Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations

Wolf S. M. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361–384; Fabsitz R. R. , “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants,” Circulation: Cardiovascular Genetics 3, no. 6 (2010): 574–580; Wolf S. M. , “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219–248.

Battistuzzi L. , “Communication of Clinically Useful NGS Results to At-Risk Relatives of Deceased Research Participants: Toward Active Disclosure?” Journal of Clinical Oncology 31, no. 32 (2013): 4164–4165; Lolkema M. P. , “Ethical, Legal, and Counseling Challenges Surrounding the Return of Genetic Results in Oncology,” Journal of Clinical Oncology 31, no. 15 (2013): 1842–1848, at 1846; Bombard Y. Offit K. Robson M. E. , “Risks to Relatives in Genomic Research: A Duty to Warn?” American Journal of Bioethics 12, no. 10 (2012); 12–14; Bredenoord A. L. van Delden J. J. M. , “Disclosing Individual Genetic Research Results to Deceased Participants' Relatives by Means of a Qualified Disclosure Policy,” American Journal of Bioethics 12, no. 10 (2012): 12–14; Chan B. , “Genomic Inheritances: Disclosing Individual Research Results From Whole-Exome Sequencing to Deceased Participants' Relatives,” American Journal of Bioethics 12, no. 10 (2012): 1–8; Fullerton S. M. , “Beneficence, Clinical Urgency, and the Return of Individual Research Results to Relatives,” American Journal of Bioethics 12, no. 10 (2012): 9–10; Office of Biorepositories and Biospecimen Research, National Cancer Institute, NCI Best Practices for Biospecimen Resources (2011), available at <http://biospecimens.cancer.gov/bestpractices/2011-NCIBestPractices.pdf> (last visited September 1, 2015), at 38 [hereinafter NCI Best Practices 2011] (“The informed consent document should state whether individual or aggregate research results will be released to…the participant's family and, if so, the mechanism….”).

National Cancer Institute, Cancer Genetics Risk and Counseling Physician Data Query: The Option of Genetic Testing (2014), available at <http://www.cancer.gov/cancertopics/pdq/genetics/risk-assessment-and-counseling/HealthProfessional/page5> (last visited September 1, 2015); Forrest L. E. , “Communicating Genetic Information in Families: A Review of Guidelines and Position Papers,” European Journal of Human Genetics 15, no. 6 (2007): 612–618; American Society of Clinical Oncology, “American Society of Clinical Oncology Policy Statement Update: Genetic Testing for Cancer Susceptibility,” Journal of Clinical Oncology 21, no. 12 (2003): 2397–2406, at 2403; Clayton E. W. , “What Should the Law Say About Disclosure of Genetic Information to Relatives?” Journal of Health Care Law & Policy 1, no. 2 (1998): 373–390.

See Offit K. , “The ‘Duty to Warn’ a Patient's Family Members about Hereditary Disease Risks,” JAMA 292, no. 12 (2004): 1469–1473; American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure, “Professional Disclosure of Familial Genetic Information,” American Journal of Human Genetics 62, no. 2 (1998): 474–483; Clayton , supra note 3, at 383; Andrews L. B. , eds., Committee on Assessing Genetic Risks, Institute of Medicine (IOM), Assessing Genetic Risks: Implications for Health and Social Policy (Washington, D.C.: National Academies Press, 1993): at 278.

Burke W. Evans B. J. Jarvik G. P. , “Return of Results: Ethical and Legal Distinctions between Research and Clinical Care,” American Journal of Medical Genetics Part C: Seminars in Medical Genetics 166, no. 1 (2014): 105–111; Richardson H. S. , Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers (New York: Oxford University Press, 2012): At 44; Garrett J. R. , “Ethical Considerations for Biobanking: Should Individual Research Results Be Shared with Relatives?” Future Medicine 9, no. 2 (2012): 159–162.

Bledsoe M. J. , “Practical Implementation Issues and Challenges for Biobanks in the Return of Individual Research Results,” Genetics in Medicine 14, no. 4 (2012): 478–483; Beskow L. M. Burke W. , “Offering Individual Genetic Research Results: Context Matters,” Science Translational Medicine 2, no. 38 (2010): 38cm20.

Graves K. D. , “Communication of Genetic Test Results to Family and Health-Care Providers Following Disclosure of Research Results,” Genetics in Medicine 16, no. 4 (2014): 294–301; Lolkema , supra note 2, at 1844, 1846; Milner L. C. , “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; Taylor H. A. Wilfond B. S. , “The Ethics of Contacting Family Members of a Subject in a Genetic Research Study to Return Results for an Autosomal Dominant Syndrome,” American Journal of Bioethics 13, no. 10 (2013): 61; Bombard , supra note 2; Bredenoord van Delden , supra note 2; Chan , supra note 2; Fullerton , supra note 2; Rothstein M. A. , “Disclosing Decedents' Research Results to Relatives Violates the HIPAA Privacy Rule,” American Journal of Bioethics 12, no. 10 (2012): 16–17; Tassé A. M. , “The Return of Results of Deceased Research Participants,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 621–630.

Radecki Breitkopf C. , “Preferences Regarding Return of Genomic Research 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; Fernandez C. V. , “Attitudes of Parents Toward the Return of Targeted and Incidental Genomic Research Findings in Children,” Genetics in Medicine 16, no. 8 (2014): 633–640, at 635, 637; Bollinger J. M. , “Public Preferences Regarding the Return of Individual Genetic Research Results: Findings from a Qualitative Focus Group Study,” Genetics in Medicine 14, no. 4 (2012): 451–457, at 455; Meulenkamp T. M. , “Communication of Biobanks' Research Results: What Do (Potential) Participants Want?” American Journal of Medical Genetics 152 Part A, no. 10 (2010): 2482–2492, at 2489–90; Murphy J. , “Public Expectations for Return of Results from Large-Cohort Genetic Research,” American Journal of Bioethics 8, no. 11 (2008): 36–43, at 40.

Compare N. L. Allen et al., “Biobank Participants' Preferences for Disclosure of Genetic Research Results: Perspectives from the OurGenes, OurHealth, OurCommunity Project,” Mayo Clinic Proceedings 89, no. 6 (2014): 738–746, at 743, with Radecki Breitkopf , supra note 8, and Amendola L. M. , “Patients' Choices for Return of Exome Sequencing Results to Relatives in the Event of Their Death,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): 476–485.

See, e.g., Breitkopf Radecki , supra note 8.

See Consortium on Law and Values in Health, Environment & the Life Sciences, Conference, “Should We Offer Genomic Results to a Research Participant's Family, Including After Death?” (November 6, 2014), available at <http://consortium.umn.edu/conference/should-we-offer-genomic-results-research-participant-s-family-including-after-death> (last visited September 1, 2015).

See, e.g., Mercy College, HIPAA & Research: What Do I Need to Know? available at <https://legacyweb.mercy.edu/my-mercy/faculty-resources/institutional-review-board/application-guidelines/hipaa-research-what-do-i-need-to-know/> (last visited September 1, 2015).

See, e.g., Johns Hopkins Medicine, Office of Human Subjects Research – Institutional Review Boards, “HIPAA Questions and Answers Relating to Research,” available at <http://www.hopkinsmedicine.org/institutional_review_board/hipaa_research/faq_research.html> (last visited September 1, 2015).

See 42 C.F.R. § 493.1291 (2014); 45 C.F.R. § 164.524 (2014); U.S. Department of Health and Human Services, CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports; Final Rule, 79 Federal Register 7290–7316 (2014); Evans B. J. , “Regulatory Changes Raise Troubling Questions for Genomic Testing,” Genetics in Medicine 16, no. 11 (2014): 799–803, at 801 (“[W]hen HHS published the Privacy Rule many years ago, it interpreted the term ‘CLIA-exempt’ as also including non-CLIA research laboratories for purposes of the § 164.524 individual access right. Forgetting this history, the recent amendments eliminated a § 164.524 exception that kept ‘CLIA exempt’ laboratories from having to comply with § 164.524. This inadvertently put HIPAA-covered, non-CLIA laboratories squarely in the crosshairs of individuals' new § 164.524 access right.” (footnote omitted)).

U.S. Department of Health and Human Services, “Health Information Privacy, Personal Representatives,” available at <http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/personalreps.html> (last visited September 1, 2015), construing 45 C.F.R. § 164.502 (g) [hereinafter DHHS, Personal Representatives].

45 C.F.R. § 164.502(a)(1)(ii) (2014).

45 C.F.R. § 164.502 (2014); McGraw D. , “Privacy and Health Information Technology,” Journal of Law, Medicine & Ethics 37, Supp. 2 (2009): 123–149, at 136; Office of Civil Rights, U.S. Department of Health and Human Services, FAQ: Under the HIPAA Privacy Rule, May a Health Care Provider Disclose Protected Health Information About an Individual to Another Provider, When Such Information Is Requested for the Treatment of a Family Member of the Individual? available at <http://www.hhs.gov/ocr/privacy/hipaa/faq/disclosures_to_friends_and_family/512.html> (last visited September 1, 2015); U.S. Department of Health and Human Services, Frequently Asked Questions About Family Medical History Information, available at <http://www.hhs.gov/ocr/privacy/familyhealthhistoryfaqs.pdf> (last visited May 10, 2015) [hereinafter HIPAA FAQ] (“The HIPAA Privacy Rule permits…. a doctor to disclose protected health information about a patient to another health care provider for the purpose of treating another patient (e.g., to assist the other health care provider with treating a family member of the doctor's patient).”); U.S. Department of Health and Human Services, Preamble to Final HIPAA Privacy Rule (2000), at 48, available at <http://aspe.hhs.gov/admnsimp/final/PvcPre03.htm> (last visited July 17, 2014) (“We agree that family members may need access to the protected health information of a deceased individual, and this regulation permits such disclosure in two ways. First, a family member may qualify as a ‘personal representative’ of the individual (see § 164.502(g)). Personal representatives include anyone who has authority to act on behalf of a deceased individual or such individual's estate, not just legally-appointed executors. We also allow disclosure of protected health information to health care providers for purposes of treatment, including treatment of persons other than the individual. Thus, where protected health information about a deceased person is relevant to the treatment of a family member, the family member's physician may obtain that information.”)

HIPAA FAQ, supra note 17.

Id.; 45 C.F.R. §164.522 (2014).

U.S. Department of Health and Human Services, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology and Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule, 78 Federal Register 5566–5702, at 5668 (2013).

M. A. Rothstein, “HIPAA Privacy Rule 2.0,” Journal of Law, Medicine & Ethics 41, no. 2 (2013): 525–528, at 528.

45 C.F.R. § 164.502 (g) (2014). See also DHHS, Personal Representatives, supra note 15. Note that once the research participant is deceased, the PR for the decedent will generally have broad authority over health information even if there was no specific grant of authority over health decisions. See id.

See supra note 17.

South Carolina Statutes § 38-93-40 (2014). For a compendium of state genetic privacy statutes, see National Human Genome Research Institute (NHGRI), Genome Statute and Legislation Database, available at <https://www.genome.gov/PolicyEthics/LegDatabase/pubsearch.cfm> (last visited September 1, 2015).

See 45 C.F.R. § 164.510 (b)(5) (2014).

Wolf (2012), supra note 1, at 378; Fabsitz , supra note 1, at 578; Wolf (2008), supra note 1, at 219.

Wolf (2012), supra note 1, at 378; Fabsitz , supra note 1, at 575–76.

American Academy of Pediatrics and American College of Medical Genetics, “Policy Statement: Ethical and Policy Issues in Genetic Testing and Screening of Children,” Pediatrics 131, no. 3 (2013): 620–622, at 621 [hereinafter AAP & ACMG 2013]; Ross L. F. , “Technical Report: Ethical and Policy Issues in Genetic Testing and Screening of Children,” Genetics in Medicine 15, no. 3 (2013): 234–245, at 237–38; American Society of Human Genetics Board of Directors and American College of Medical Genetics Board of Directors, “Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents,” American Journal of Human Genetics 57, no. 5 (1995): 1233–1241 [hereinafter ASHG & ACMG 1995].

Green R. C. , “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574, at 572.

Clayton E. W. , “Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children,” American Journal of Bioethics 14, no. 3 (2014): 3–9; Burke W. , “Recommendations for Returning Genomic Incidental Findings? We Need to Talk!” Genetics in Medicine 15, no. 11 (2013): 854–859; McGuire A. M. , “Ethics and Genomic Incidental Findings,” Science 340, no. 6136 (2013): 1047–1048; Wolf S. M. Annas G. J. Elias S. , “Patient Autonomy and Incidental Findings in Clinical Genomics,” Science 340, no. 6136 (2013): 1049–1050.

ACMG Board of Directors, “ACMG Policy Statement: Updated Recommendations Regarding Analysis and Reporting of Secondary Findings in Clinical Genome-scale Sequencing,” Genetics in Medicine 17, no. 1 (2015): 68–69 (noting approval by the ACMG Board of Directors in September 2014).

Madadi P. , “Ethical Perspectives on Translational Pharmacogenetic Research Involving Children,” Pediatric Drugs 17, no. 1 (2015): 91–95; Holm I. A. , “Guidelines for Return of Research Results from Pediatric Genomic Studies: Deliberations of the Boston Children's Hospital Gene Partnership Informed Cohort Oversight Board,” Genetics in Medicine 16, no. 7 (2014): 547–552, at 550–51; Kleiderman E. , “Returning Incidental Findings from Genetic Research to Children: Views of Parents of Children Affected by Rare Diseases,” Journal of Medical Ethics 40, no. 10 (2014): 691–696; AAP and ACMG 2013, supra note 28, at 621; Haga S. B. Zhao J. Q. , “Stakeholder Views on Returning Research Results,” Advances in Genetics 84 (2013): 41–81, at 52.

Bui E. T. , “Do Participants in Genome Sequencing Studies of Psychiatric Disorders Wish to Be Informed of Their Results? A Survey Study,” PLoS One 9, no. 7 (2014): e101111; Bennette C. S. , “Return of Incidental Findings in Genomic Medicine: Measuring What Patients Value: Development of an Instrument to Measure Preferences for Information from Next-Generation Testing (IMPRINT),” Genetics in Medicine 15, no. 11 (2013): 873–881, at 878; Facio F. M. , “Motivators for Participation in a Whole-Genome Sequencing Study: Implications for Translational Genomics Research,” European Journal of Human Genetics 19, no. 12 (2011): 1213–1217, at 1215; O'Daniel J. Haga S. B. , “Public Perspectives on Returning Genetics and Genomics Research Results,” Public Health Genomics 14, no. 6 (2011): 346–355, at 353; Meulenkamp , supra note 8, at 2490; Murphy , supra note 8, at 40. See also sources cited supra note 9.

Bui , supra note 33 (in a psychiatric genome sequencing study, more than half of respondents anticipated sharing results with relatives and most felt personally responsible for informing family members); Graves , supra note 7, at 298 (in a study of individuals in a colon cancer registry, most of those who were positive for a variant associated with colon cancer reported sharing results with family); Esplen M. J. , “Colorectal Cancer Survivors Undergoing Genetic Testing for Hereditary Nonpolyposis Colorectal Cancer: Motivational Factors and Psychosocial Functioning,” Clinical Genetics 72, no. 5 (2007): 394–401, at 397 (in a study of Canadian survivors of colorectal cancer, most anticipated sharing their genetic results with family members).

Peters J. A. , “Unpacking the Blockers: Understanding Perceptions and Social Constraints of Health Communication in Hereditary Breast and Ovarian Cancer (HBOC) Susceptibility Families,” Journal of Genetic Counseling 20, no. 5 (2011): 450–464; MacDonald D. J. , “Women's Perceptions of the Personal and Family Impact of Genetic Cancer Risk Assessment: Focus Group Findings,” Journal of Genetic Counseling 19, no. 2 (2010): 148–160; Hallowell N. , “Communication About Genetic Testing in Families of Male BRCA1/2 Carriers and Non-carriers: Patterns, Priorities and Problems,” Clinical Genetics 67, no. 6 (2005): 492–502; Foster C. , “Juggling Roles and Expectations: Dilemmas Faced by Women Talking to Relatives About Cancer and Genetic Testing,” Psychology & Health 19, no. 4 (2004): 439–455; Claes E. , “Communication with Close and Distant Relatives in the Context of Genetic Testing for Hereditary Breast and Ovarian Cancer in Cancer Patients,” American Journal of Medical Genetics 116 Part A, no. 1 (2003): 11–19.

Peters , supra note 35, at 453.

Ormondroyd E. , “Communicating Genetics Research Results to Families: Problems Arising When the Patient Participant Is Deceased,” Psychooncology 17, no. 8 (2008): 804–811; Hallowell , supra note 35.

Koehly L. M. , “Characteristics of Health Information Gatherers, Disseminators, and Blockers Within Families at Risk of Hereditary Cancer: Implications for Family Health Communication Interventions,” American Journal of Public Health 99, no. 12 (2009): 2203–2209, at 2206–07.

Atkinson P. , “Kinscapes, Timescapes, and Genescapes: Families Living with Genetic Risk,” Sociology of Health & Illness 35, no. 8 (2013): 1227–1241.

Rothstein M. A. , “GINA, the ADA, and Genetic Discrimination in Employment,” Journal of Law, Medicine & Ethics 36, no. 4 (2008): 837–840.

Bui , supra note 33; Lohn Z. , “Incidental Findings from Clinical Genome-Wide Sequencing: A Review,” Journal of Genetic Counseling 23, no. 4 (2014): 463–473; Bevan J. L. , “Critical Social Theory Approaches to Disclosure of Genomic Incidental Findings,” Nursing Ethics 19, no. 6 (2012): 819–828. See generally Green R. C. Lautenbach D. McGuire A. L. , “GINA, Genetic Discrimination, and Genomic Medicine,” New England Journal of Medicine 372, no. 5 (2015): 397–399.

U.S. Department of Health and Human Services, “Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules,” Federal Register 78 (2013): 5566–5702, at 5689.

Woodward v. Commissioner of Social Security , 760 N.E.2d 257 (Mass. 2002); Hecht v. Superior Court, 20 Cal. Rptr.2d 275 (Cal. Ct. App. 1993).

Saleh v. Reichert , 104 D.L.R. 4th 384, 391 (Can. Ont. Gen. Div. 1993).

Smolensky K. R. , “Rights of the Dead,” Hofstra Law Review 37, no. 3 (2009): 763–803; Strong C. , “Ethical and Legal Aspects of Sperm Retrieval after Death or Persistent Vegetative State,” Journal of Law, Medicine & Ethics 27, no. 4 (1999): 347–358.

Partridge E. , “Posthumous Interests and Posthumous Respect,” Ethics 91, no. 2 (1981): 243–264.

American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure, supra note 4, at 482. See also other sources cited supra note 4.

American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure, supra note 4, at 474.

Wolf (2008), supra note 1, at 228, 232; Richardson H. S. Belsky L. , “An Ethical Framework for Thinking about the Clinical Care that Researchers Owe Their Subjects,” Hastings Center Report 34, no. 1 (2004): 25–33.

Bledsoe M. J. , “Return of Research Results from Genomic Biobanks: Cost Matters,” Genetics in Medicine 15, no. 2 (2013): 103–105; Wolf (2012), supra note 1, at 373; Beskow Burke , supra note 6.

Bledsoe , supra note 50, at 103; Wolf (2012), supra note 1, at 366, 375–376.

Wolf (2012), supra note 1, at 373; Fabsitz , supra note 1, at 575–576, 580.

Wolf (2012), supra note 1, at 373; Fabsitz , supra note 1, at 575.

Tarasoff v. Regents of the University of California , 17 Cal. 3d 425 (Cal. 1976).

Shah S. K. , “What Does the Duty to Warn Require?” American Journal of Bioethics 13, no. 10 (2013): 62–63; Bombard , supra note 2; Wolf S. M. , “The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 361–383; Offit , supra note 4; Clayton , supra note 3.

See Molloy v. Meier, 679 N.W.2d 711 (Minn. 2004); Safer v. Estate of Pack, 677 A.2d 1188 (N.J. App. 1996), cert. denied, 683 A.2d 1163 (N.J. 1996). But see N.J. Stat.10: 5–47 (restricting disclosure of an individual's genetic information); Pate v. Threkel, 661 So. 2d 278 (Fla. 1995).

See Clayton , supra note 3, at 383.

For a rare case in which plaintiffs alleged a duty to disclose a research result – a positive newborn test for cystic fibrosis – see Ande v. Rock, 647 N.W.2d 265 (Ct. App. Wisc. 2002).

Beskow Burke , supra note 6. See also Shah , supra note 55; Bombard , supra note 2, at 13.

Beskow Burke , supra note 6.

Fullerton , supra note 2; Garrett , supra note 5, at 161.

NCI Best Practices 2011, supra note 2, at 38.

For discussion of different oversight models for return of results issues, including an Informed Cohort Oversight Board (ICOB) and a Return of Results Oversight Committee, see, e.g., Wolf (2012), supra note 1, at 374, and sources cited therein.

Beskow Burke , supra note 6.

Jarvik G. P. , “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, at 823; 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/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf> (last visited September 1, 2015), at 91–93; Clayton E. W. McGuire A. L. , “The Legal Risks of Returning Results of Genomics Research,” Genetics in Medicine 14, no. 4 (2012): 473–477, at 476; Wolf et al. (2012), supra note 1.

Chan , supra note 2, at 7. Note that individual research studies may decide to experiment with active return to family for the purpose of collecting data on that practice.

Burke , supra note 5; Bledsoe , supra note 50, at 104.

Rothstein , supra note 21, at 528.

Our group considered whether the representative should use a 3-tier standards similar to the 3-tier standard that surrogates use to make treatment decisions for a living patient who has lost decisional capacity: (1) follow the patient's expressed preferences if known, (2) otherwise decide as the patient would as best that can be determined based on the patient's known values (in an exercise of what is often called “substituted judgment”), or (3) if those values are unknown, decide in the patient's best interests. See, e.g., Berlinger N. Jennings B. Wolf S. M. , The Hastings Center Guidelines for Decisions on Life-Sustaining Treatment and Care Near the End of Life , 2nd ed. (New York, NY: Oxford University Press, 2013). However, our group concluded that deciding about sharing research results with relatives, including after death, was not the same as deciding a patient's treatment. In deciding about sharing results with relatives, the interests of both the participant and the relatives need to be considered, and in genomic research, the standard needs to apply after participant death. A simpler standard that respects participant preferences if known, but then gives the representative the latitude to balance the participant's privacy and personal interests with the relative's interests thus seemed more appropriate.

Anastasova V. , “Communication of Results and Disclosure of Incidental Findings in Longitudinal Paediatric Research,” Pediatric Allergy and Immunology 24, no. 4 (2013): 389–394, at 392–93; AAP and ACMG 2013, supra note 28, at 621; Ross , supra note 28, at 237–38; ASHG and ACMG 1995, supra note 28, at 1233.

Holm , supra note 32, at 551; Kleiderman , supra note 32; AAP & ACMG 2013, supra note 28, at 621–22; Haga Zhao , supra note 32, at 52.

45 C.F.R. § 164.502(g) (2014); Office for Civil Rights, U.S. Department of Health and Human Services, Does the HIPAA Privacy Rule Allow Parents the Right to See Their Children's Medical Records? available at <http://www.hhs.gov/ocr/privacy/hipaa/faq/right_to_access_medical_records/227.html> (last visited September 1, 2015).

Strong K. A. , “In the Absence of Evidentiary Harm, Existing Societal Norms Regarding Parental Authority Should Prevail,” American Journal of Bioethics 14, no. 3 (2014): 24–26, at 25.

Wolf (2012), supra note 1; Fabsitz , supra note 1; Wolf (2008), supra note 1.

Wolf (2012), supra note 1, at 378; Fabsitz , supra note 1, at 575–77.

Berg J. S. Khoury M. J. Evans J. P. , “Deploying Whole Genome Sequencing in Clinical Practice and Public Health: Meeting the Challenge One Bin at a Time,” Genetics in Medicine 13, no. 6 (2011): 499–504, at 501–02.

U.S. Department of Health and Human Services, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology and Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule, 78 Federal Register 5566–5702 (2013), at 5668.

Rothstein , supra note 21, at 528.

As also noted earlier, some states similarly offer posthumous access to an individual's health information to treat a relative. See South Carolina Statutes, supra note 21.

Holm , supra note 32, at 549.