Genetic property

Georgetown Law Journal

Volumn 105, Issue 1, 2016, Pages 1-54

  Contreras, Jorge L ^a  

^a UNIVERSITY OF UTAH   (United States)

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[No Author keywords available]

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EID: 85000868697     PISSN: 00168092     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (172)

1. Julie Hirschfeld Davis, President Weighs in on Data from Genes, N.Y. Times, Feb. 25, 2016, at A15.
2. Feist Publ'ns, Inc. v. Rural Tel. Serv. Co., 499 U.S. 340, 344-45 (1991) ("That there can be no valid copyright in facts is universally understood. The most fundamental axiom of copyright law is that '[n]o author may copyright his ideas or the facts he narrates.'")
3. Int'l News Serv. v. Associated Press, 248 U.S. 215, 234 (1918).
4. Int'l News Serv., 248 U.S. at 250 (Brandeis, J., dissenting).
5. See Nat'l Basketball Ass'n v. Motorola, Inc., 105 F.3d 841, 853 (2d Cir. 1997).
6. See News Copyright Bill, S. 1728, 48th Cong. (1884); J. H. Reichman & Paul F. Uhlir, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, 66 L. & CONTEMP. PROBS. 315, 388-95 (2003) (discussing the database protection debate of the 1990s)
7. Peter K. Yu, The Political Economy of Data Protection, 84 Chi.-Kent L. Rev. 777, 780-82 (2010) (same).
8. When discussed in the literature, the concept of personal health information includes a wide range of items including medical records, test results, physical tissue samples, and aggregated data concerning an individual's family, community, ethnicity, and other demographic information. For a discussion of some of these data types, see Barbara J. Evans, Much Ado About Data Ownership, 25 HARV. J.L. & TECH. 69, 90-92 (2011).
9. The literature concerning information privacy and the ownership of personal data is extensive. See, e.g., LAWRENCE LESSIG, CODE AND OTHER LAW S OF CYBERSPACE 142-63 (1999) (proposing a property-based framework to protect personal online privacy)
10. Julie E. Cohen, Examined Lives: Informational Privacy and the Subject as Object, 52 STAN. L. REV. 1373, 1379 (2000)
11. Evans, supra note 11, at 73 n.26 (citing several patient advocates and works in the popular press that have called for patient ownership of health data); Jessica Litman, Information Privacy/Information Property, 52 STA N. L. REV. 1283, 1289-95 (2000)
12. Patricia Mell, Seeking Shade in a Land of Perpetual Sunlight: Privacy as Property in the Electronic Wilderness, 11 BERKELEY TECH. L.J. 1, 26-41 (1996)
13. Paul M. Schwartz, Property, Privacy, and Personal Data, 117 HARV. L. REV. 2056, 2056 (2004) (proposing a five-part framework defining rights in personal information).
14. Mark A. Hall, Property, Privacy, and the Pursuit of Interconnected Electronic Medical Records, 95 IOWA L. REV. 631, 659-63 (2010)
15. Mark A. Hall & Kevin A. Schulman, Ownership of Medical Information, 301 J. AM. MED. ASS'N 1282, 1284 (2009) (urging the adoption of "clear and adaptable laws" to enable patients to "assign economic value to the access, control, and use of the medical information contained in electronic health record networks")
16. see also Anita L. Allen, Genetic Privacy: Emerging Concepts and Values, in GENETIC SECRETS: PROTECTING PRIVACY AND CONFIDENTIALITY IN THE GENETIC ERA 31, 50 (Mark A. Rothstein ed., 1997) (allowing individuals to sell their genetic information will make them equal participants in the market, avoiding exploitation by others)
17. David F. Partlett, Misuse of Genetic Information: The Common Law and Professionals' Liability, 42 WASHBURN L.J. 489, 497 (2003) ("If the genetic information is property, it can presumably be sold, leading to a market in the information.").
18. Marc A. Rodwin, Patient Data: Property, Privacy & the Public Interest, 36 AM. J.L. & MED. 586, 589 (2010) (arguing for public ownership and stewardship of health databases)
19. see also G. Haddow et al., Tackling Community Concerns About Commercialisation and Genetic Research: A Modest Interdisciplinary Proposal, 62 SOC. SCI. & MED. 272, 276-77 (2007) (finding that many survey respondents believed that a national Scottish genetic database (Generation Scotland) should be publicly owned or controlled by public servants).
20. See, e.g., Laura Maria Franciosi & Attilio Guarneri, The Protection of Genetic Identity, 1 J. CIV. L. STUD. 139, 186 (2008) ("[P]roperty laws may better serve as a paradigm to ensure that a greater level of protection is provided for information that belongs to all of the individuals involved.")
21. Natalie Ram, DNA by the Entirety, 115 COLUM. L. REV. 873, 906-10 (2015) (proposing that DNA be owned through a "tenancy by the entirety" joint ownership model in order to account for the interests of related family members).
22. See Jane B. Baron, Property as Control: The Case of Information, 18 MICH. TELECOMM. & TECH. L. REV. 367, 370, 372-90 (2012) (arguing that property law concepts such as alienability and in rem treatment are difficult to translate to the realm of personal health data).
23. Sonia M. Suter, Disentangling Privacy from Property: Toward a Deeper Understanding of Genetic Privacy, 72 GEO. WASH. L. REV. 737, 798-811 (2004)
24. Suter follows in the tradition of seminal work by Margaret Jane Radin, arguing that certain things such as human blood and infants, as a general philosophical principal, should never be alienable. See generally Margaret Jane Radin, Market-Inalienability, 100 HARV. L. REV. 1849 (1987).
25. Barbara J. Evans, Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science, 42 AM. J.L. & MED. (forthcoming 2016)
26. Evans, supra note 11, at 82; Barbara J. Evans, Would Patient Ownership of Health Data Improve Confidentiality?, 14 AM. MED. ASS'N J. ETHICS 724, 728 (2012) ("There are few discernible differences between the level of confidentiality patients would enjoy if they owned their data and biospecimens and what they presently have under the HIPAA Privacy Rule and the Common Rule.").
27. OECD, DATA-DRIVEN INNOVATION: BIG DATA FOR GROWTH AND WELL-BEING 195-97 (2015) (identifying numerous possible candidates for data ownership and concluding that ownership itself is an inapt construct for data).
28. See, e.g., Jennifer Couzin-Frankel, DNA Returned to Tribe, Raising Questions About Consent, 328 SCIENCE 558, 558 (2010) (quoting Kimberly TallBear of the University of California, Berkeley as saying "[r]esearch subjects need to have some ability to assert their property interest in their own biological samples")
29. Evans, supra note 11, at 73 & n.26 (citing numerous sources); Mark A. Rothstein, Ethical Issues in Big Data Health Research, 43 J.L. MED. & ETHICS 425, 427 (2015) ("[M]any individuals strongly believe that their biological specimens and health records 'belong to them.'")
30. Leslie E. Wolf, Biology & Genetics: Advancing Research on Stored Biological Materials: Reconciling Law, Ethics, and Practice, 11 MINN. J.L. SCI. & TECH. 99, 103 (recommending recognition of "donor control over the research use of materials, even though this right of control is not fully recognized in the court opinions and in the federal regulations")
31. Richard H. Thaler, Show Us the Data. (It's Ours, After All.), N.Y. TIMES, Apr. 23, 2011, at BU4.
32. See Anya E.R. Prince, Comprehensive Protection of Genetic Information: One Size Privacy or Property Models May Not Fit All, 79 BROOK. L. REV. 175, 195-98 (2013) (discussing statutory enactments in Alaska, Colorado, Georgia, Louisiana, and Florida).
33. See, e.g., Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063, 1066, 1073 (Ariz. Ct. App. 2008) (claiming $50 million in damages and leading to the return of tribal DNA samples and discontinuation of research programs)
34. Beleno v. Lakey, Order, No. SA-09-CA-188-FB (W.D. Tex. Sept. 17, 2009) (leading to the destruction of more than five million infant blood spot samples in Texas)
35. See, e.g., INST. OF MED., BEYOND THE HIPAA PRIVACY RULE: ENHANCING PRIVACY, IMPROVING HEALTH THROUGH RESEARCH 31 (Sharyl J. Nass et al. eds., 2009) (concluding that "the [current] HIPAA Privacy Rule impedes important health research")
36. Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 SCIENCE 698, 698 (1998)
37. This phrase is a variation on Garrett Hardin's "tragedy of the commons." Garrett Hardin, The Tragedy of the Commons, 162 SCIENCE 1243 (1968).
38. The scenario is based on Heller's earlier work on fragmentation of ownership rights in postSoviet retail space arrangements. Michael A. Heller, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 HARV. L. REV. 621 (1998)
39. David E. Adelman, A Fallacy of the Commons in Biotech Patent Policy, 20 BERKELEY TECH. L.J. 985, 985-86, 1020 (2005) (arguing that the public commons model incorrectly assumes that the commons for biomedical science is "finite and congested," thus overstating the value of a commons approach)
40. F. Scott Kieff, Facilitating Scientific Research: Intellectual Property Rights and the Norms of Science-A Response to Rai and Eisenberg, 95 NW. U. L. REV. 691 (2001) (rebutting the commons-based arguments posited by Rai and Eisenberg).
41. President Barack Obama, State of the Union Address (Jan. 20, 2015) ("[T]onight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier.").
42. See About the Precision Medicine Initiative Cohort Program, NAT 'L INST. HEALTH, https://www.nih.gov/precision-medicine-initiative-cohort-program [https://perma.cc/7XR7-2SZG] ("The [PMI] program will seek to extend precision medicine's success to many diseases, including common diseases such as diabetes, heart disease, Alzheimer's, obesity, and mental illnesses like depression, bipolar disorder, and schizophrenia, as well as rare diseases.").
43. See, e.g., INST. OF MED., supra note 28, at 114-16 (listing numerous health advances achieved through data-driven research); Francis S. Collins & Harold Varmus, A New Initiative on Precision Medicine, 372 NEW ENGL. J. MED. 793, 793-794 (2015) (describing recent advances enabled by genetic research)
44. Eric S. Lander, Cutting the Gordian Helix-Regulating Genomic Testing in the Era of Precision Medicine, 372 NEW ENGL. J. MED. 1185, 1185 (2015) (indicating that more than 3,600 specific disease-associated genes and 4,000 genetic markers for more common diseases have been identified to date).
45. Dr. Francis Collins, the Director of the U.S. National Institutes of Health, estimates that full genetic data is currently available for between 10,000 and 20,000 individuals. Thomas M. Burton, Jonathan D. Rockoff & Ron Winslow, Obama Announces $215 Million Precision-Medicine Genetic Plan, WALL ST. J. (Jan. 30, 2015), http://www.wsj.com/articles/obama-to-lay-out-215-million-precision-medicine-plan-1422615602 [https://perma.cc/Y97F-79TP].
46. See Collins & Varmus, supra note 33, at 794 ("Qualified researchers from many organizations will, with appropriate protection of patient confidentiality, have access to the cohort's data, so that the world's brightest scientific and clinical minds can contribute insights and analysis."); cf. Brenda M. Simon & Ted M. Sichelman, Data-Generating Patents, 111 NW. L. REV. (forthcoming 2017) (discussing the significant amount of valuable genetic data generated and commercialized by private sector firms such as Myriad Genetics).
47. This Article does not attempt to address the companion question of property rights in human tissue, organs, and body parts. This question is fraught with legal complexities and dispute, and has been the subject of an extensive literature. See, e.g., LORI B. ANDREWS & DOROTHY NELKIN, BODY BAZAAR: THE MARKET FOR HUMAN TISSUE IN THE BIOTECHNOLOGYAGE (2001).
48. Guido Calabresi & A. Douglas Melamed, Property Rules, Liability Rules, and Inalienability: One View of the Cathedral, 85 HARV. L. REV. 1089, 1092 (1972).
49. Barbara Evans has written that the current system of federal research regulations embodied in the Common Rule, the HIPAA Privacy Rule, and elsewhere offers a combination of property-like and liability-like features. Evans, supra note 11, at 74 & nn.27 & 32, 82-83 (describing the combination of features as "pliability" rules) (first citing Hall & Schulman, supra note 13; then citing Abraham Bell & Gideon Parchomovsky, Pliability Rules, 101 MICH. L. REV. 1 (2002)
50. See TOM L. BEAUCHAMP & JAMES F. C HILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 117-24 (5th ed. 2009). In addition to medical research, the doctrine of informed consent also applies to procedures performed by physicians and other medical practitioners on patients. Id.
51. NAT 'L COMM'N FOR THE PROT. OF HUMAN SUBJECTS OF BIOMEDICAL & BEHAVIORAL RESEARCH, THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH, at § C.I (1979) [hereinafter BELMONT REPORT]
52. See generally BEAUCHAMP & CHILDRESS, supra note 51; JESSICA W. BERG ET AL., INFORMED CONSENT: LEGAL THEORY AND CLINICAL PRACTICE (2d ed. 2001).
53. See Valerie Gutmann Koch, A Private Right of Action for Informed Consent in Research, 45 SETON HALL L. REV. 173, 178-79 (2015).
54. See Sheldon F. Kurtz, The Law of Informed Consent: From "Doctor is Right" to "Patient has Rights," 50 SYRACUSE L. REV. 1243, 1246-47 (2000).
55. TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW NO. 10, at 181-82 (1949) [hereinafter NUREMBERG CODE].
56. See TUSKEGEE SYPHILIS STUDY LEGACY COMM., FINAL REPORT OF THE SYPHILIS STUDY LEGACY COMMITTEE-MAY 20, 1996 (1996).
57. STANLEY MILGRAM, OBEDIENCE TO AUTHORITY: AN EXPERIMENTAL VIEW (1974)
58. Stanley Milgram, Behavioral Study of Obedience, 67 J. ABNORMAL PSYCH. & SOC. PSYCHOL. 371 (1963).
59. LAUD HUMPHREYS, TEAROOM TRADE: IMPERSONAL SEX IN PUBLIC PLACES (1970).
60. See MARK ISRAEL & IAIN HAY, RESEARCH ETHICS FOR SOCIAL SCIENTISTS 33-34 (2006).
61. WORLD MED. ASS'N, DECLARATION OF HELSINKI: ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (1964).
62. Id. at sec. B.1. The principle of autonomy as a basis of informed consent has been discussed extensively in the literature. See, e.g., JAY KATZ, THE SILENT WORLD OF DOCTOR AND PATIENT (1984)
63. Koch, supra note 55, at 203-06 & nn.144-59 (discussing much of the recent literature); Russell Korobkin, Autonomy and Informed Consent in Nontherapeutic Biomedical Research, 54 UCLA L. REV. 605, 610 (2007)
64. Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899, 924 (1994).
65. Federal Policy for the Protection of Human Subjects, 80 Fed. Reg. 53,933 (Sept. 8, 2015). The NPRM was issued four years after an earlier Advance Notice of Proposed Rulemaking (ANPRM), which attracted hundreds of comments from the public. Human Subjects Research Protections, 76 Fed. Reg. 44,512 (July 26, 2011). For a discussion of the potential impact of the NPRM on the Common Rule consent requirements, see Kathy L. Hudson & Francis S. Collins, Bringing the Common Rule into the 21st Century, 373 New Engl. J. Med. 2293 (2015)
66. DHHS received 2,186 comments on the NPRM during the public comment period, many of which expressed significant concern with the NPRM's proposals. COUNCIL ON GOVERNMENTAL RELATIONS AND ASS'N OF PUBLIC & LAND-GRANT UNIVS., ANALYSIS OF PUBLIC COMMENTS ON THE COMMON RULE NPRM (2016). In response to the release of the NPRM and the public comments submitted, the National Academies of Sciences, Engineering, and Medicine issued a report highly critical of the proposal that urged that the NPRM be withdrawn: The NPRM is marred by omissions, the absence of essential elements, and a lack of clarity. In addition, important questions about the overall impact and long-term costs of the proposed regulatory changes are unresolved. In light of these deficiencies, it would be impractical to use the current NPRM as the basis for achieving a meaningful, consistent, and harmonious revision of the regulations governing human subjects research that is optimally responsive to developments that have occurred since the publication of the Belmont Report. NAT 'LACADS. SCIS., ENG'G, & MED., OPTIMIZING THE NATION'S INVESTMENT IN ACADEMIC RESEARCH: ANEW REGULATORY FRAMEWORK FOR THE 21ST CENTURY 167 (2016).
67. See, e.g., Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064, 1069-70 (S.D. Fla. 2003) ("[I]n certain circumstances [under Florida law] a medical researcher does have a duty of informed consent.")
68. Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807, 844 (Md. 2001) (holding that researchers had a duty to disclose that children participating in a study would be exposed to lead paint).
69. Samuel D. Warren & Louis D. Brandeis, The Right to Privacy, 4 HARV. L. REV. 193 (1890)
70. see also PROSSER AND KEETON ON THE LAW OF TORTS 849-50 (W. Page Keeton eds., 4th ed. 1984) (tracing origin of "right of privacy" to Warren and Brandeis's 1890 article).
71. William L. Prosser, Privacy, 48 CALIF. L. REV. 383, 389 (1960).
72. See, e.g., Neil M. Richards & Daniel J. Solove, Prosser's Privacy Law: A Mixed Legacy, 98 CALIF. L. REV. 1887 (2010) (exploring the influence of Prosser's work on the development of American privacy law) [hereinafter Richards & Solove, Prosser]
73. Daniel J. Solove, A Taxonomy of Privacy, 154 U. PA. L. REV. 477 (2006) [hereinafter Solove, Taxonomy].
74. See supra notes 12-18. As noted by Prosser, "no other tort has received such an outpouring of comment in advocacy of its bare existence." PROSSER AND KEETON ON THE LAW OF TORTS, supra note 79, at 850. For a recent snapshot of the volume of scholarly legal literature relating to data privacy, see SSRN's Information Privacy Law eJournal, which, as of this writing, boasted 3,565 different articles on the topic. Information Privacy Law eJournal, SOC. SCI. RESEARCH NETWORK, http://papers.ssrn.com/sol3/JELJOUR-Results.cfm?form-name=journalBrowse&journal-id= 1125502 [https://perma.cc/W4EF-XQEV].
75. See, e.g., Motschenbacher v. R. J. Reynolds Tobacco Co., 498 F.2d 821, 825-26 (9th Cir. 1974)
76. Moore v. Regents of the Univ. of Cal., 51 Cal. 3d 120, 138 (Cal. 1990)
77. Lugosi v. Universal Pictures, 25 Cal. 3d 813, 818-19, 823-26 (Cal. 1979).
78. John Wilbanks, Portable Approaches to Informed Consent and Open Data, in PRIVACY, BIG DATA, AND THE PUBLIC GOOD: FRAMEWORKS FOR ENGAGEMENT 234, 235 (Julia Lane et al. eds., 2014).
79. FED. TRADE COMM'N, PRIVACY ONLINE: FAIR INFORMATION PRACTICES IN THE ELECTRONIC MARKETPLACE 4 (2000), http://www.ftc.gov/sites/default/files/documents/reports/privacy-online-fair-information-practices-electronic-marketplace-federal-trade-commission-report/privacy2000text.pdf [https://perma.cc/ UX8B-CBLT] [hereinafter FTC PRIVACY PRINCIPLES].
80. See, e.g., Id. at 77; Jonathan Zittrain, What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication, 52 STA N. L. REV. 1201, 1227 & n.83 (2000) (listing numerous "scare stories" about the inappropriate use of personal health data).
81. Leslie P. Francis & John G. Francis, Informatics and Public-Health Surveillance, in BIOINFORMAT-ICS LAW: LEGAL ISSUES FOR COMPUTATIONAL BIOLOGY IN THE POST-GENOME ERA 191, 193 (Jorge L. Contreras & A. James Cuticchia eds., 2013).
82. C. Heeney et al., Assessing the Privacy Risks of Data Sharing in Genomics, 14 PUB. HEALTH GENOMICS 17, 21-22 (2010)
83. J.M. Oliver et al., Balancing the Risks and Benefits of Genomic Data Sharing: Genome Research Participants' Perspectives, 15 PUB. HEALTH GENOMICS 106, 109 (2012).
84. See, e.g., Katherine Drabiak-Syed, Lessons from Havasupai Tribe v. Arizona State University Board of Regents: Recognizing Group, Cultural, and Dignitary Harms as Legitimate Risks Warranting Integration into Research Practice, 6 J. HEALTH & BIOMEDICAL L. 175 (2010).
85. Coll. Sav. Bank v. Fla. Prepaid Postsecondary Educ. Expense Bd., 527 U.S. 666, 673 (1999).
86. See, e.g., Felix S. Cohen, Dialogue on Private Property, 9 RUTGERS L. REV. 357, 374 (1954) (acknowledging a property owner's nearly absolute right to prevent others from entering his property without permission)
87. Thomas W. Merrill, Property and the Right to Exclude, 77 NEB. L. REV. 730, 730 (1998)
88. Lior Jacob Strahilevitz, Information Asymmetries and the Rights to Exclude, 104 MICH. L. REV. 1835, 1836 (2006).
89. Jacque v. Steenberg Homes, Inc., 563 N.W.2d 154, 160 (Wis. 1997) (permitting a property owner to prevent passage over his property for no apparent cause).
90. Adam Doerr, Newborn Blood Spot Litigation: 70 Days to Destroy 5+ Million Samples, GENOMICS L. REP. (Feb. 2, 2010), http://www.genomicslawreport.com/index.php/2010/02/02/newborn-blood-spot-litigation-70-days-to-destroy-5-million-samples/ [https://perma.cc/5KQ8-KT64]
91. Peggy Fikac, State to Destroy Newborns' Blood Samples, HOUS. CHRON. (Dec. 22, 2009), http://www.chron.com/news/houston-texas/article/State-to-destroy-newborns-blood-samples-1599212.php [https://perma.cc/Y2YW-DHBF].
92. See Beleno v. Lakey, Order, No. SA-09-CA-188-FB, at 3 (W.D. Tex. Sept. 17, 2009) (describing collection of infant blood samples from 2002 through 2009 when suit was initiated)
93. For an overview of the history of newborn screening programs, see Sonia M. Suter, Did You Give the Government Your Baby's DNA? Rethinking Consent in Newborn Screening, 15 MINN. J.L. SCI. & TECH. 729, 734-37 (2014). In Texas, participation in the screening program was required by law, with a right to opt-out for religious reasons only. See id. at 784.
94. See Michelle J. Bayefsky et al., Parental Consent for the Use of Residual Newborn Screening Bloodspots: Respecting Individual Liberty vs Ensuring Public Health, J. AM. MED. ASS'N, June 8, 2015, at E1, E2.
95. See, e.g., Bearder v. State, 806 N.W.2d 766, 776 (Minn. 2011) (holding that the use of newborn blood spots for research purposes without consent violated state law). See generally Suter, supra note 124, at 757-59 (discussing state cases challenging infant blood spot collection and storage).
96. Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063, 1066 (Ariz. Ct. App. 2008). A detailed account of the background and facts of the dispute can be found in Wolf, supra note 20, at 118-25.
97. See Michelle M. Mello & Leslie E. Wolf, The Havasupai Indian Tribe Case-Lessons for Research Involving Stored Biologic Samples, 363 NEW ENGL. J. MED. 204, 204 (2010).
98. See Couzin-Frankel, supra note 20, at 558 ("The outcome suggests that consent forms alone may not be enough to ensure that subjects understand how their samples may be used or to protect researchers."); Sandra Soo-Jin Lee et al., The Illusive Gold Standard in Genetic Ancestry Testing, 325 SCIENCE 38, 38 (2009) (noting of the Havasupai case that "research can be compliant with existing human subjects protections yet fail to recognize long-standing differences in access to institutional and legal power, as well as questions about who holds authority to determine future uses of samples").
99. See, e.g., Jennifer Couzin-Frankel, Researchers to Return Blood Samples to the Yanomamo, 328 SCIENCE 1218 (2010).
100. See Roscoe Pound, The Law of Property and Recent Juristic Thought, 25 A.B.A. J. 993, 997 (1939)
101. Lior Jacob Strahilevitz, The Right to Destroy, 114 YALE L.J. 781, 787 (2005).
102. See Strahilevitz, supra note 143, at 784-85 (discussing critiques by Joseph Sax and Edward McCaffery). Recent calls for international limitations on the right to destroy priceless cultural artifacts have been made in the wake of the Islamic State's destruction of the ruins of the ancient city of Nimrud and many of its artifacts. See Graham Bowley & Robert Mackey, Destruction of Antiquities by ISIS Militants Is Denounced, N.Y. TIMES (Feb. 27, 2015), http://www.nytimes.com/2015/02/28/world/middleeast/destruction-of-antiquities-by-militants-is-denounced.html?-r=0 [https://perma.cc/C9DZ-MZXJ].
103. See, e.g., Eyerman v. Mercantile Tr. Co., 524 S.W.2d 210, 215 (Mo. Ct. App. 1975) ("One is generally restrained from wasteful expenditure or destructive inclinations by the natural desire to enjoy his property or to accumulate it during his lifetime.")
104. Amy Harmon, Where'd You Go with My DNA?, N.Y. TIMES (Apr. 24, 2010), http://www.nytimes.com/2010/04/25/weekinreview/25harmon.html [https://perma.cc/9KW6-58RK] ("The irony is if you had asked me, I probably would have consented⋯ I would love for there to be a cure for breast cancer, which runs in my family. I would love for there to be a cure for diabetes. The way the state went about it just made me distrustful." (quoting Andrea Beleno, lead plaintiff in Beleno v. Lakey)).
105. See Henry E. Smith, Property as Platform: Coordinating Standards for Technological Innovation, 9 J. COMPETITION L. & ECON. 1057, 1061 (2013) ("Much of what property does, in terms of setting up things and defining rights over them, involves fragmentation and separation⋯. [S]eparation is the key to entity property⋯.").
106. See, e.g., Kaiser Aetna v. United States, 444 U.S. 164, 176 (1979) (referring to the right to exclude as "one of the most essential sticks in the bundle of rights that are commonly characterized as property")
107. Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 509 (Cal. 1990) (Mosk, J., dissenting) ("[T]he concept of property is often said to refer to a 'bundle of rights' that may be exercised with respect to [an] object-principally the rights to possess the property, to use the property, to exclude others from the property, and to dispose of the property by sale or by gift.")
108. JOHN G. SPRANKLING & RAYMOND R. COLETTA, PROPERTY: A CONTEMPORARY APPROACH 25 (2d ed. 2012) ("[P]roperty is often described as a bundle of rights or, more informally, a bundle of sticks.")
109. But see J.E. Penner, The "Bundle of Rights" Picture of Property, 43 UCLA L. REV. 711 (1996) (critiquing the bundle of rights metaphor).
110. Database of Genotypes and Phenotypes, NAT 'L CTR. FOR BIOTECHNOLOGY INFO., http://www.ncbi.nlm.nih.gov/gap [https://perma.cc/LFU7-HB7M].
111. For example, in the Alzheimer's Disease Sequencing Project (ADSP) hosted on dbGaP, six different consent groups exist with restrictions including use only for Alzheimer's Disease research, for research on any neurodegenerative diseases, for any research conducted by nonprofit entities, for health/medical/biomedical purposes, and for purposes excluding the study of population origins or ancestry. Alzheimer's Disease Sequencing Project, NAT 'L INST. ON AGING GENETICS OF ALZHEIMER'S DISEASE DATA STORAGE SITE, https://www.niagads.org/adsp/content/home [https://perma.cc/FTK8-GFAY].
112. See generally Gregory S. Alexander, The Dead Hand and the Law of Trusts in the Nineteenth Century, 37 STAN. L. REV. 1189 (1985)
113. Adam J. Hirsch & William K.S. Wang, A Qualitative Theory of the Dead Hand, 68 IND. L.J. 1 (1992).
114. See Eyerman v. Mercantile Trust Co, 524 S.W.2d 210 (Mo. Ct. App. 1975) ("To allow an executor to exercise such power [to demolish an expensive home] stemming from apparent whim and caprice of the testatrix contravenes public policy")
115. In this respect the considerations underlying posthumous consent to the use of data differ from those underlying the need for posthumous consent to organ donation, in which the illusion of lingering life and other factors increase the need for obtaining an individual's consent to organ donation. See D. GARETH JONES & MAJA I. WHITAKER, SPEAKING FOR THE DEAD: THE HUMAN BODY IN BIOLOGY AND MEDICINE 111-14 (2d ed. 2009).
116. See Evan G. DeRenzo, Leslie G. Biesecker & Noah Meltzer, Genetics and the Dead: Implications for Genetics Research with Samples from Deceased Persons, 69 AM. J. MED. GENETICS 332, 332 (1997)
117. Béatrice Godard et al., Data Storage and DNA Banking for Biomedical Research: Informed Consent, Confidentiality, Quality Issues, Ownership, Return of Benefits. A Professional Perspective, 11 EUR. J. HUM. GENETICS S88, S94 (2003).
118. see also Jorge L. Contreras, NIH's Genomic Data Sharing Policy: Timing and Tradeoffs, 31 TRENDS IN GENETICS 55, 55 (2015).
119. See JESSE DUKEMINIER ET AL., PROPERTY 232-33 (8th ed. 2014).
120. See, e.g., White v. Brown, 559 S.W.2d 938, 941 (Tenn. 1977) ("[The testatrix's] attempted restraint on alienation must be declared void as inconsistent with the incidents and nature of the estate devised and contrary to public policy.")
121. Mountain Brow Lodge No. 82 v. Toscano, 64 Cal. Rptr. 816, 817 (Cal. Ct. App. 1967) ("Conditions restraining alienation, when repugnant to the interest created, are void." (quoting Cal. Civ. Code § 711).
122. Barbara A. Koenig, Have We Asked Too Much of Consent?, 44 HASTINGS CENT. REP. 33, 33 (2014).
123. Of clickwrap agreements, Chief Justice John Roberts of the Supreme Court recently admitted that even he does not read the fine print of online agreements or medications. Debra Cassens Weiss, Chief Justice Roberts Admits He Doesn't Read the Computer Fine Print, A.B.A. J. (Oct. 20, 2010, 12:17 PM), www.abajournal.com/news/chief-justice-roberts-admits-he-doesnt-read-the-computer-fine-print [https://perma.cc/5WW4-K9YV].
124. See Howard Brody, Transparency: Informed Consent in Primary Care, 19 HASTINGS CENT. REP. 5, 5 (1989) ("Physicians may also view informed consent as an empty charade, since they are confident in their abilities to manipulate consent by how they discuss or divulge information.").
125. See Jay Katz, Informed Consent-Must It Remain a Fairy Tale?, 10 J. CONTEMP. HEALTH L. & POL'Y 69 (1994)
126. See, e.g., David Kaufman et al., Subjects Matter: A Survey of Public Opinions About a Large Genetic Cohort Study, 10 GENETICS IN MED. 831, 836-37 (2008) (detailing that 90% of U.S. respondents said they would be willing to have samples placed in biobank for research)
127. Evette J. Ludman et al., Glad You Asked: Participants' Opinions of Re-Consent for dbGap Data Submission, 5 J. EMPIRICAL RES. ON HUM. RES. ETHICS 9, 14 (2010) (detailing that 86% of respondents gave consent to use of deidentified data for future research use)
128. S.B. Trinidad et al., Research Practice and Participant Preferences: The Growing Gulf, 331 SCIENCE 287 (2011).
129. See, e.g., Katherine M. Brown et al., Differences in Preferences for Models of Consent for Biobanks Between Black and White Women, 7 J. COMMUNITY GENETICS 41 (2015)
130. Sharon Hensley Alford et al., Participation in Genetic Testing Research Varies by Social Group, 14 PUB. HEALTH GENOMICS 85 (2011)
131. Jasmine A. McDonald et al., Understanding Participation by African Americans in Cancer Genetics Research, 104 J. NAT 'L MED. ASS'N 324 (2012).
132. See Mello & Wolf, supra note 132, at 206 (indicating that a "sizable minority" of the public "prefers to be asked for specific consent for new uses"); Krishanu Saha & J. Benjamin Hurlbut, Treat Donors as Partners in Biobank Research, 478 NATURE 312, 312 (2011) ("[W]e believe that [the ANPRM's blanket consent proposal] will decrease, not increase, public involvement in biobanks⋯.").
133. See Mello & Wolf, supra note 132, at 205 (describing the view that "such consent is not informed because without knowing the nature of the studies, one cannot evaluate the risks and benefits of participation"); Christian M. Simon et al., Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models, 13 GENETICS MED. 821, 822 (2011) ("Some have insisted that broad consent should not even be thought of as 'informed consent⋯.'").
134. See Mello & Wolf, supra note 132, at 205. The American Society of Human Genetics has, for the past two decades, maintained a policy against blanket consent when samples may be identifiable in subsequent studies. AM. SOC'Y HUMAN GENETICS, Statement on Informed Consent for Genetic Research, 59 AM. J. HUM. GENETICS 471, 473 (1996).
135. In addition to the exception for deidentified data, discussed here, numerous other exceptions permitting the use of individual medical data for research exist under HIPAA and the Common Rule. See Barbara J. Evans, Ethical and Privacy Issues in Pharmacogenomic Research, in PHARMACOGENOM-ICS: APPLICATIONS TO PATIENT CARE 313 (Howard L. McLeod et al. eds., 2d ed. 2009).
136. See Jennifer Couzin-Frankel, Trust Me, I'm a Medical Researcher, 347 SCIENCE 501, 502 (2015)
137. discussing implications of Nils Homer et al., Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-Density SNP Genotyping Microarrays, 4 PLOS GENETICS e1000167, e1000167 (2008)).
138. Elias A. Zerhouni & Elizabeth G. Nabel, Protecting Aggregate Genomic Data, 322 SCIENCE 44, 44 (2008). NIH's solution to the potential identifiability of human subjects in dbGaP was to move some genomic data from the "open" to the "closed" sections of the site, thus giving access only to approved investigators rather than the public at large. See Wilbanks, supra note 95, at 238.
139. John Bohannon, Genealogy Databases Enable Naming of Anonymous DNA Donors, 339 SCIENCE 262, 262 (2013).
140. See, e.g., Sejin Ahn, Whose Genome Is It Anyway? Re-identification and Privacy Protection in Public and Participatory Genomics, 52 SAN DIEGO L. REV. 751, 768 (2015). Moreover, some bioethi-cists view deidentification of data as largely irrelevant to concerns over individual autonomy. See Couzin-Frankel, supra note 205, at 503 (citing a 2007 study finding that 81% of respondents "were not happy to have researchers parsing even so-called deidentified health data without their consent" and quoting Mark Rothstein, "[l]et's assume that you've de-identified, anonymized, and nobody can figure out who it is-but if people think you've used that information without their permission, they're still going to be very angry").
141. See JAMES D. WATSON, DNA: THE SECRET OF LIFE 165-66 (2003).
142. See Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063 (Ariz. Ct. App. 2008).
143. See Beleno v. Lakey, Order, No. SA-09-CA-188-FB, at 2-6 (W.D. Tex. Sept. 17, 2009)
144. Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063, 1070 (Ariz. Ct. App. 2008).
145. See Beleno v. Lakey, Order, No. SA-09-CA-188-FB, at 3 (W.D. Tex. Sept. 17, 2009).
146. It is a relatively settled principle of tort law that compliance with governmental regulations does not provide a tortfeasor with a complete defense (the so-called "regulatory compliance defense"). See, e.g., RESTATEMENT (SECOND) OF TORTS § 288C (AM. LAW INST. 1965)
147. Mark A. Geistfeld, Tort Law in the Age of Statutes, 99 IOWA L. REV. 957, 991 (2014). Although evidence of compliance with regulations may be presented to a jury, it is not itself exculpatory or a complete defense to claims of injury.
148. The historical development of the informed consent rule, from the Nuremberg Code to the Belmont Report to the Common Rule, See supra Section I.A, supports the notion that the rule was intended first and foremost as a means for protecting individuals from coerced (and inhumane) procedures carried out in the name of research, and less for the protection of privacy inherent in data-based research. See INST. OF MED., supra note 28, at 250 ("It was primarily considered a protection against physical harm, permitting informed, competent patients to refuse unwanted medical interventions, to choose among medically available alternatives, and to make choices that conflict with the wishes of family members or the recommendations of physicians."); Alan R. Tait, Priorities for Disclosure of the Elements of Informed Consent for Research: A Comparison Between Parents and Investigators, 12 PAEDIATRIC ANAESTHESIA 332, 335 (2002) (finding that confidentiality is one of the least important considerations for potential research participants). But see Rothstein, supra note 20, at 426 ("The regulation of research is intended to protect against both physical and dignitary harms.") Accordingly, this proposal would only impose affirmative consent requirements when sample collection involves a risk of physical or mental duress. Consent would not be required for noninvasive or risk-free sample collection through cheek swabs, residual hair and skin collection, and discarded tissue from otherwise permitted procedures.
149. Id. at 486. In California, as in most states, a patient's informed consent is required for medical treatment. Id. at 483 (citing Cobbs v. Grant, 502 P.2d 1, 9 (Cal. 1972)).
150. Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063, 1069 (Ariz. Ct. App. 2008).
151. In fact, Moore did plead a claim sounding in fraud and deceit, though the California Supreme Court did not address this claim on appeal. Moore v. Regents of the Univ. of Cal., 793 P.2d 479, 482 n.4 (Cal. 1990). If Moore had been able to prove the allegations in his complaint, an action for common law fraud and deceit might have had a reasonable chance of success. See id. at 513 n.14 (Mosk, J., dissenting) (enumerating allegedly false and misleading statements by the defendants).
152. Kathy L. Hudson, M.K. Holohan & Francis S. Collins, Keeping Pace with the Times-The Genetic Information Nondiscrimination Act of 2008, 358 NEW. ENG. J. MED. 2661, 2662 (2008).
153. See Prince, supra note 23, at 210-11 (describing state statutes); Mark A. Rothstein, Putting the Genetic Information Nondiscrimination Act in Context, 10 GENETICS MED. 655, 655 (2008).
154. GINA does not prohibit discrimination in the areas of life, disability, or long-term care insurance, by the military or employers with fewer than fifteen employees, or against individuals already diagnosed with a genetic disease. Genetic Information Nondiscrimination Act of 2008 § 2(5), 122 Stat. at 882-83; see also Hudson, Holohan & Collins, supra note 252, at 2662; Rothstein, supra note 254, at 656. Today, the Affordable Care Act prohibits discrimination by health insurers on the basis of any preexisting condition, including the results of genetic tests, thus addressing the gap for individuals with existing genetic diseases. The Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119 (2010) (codified as amended in scattered sections of 26, 29, 30 and 42 U.S.C.). Likewise, a number of states including California have enacted prohibitions on genetic discrimination in life and disability insurance, closing these gaps. See Beyond GINA, States Build Patchwork of Protections, GENOMEWEB, (Aug. 22, 2012), https://www.genomeweb.com/beyond-gina-states-build-patchwork-protections [https://perma.cc/LZ4A-EHJK] [hereinafter GENOMEWEB].
155. Robert C. Green, Denise Lautenbach & Amy L. McGuire, GINA, Genetic Discrimination, and Genomic Medicine, 372 NEW ENG. J. MED. 397, 397-98 (2015).
156. Lowe v. Atlas Logistics Grp. Retail Serv. (Atlanta), LLC, 102 F. Supp. 3d 1360, 1360 (N.D. Ga. 2015).
157. Gina Kolata, Georgia: $2.2 Million Penalty for Illegal DNA Testing, N.Y. TIMES (June 22, 2015), http://www.nytimes.com/2015/06/23/us/georgia-dollar2-2-million-penalty-for-illegal-dna-testing.html?-r=0 [https://perma.cc/98L7-6Z3M].
158. See Sharon F. Terry et al., Advocacy Groups as Research Organizations: The PXE International Example, 8 NATURE REV. GENETICS 157, 157-58 (2007)
159. Sharon F. Terry & Charles D. Boyd, Researching the Biology of PXE: Partnering in the Process, 106 AM. J. MED. GENETICS 177, 180 (2001).
160. See, e.g., Ségoléne Aymé, Anna Kole & Stephen Groft, Empowerment of Patients: Lessons From the Rare Diseases Community, 371 LANCET 2048, 2050 (2008).
161. Susan Wolf, among others, has criticized the legislative focus on genetic discrimination as "mired in a first-stage understanding of equality theory" and too narrow to address underlying systemic failures to remedy broader racial, gender, and other disparities. Susan M. Wolf, Beyond 'Genetic Discrimination': Toward the Broader Harm of Geneticism, 23 J.L. MED. & ETHICS 345, 345 (1995).
162. See Sue Chang, U.S. Military Is the Largest Employer in the World, MARKETWATCH (June 17, 2015), http://www.marketwatch.com/story/us-military-is-the-largest-employer-in-the-world-2015-06-17 [https://perma.cc/DR9B-HS94].
163. See Facts About the Genetic Information Nondiscrimination Act, U.S. EQUAL EMPLOYMENT OPPORTUNITY COMMISSION, https://www.eeoc.gov/eeoc/publications/fs-gina.cfm [https://perma.cc/9FZF-G4L7].
164. See Jennifer K. Wagner, Genetic Discrimination Case Against School District Is Appealed to Ninth Circuit, GENOMICS LAW REP. (Feb. 2, 2016), http://www.genomicslawreport.com/index.php/2016/02/02/genetic-discrimination-case-against-school-district-is-appealed-to-ninth-circuit/ [https://perma.cc/ 9SU6-A78H].
165. Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063, 1067 (Ariz. Ct. App. 2008).
166. See, e.g., Frederic L. Coe, The Costs and Benefits of a Well-Intended Parasite: A Witness and Reporter on the IRB Phenomenon, 101 NW. L. REV. 723 (2007).
167. Stewart E. Sterk, Property Rules, Liability Rules, and Uncertainty About Property Rights, 106 MICH. L. REV. 1285, 1328-29 (2008).
168. Boomer v. Atlantic Cement Co., 257 N.E.2d 870, 875 (N.Y. 1970).
169. Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064, 1068 (S.D. Fla. 2003).
170. Admittedly, the common law of tort is generally less amenable to the award of compensatory damages for nonphysical than physical injuries. See PROSSER AND KEETON ON THE LAW OF TORTS § 12 (W. Page Keeton et al. eds., 5th ed. 1984) ("[I]t has been said that mental consequences are so evanescent, intangible, and peculiar, and vary to such an extent with the individual concerned, that they cannot be anticipated, and so lie outside the boundaries of any reasonable 'proximate' connection with the act of the defendant."). This bias against compensation for nonphysical injuries could result in relatively low monetary rewards for breaches of data-based research restrictions, but if it is generally perceived that an injustice is worked by the paucity of such rewards, the situation can be addressed through appropriate legislative action.
171. See, e.g., GEORGE RUTHERGLEN, EMPLOYMENT DISCRIMINATION LAW 181-82 (3d ed. 2009).
172. One of the most extreme examples of institutional liability for rule violations was the criminal indictment of the Arthur Andersen firm in connection with its role in the Enron scandal. See Kurt Eichenwald, Enron's Many Strands: The Investigation; Andersen Charged With Obstruction in Enron Inquiry, N.Y. TIMES, Mar. 15, 2002, at C6.