEYS AND QUESTIONNAIRES;

EID: 84944676978     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/jlme.12292     Document Type: Article

References (47)

1. L. Eckstein, J. R. Garrett, and B. E. Berkman, "A Framework for Analyzing the Ethics of Disclosing Genetic Research Findings, " Journal of Law, Medicine & Ethics 42, no. 2 (2014): 190-207;
2. L. M. Johnson, C. L. Church, M. F. Walsh, and J. N. Baker, "Clinically Significant? Depends on Whom You Ask, " American Journal of Bioethics 12, no. 10 (2012): 18-20;
3. A. L. Bredenoord, H. Y. Kroes, E. Cuppen, M. Parker, and J. J. Van Delden, "Disclosure of Individual Genetic Data to Research Participants: The Debate Reconsidered, " Trends in Genetics 27, no. 2 (2011): 41-47;
4. J. S. Forsberg, M. G. Hansson, and S. Eriksson, "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;
5. F. A. Miller, R. Christensen, M. Giacomini, and J. S. Robert, "Duty to Disclose What? Querying the Putative Obligation to Return Research Results to Participants, " Journal of Medical Ethics 34, no. 3 (2008): 210-213;
6. D. I. Shalowitz and F. G. Miller, "The Search for Clarity in Communicating Research Results to Study Participants, " Journal of Medical Ethics 34, no. 9 (2008): E17.
7. L. C. Milner, E. Y. Liu, and N. A. Garrison, "Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects, " American Journal of Bioethics 13, no. 10 (2013): 66-67;
8. M. A. Rothstein, "Should Researchers Disclose Results to Descendants?" American Journal of Bioethics 13, no. 10 (2013): 64-65;
9. B. Chan, F. M. Facio, H. Eidem, S. C. Hull, L. G. Biesecker, and B. E. Berkman, "Genomic Inheritances: Disclosing Individual Research Results From Whole-Exome Sequencing to Deceased Participants' Relatives, " American Journal of Bioethics 12, no. 10 (2012): 1-8;
10. E. Ormondroyd, C. Moynihan, M. Watson, C. Foster, S. Davolls, A. Ardern-Jones, and R. Eeles, "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;
11. E. Ormondroyd, C. Moynihan, A. Ardern-Jones, R. Eeles, C. Foster, S. Davolls, and M. Watson, "Communicating Genetics Research Results to Families: Problems Arising When the Patient Participant is Deceased, " Psychooncology 17, no. 8 (2008): 804-811;
12. A. M. Tassé, "The Return of Results of Deceased Research Participants, " Journal of Law, Medicine & Ethics 39, no. 4 (2011): 621-630;
13. A. M. Tassé, "Biobanking and Deceased Persons, " Human Genetics 130, no. 3 (2011): 415-423.
14. 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;
15. C. Kozanczyn, K. Collins, and C. V. Fernandez, "Offering Results to Research Subjects: U.S. Institutional Review Board Policy," Accountability in Research 14, no. 4 (2007): 255-267;
16. C. Simon, L. A. Shinkunas, D. Brandt, and J. K. Williams, "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;
17. C. M. Simon, J. K. Williams, L. Shinkunas, D. Brandt, S. Daack-Hirsch, and M. Driessnack, "Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives," Journal of Empirical Research on Human Research Ethics 6, no. 4 (2011): 53-67.
18. R. R. McWilliams, E. D. Wieben, K. G. Rabe, K. S. Pedersen, Y. Wu, H. Sicotte, and G. M. Petersen, "Prevalence of CDKN2A Mutations in Pancreatic Cancer Patients: Implications for Genetic Counseling, " European Journal of Human Genetics 19, no. 4 (2011): 472-478.
19. E. J. Gordon and S. Philpott, "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;
20. E. Ripley, F. Macrina, M. Markowitz, and C. Gennings, "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
21. T. H. Wagner, C. Murray, J. Goldberg, J. M. Adler, and J. Abrams, "Costs and Benefits of the National Cancer Institute Central Institutional Review Board, " Journal of Clinical Oncology 28, no. 4 (2010): 662-666
22. E. A. Largent, C. Grady, F. G. Miller, and A. Wertheimer, "Money, Coercion, and Undue Inducement: Attitudes About Payments to Research Participants, " IRB 34, no. 1 (2012): 1-8
23. L. M. Beskow, E. E. Namey, P. R. Miller, D. K. Nelson, and A. Cooper, "IRB Chairs' Perspectives on Genotype-Driven Research Recruitment," IRB 34, no. 3 (2012): 1-10 [hereinafter Beskow 2012A];
24. L. M. Beskow, D. K. Check, E. E. Namey, L. A. Dame, L. Lin, A. Cooper, K. P. Weinfurt, and L. E. Wolf, "Institutional Review Boards' Use and Understanding of Certificates of Confidentiality," PLoS One 7, no. 9 (2012): E44050;
25. J. S. Crites, T. D. Harter, L. M. Furman, and B. J. Daly, "Payment to Participants in Pediatric Research: Variation in IRB Members' Attitudes," IRB 35, no. 5 (2013): 9-13.
26. Broad Institute, Creating A Global Alliance to Enable Responsible Sharing of Genomic and Clinical Data, available at (last visited August 3, 2015).
27. D. I. Shalowitz and F. G. Miller, "Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions, " PLoS Medicine 5, no. 5 (2008): E91.
28. L. M. Beskow, W. Burke, S. M. Fullerton, and R. R. Sharp, "Offering Aggregate Results to Participants in Genomic Research: Opportunities and Challenges, " Genetics in Medicine 14, no. 4 (2012): 490-496.
29. S. M. Wolf, "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.
30. M. J. Bledsoe, E. W. Clayton, A. L. McGuire, W. E. Grizzle, P. P. O'Rourke, and N. Zeps, "Return of Research Results from Genomic Biobanks: Cost Matters, " Genetics in Medicine 15, no. 2 (2013): 103-105;
31. L. Black, D. Avard, M. H. Zawati, B. M. Knoppers, J. Hebert, and G. Sauvageau, "Funding Considerations for the Disclosure of Genetic Incidental Findings in Biobank Research, " Clinical Genetics 84, no. 5 (2013): 397-406.
32. S. M. Wolf, F. P. Lawrenz, C. A. Nelson, J. P. Kahn, M. K. Cho, E. W. Clayton, J. G. Fletcher, M. K. Georgieff, D. Hammerschmidt, K. Hudson, J. Illes, V. Kapur, M. A. Keane, B. A. Koenig, B. S. Leroy, E. G. McFarland, J. Paradise, L. S. Parker, S. F. Terry, B. Van Ness, and B. S. Wilfond, "Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, " Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219-248;
33. R. R. Fabsitz, A. McGuire, R. R. Sharp, M. Puggal, L. M. Beskow, L. G. Biesecker, E. Bookman, W. Burke, E. G. Burchard, G. Church, E. W. Clayton, J. H. Eckfeldt, C. V. Fernandez, R. Fisher, S. M. Fullerton, S. Gabriel, F. Gachupin, C. James, G. P. Jarvik, R. Kittles, J. R. Leib, C. O'Donnell, P. P. O'Rourke, L. L. Rodriguez, S. D. Schully, A. R. Shuldiner, R. K. Sze, J. V. Thakuria, S. M. Wolf, and G. L. Burke, "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;
34. S. M. Wolf, B. N. Crock, B. Van Ness, F. Lawrenz, J. P. Kahn, L. M. Beskow, M. K. Cho, M. F. Christman, R. C. Green, R. Hall, J. Illes, M. Keane, B. M. Knoppers, B. A. Koenig, I. S. Kohane, B. Leroy, K. J. Maschke, W. McGeveran, P. Ossorio, L. S. Parker, G. M. Petersen, H. S. Richardson, J. A. Scott, S. F. Terry, B. S. Wilfond, and W. A. Wolf, "Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets, " Genetics in Medicine 14, no. 4 (2012):361-384;
35. 361-384; E. B. Bookman, C. Din-Lovinescu, B. B. Worrall, T. A. Manolio, S. N. Bennett, C. Laurie, D. B. Mirel, K. F. Doheny, G. L. Anderson, K. Wehr, R. Weinshilboum, and D. T. Chen, "Incidental Genetic Findings in Randomized Clinical Trials: Recommendations from the Genomics and Randomized Trials Network (GARNET), " Genome Medicine 5, no. 1 (2013): 7;
36. Presidential Commission for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing (2012), available at (last visited August 3, 2015);
37. B. M. Knoppers, M. Deschenes, M. H. Zawati, and A. M. Tassé, "Population Studies: Return of Research Results and Incidental Findings Policy Statement, " European Journal of Human Genetics 21, no. 3 (2013): 245-247;
38. Wellcome Trust and Medical Research Council, Framework on the Feedback of Health-Related Findings in Research, available at (last visited August 2, 2015);
39. G. P. Jarvik, L. M. Amendola, J. S. Berg, K. Brothers, E. W. Clayton, W. Chung, B. J. Evans, J. P. Evans, S. M. Fullerton, C. J. Gallego, N. A. Garrison, S. W. Gray, I. A. Holm, I. J. Kullo, L. S. Lehmann, C. McCarty, C. A. Prows, H. L. Rehm, R. R. Sharp, J. Salama, S. Sanderson, S. L. Van Driest, M. S. Williams, S. M. Wolf, W. A. Wolf, and W. Burke, "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.
40. 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 (last visited September 25, 2015).
41. M. A. Keane, "Institutional Review Board Approaches to the Incidental Findings Problem, " Journal of Law, Medicine, & Ethics 36, no. 2 (2008): 352-355
42. S. M. Wolf, J. P. Kahn, F. P. Lawrenz, and C. A. Nelson, "The Incidentalome, " JAMA 296, no. 23 (2006): 2800-2801; Author Reply 2801-2802;
43. L. M. Beskow, "Considering the Nature of Individual Research Results, " American Journal of Bioethics 6, no. 6 (2006): 38-40; Author Reply W10-32.
44. S. M. Wolf, W. Burke, and B. A. Koenig, "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.
45. C. V. Fernandez, P. P. O'Rourke, and L. M. Beskow, "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.
46. C. Radecki Breitkopf, G. M. Petersen, S. M. Wolf, K. G. Chaffee, M. E. Robinson, D. R. Gordon, N. M. Lindor, and B. A. Koenig, "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.
47. S. M. Wolf 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.