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

Published online by Cambridge University Press:  01 January 2021

Extract

In the last few years, a great deal of attention has been paid to the effects that the achievements of the Human Genome Project will have on the confidentiality of medical information. The Genetic Privacy Act (GPA) is an attempt to address the privacy, confidentiality, and property rights relating to obtaining, requesting, using, storing, and disposing of genetic material. The GPA grew out of concerns over the vast amount of genetic information that is a product of the Human Genome Project. The central goals of the GPA are twofold: (1) to define an individual's right to control access to their genetic material and the privilege to control the information derived therefrom; and (2) to prevent potential and actual abuse of genetic information by third parties, such as insurance companies, employers, and government. The GPA is one of a group of proposals that seek to control the flow of medical information from the individual to health care professionals and to other persons.

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Article
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Copyright © American Society of Law, Medicine and Ethics 1997

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References

See Merz, J., “Privacy, Genetics, and Human Tissue Research,” Center for Bioethics Newsletter, 1 (1996): 14.Google Scholar
See Annas, G.J. Glantz, L.H. Roche, P.A., The Genetic Privacy Act and Commentary (Boston: Boston University-School of Public Health, 1995) (hereinafter Genetic Privacy Act).Google Scholar
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.Google Scholar
See id. at vi–vii.Google Scholar
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). See also Brown, B., “Genetic Testing, Access to Genetic Data, and Discrimination: Conceptual Legislative Models,” Suffolk University Law Review, 27 (1993): 1573–92.Google Scholar
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.Google Scholar
See Genetic Privacy Act, supra note 2, §§ 111–15.Google Scholar
See id. §§ 101–05.Google Scholar
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.Google Scholar
See Watson, J., Molecular Biology of the Gene (Menlo Park: Benjamin Cummins, 4th ed., 1987): At 8. Georg Mendel's work was rediscovered in 1900 by DeVries, Hugo Correns, Karl Tschermak, Erich, 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.Google Scholar
See Annas, G.J., “Mapping the Human Genome and the Meaning of Monster Mythology,” Emory Law Journal, 39 (1990): At 645.Google Scholar
See Flores, E., “PEP is a Nuclear Protein Tyrosine Phosphatase,” Molecular and Cellular Biology, 14 (1994): 4938–46.CrossRefGoogle Scholar
Given the state of the art when the human immunodeficiency virus spread outside limited areas of Africa, any man-made construct would bear the molecular biologic fingerprint of the tools then available.Google Scholar
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”).Google Scholar
See Weinberg, J., “Breaking Bonds: Discrimination in the Genetic Revolution,” JAMA, 268 (1992): 1767–71.CrossRefGoogle Scholar
See Andrews, L., Medical Genetics: A Legal Frontier (Chicago: American Bar Foundation, 1987): At 190.Google Scholar
See id. at 191.Google Scholar
See Simonsen v. Swenson, 177 N.W. 831 (1920) (public disclosure that a patient had syphilis).Google Scholar
See Hague v. Williams, 181 A.2d 345 (1962).Google Scholar
See, for example, Robinson v. Lane, 480 P.2d 620 (Okla. 1971).Google Scholar
See, for example, Gellman, R.M., “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 Turkington, R.C., “Medical Record Confidentiality Law, Scientific Research, and Data Collection in the Information Age,” Journal of Law, Medicine & Ethics, 25 (1997): 113–29.Google Scholar
Andrews, , supra note 16, at 192 (citing Hammonds v. Aetna Casualty & Surety Co., 243 F. Supp. 793 (N.D. Ohio 1965)).Google Scholar
See Fed. R. Evid. 501, which is the general rule indicating that privileged information is based on state law.Google Scholar
Baker v. Industrial Commission of Ohio, 21 N.E.2d 593, 595 (1939).Google Scholar
See Andrews, , supra note 16, at 192.CrossRefGoogle Scholar
Id. at 209. See also Rothenberg, K.H., “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).CrossRefGoogle Scholar
See generally Annas, G.J. Glantz, L.H. Roche, P.A., “Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations,” Journal of Law, Medicine & Ethics, 23 (1995): 360–66.CrossRefGoogle Scholar
See Genetic Privacy Act, supra note 2, § 2.Google Scholar
Id. § 2(a)(1).Google Scholar
Annas, Glantz, Roche, , supra note 29, at 360.Google Scholar
Genetic Privacy Act, supra note 2, § 3(m).Google Scholar
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)).Google Scholar
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.Google Scholar
See Watson, , supra note 10, at 8.Google Scholar
See Paul, W., ed., Fundamental Immunology (New York: Raven Press, 1989): At 445.Google Scholar
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.Google Scholar
Others have coined the term blueprint. See, for example, Shapiro, R., The Human Blueprint: The Race to Unlock the Secrets of Our Genetic Script (New York: St. Martin's Press, 1991).Google Scholar
Examples include patent, tax, and securities legislation.Google Scholar
See Genetic Privacy Act, supra note 2, §§ 101–05.Google Scholar
See Wills, G., The Wisdom of the Genes (New York: Basic Books, 1989): At 163.Google Scholar
See Baker, 21 N.E.2d at 596 (holding that even the “exhibition” of one's body to a physician is a privileged communication).Google Scholar
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.Google Scholar
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.Google Scholar
Compare Gilbert, Walter, 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).Google Scholar
See Sisnowski, R.G., “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.CrossRefGoogle Scholar
See Hawking, S., A Brief History of Time: From the Big Bang to Black Holes (New York: Bantam 1988): At 55 (describing Werner Heisenberg's Uncertainty Principle).CrossRefGoogle Scholar
See Glick, J., Chaos: Making a New Science (New York: Viking, 1987): At 314. See also Ridge, J.P. Fuchs, E.J. Matzinger, P., “Neonatal Tolerance Revisited: Turning on Newborn T Cells with Dendritic Cells,” Science, 271 (Mar. 22, 1996): 1723–26.Google Scholar
See Genetic Privacy Act, supra note 2, § 3(m) & pp. 4570.Google Scholar
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”).Google Scholar
See id. § 2.Google Scholar
Id. § 2(e).Google Scholar
See generally Sambrook, J. Fristch, E.F. Maniatis, T., Molecular Cloning (Cold Spring Harbor: Cold Spring Harbor Press, 1989).Google Scholar
See Genetic Privacy Act, supra note 2, § 104(a).Google Scholar
See id. § 3(e).Google Scholar
See Mullis, K., U.S. Patent Nos. 4,683,195, 4,683,202.Google Scholar
See Genetic Privacy Act, supra note 2, § 3(e).Google Scholar
See id. at 46–47.Google Scholar
Id. at ii.Google Scholar
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.Google Scholar
See O'Hara, S., “The Use of Genetic Testing in the Health Insurance Industry: The Creation of a Biological Underclass,” Southwestern University Law Review, 22 (1993): 1211–28.Google Scholar
See Smith, C., “Prying into Employees' Private Lives Seattle-Post Intelligencer, Aug. 19, 1994, at E1.Google Scholar
See Billings, P.R., “Discrimination as a Consequence of Genetic Testing,” American journal of Human Genetics, 50 (1992): 476.Google Scholar
See Friend, T., “Genetic Findings Used to Deny Jobs, Coverage,” USA Today, Apr. 12, 1996, at A1.Google Scholar
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).Google Scholar
Friend, T., “Researchers Uncover Genetic Discrimination: Technology Abuse a Growing Concern,” USA Today, Apr. 12, 1996, at A3.Google Scholar
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.Google Scholar
Gostin, L.O., “Genetic Privacy,” journal of Law, Medicine & Ethics, 23 (1995): At 324.CrossRefGoogle Scholar
Genetic Privacy Act, supra note 2, § 2(a)(2).Google Scholar
Id. at ii–iii.Google Scholar
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 Robertson, J.A., Children of Choice: Freedom and the New Reproductive Technology (Princeton: Princeton University Press, 1994): At 90.Google Scholar
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.Google Scholar
See 274 U.S. 200.Google Scholar
See Annas, , supra note 11, at 641–47.Google Scholar
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).Google Scholar
See Roe v. Wade, 410 U.S. 113 (1973) (finding a liberty interest to abortion).Google Scholar
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).Google Scholar
See Griswold v. Connecticut, 381 U.S. 479 (1965).Google Scholar
See Genetic Privacy Act, supra note 2, § 101.Google Scholar
See id. § 123(2)(D).Google Scholar
See id. § 123(b)(1–2).Google Scholar
See Fed. R. Civ. P. 65(b).Google Scholar
Genetic Privacy Act, supra note 2, at 91.Google Scholar
See Fed. R. Civ. P. 35.Google Scholar
Genetic Privacy Act, supra note 2, at 93.Google Scholar
See Fed. R. Civ. P. 8.Google Scholar
Genetic Privacy Act, supra note 2, at ii.Google Scholar
See id. § 2.Google Scholar
Andrews, , supra note 16, at 188.Google Scholar
See Whalen v. Roe, 429 U.S. 589 (1977).Google Scholar
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.Google Scholar
See Brown, supra note 5.Google Scholar
See Hudson, K., “Genetic Discrimination and Health Insurance: An Urgent Need for Reform,” Science, 270 (Oct. 20, 1995): 391–92.CrossRefGoogle Scholar
See definition, supra note 63.Google Scholar
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.”).Google Scholar
See O'Hara, , supra note 64, at 1214.Google Scholar
Moore v. Regents of the University of California, 51 Cal. 3d 120, 793 P.2d 479 (1990).Google Scholar
Americans with Disabilities Act, 42 U.S.C. §§ 12101–213 (1994).Google Scholar
See Genetic Privacy Act, supra note 2, § 3.Google Scholar
Id. at 45–46.Google Scholar
Id. at 46.Google Scholar
See id. § 3(m) & pp. 4546.Google Scholar
See Harper, P., “Insurance and Genetic Testing,” Lancet, 341 (1993): 224–27.CrossRefGoogle Scholar
Genetic Privacy Act, supra note 2, § 2(a)(4).Google Scholar
See, for example, Wolf, S.M., “Beyond ‘Genetic Discrimination’: Toward the Broader Harm of Geneticism,” Journal of Law, Medicine & Ethics, 23 (1995): At 346.CrossRefGoogle Scholar
See Hudson, , supra note 103.Google Scholar
Id. at 391–92.Google Scholar
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.”).Google Scholar
See Billings, P., “The Context of Genetic Screening,” Yale Journal of Biology and Medicine, 64 (1991): At 50.Google Scholar
See id. at 45.Google Scholar
See Genetic Privacy Act, supra note 2, § 104(a).Google Scholar
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.Google Scholar
Genetic Privacy Act, supra note 2, at 98.Google Scholar
See id. §§ 131(a), 182.Google Scholar
See id. § 131(a) & p. 98.Google Scholar
Id. § 131(a)(2).Google Scholar
See id. § 171.Google Scholar
See id. §§ 171–72.Google Scholar
See Public Health Service Act, 42 U.S.C. § 241(d) (1995).Google Scholar
Genetic Privacy Act, supra note 2, at 62.Google Scholar
See id. § 171 (entitled “Civil Remedies”).Google Scholar
See id. § 172 (entitled “Civil Penalties and Injunctive Relief”).Google Scholar
See id. § 104(b).Google Scholar
See id. § 104(b) & p. 67.Google Scholar
See Pollard, J., “Primary Care: The Driver in Health Care Reform,” Physician Executive, 10 (5 Oct. 1995).Google Scholar
See Hamburger, T. Black, E., “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…”).Google Scholar
See Clayton, E.W., “Informed Consent for Genetic Research on Stored Tissue Samples,” JAMA, 274 (1995): 1786–92; and Weir, R.F. Horton, J.R., “DNA Banking and Informed Consent—Part I,” IRB: A Review of Human Subjects Research, 17, no. 4 (1995): 14.Google Scholar
See Moore, 51 Cal. 3d 120, 793 P.2d 479.Google Scholar
At least fifty published cases have cited Moore.Google Scholar
See Marshall, E., “Policy on DNA Research Troubles Tissue Bankers,” Science, 271 (Jan. 26, 1996): 440.CrossRefGoogle Scholar
Weir, R.F. Horton, J.R., “DNA Banking and Informed Consent—Part II,” IRB: A Review of Human Subjects Research, 17, nos. 5–6 (1995): 18.Google Scholar
Compare Genetic Privacy Act, supra note 2, § 101(b).Google Scholar
See Weir, Horton, , supra note 139, at 1. The authors define seven parameters of consent as follows:Google Scholar
Will information about my DNA [from my banked sample] get into the wrong hands?;Google Scholar
It is my DNA [my banked sample], right?;Google Scholar
Can I withdraw my personal involvement [my banked sample] from this research project at any time?;Google Scholar
How long do you plan to keep my DNA [my banked sample]?;Google Scholar
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?;Google Scholar
Will other people in the future have access to my DNA sample [genetic information about me]?; andGoogle Scholar
Will other scientists do experiments with my DNA [my banked sample] for other purposes?Google Scholar
See Weir, Horton, , supra note 144, at 7.Google Scholar
See Marshall, , supra note 142, at 440.Google Scholar
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.Google Scholar
See generally, Journal of Law, Medicine & Ethics, 23 (1995): 309–81.CrossRefGoogle Scholar