[2] Council of State Governments, Advances in Genetic Information: A Guide for State Policy Makers, Lexington, Ky: Council of State Governments, 1992; Privacy Commissioner of Canada, Genetic Testing and Privacy, Ottawa, Ontario: Privacy Commissioner of Canada, 1992.

[3] Annas GJ, "Privacy Rules for DNA Databanks", 270 JAMA 2346 (1993).

[4] Domestic and International Data Protection Issues, Hearings before the Subcommittee on Government Information, Justice, and Agriculture of the Committee on Government Operations, U.S. House of Representatives, 102d Cong., 2d Sess. (1991).

[5] Current confidentiality protections are inadequate even to protect individual medical records, a circumstance widely recognized during the recent health care reform debate. See, e.g., the medical records section of The Health Security Act as amended in the U.S. House of Representatives, Report on the Health Security Act, Committee on Government Operations, Aug. 12, 1994; and Hearings on Health Reform, Health Records, Computers and Confidentiality, Committee on Government Operations, U.S. House of Representatives, 103d Cong. 1st Sess., Nov. 4, 1993; and Hearings on Fair Health Information Practices Act of 1994, April 20, May 4-5, 1994. See also, Wilker NL, Stawski S, Lewontin R, Billings PR, "DNA Data Banking and the Public Interest", in Billings PR, ed, DNA on Trial: Genetic Information and Criminal Justice, Cold Spring Harbor, NY: Cold Spring Harbor Laboratory Press, 1992, pp. 141-149; Yates JRW, Malcom S, Read AP, "Guidelines for DNA Banking: Report of the Clinical Genetics Society Working Party on DNA Banking", 16 J. Med. Genet. 245 (1989); Ad Hoc Committee on DNA Technology, American Society of Human Genetics, DNA Banking and DNA Analysis: Points to Consider. 42 Am. J. Hum. Genet. 781 (1986); and Andrews LB, DNA Testing, Banking and Individual Rights, in Knoppers BM & Laberge GM, eds, Genetic Screening: From Newborns to DNA Typing, Amsterdam: Excerpta Medica, 1990, pp. 217-242.

[6] Designing Genetic Information Policy: The Need for an Independent Policy Review of the Ethical, Legal and Social Implications of the Human Genome Project, Committee on Government Operations, U.S. House of Representatives, 102d Cong, 2d Sess., Rep. No.16, April 2, 1992, p.25.

[7] Congress has recently acted to protect genetic information derived from DNA samples held by law enforcement agencies for identification purposes. See, Violent Crime Control and Law Enforcement Act of 1994, P.L. 103-322  210305. This law would not be affected by the Genetic Privacy Act.

[8] See discussion of the use of family history by physician to conclude that an individual suffered from breast-ovarian carcinoma syndrome despite no manifested symptoms of disease in Katskee v. Blue Cross/Blue Shield of Nebraska, 245 Neb. 808, 515 N.W.2d 645 (1994), discussed in Annas, GJ, "When Should Preventive Treatment be Paid for by Health Insurance?" 331 New Eng. J. Med. 1027 (1994).

[9] Ad Hoc Committee on DNA Technology, American Society of Human Genetics, "DNA Banking and DNA Analysis: Points to Consider," 42 Am. J. Hum. Genetics 781 (1988).

[10]Office of Technology Assessment, U.S. Congress, Genetic Witness: Forensic Uses of DNA Tests, Washington, D.C.: U.S. Government Printing Office, 1990, p.132.

For detailed descriptions of the process and procedures used in DNA typing see Thompson, WC, "Evaluating the Admissibility of New Genetic Identification Tests: Lessons form the 'DNA War'", 84 J. Crim. L. 22 (1993); Committee on DNA Technology in Forensic Science, "DNA Typing Technical Considerations" in DNA Technology in Forensic Science, National Academy Press, Washington, D.C., 1992, pp.51-73.

[11] See, e.g., Cal. Ins. Code  799.03(Deering 1994) (requiring that prior to execution of consent for HIV related test, insurers must provide printed materials on HIV, information on what the subject can do with the results, a list of available counseling services and sources of additional help); N.Y. Pub. Health Law  2781 (Consol 1993) (requiring that person ordering an HIV related test explain the nature of the illness, and provide information about discrimination problems that might result); Pa. Cons. Stat.  7605 (1993) (requiring that explanation of HIV related test and information on the availability of information about exposure and transmission and suggestion that subject may desire pre-test counseling be communicated prior to test).

[12] President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Screening and Counseling for Genetic Conditions Washington, D.C.: U.S. Government Printing Office, 1983, p.43.

[13] Chapman M, "Invited Editorial: Predictive Testing for Adult Onset Genetic Disease: Ethical and Legal Implications of the Use of Linkage Analysis for Huntington Disease", 47 Am. J. Hum. Genet. 1, 2 (1990).

[14] Chapman M, "Canadian Experience with Predictive Testing for Huntington Disease: Lessons for Genetic Testing Centers and Policy Makers", 42 Am. J. Hum. Genet. 491, 493 (1992); The Institute of Medicine's Committee on Assessing Genetic Risks recommends more stringent requirements in regard to genetic counseling and believes that "genetic counseling and education must be an integral part of genetic testing; anyone who is offering, or referring for, genetic testing must provide--or refer for --appropriate genetic counseling and education prior to testing and follow-up after testing." Assessing Genetic Risks, Andrews LB, Fullarton JE, Holtzman NA & Motulsky G, eds., Washington, D.C. National Academy Press, 1994, p.170. As more primary care physicians provide and use genetic tests, they are the likely candidates to perform such counseling. However, before they will be adequately prepared to do so effectively, research and education on appropriate counseling methods must be undertaken. Id. at 173.

[15] Chapman, supra note 7, at 492; For discussion of issues that arise in the different contexts in which genetic counseling takes place, including pre-natal testing and screening for late onset disorders see IOM Report on Assessing Genetic Risks, supra note 7, Chap. 4, "Issues in Genetic Counseling."

[16] Huggins M, et al, "Ethical and Legal Dilemmas Arising During Predictive Testing for Adult-Onset Disease: The Experience of Huntington Disease", 47 Am. J. Human Genet. 4 (1990); Chapman, supra note 7 at 493; Assessing Genetic Risks, supra note 7, at 88-89.

[17] See Chapman, supra note 7, at 492; Huggins M. et al, "Predictive Testing for Huntington Disease in Canada: Adverse Effects and Unexpected Results in Those Receiving a Decreased Risk", 42 Am. J. Med. Genet. 508, 514-515 (1992). These commentators view the role of genetic counseling as particularly warranted in predictive testing since results will be an expression of altered risk and the individual who is tested may not appreciate the significance, for example, between being at 11% as opposed to 50% increased risk of having a particular gene or disease and act on such misunderstanding with harmful results.

[18] If discussion and forms are to be understandable by the average individual, considerable effort should go into their development. As a recent study at Johns Hopkins Oncology Center in Baltimore revealed, the average form for experimental therapies required at least an 11th grade reading level, despite the fact that most specialists recommend that important documents should be written at or below an 8th grade level. McFarling UL, Medical Notebook, Cancer Consent Forms Found Difficult to Read, Boston Globe, October 13, 1994, p.3.

[19] See, e.g., 42 CFR 2.22 (1993)(requiring that at the time of admission for alcohol or drug abuse treatment, patients receive notice of the federal law and regulations that protect the confidentiality of such treatment records); Uniform Health Care Information Act  5-101, 9 U. L. A. 509 (1988)(requiring that a health care provider post a notice of information practices); Health Information Model Legislation  106 (Am. H. Info. Manag. Assoc.) (requiring those who receive health care information from patients to provide patients with a statement of the recipient's fair information practices); Insurance Information and Privacy Model Act  4 (N.A.I.C. 1989)(requiring insurance institutions and agents to provide a notice of information practices to applicants).

[20] See, e.g., The Health Security Act, H.R. 3600, 103d Cong. 2d Sess.  5137 (permitting disclosures without patient's authorization if it is believed that the disclosure will avoid or minimize imminent danger to the health or safety of any individual), Uniform Health-Care Act  2-104 (additionally permitting disclosures to immediate family members, unless prohibited by the patient); and 42 U.S.C.  290dd-2(b)(2)(permitting disclosures of substance abuse treatment information to medical personnel in bona fide emergencies). It should be noted that the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research also recognizes that a genetic counselor's ethical duty of confidentiality can be overridden if several conditions are met, including a determination of a high probability of harm from withholding of the information, that the information will actually be used to avert the harm, and that only genetic information necessary for diagnosis or treatment of disease is disclosed. Screening and Counseling for Genetic Conditions, supra note 5 at 44. This issue is discussed in detail in the Appendix.

[21] McEwen J, McCarty K & Reilly P, "A Survey of Medical Directors of Life Insurance Companies Concerning Use of Genetic Information", 53 Am. J. Hum. Genet. 33 (1993).

[22] Marshall E, "Genetic Testing Set for Takeoff", 265 Science 464 (1994).

[23] See, 42 CFR  2.31 (1993) for contents of written consent to disclosure of substance abuse treatment information under the regulations and a sample form.

[24] See, e.g., Uniform Health Care Information Act  3-101, 3-102, 9 U. L. A. 499, 501 (1988)(requiring that health care providers permit patients examine and copy records except in particular circumstances); Health Information Model Legislation  106(b)(6) (Am. H. Info. Manag. Assoc.) (providing that patients may have access to health care information); Mass. Gen. Laws Ann. ch. 112  12CC (West 1993); Fair

[25] See, e.g., Mass. Gen. Laws Ann. ch. 112  12CC (permitting provider to withhold inspection of psychotherapy records when in the exercise of reasonable professional judgment, seeing these records would adversely affect the patient's well being; on request of the patient, however, the total record is to be made available to an attorney or another therapist.) In its Report on the Health Security Act, H.R. 3600, the Committee on Government Operations recommended amendment to include provisions of H.R. 4077 which allow withholding of seven categories of information from patients who request record inspection, H.R. Rptr. No. 601, 103d Cong., 2d Sess. Pt. 5, pp.25-26 (1994).Health Information Practices Act  111,112, H. R. 4077 103Rd Cong. 2d Sess. (1994)(requiring health information trustees to permit individuals to inspect and copy most health information).

[26] H.R. 4077. After introduction by Rep. Gary Condit in March, 1994, hearings were held by the Subcommittee on Information, Justice, Transportation and Agriculture, Committee on Government Operations, U.S. House of Representatives. The provisions of this bill form the basis for the Fair Health Information Practices Part of amendments to the Health Security Act (H.R. 3600) as reported in H.R. Rep. No. 601, 103d Cong., 2d Sess., Pt. 5, p.101 (1994).

[27] See, e.g., Terre Haute Regional Hospital v. Trueblood, 600 N.E.2d 1358 (Ind. 1992) (permitting discovery of medical records of non-party patients but nonetheless requiring that identity of patients be redacted from them).

[28] Commonwealth v. Kobrin, 479 N.E.2d 674 (Mass. 1985).

[29] Khajezadeh D, "Patient Confidentiality Statutes in Medicare and Medicaid Fraud Investigations", 13 Am. J. L. & Med. 105, 120-121 (1987) In some cases the court has simply noted that disclosures are limited to the purposes connected to the plan's administration without any specific guidance as to which informational components of patient records meet particular purposes of the plan.

[30] For description of the range of law enforcement activities in which collection and analysis is allowed under various state laws see McEwen J & Reilly P, "A Review of State Legislation on DNA Forensic Databanking," 54 Am. J. Hum Genet. 941 (1994).

[31] See generally, Thompson, supra note 3.

[32] Shapiro ED & Weinberg ML, "DNA Data Banking: The Dangerous Erosion of Privacy," 38 Cleve. St. L. Rev. 455, 477 (1990).

[33] U.S. v. Laub Baking Company, 283 F.Supp. 217 (1968) (rejecting claims that fingerprinting violates rights against self-incrimination, unreasonable search and seizure, and right of privacy).

[34] Private genetic information could be developed under such laws because state statutes that authorize the establishment of forensic DNA databanks differ in defining the scope of authority to conduct DNA analysis in connection with such banking. For example, while Michigan identifies the process that is authorized as "DNA identification profiling" which is a "validated scientific method of analyzing components of deoxyribonucleic acid molecules for the purpose of identifying the pattern of the components' chemical structure that is unique to an individual" Mich. Comp. Law  28.172 (1992), not all states are as specific. Alabama's statute, which authorizes the establishment of that state's forensic databank, states that "the Alabama Department of Forensic Sciences should be authorized and empowered to analyze, type and record any and all genetic markers contained in or derived from DNA and to create a statewide DNA database system for collection, storage and maintenance of genetic identification information as the same may pertain to the identification of criminal suspects." Code of Ala. 36-18-20 (1994).

[35] The only circumstance in which paternity tests involving genetic analysis would fall outside of this provision, and this Act could be construed as prohibiting them, would be if an order for such tests was not issued under Rule 35 or what was considered a "comparable rule". Paternity actions are routinely brought as civil actions in most states. Even when paternity is one element to be proven in a criminal action for failure to pay support by an enforcement agency, the civil rules of procedure are often applied. Some states, such as Ohio, have specific statutes regarding authority to issue orders for paternity testing on motion to the court. For example, ORCA  2317.47 (refering to blood tests in paternity actions) and ORCA  3111.09 (containing similar provisions for genetic tests in paternity actions). The consequences of willful failure to obey a court order under these circumstances includes having the refusal disclosed in trial or permitting the court to issue an order determining paternity without genetic testing. ORCA  3111.09 Most DNA identification tests are currently done to determine paternity; more than 100,000 a year for paternity and less than 10,000 for use in a criminal proceeding. Bishop JE, How DNA Scientists Help Track Criminals and Clear the Innocent, Wall St. J., Jan. 6, 1995, p.1.

[36] Lewis, Under a Genetic Cloud, Boston Globe, August 14, 1994, p.A1. The named plaintiff, Le Ann Sevenson, filed suit in Santa Clara against KTI Chemicals, Inc.

[37] The Common Rule, based on the regulations of the Department of Health and Human Services (see 45 CFR Part 46) has been adopted in whole or as modified by individual departments and agencies. For a particular agency's version, see 56 Fed. Reg. 28019-28031 (1991).

[38] This requirement coincides with the recommendations of the NIH Office for Protection from Research Risks that IRB make sure adequate counseling is provided to pedigree research participants on the meaning of the genetic information they receive so as to minimize the psychological risks of participation. National Institute of Health, Protecting Human Research Subjects, Institutional Review Board Guidebook, Washington, D.C.: U.S. Gov. Printing Office, 1993, pp. 5-54.

[39] Revelation during the authorization process that such information may result from participation is also recommended by OPRR. Id.

[40] Examples include the Uniform Health Care Information Act  52-104(a)(7), and H.R. 4077,  128 supra note 17. These acts contain similar provisions for access for research use to patient information without the authorization of patients if an IRB has determined that the project's importance outweighs the intrusion into the patient's privacy, and that it would be impracticable to conduct the project without such information. Although 42 U.S.C. 290dd-2(b)(2) is less restrictive and permits disclosures of information regarding substance abuse treatment without patient authorization to "qualified personnel for purposes of conducting research", regulations under the same statute require that an independent panel of three persons determine the welfare of the patients will be adequately protected and that the risks in disclosure of alcohol and substance abuse treatment information are outweighed by the benefits of the research. 42 CFR  2.51 (1993). None of these models is more specific in regard to what factors must be considered by the reviewer in conducting such balancing tests.

[41] H.R. Rep. No. 601, supra note 19, 124-125.

[42] Courts have held that an administrator of an estate can waive the attorney client priviledge on behalf of the deceased in some instances. In the Matter of John Doe Grand Jury Investigation, 562 N.E.2d (Mass. 1990) Statutes can also vest authority in a decendent's personal representative to exercise the decisional right to waive psychiatrist-patient privilege. See, for example, Mont. Code Ann. 50-16-222 (1993) granting such authority in the personal representative, or if none available, in a surviving spouse, parent or adult child.

[43] Assessing Genetic Risks, supra note 7, at 10.

[44] Bloch M & Hayden MR, "Opinion: Predictive Testing for Huntington Disease in Childhood: Challenges and Implications," 46 Am. J. Hum. Genet. 1-4 (1990).

[45] Pierce v. Society of Sisters, 268 U.S. 510 (1925).

[46] Wisconsin v. Yoder, 406 U.S. 205 (1972).

[47] See, e.g., Mass. Gen. Laws Ch. 112  12F.

[48] Planned Parenthood v. Danforth, 428 U.S. 52 (1976); Bellotti v. Baird, 443 U.S. 622 (1979).

[49] Carey v. Population Services International, 431 U.S. 678 (1977).

[50] Ramsey P, "Children in Medical Investigation" in The Patient as Person, New Haven, Conn., Yale University Press, 1970, pp.11-17; and Ramsey P, "Children as Research Subjects: A Reply," 7(2) Hastings Center Report 40 (April, 1977).

[51] Bloch & Hayden, supra note 37 at 1-3. The authors acknowledge that most parents who request such tests are seeking a way to allay their own anxieties about the child's future. However, they caution that the results could have negative impact on the child's upbringing and relationship to siblings with a different risk. They recommend that predictive testing in childhood only be done when an advantage can be clearly demonstrated for the child.

[52] See, e.g., Me. Rev. Stat., tit.22,  1597-A4, requiring that the physician or counselor who provides information to the pregnant minor explore with her whether or not involvement of a parent, guardian or adult family member in the decision making process would be in her best interests.

[53] See, e.g., Strunk v. Strunk, 445 S.W.2d 145 (Ky. 1969) in which the court exercised its equitable power to permit transplantation of a kidney from an incompetent man to his brother who was dying.

[54] Id. See also, Curran v. Bosze, 566 N.E.2d 1319 (Ill. 1990). Although the principal issue in this case was whether or not it was in a child's best interests for a parent to withhold consent for a donation to a half-sibling, the court specifically held that a parent could consent to such donation only when it would be in the minor's best interests. Id. at 1331.

[55] In In re Richardson, 284 So. 2d 185, 188 (La. App. 1973) the court concluded that before application of the best interests standard was considered to determine if consent could be given for transplantation of a kidney from a brother to a sister, it must first be established that the surgical intrusion was urgent, there were no reasonable alternatives, and that the contingencies were minimal.

[56] S. 1735, 103d Cong., 1st Sess. (1993), The Privacy Protection Act of 1993 was introduced by Sen. Paul Simon to establish a Privacy Protection Commission. Like previous proposals, although granting investigative powers to the Commission, this bill contained no similar grant of enforcement powers to the Commission itself but charged it with reporting violations of the Privacy Act for which criminal but not civil penalties are available, to the president, Attorney General and Congress. It also leaves activities of the private sector outside the Commission's jurisdiction.

[57] Rotenberg M, "In Support of a Data Protection Board in the United States," 8 Gov. Info. Q. 79, 88 (1991).

[58] See, e.g., Iowa Code Ann.  729.6 (1992) (prohibiting employers from requiring or administering genetic tests as a condition of employment); Wis. Stat. Ann.  631.89 (1994) (restricting the use of genetic tests and results of such tests by insurers), Cal. Ins. Code  10146 (1994) (establishing standards for underwriting life and disability insurance on the basis of tests for genetic characteristics) and Cal. Health & Safety Code  1374.7 (1994) (prohibiting health insurance plans from rejecting applicants, or setting higher rates for applicants, on the basis of genetic characteristics).

[59] For instance, in regard to genetic testing that is permissible by life and disability insurers, California requires that written informed consent for such test include, in addition to information that would also be required by this Act, the limitations of the test and procedures for notifying the applicant of the results. Cal. Ins. Code  10148 (1994).