Drafting the Genetic Privacy Act: Science,Policy,and Practical Considerations

Harris Poll No. 34, May 29, 1995.

Annas G.J. , “Privacy Rules for DNA Databanks: Protecting Coded ‘Future Diaries’,” JAMA, 270 (1993): 2346–50.

Annas G.J. , Editorial, “Genetic Prophecy and Genetic Privacy: Can We Prevent the Dream from Becoming a Nightmare?,” American Journal of Public Health, 85 (1995): 1196–97.

Annas G.J. Glantz L.H. Roche P.A. , The Genetic Privacy Act and Commentary (Boston: Boston University School of Public Health, 1995) (available by request from the Health Law Dept., 80 East Concord Street, Boston, MA 02118, and also at http://www-busph.bu.edu/Depts/HealthLaw/).

Genetic test means a presymptomatic test of a person's genes, gene products, or chromosomes for the purpose of determining the presence or absence of a gene or genes that exhibit abnormalities, defects or deficiencies, including carrier status, that are known to be the cause of a disease or disorder, or are determined to be associated with a statistically increased risk of development of a disease or disorder. Genetic test does not include a cholesterol test or other test not conducted for the purpose of determining the presence or absence of a person's gene or genes. Minn. Stat. § 72A.139 (Supp. 1995). Likewise, Oregon's recently enacted genetics bill defines genetic test to include a “test for determining the presence or absence of genetic characteristics in an individual, including tests of nucleic acids such as DNA, RNA and mitochondrial DNA, chromosomes or proteins in order to diagnose a genetic characteristic.” Or. Rev. Stat. § 659.036(1) (1995).

Annas Glantz Roche , supra note 4, § 101(b).

Id. § 102(b)(8).

Id. § 102(b)(9).

Id. § 103.

Id. § 104(b).

Id. § 113.

Id. § 104(c).

Id. § 103(a).

Hubbard R. McGoodwin W. , “The Danger of ‘Ethnic Genetics’,” Boston Globe, Oct. 13, 1995, at 19.

Annas Glantz Roche , supra note 4, § 104.

Institute of Medicine, Andrews L.B. , eds., Assessing Genetic Risks (Washington, D.C.: National Academy Press, 1994).

Bloch M. Hayden M.R. , “Opinion: Predictive Testing for Huntington Disease in Childhood: Challenges and Implications,” American Journal of Human Genetics, 46 (1990): 1–4.

The presence of an adult family member would be required unless the minor is pregnant. Because a pregnant woman has all the rights and authority of a competent adult in regard to analysis of her DNA or that of her fetus (§§ 151, 152), the presence of a family member would not be required if a pregnant sixteen or seventeen year old sought genetic analysis in regard to decisions regarding pregnancy. That such young women would seek such information is highly unlikely. Requiring the involvement of at least one adult member at the point, where questions regarding the benefits of DNA analysis are normally raised and answered, is intended to encourage discussion and support among family members. As stated earlier, genetic information includes family information. We also think it important to have an adult available to help the minor deal with information that might affect other family members.

Annas Glantz Roche , supra note 4, § 131(c)(2).

Id. § 131.

Id. § 131(b).

Id. § 131.

Id. at App. 142–65.

See in context, the Uniform Health Care Information Act, U.L.A. 478–504 (1988), which permits disclosure of patient information in a variety of circumstances without the patient's prior authorization.

Annas Glantz Roche , supra note 4, §§ 121, 122.

Id. § 171.

Nelkin D. Lindee M.S. , The DNA Mystique: The Gene as a Cultural Icon (New York: W.H. Freeman, 1995): At 2.

Institute of Medicine, supra note 16.

This project had its genesis during a meeting in Cold Spring Harbor in November 1989, at which one of the drafters (Annas) gave a presentation on the privacy issues involved in DNA banking. Fourteen months later, he and Dr. Sherman Elias co-hosted an NIH-sponsored workshop in Bethesda, Maryland, the purpose of which was to suggest a prioritized research agenda for the Ethical, Legal, and Social Implications (ELSI) program of the Human Genome Project. Protecting genetic privacy was ranked as one of the two highest priority issues at that workshop (regulating the introduction of new genetic tests into clinical practice was ranked slightly higher). Shortly thereafter, the director of the ELSI program for the U.S. Department of Energy (DOE), Michael Yesley, asked us to draft guidelines to protect the privacy of individual's whose DNA was stored in DNA banks. We agreed, and began this project in June 1993, with Dr. Daniel Drell of the DOE (Health Effects and Life Sciences Research Division, Office of Health and Environmental Research, Office of Energy Research) as the project monitor. In the course of the first year of research, we concluded that it was necessary to broaden the project's scope, and we presented the rationale for this change to the ELSI Working Group in June 1994. They concurred. The first draft of the GPA was completed in September 1994, and presented to the ELSI Working Group in December 1994. Many people, in addition to the members of the ELSI Working Group, contributed in substantial ways to the final product. These included our research assistants Nan Elster, Sue Yeu, Chris Hager, and Alex Klickstein, as well as our support staff, especially the administrative coordinator of the Health Law Department, Marilyn Ricciardelli, and the department's secretary, Deborah Darling. The director of the Boston University School of Public Health, Dr. Robert F. Meenan, was especially supportive. We are grateful for the generous and thoughtful comments of our colleagues who reviewed drafts and provided needed insight into both legal and genetic issues. Dr. Elias was our primary genetics consultant; his advice was invaluable. Robert Gellman's thoughtful comments and advice helped us to avoid many legislative drafting pitfalls. Lori Andrews worked especially hard to make sure we had taken all of the genetic privacy issues into account. Others who provided valuable comments and input include Wendy Mariner, Michael Grodin, Philip Reilly, Jean McEwen, Wendy Parmet, Bernard Dickens, Margaret Somerville, Alan Westin, Judy Garber, and Margaret Dreyfus.