The Genetic Privacy Act: An Analysis of Privacy and Research Concerns

Journal of Law, Medicine and Ethics

Volumn 25, Issue 4, 1997, Pages 256-272

  Flores Troy, Edwin S ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CIVIL RIGHTS; CONFIDENTIALITY; GENETIC DISORDER; GENETIC PRIVACY; GENETIC PRIVACY ACT; GENETIC SCREENING; GENETICS; GENETICS AND REPRODUCTION; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LAW ENFORCEMENT; LEGAL APPROACH; LEGAL ASPECT; NOMENCLATURE; NUCLEIC ACID DATABASE; PROFESSIONAL PATIENT RELATIONSHIP; RESEARCH; REVIEW; RISK ASSESSMENT; SOCIAL CHANGE; UNITED STATES;

GENETIC PRIVACY ACT; GENETICS AND REPRODUCTION; LEGAL APPROACH; PROFESSIONAL PATIENT RELATIONSHIP;

CIVIL RIGHTS; CONFIDENTIALITY; CONSENT FORMS; DATABASES, NUCLEIC ACID; DISCLOSURE; FEDERAL GOVERNMENT; GENETIC DISEASES, INBORN; GENETIC PRIVACY; GENETIC RESEARCH; GENETIC SCREENING; GOVERNMENT REGULATION; HUMANS; INFORMED CONSENT; LAW ENFORCEMENT; RESEARCH; RISK ASSESSMENT; SOCIAL CHANGE; TERMINOLOGY; UNITED STATES;

EID: 0042422906     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720x.1997.tb01408.x     Document Type: Article

References (159)

1. See J. Merz, "Privacy, Genetics, and Human Tissue Research," Center for Bioethics Newsletter, 1 (1996): 1-4.
2. See G.J. Annas, L.H. Glantz, and P.A. Roche, The Genetic Privacy Act and Commentary (Boston: Boston University School of Public Health, 1995) (hereinafter Genetic Privacy Act).
3. The Genetic Privacy Act (GPA) was supported by a grant from the Human Genome Project Working Group on Ethical, Legal and Social Implications. Id. at ix-x.
4. See id. at vi-vii.
5. See American Jurisprudence (Eagan: West Group, 2nd ed., Vol. 61, Supp. 1995): § 165.3 (citing a new section that includes the Uniform Health-Care Information Act).
6. See also B. Brown, "Genetic Testing, Access to Genetic Data, and Discrimination: Conceptual Legislative Models," Suffolk University Law Review, 27 (1993): 1573-92.
7. The GPA can be subdivided into the following categories: (1) the drafters' intent and basis for the Act; (2) consent requirements for the collection and analysis of deoxyribonucleic acid (DNA) samples; (3) rights relating to the disclosure of private genetic information; (4) exceptions to the confidentiality provisions of the Act; (5) rules relating to research activities; (6) the rights of individuals who are incompetent to give their consent; (7) miscellaneous provisions; and (8) enforcement and other laws.
8. See Genetic Privacy Act, supra note 2, §§ 111-15.
9. See id. §§ 101-05.
10. Although the founding fathers did not know about genetics in the modern context, animal husbandry, the selective breeding of plants, and the selection on strains of yeast for bread and beer making have been practiced since the beginning of recorded history.
11. See J. Watson et al., Molecular Biology of the Gene (Menlo Park: Benjamin Cummins, 4th ed., 1987): at 8. Georg Mendel's work was rediscovered in 1900 by Hugo DeVries, Karl Correns, and Erich Tschermak, each working independently. Knowledge of the transmission of traits through sperm and the egg, however, was known as early as 1860, through the selective breeding of plants and animals.
12. See G.J. Annas, "Mapping the Human Genome and the Meaning of Monster Mythology," Emory Law Journal, 39 (1990): at 645.
13. See E. Flores et al., "PEP is a Nuclear Protein Tyrosine Phosphatase," Molecular and Cellular Biology, 14 (1994): 4938-46.
14. Given the state of the art when the human immunodeficiency virus spread outside limited areas of Africa, any manmade construct would bear the molecular biologic fingerprint of the tools then available.
15. See Comm. on Government Operations, H.R. Rep. No. 16, at 25 (1992) ("Designing Genetic Information Policy: The Need for an Independent Policy Review of the Ethical, Legal and Social Implications of the Human Genome Project").
16. See J. Weinberg, "Breaking Bonds: Discrimination in the Genetic Revolution," JAMA, 268 (1992): 1767-71.
17. See L. Andrews, Medical Genetics: A Legal Frontier (Chicago: American Bar Foundation, 1987): at 190.
18. See id. at 191.
19. See id.
20. See Simonsen v. Swenson, 177 N.W 831 (1920) (public disclosure that a patient had syphilis).
21. See Hague v. Williams, 181 A.2d 345 (1962).
22. See, for example, Robinson v. Lane, 480 P.2d 620 (Okla. 1971).
23. See, for example, R.M. Gellman, "Can Privacy Be Regulated Effectively on a National Level? Thoughts on the Possible Need for International Privacy Rules," Villanova Law Review, 41 (1996): 129-72; and R.C. Turkington, "Medical Record Confidentiality Law, Scientific Research, and Data Collection in the Information Age," Journal of Law, Medicine & Ethics, 25 (1997): 113-29.
24. See, for example, R.M. Gellman, "Can Privacy Be Regulated Effectively on a National Level? Thoughts on the Possible Need for International Privacy Rules," Villanova Law Review, 41 (1996): 129-72; and R.C. Turkington, "Medical Record Confidentiality Law, Scientific Research, and Data Collection in the Information Age," Journal of Law, Medicine & Ethics, 25 (1997): 113-29.
25. Andrews, supra note 16, at 192 (citing Hammonds v. Aetna Casualty & Surety Co., 243 F. Supp. 793 (N.D. Ohio 1965)).
26. See id.
27. See Fed. R. Evid. 501, which is the general rule indicating that privileged information is based on state law.
28. Baker v. Industrial Commission of Ohio, 21 N.E.2d 593, 595 (1939).
29. See Andrews, supra note 16, at 192.
30. Id. at 209. See also K.H. Rothenberg, &Genetic Information and Health Insurance: State Legislative Approaches,& Journal of Law, Medicine & Ethics, 23 (1995): 312-19 (analyzing state statutes and bills on genetic information and health insurance).
31. Id. at 209. See also K.H. Rothenberg, &Genetic Information and Health Insurance: State Legislative Approaches,& Journal of Law, Medicine & Ethics, 23 (1995): 312-19 (analyzing state statutes and bills on genetic information and health insurance).
32. See generally G.J. Annas, L.H. Glantz, and P.A. Roche, &Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations,& Journal of Law, Medicine & Ethics, 23 (1995): 360-66.
33. See Genetic Privacy Act, supra note 2, § 2.
34. Id. § 2(a)(1).
35. Annas, Glantz, and Roche, supra note 29, at 360.
36. Id.
37. Genetic Privacy Act, supra note 2, § 3(m).
38. Id. at i-ii (citing Council of State Governments, Advances in Genetic Information: A Guide for State Policy Makers (Lexington: Council of State Governments, 1992); and Privacy Commissioner of Canada, Genetic Testing and Privacy (Ottawa: Privacy Commissioner of Canada, 1992)).
39. Id. at i-ii (citing Council of State Governments, Advances in Genetic Information: A Guide for State Policy Makers (Lexington: Council of State Governments, 1992); and Privacy Commissioner of Canada, Genetic Testing and Privacy (Ottawa: Privacy Commissioner of Canada, 1992)).
40. Id. at i-ii (citing Council of State Governments, Advances in Genetic Information: A Guide for State Policy Makers (Lexington: Council of State Governments, 1992); and Privacy Commissioner of Canada, Genetic Testing and Privacy (Ottawa: Privacy Commissioner of Canada, 1992)).
41. A true maximum protection statute would forbid all genetic testing. That kind of protection is unlikely, because even in countries that severely limit genetic manipulation (for example, Germany), research is permitted in highly regulated laboratories.
42. See Watson et al., supra note 10, at 8.
43. See W. Paul, ed., Fundamental Immunology (New York: Raven Press, 1989): at 445.
44. Although not discussed by the GPA, but relevant to my point, if individuality and autonomy are the driving forces of the GPA, then the principles of individuality and autonomy could be extended to apply to individuals who wish to manipulate or clone of their own genes to improve themselves and their offspring genetically.
45. Others have coined the term blueprint. See, for example, R. Shapiro, The Human Blueprint: The Race to Unlock the Secrets of Our Genetic Script (New York: St. Martin's Press, 1991).
46. Examples include patent, tax, and securities legislation.
47. See Genetic Privacy Act, supra note 2, §§ 101-05.
48. See G. Wills, The Wisdom of the Genes (New York: Basic Books, 1989): at 163.
49. See Baker, 21 N.E.2d at 596 (holding that even the "exhibition" of one's body to a physician is a privileged communication).
50. Biochemical testing as used herein includes the entire gamut of medical biophysiological testing, including but not limited to determining the presence or absence of enzymatic activity, biochemical structures, proteins, carbohydrates, biochemical modifications, or proteins carbohydrates or lipids.
51. Genetic testing as used herein includes the entire gamut of medical testing using all the techniques of molecular biology, including but not limited to determining the presence or absence of genes, gene mutations, recombinations, post-replicative and transcriptional modifications, tertiary and quaternary chromosomal infrastructure, and so forth.
52. Compare Walter Gilbert, who is quoted as saying that by 2020 we should be able to go into a drugstore and have all our genetic code sequenced and handed to us in a CD-ROM. See Shapiro, supra note 39, at 271. (Gilbert pioneered DNA sequencing in the 1970s).
53. See R.G. Sisnowski et al., "Rapid Determination of Single Base Mismatch Mutations in DNA Hybrids by Direct Electric Field," Proceedings of the National Academy of Sciences (USA), 94 (1997): 1119-23.
54. See S. Hawking, A Brief History of Time: From the Big Bang to Black Holes (New York: Bantam 1988): at 55 (describing Werner Heisenberg's Uncertainty Principle).
55. See J. Glick, Chaos: Making a New Science (New York: Viking, 1987): at 314. See also J.P. Ridge, E.J. Fuchs, and P. Matzinger, "Neonatal Tolerance Revisited: Turning on Newborn T Cells with Dendritic Cells," Science, 271 (Mar. 22, 1996): 1723-26.
56. See J. Glick, Chaos: Making a New Science (New York: Viking, 1987): at 314. See also J.P. Ridge, E.J. Fuchs, and P. Matzinger, "Neonatal Tolerance Revisited: Turning on Newborn T Cells with Dendritic Cells," Science, 271 (Mar. 22, 1996): 1723-26.
57. See Genetic Privacy Act, supra note 2, § 3(m) & pp. 45-70.
58. See id. at 48 (acknowledging that the exclusion of biochemical tests, family histories, and other forms of analysis was to "avoid the enormous problems presented by including it").
59. See id. § 2.
60. Id. § 2(e).
61. See generally J. Sambrook, E.F. Fristch, and T. Maniatis, Molecular Cloning (Cold Spring Harbor: Cold Spring Harbor Press, 1989).
62. See id.
63. See Genetic Privacy Act, supra note 2, § 104(a).
64. See id. § 3(e).
65. See K. Mullis, U.S. Patent Nos. 4,683,195, 4,683,202.
66. See Genetic Privacy Act, supra note 2, § 3(e).
67. See id. at 46-47.
68. Id. at ii.
69. Phenotypic penetrance is defined as "The proportion of individuals of a particular genotype that express its phenotypic effect in a given environment." Webster's Medical Desk Dictionary (Springfield: Merriam Webster, 1986): at 525.
70. See S. O'Hara, "The Use of Genetic Testing in the Health Insurance Industry: The Creation of a Biological Underclass," Southwestern University Law Review, 22 (1993): 1211-28.
71. See C. Smith, "Prying into Employees' Private Lives," Seattle-Post Intelligencer, Aug. 19, 1994, at E1.
72. See P.R. Billings et al., "Discrimination as a Consequence of Genetic Testing," American Journal of Human Genetics, 50 (1992): 476.
73. See id.
74. See T. Friend, "Genetic Findings Used to Deny Jobs, Coverage," USA Today, Apr. 12, 1996, at A1.
75. Adoption agencies present a particularly poignant example of the opposite contention. An agency would want to have the information and pass it along to prospective parents due to case law holding that an agency is liable for the damages imposed on the adoptive parents. See Mohr v. Commonwealth, 653 N.E.2d 1104 (Mass. 1995). For denial of veteran's benefits, see Dean v. Brown, 8 Vet. App. 449 (1995).
76. T. Friend, "Researchers Uncover Genetic Discrimination: Technology Abuse a Growing Concern," USA Today, Apr. 12, 1996, at A3.
77. See id.
78. See id.
79. See id.
80. Id.
81. Id.
82. This would be especially true where the etiology is completely unknown, as in the early years of the acquired immunodeficiency disease syndrome epidemic, a Hantavirus outbreak, or as is the case with Gulf-War Syndrome. The GPA is silent on the testing of samples due to an overriding social need, such as a pandemic.
83. L.O. Gostin, "Genetic Privacy," Journal of Law, Medicine & Ethics, 23 (1995): at 324.
84. Genetic Privacy Act, supra note 2, § 2(a)(2).
85. Id. at ii-iii.
86. See Buck v. Bell, 274 U.S. 200 (1927) (upholding the constitutionality of compulsory sterilization laws for "mental defects" and "feeble-minded persons"). See also J.A. Robertson, Children of Choice: Freedom and the New Reproductive Technology (Princeton: Princeton University Press, 1994): at 90.
87. See Buck v. Bell, 274 U.S. 200 (1927) (upholding the constitutionality of compulsory sterilization laws for "mental defects" and "feeble-minded persons"). See also J.A. Robertson, Children of Choice: Freedom and the New Reproductive Technology (Princeton: Princeton University Press, 1994): at 90.
88. In addition to the Aryan eugenics programs that sought to use selective breeding to develop the "Master race," the twentieth century has witnessed the mass murders of Jews in Nazi Germany, Cossacks and Jews during the Stalinist purges, Kurds by Iraqis, Serbs by Bosnians, Bosnians by Serbs, Christians by Sudanese Moslems, Moslems by Hindus, enemies of the people by Chinese Communists, to list a few contemporary examples.
89. See 274 U.S. 200.
90. See Annas, supra note 11, at 641-47.
91. See Skinner v. Oklahoma, 316 U.S. 535 (1942) (finding Oklahoma's Habitual Criminal Sterilization Act unconstitutional, as interfering with a constitutional right to procreate). Compare Goodwin v. Turner, 908 F.2d 1395 (8th Cir. 1990) (holding that states may regulate a prisoner's wish to procreate through artificial insemination).
92. See Roe v. Wade, 410 U.S. 113 (1973) (finding a liberty interest to abortion).
93. See Meyer v. Nebraska, 262 U.S. 390 (1923) (invalidating a Nebraska statute that prohibited the teaching of a foreign language in primary schools and the teaching of any subject in a language other than English. The U.S. Supreme Court held that the statute was invalid because it infringed on the liberty of parents as protected by the due process clause of the Fourteenth Amendment to teach their children in whatever language they wanted).
94. See Griswold v. Connecticut, 381 U.S. 479 (1965).
95. See Genetic Privacy Act, supra note 2, § 101.
96. See id. § 123(2)(D).
97. See id. § 123(b)(1-2).
98. See Fed. R. Civ. P. 65(b).
99. See id.
100. Genetic Privacy Act, supra note 2, at 91.
101. See Fed. R. Civ. P. 35.
102. Genetic Privacy Act, supra note 2, at 93.
103. See Fed. R. Civ. P. 8.
104. Genetic Privacy Act, supra note 2, at ii.
105. See id. § 2.
106. Andrews, supra note 16, at 188.
107. See Whalen v. Roe, 429 U.S. 589 (1977).
108. In other words, the doctor would present the availability of the test to the patient, at which point the patient would decide whether to have it conducted. In this scenario, it is the doctor who is requesting that the test be conducted.
109. See Brown, supra note 5.
110. See K. Hudson et al., "Genetic Discrimination and Health Insurance: An Urgent Need for Reform," Science, 270 (Oct. 20, 1995): 391-92.
111. See definition, supra note 63.
112. See Genetic Privacy Act, supra note 2, at 46 ("[K]nowledge about the presence of a gene that makes it probable that the individual will suffer a debilitating disease later in life is private information, at least until a point in time when symptoms become manifest or the individual intentionally discloses the information.").
113. See O'Hara, supra note 64, at 1214.
114. Id.
115. Moore v. Regents of the University of California, 51 Cal. 3d 120, 793 P.2d 479 (1990).
116. Americans with Disabilities Act, 42 U.S.C. §§ 12101-213 (1994).
117. See Genetic Privacy Act, supra note 2, § 3.
118. Id. at 45-46.
119. See id.
120. Id. at 46.
121. See id. § 3(m) & pp. 45-46.
122. See P. Harper, "Insurance and Genetic Testing," Lancet, 341 (1993): 224-27.
123. Genetic Privacy Act, supra note 2, § 2(a)(4).
124. See, for example, S.M. Wolf, "Beyond 'Genetic Discrimination': Toward the Broader Harm of Geneticism," Journal of Law, Medicine & Ethics, 23 (1995): at 346.
125. See Hudson et al., supra note 103.
126. Id. at 391-92.
127. Genetic Privacy Act, supra note 2, at 71 ("These provisions apply to health care providers, lab technicians, genetic counselors, researchers, insurers and anyone else whose activities fall within the description in this section, regardless of the number of individuals on whom they have information.").
128. See P. Billings, "The Context of Genetic Screening," Yale Journal of Biology and Medicine, 64 (1991): at 50.
129. See id. at 45.
130. See Genetic Privacy Act, supra note 2, § 104(a).
131. The problem with looking at DNA as "property" is that one must define what aspects of property rights apply to the physical sample, such as the right to possess, the right to use, the right to transfer, or the right to exclude. The GPA states that a DNA sample is "property" but does not address the more refined legal aspects such as: the rights per stick, as a bundle, as a subdivided part of the bundle of rights, and so forth. An important question is whether these rights can be subdivided, and if we should look at the interests of third parties. Finally, the policy implications that derive from taking a position on each of the sticks in the bundle are not defined by the GPA. One must first clarify that there may be two different property rights: a property right (1) to the physical DNA and (2) to the genetic information derived from the sample.
132. Genetic Privacy Act, supra note 2, at 98.
133. See id. § 131(a), 182.
134. See id. § 131(a) & p. 98.
135. Id. § 131(a)(2).
136. See id. § 171.
137. See id. §§ 171-72.
138. See Public Health Service Act, 42 U.S.C. § 241(d) (1995).
139. Genetic Privacy Act, supra note 2, at 62.
140. See id. § 171 (entitled "Civil Remedies").
141. See id. § 172 (entitled "Civil Penalties and Injunctive Relief").
142. See id. § 104(b).
143. See id. § 104(b) & p. 67.
144. See J. Pollard, "Primary Care: The Driver in Health Care Reform," Physician Executive, 10 (5 Oct. 1995).
145. See T. Hamburger and E. Black, "Seeking a Cure: The Problem," Star-Tribune, Oct. 25, 1993, at A1 ("The U.S. system spent almost $170 billion on administrative expenses."). Business Editors, "IBM to Deliver Network-Centric Computing Solutions for Leading U.S. Health Care Organizations," Business Wire, Mar. 4, 1996 ("Reducing the volume of paper forms and medical tests has long been a priority of healthcare institutions...").
146. See T. Hamburger and E. Black, "Seeking a Cure: The Problem," Star-Tribune, Oct. 25, 1993, at A1 ("The U.S. system spent almost $170 billion on administrative expenses."). Business Editors, "IBM to Deliver Network-Centric Computing Solutions for Leading U.S. Health Care Organizations," Business Wire, Mar. 4, 1996 ("Reducing the volume of paper forms and medical tests has long been a priority of healthcare institutions...").
147. See E.W. Clayton et al., "Informed Consent for Genetic Research on Stored Tissue Samples," JAMA, 274 (1995): 1786-92; and R.F. Weir and J.R. Horton, "DNA Banking and Informed Consent - Part I," IRB: A Review of Human Subjects Research, 17, no. 4 (1995): 1-4.
148. See E.W. Clayton et al., "Informed Consent for Genetic Research on Stored Tissue Samples," JAMA, 274 (1995): 1786- 92; and R.F. Weir and J.R. Horton, "DNA Banking and Informed Consent - Part I," IRB: A Review of Human Subjects Research, 17, no. 4 (1995): 1-4.
149. See Moore, 51 Cal. 3d 120, 793 P.2d 479.
150. At least fifty published cases have cited Moore.
151. See E. Marshall, "Policy on DNA Research Troubles Tissue Bankers," Science, 271 (Jan. 26, 1996): 440.
152. See id.
153. R.F. Weir and J.R. Horton, "DNA Banking and Informed Consent - Part II," IRB: A Review of Human Subjects Research, 17, nos. 5-6 (1995): 1-8.
154. Compare Genetic Privacy Act, supra note 2, § 101(b).
155. See Weir and Horton, supra note 139, at 1. The authors define seven parameters of consent as follows: 1. Will information about my DNA [from my banked sample] get into the wrong hands?; 2. It is my DNA [my banked sample], right?; 3. Can I withdraw my personal involvement [my banked sample] from this research project at any time?; 4. How long do you plan to keep my DNA [my banked sample]?; 5. If you find something important about me from my DNA [my banked sample], will you tell me? What if I don't want to have that information?; 6. Will other people in the future have access to my DNA sample [genetic information about me]?; and 7. Will other scientists do experiments with my DNA [my banked sample] for other purposes? Id. at 2.
156. See Weir and Horton, supra note 144, at 7.
157. See Marshall, supra note 142, at 440.
158. An important factor in this debate is the extent to which we allow science to self-regulate. In fact, we trust scientists to self-regulate so not to create dangerous genetic pathogens, to handle confidential information during peer review, to decide whose research proposals merit funding, and to review work for tenure selection. All these activities involve private and confidential information that can affect third parties. So far, none of these areas has required federal legislative intervention.
159. See generally, Journal of Law, Medicine & Ethics, 23 (1995): 309-81.