International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access

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 August 7, 2015); 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.

Wolf S.M. , “Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 43, no. 3 (2015): Page numbers coming; 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.

Zawati M. H. Knoppers B. M. , “International Normative Perspectives on the Return of Individual Research Results and Incidental Findings in Genomic Biobanks,” Genetics in Medicine 14, no. 4 (2012): 484–489; Zawati M. H. Van Ness B. Knoppers B. M. , “Incidental Findings in Genomic Research: A Review of International Norms,” GenEdit 9, no. 1 (2012): 1–8 to 8–8; Knoppers B. M. Dam A. , “Return of Results: Towards a Lexicon?” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 577–582; Lévesque E. Joly Y. Simard J. , “Return of Research Results: General Principles and International Perspectives,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 583–592.

Zawati Knoppers , supra note 3; Zawati , supra note 3.

Knoppers Dam , supra note 3.

Lévesque , supra note 3.

See, e.g., Knoppers B. M. , “Return of Whole-Genome Sequencing Results in Paediatric Research: A Statement of the P3G International Paediatrics Platform,” European Journal of Human Genetics 22, no. 1 (2014): 3–5; Knoppers B. M. , “Population Studies: Return of Research Results and Incidental Findings Policy Statement,” European Journal of Human Genetics 21, no. 3 (2013): 245–247.

Tassé A. M. , “The Return of Results of Deceased Research Participants,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 621–630.

See generally Wolf (2015), supra note 2.

See Jones N. L. Sarata A. K. , Genetic Discrimination: Legal Issues Relating to Discrimination and Privacy (2008), available at <http://assets.opencrs.com/rpts/RL30006_20080310.pdf> (last visited August 7, 2015).

See, e.g., S.C. Code Ann. § 38-93-40 (2010).

5 U.S.C. § 552a(b)(8) (2010); U.S. Department of Justice, Overview of the Privacy Act (2014), available at <http://www.justice.gov/opcl/introduction> (last visited August 7, 2015).

45 C.F.R. § 160 (2014); 45 C.F.R. § 164 (2014); Office for Civil Rights, U.S. Department of Health and Human Services, Privacy Rule (2014), available at <http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/> (last visited August 7, 2015).

5 U.S.C. § 552a(b)(8) (2010).

See id.

Shah S. K. , “What Does the Duty to Warn Require?” American Journal of Bioethics 13, no. 10 (2013): 62–63; 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; 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 K. , “The ‘Duty to Warn’ a Patient's Family Members about Hereditary Disease Risks,” JAMA 292, no. 12 (2004): 1469–1473. See also 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.

U.S. Department of Justice, Overview of the Privacy Act – Conditions of Disclosure to Third Parties, available at <http://www.justice.gov/opcl/conditions-disclosure-third-parties#health> (last visited August 7, 2015). See also Justice v. Fuddy, 253 P.3d 665, 672–73 (Ct. App. 2011), as corrected (Apr. 26, 2011); DePlanche v. Califano, 549 F. Supp. 685, 704 (W.D. Mich.1982).

Office of the Secretary, 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, no. 17 (January 25, 2013): 5658–5669 [hereinafter DHHS Modifications].

45 C.F.R. § 164.501 (1)–(2) (2014).

U.S. Department of Health and Human Services, To Whom Does the Privacy Rule Apply and Whom Will It Affect?, available at <http://privacyruleandresearch.nih.gov/pr_06.asp> (last visited August 7, 2015); 45 C.F.R. § 160.103 (2014).

45 C.F.R. § 164.502(a)(1)(ii) (2014); 45 C.F.R. § 164.506 (2014); 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 August 7, 2015) [hereinafter HIPAA FAQ].

HIPAA FAQ, supra note 23; 45 C.F.R. §164.522 (2014).

45 C.F.R. § 164.510(b)(5) (2014).

45 C.F.R. § 164.502(g) (2014).

U.S. Department of Health and Human Services, “CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports; Final Rule,” Federal Register 79, no. 25 (February 6, 2014): 7290–7316; 42 C.F.R. § 493.1291 (2014); 45 C.F.R. § 164.524 (2014).

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

Id., at 528.

American Society of Human Genetics, “Statement on Informed Consent for Genetic Research,” American Journal of Human Genetics 59, no. 2 (1996): 471–474.

American Society of Human Genetics, “Professional Disclosure of Familial Genetic Information,” American Journal of Human Genetics 62, no. 2 (1998): 474–483 [hereinafter ASHG 1998], at 474.

Compare 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 August 7, 2015) with Office of Human Subjects Research, Johns Hopkins Medicine, HIPAA Questions and Answers Relating to Research, available at <http://www.hopkinsmedicine.org/institutional_review_board/hipaa_research/faq_research.html> (last visited August 7, 2015).

45 C.F.R. § 164.103 (2014); 45 C.F.R. § 164.105 (2014); Office for Civil Rights, U.S. Department of Health and Human Services, Can a Postsecondary Institution Be a “Hybrid Entity” under the HIPAA Privacy Rule?, available at <http://www.hhs.gov/ocr/privacy/hipaa/faq/ferpa_and_hipaa/522.html> (last visited August 7, 2015).

Office for Human Research Protections, U.S. Department of Health and Human Services, Federal Policy for the Protection of Human Subjects (‘Common Rule’), available at <http://www.hhs.gov/ohrp/humansubjects/commonrule/> (last visited August 7, 2015).

Office for Human Research Protections, U.S. Department of Health and Human Services, Federalwide Assurance for the Protection of Human Subjects (2011), available at <http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html> (last visited August 7, 2015).

45 C.F.R. § 46.116(a)(5) (2014).

45 C.F.R. § 46.102(f) (2014).

Compare Wolf (2015), supra note 2, with Chan , supra note 2.

Office for Human Research Protections, U.S. Department of Health and Human Services, International Compilation of Human Research Standards (2013), available at <http://www.hhs.gov/ohrp/international/intlcompilation/intlcomp2013.pdf.pdf> (last visited August 7, 2015).

United Nations Development Programme, Human Development Index (HDI) – 2012 Rankings, available at <http://hdr.undp.org/en/statistics/> (last visited August 7, 2015); United Nations Development Programme, “Table 1: Human Development Index and its Components” (2013), available at <http://hdr.undp.org/en/content/table-1-human-development-index-and-its-components> (last visited August 7, 2015).

Office for Human Research Protections, U.S. Department of Health and Human Services, International Compilation of Human Research Standards (2014), available at <http://www.hhs.gov/ohrp/international/intlcompilation/2014intlcomp.pdf.pdf> (last visited August 7, 2015).

See, e.g., Tassé , supra note 8, at 625 (discussing French case law on access to relatives' medical records after death).

Council for Science and Technology, Bioethics Committee (Japan), Fundamental Principles of Research on the Human Genome (2000), available at <http://www.lifescience.mext.go.jp/files/pdf/43_137.pdf> (translation provided by Ministry of Education, Culture, Sports, Science and Technology) (last visited August 7, 2015) [hereinafter Fundamental Principles (Japan)]; Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry (Japan), Ethical Guidelines for Human Genome/Gene Analysis Research (2001), available at <http://www.lifescience.mext.go.jp/files/pdf/n796_00.pdf> (last visited August 7, 2015) [hereinafter Ministry of Education (Japan)].

Health Research Council (New Zealand), Ethical Considerations Relating to Research in Human Genetics (2000), available at <http://www.hrc.govt.nz/sites/default/files/HRC%20Guidelines%20on%20Ethical%20Considerations%20Relating%20to%20Research%20in%20Human%20Genetics.pdf> (last visited August 7, 2015).

Research Governance Framework for Health and Social Care, 2nd ed. (2005): At 8, available at <http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAnd-Guidance/DH_4108962> (last visited August 7, 2015) [hereinafter Research Governance (UK)].

National Consultative Bioethics for Health and Life and Sciences (France), “Opinion Regarding the Application of Genetic Testing to Individual Studies, Family Studies and Population Studies. (Problems Related to DNA ‘Banks,’ Cell ‘Banks’ and Computerisation)” (1991), available at <www.ccne-ethique.fr/sites/default/files/publications/avis025en.pdf> (last visited August 7, 2015) (English translation provided by National Consultative Bioethics for Health and Life and Sciences) [hereinafter National Consultative Bioethics (France)]; Genetic Integrity Act (Sweden) (2006), available at <http://www.smer.se/news/the-genetic-integrity-act-2006351/> (last visited January 29, 2015).

National Health and Medical Research Council & Australian Research Council, National Statement on Ethical Conduct in Human Research (2013): 44, available at <http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e72.pdf> (last visited August 28, 2015) [hereinafter Australian Research Council].

Health Research Council (New Zealand), supra note 47.

Fundamental Principles (Japan), supra note 46.

Research Governance (UK), supra note 48.

Health Research Council (New Zealand), supra note 47.

Fundamental Principles (Japan), supra note 46.

Research Governance (UK), supra note 48.

National Consultative Bioethics (France), supra note 49.

Genetic Integrity Act (Sweden), supra note 49.

Bioethics Commission at the Federal Chancellery (Austria), “Biobanks for Medical Research,” (2007), available at <http://www.bundeskanzleramt.at/DocView.axd?CobId=25510> (last visited January 29, 2015) [hereinafter Federal Chancellery (Austria)].

Australian Research Council, supra note 50.

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada, TriCouncil Policy Statement (2014), available at <http://www.ethics.gc.ca/pdf/eng/tcps2–2014/TCPS_2_FINAL_Web.pdf> (last visited August 7, 2015) [hereinafter TriCouncil Policy Statement (Canada)].

Genetic Information Law (Israel), 5761–2000, available at <https://www.jewishvirtuallibrary.org/jsource/Health/GeneticInformationLaw.pdf> (last visited August 7, 2015) (translation provided by Jewish Virtual Library).

ASHG 1998, supra note 31.

Fundamental Principles (Japan), supra note 46.

Ministry of Education (Japan), supra note 46.

Health Research Council (New Zealand), supra note 47.

Australian Research Council, supra note 50.

Ministry of Health National Ethics Committee (Singapore), Ethical Guidelines on Research Involving Human Subjects (1997): At 8, available at <http://www.moh.gov.sg/content/dam/moh_web/Publications/Guidelines/NationalMedicalEthicsCommitteeGuidelines/1997/human_bmr.pdf> (last visited August 7, 2015).

Research Governance (UK), supra note 48.

See infra Table 1, Table 2.

See infra Table 2.

Australian Research Council, supra note 50, at 44; TriCouncil Policy Statement (Canada), supra note 63; Genetic Information Law (Israel), supra note 65; Ministry of Health National Ethics Committee (Singapore), supra note 84.

Australian Research Council, supra note 50; TriCouncil Policy Statement (Canada), supra note 63.

Genetic Information Law (Israel), supra note 65.

Ministry of Health National Ethics Committee (Singapore), supra note 84.

Health Research Council (New Zealand), supra note 47.

Genetic Information Law (Israel), supra note 65.

Australian Research Council, supra note 50, at 44.

TriCouncil Policy Statement (Canada), supra note 63.

Genetic Information Law (Israel), supra note 65.

Fundamental Principles (Japan), supra note 46.

Bioethics Committee (Japan), supra note 46, at 34.

Ministry of Education (Japan), supra note 46.

Australian Research Council, supra note 50, at 44.

Health Research Council (New Zealand), supra note 47.

5 U.S.C. § 552a(b)(8) (2013).

45 C.F.R. § 164.502(a)(1)(ii) (2014); 45 C.F.R. § 164.502(g) (2014); HIPAA FAQ, supra note 23.

Rothstein , supra note 28.

ASHG 1998, supra note 31.

Rothstein , supra note 28.

Ministry of Education (Japan), supra note 46.

Rothstein , supra note 28.

Australian Research Council, supra note 50, at 44.

Federal Chancellery (Austria), supra note 60.

TriCouncil Policy Statement (Canada), supra note 63.

National Consultative Bioethics (France), supra note 49.

Genetic Information Law (Israel), supra note 65.

Bioethics Committee (Japan), supra note 46; Ministry of Education (Japan), supra note 46.

Health Research Council (New Zealand), supra note 47.

Ministry of Health National Ethics Committee (Singapore), supra note 84.

Genetic Integrity Act (Sweden) (2006), supra note 49.

Research Governance (UK), supra note 48, at 8 (“Arrangements must be described for the respectful disposal of material once the research is completed, and for the reporting of the findings of the research to relatives, if they wish it.”).

5 U.S.C. § 552a(b)(8) (2013); DHHS Modifications, supra note 19, at 5668.

Australian Research Council, supra note 50, at 44.

Federal Chancellery (Austria), supra note 60.

TriCouncil Policy Statement (Canada), supra note 63.

Genetic Information Law (Israel), supra note 65.

Fundamental Principles (Japan), supra note 46, at 6.

Ministry of Education (Japan), supra note 46.

Health Research Council (New Zealand), supra note 47.

Ministry of Health National Ethics Committee (Singapore), supra note 84.

Research Governance (UK), supra note 48.

5 U.S.C. § 552a(b)(8) (2013).

DHHS Modifications, supra note 19, at 5668.