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Assessing Genetic Risks: Implications for Health and Social Policy 8 Social, Legal, and Ethical Implications of Genetic Testing Each new genetic test that is developed raises serious issues for medicine, public health, and social policy regarding the circumstances under which the test should be used, how the test is implemented, and what uses are made of its results. Should people be allowed to choose or refuse the test, or should it be mandatory, as newborn screening is in some states? Should people be able to control access to the results of their tests? If test results are released to third parties such as employers or insurers, what protections should be in place to ensure that people are not treated unfairly because of their genotype? The answers to these questions depend in part on the significance given to four important ethical and legal principles: autonomy, confidentiality, privacy, and equity. A review of the meaning of those concepts and how they are currently protected by the law provides a starting point for the development of recommendations on the degree of control people should have in deciding whether to undergo genetic testing and what uses should be made of the results. The task is a pressing one. In a 1992 national probability survey of the public, sponsored by the March of Dimes, 38 percent of respondents said that new types of genetic testing should be stopped altogether until the privacy issues are settled.1 This chapter reviews some of the conflicts that will arise in the research and clinical settings, and suggests general principles that should be the starting point for policy analyses in this evolving field. Since many of the references in this chapter are legal citations, its references appear in legal style as numbered end notes.
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Assessing Genetic Risks: Implications for Health and Social Policy KEY DEFINITIONS Autonomy Ethical Analysis Autonomy can be defined as self-determination, self-rule, or self-governance. Autonomous agents or actions presuppose some capacity of reasoning, deciding, and willing. Moral, social, and legal norms establish obligations to respect autonomous agents and their choices. Respect for personal autonomy implies that agents have the right or power to be self-governing and self-directing, without outside control. In the context of genetic testing and screening, respect for autonomy refers to the right of persons to make an informed, independent judgment about whether they wish to be tested and then whether they wish to know the details of the outcome of the testing. Autonomy is also the right of the individual to control his or her destiny, with or without reliance on genetic information, and to avoid interference by others with important life decisions, whether these are based on genetic information or other factors. Respect for autonomy also implies the right of persons to control the future use of genetic material submitted for analysis for a specific purpose (including when the genetic material itself and the information derived from that material may be stored for future analysis, such as in a DNA bank or registry file). Even though respect for autonomy is centrally important in our society, it is not absolute. It can be overridden in some circumstances, for example, to prevent serious harm to others, as is the case in mandatory newborn screening for phenylketonuria (PKU) and hypothyroidism. Legal Issues The legal concept of autonomy serves as the basis for numerous decisions protecting a person's bodily integrity. In particular, cases have held that competent adults have the right to choose whether or not to undergo medical interventions.2 Before people make such a choice, they have a right to be informed of facts that might be material to their decision,3 such as the nature of their condition and its prognosis,4 the potential risks and benefits of a proposed test or treatment,5 and the alternatives to the proposed intervention.6 In the genetics context, health care providers have been held liable for not providing the information that a genetic test is available. 7 People also have a right to be informed about and to control the subsequent use of tissue that has been removed from their bodies. 8 There is some leeway under the federal regulations governing research involving human subjects for researchers to undertake subsequent research on blood samples provided for genetic tests (as in the newborn screening context) as long as the samples are anon-
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Assessing Genetic Risks: Implications for Health and Social Policy ymous and as long as the subsequent use was not anticipated at the time the sample was collected.9 If the additional test was anticipated at the time the sample was collected, informed consent for that use should be obtained prior to the collection of the original sample. Such an approach is thought appropriate to avert conflicts of interest, such as a physician/researcher suggesting that a patient undergo a particular test when the researcher actually wanted the tissue for the researcher's own additional use in a research or commercial project. In such a situation, the patient's autonomy is compromised even if the sample is used anonymously in the subsequent use. A report from the Office of Technology Assessment similarly stressed the importance of knowledge and consent: The consent of the patient is required to remove blood or tissue from his or her body, and also to perform tests, but it is important that the patient be informed of all the tests which are done and that a concern for the privacy of the patient extends to the control of tissues removed from his or her body. 10 Privacy Ethical Analysis Among the various definitions of privacy, one broad definition captures its central element: privacy is "a state or condition of limited access to a person."11 People have privacy if others lack or do not exercise access to them. They have privacy if they are left alone and do not suffer unauthorized intrusion by others. Once persons undergo genetic tests, privacy includes the right to make an informed, independent decision about whether—and which—others may know details of their genome (e.g., insurers, employers, educational institutions, spouses and other family members, researchers, and social agencies). Various justifications have been offered for rules of privacy. First, some philosophers argue that privacy rights are merely shorthand expressions for a cluster of personal and property rights, each of which can be explicated without any reference to the concept of privacy. In making this argument, Judith Jarvis Thomson holds that privacy rights simply reflect personal and property rights, such as the rights not to be looked at, not to be overheard, and not to be caused distress. 12 A second justification holds that rights to privacy are important instruments or means to other goods, including intimate relations such as trust and friendship. Being able to control access to themselves enables people to have various kinds of relationships with different people, rather than being equally accessible to all others. A third approach finds the basis for rights to privacy in respect for personal autonomy. Decisional privacy is often very close to personal autonomy. The language of personal autonomy reflects the idea of a domain or territory of self-rule, and thus overlaps with zones of decisional privacy.
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Assessing Genetic Risks: Implications for Health and Social Policy Whatever their rationale or justification, rights of privacy are the subject of ongoing debate about their scope and weight. However, their scope is not unlimited, and they do not always override all other competing interests, such as the interests of others. Legal Issues In the legal sphere, the principle of privacy is an umbrella concept encompassing issues of both autonomy and confidentiality. The right to make choices about one's health care is protected, in part, by the right to privacy guaranteed by the U.S. Constitution, as well as state constitutions. This includes a right to make certain reproductive choices,13 such as whether to use genetic testing.l4 It also includes a right to refuse treatment. An entirely different standard of privacy protects personal information. A few court decisions find protection for such information under the constitutional doctrine of privacy,15 but more commonly, privacy protection against disclosure of personal information is found under common law tort principles.16 In addition, there is a federal privacy act,17 as well as state statutes protecting privacy. Confidentiality Ethical Analysis Confidentiality as a principle implies that some body of information is sensitive, and hence, access to it must be controlled and limited to parties authorized to have such access. The information provided within the relationship is given in confidence, with the expectation that it will not be disclosed to others or will be disclosed to others only within limits. The state or condition of nondisclosure or limited disclosure may be protected by moral, social, or legal principles and rules, which can be expressed in terms of rights or obligations. In health care and various other relationships, we grant others access to our bodies. They may touch, observe, listen, palpate, and even physically invade. They may examine our bodies as a whole or in parts; and parts, such as tissue, may be removed for further study, as in some forms of testing. Privacy is necessarily diminished when others have such access to us; rules of confidentiality authorize us to control and thus to limit further access to the information generated in that relationship. For example, rules of confidentiality may prohibit a physician from disclosing some information to an insurance company or an employer without the patient's authorization. Rules of confidentiality appear in virtually every code or set of regulations for health care relationships. Their presence is not surprising, because such rules are often justified on the basis of their instrumental value: if prospective patients cannot count on health care professionals to maintain confidentiality, they will be
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Assessing Genetic Risks: Implications for Health and Social Policy reluctant to allow professionals the full and complete access necessary for diagnosis and treatment. Hence, rules of confidentiality are indispensable for patient and social welfare; without those rules, people who need medical, psychiatric, or other treatment will refrain from seeking or fully participating in it. Another justification for rules of confidentiality is based on the principles of respect for autonomy and privacy, above. Respecting persons involves respecting their zone of privacy and accepting their decisions to control access to information about them. When people grant health care professionals access to them, they should retain the right to determine who else has access to the information generated in that relationship. Hence, the arguments for respect for autonomy and privacy support rules of confidentiality. Finally, duties of confidentiality often derive from explicit or implicit promises in the relationship. For instance, if the professional's public oath or the profession's code of ethics promises confidentiality of information, and the particular professional does not specifically disavow it, then the patient has a right to expect that information generated in the relationship will be treated as confidential.18 There are at least two distinct types of infringements of rules of confidentiality. On the one hand, rules of confidentiality are sometimes infringed through deliberate breaches. On the other hand, rules of confidentiality are often infringed through carelessness, for example, when health care professionals do not take adequate precautions to protect the confidential information. Some commentators argue that both carelessness and modern practices of health care have rendered medical confidentiality a "decrepit concept," since it is compromised routinely in the provision of health care.19 It is widely recognized that the rules of confidentiality are limited in at least two senses: (1) some information may not be protected, and (2) the rules may sometimes be overridden to protect other values. First, not all information is deemed confidential, and patients do not have a right to expect that such information will be protected from disclosure to others. For example, laws frequently require that health care professionals report gunshot wounds, venereal diseases, and other communicable diseases such as tuberculosis. Second, health care professionals may also have a moral or legal right (and sometimes even an obligation) to infringe rules of confidentiality, for example, to prevent a serious harm from occurring. In such cases, rules of confidentiality protect the information, but they can be overridden in order to protect some other value. Judgments about such cases depend on the probability of serious harm occurring unless confidentiality is breached. Any justified infringements of rules of confidentiality should satisfy the conditions identified earlier in the discussion of justified infringements of the principle of respect for autonomy. Legal Issues The legal concept of confidentiality focuses on the information that people
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Assessing Genetic Risks: Implications for Health and Social Policy provide to their physicians. The protection of confidentiality is thought to serve an important public health goal in encouraging people to seek access to health care. It is thought that the patient's interest can be served only in an atmosphere of total frankness and candor. 20 Without the promise of confidentiality, people might avoid seeking medical treatment, thus potentially harming themselves as well as the community. In fact, the first doctor-patient confidentiality statute was passed in 1828 in New York during the smallpox epidemic to encourage people to seek health care. Various legal decisions have protected confidentiality of health care information,21 as have certain state and federal statutes. Confidentiality of health care information is also protected because disclosure of a person's medical condition can cause harm to him or her. An alternative set of legal principles-those penalizing discrimination (see below)-protects people against unfair uses of certain information. Equity Ethical Analysis Issues of justice, fairness, and equity crop up in several actions, practices, and policies relating to genetic testing. It is now commonplace to distinguish formal justice from substantive justice. Formal justice requires treating similar cases in a similar way. Standards of substantive or material justice establish the identity of the relevant similarities and differences and the appropriate responses to those similarities and differences. For instance, a society has to determine whether to distribute a scarce resource such as health care according to persons' differences in need, social worth, or ability to pay. One crucial question is whether genetic disorders or predispositions provide a basis for blocking access to certain social goods, such as employment or health insurance. Most conceptions of justice dictate that employment be based on the ability to perform particular tasks effectively and safely. For these conceptions, it is unjust to deny employment to someone who meets the relevant qualifications but also has a genetic disease. Frequently these questions of employment overlap with questions of health insurance. Practices of medical underwriting in health insurance reflect what is often called "actuarial fairness"-that is, grouping those with similar risks together so insurers can accurately predict costs, and set fair and sufficient premium rates. Although actuarial fairness may be intuitively appealing, critics argue that it does not express moral or social fairness. According to Norman Daniels, there is "a clear mismatch between standard underwriting practices and the social function of health insurance" in providing individuals with resources for access to health care22 (see Chapter 7). The fundamental argument for excluding genetic discrimination in health insurance amounts to an argument for establishing a right to health care. One of the central issues in debates about the distribution of health care is one's view of the
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Assessing Genetic Risks: Implications for Health and Social Policy "natural lottery," in particular, a "genetic lottery."23 The metaphor of a lottery suggests that health needs result largely from an impersonal natural lottery and are thus undeserved. But even if health needs are largely undeserved because of the role of chance, society's response to those needs may vary, as H. Tristram Engelhardt notes, depending on whether it views those needs as unfair or as unfortunate.24 If health needs are unfortunate, but not unfair, they may be the object of individual or social compassion. Other individuals, voluntary associations, and even society may be motivated by compassion to try to meet those needs. If, however, the needs are viewed as unfair as well as unfortunate, society may have a duty of justice to try to meet those needs. One prominent argument for the societal provision of a decent minimum of health care is that, generally, health needs are randomly distributed and unpredictable, as well as overwhelming when health crises occur. 25 Because of these features of health needs, many argue that it is inappropriate to distribute health care according to merit, societal contribution, or even ability to pay. Another version of the argument from fairness holds that health needs represent departures from normal species functioning and deprive people of fair equality of opportunity. Thus, fairness requires the provision of health care to "maintain, restore, or compensate for the loss of normal functioning" in order to ensure fair equality of opportunity.26 Several committee members expressed concerns that these stated arguments are somewhat weakened by the fact that a number of diseases are not the result of random events, but are brought on or exacerbated by dispensable habits such as cigarette smoking and excessive alcohol ingestion. While our and other societies attempt to discourage such habits by education and taxation, there is general agreement that access to full health care must be ensured once illness develops. If a tendency to abuse alcohol, for example, were to have a genetic predisposition, an additional argument could be made for providing the same level of health care to everyone since a person does not choose his or her genetic propensities. The argument that society should guarantee or provide a decent minimum of health care for all citizens and residents points toward a direction for health policy, but it does not determine exactly how much health care the society should provide relative to other goods it also seeks. And, within the health care budget, there will be difficult allocation questions, including how much should be used for particular illnesses and for particular treatments for those illnesses. Questions of allocation cannot be resolved in the abstract. In democratic societies, they should be resolved through political processes that express the public's will. In specifying and implementing a conception of a decent minimum, an adequate level, or a fair share of health care in the context of scarce resources, as the President's Commission noted in 1983, it is reasonable for a society to turn to fair, democratic political procedures to choose among alternative conceptions of adequate health care, and in view of "the great imprecision in the notion of adequate health care ... it is especially important that the procedures used to define that level be—and be perceived to be—fair."27
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Assessing Genetic Risks: Implications for Health and Social Policy Legal Issues The concept of equity serves as the underpinning for a variety of legal doctrines and statutes. Certain needy people are provided health care, including some genetics services, under government programs such as Medicaid (see Chapter 7). In addition, some legislative efforts have been made to prohibit discrimination based on genotype. For example, some states have statutes prohibiting discrimination in employment based on one's genotype.28 And nearly all people over age 65 are deemed to have a right to care (under Medicare). CURRENT PRACTICE OF PROTECTION IN GENETICS The development of genetic testing has raised numerous concerns about autonomy, confidentiality, privacy, and equity that are exacerbated by the range of contexts in which such tests are undertaken, the sheer volume of tests that could be offered, the many uses that can be made of test results, and the variety of institutions that store genetic information. To date, most genetic testing has been done in the reproductive context or with newborns, to identify serious disorders that currently or soon will affect the fetus or infant. However, the types of genetic conditions or predispositions that can potentially be tested for are much broader than those signaling serious, imminent diseases. These include characteristics (such as sex or height) that are not diseases, potential susceptibility to diseases if the person comes into contact with particular environmental stimuli, and indications that a currently asymptomatic person will suffer later in life from a debilitating disease such as Huntington disease. The genetic anomalies that can be tested for range widely in their manifestations, their severity, their treatability, and their social significance. People's ability to define themselves, to manage their destiny and self-concept, will depend in large measure on the control they have over whether they and others come to know their genetic characteristics. Most medical testing is done within a physician-patient relationship. With genetic testing, however, the potential range of contexts in which it can be undertaken is large. Already, in the public health context, more than 4 million newborns are tested annually for metabolic disorders so that effective treatment can be started in a few hundred. Researchers are inviting people to participate in family studies and undergo genetic testing, including collection of DNA samples for present or future analyses. There are a growing number of nonmedical applications of genetic testing as well. In the law enforcement context, DNA testing is undertaken to attempt to identify criminal offenders. At least 17 states have DNA fingerprint programs for felons.29 The armed services are collecting DNA samples from all members of the military, the primary purpose of which is to identify bodies of deceased soldiers. Employers and insurers may require people to undergo testing for genetic disorders for exclusionary purposes. One challenge for policy posed by this wide array of testing settings is that many of the existing legal
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Assessing Genetic Risks: Implications for Health and Social Policy precedents about autonomy, confidentiality, and privacy apply only to the traditional doctor-patient relationship. For example, some state statutes governing confidentiality deal only with information provided to physicians and might not cover information provided to Ph.D. researchers or employers. There seems to be great variation among institutions and among providers in the amount of attention paid to autonomy, confidentiality, and privacy. For example, some obstetricians recognize the patient's autonomy by providing them the information about maternal serum alpha-fetoprotein (MSAFP) screening but acknowledging the patient's right to decide whether or not to undergo the test. Other obstetricians run the test on blood gathered from the woman for other purposes, so the woman does not even know she has been the subject of the test unless the obstetrician delivers the bad news that she has had an abnormal result. Geneticists differ with respect to the emphasis they place on the confidentiality of the results of genetic testing. In a survey by Dorothy Wertz and John Fletcher,30 numerous geneticists suggested that there were at least four situations in which they would breach confidentiality and disclose genetic information without the patient's permission, even over the patient's refusal: (1) 54 percent said they would disclose to a relative the risk of Huntington disease; (2) 53 percent said they would disclose the risk of hemophilia A; (3) 24 percent said they would disclose genetic information to a patient's employer; and (4) 12 percent said they would disclose such information to the patient's insurer. Primary care physicians may be even more likely to disclose such information.31 Health care providers should explain their policies for disclosure in advance, including for disclosure to relatives. Institutions that store DNA samples32 or store the results of genetic tests also differ in the amount of respect they give to autonomy, confidentiality, and privacy.33 Some institutions do additional tests on DNA samples without the permission of the person who provided the sample. Some share samples with other institutions. Some store samples or information with identifiers attached, rather than anonymously. Indeed, storage conditions themselves differ widely. Some newborn screening programs store filter papers in a temperature-controlled, secure setting; others merely pile them in a file cabinet or storage closet. Programs also differ in the length of time the sample or the test results are maintained. Once DNA material has been submitted, there are few safeguards concerning other present or future uses that may be made of the material. DNA from the blood spots collected for newborn screening can now be extracted for further testing.34 No standards or safeguards currently exist to govern the appropriate use of DNA analysis and storage from newborn screening tests. These possibilities raise questions about the need to obtain consent for additional and subsequent uses (particularly since consent is almost never obtained initially in newborn screening), as well as questions about the duty to warn if disorders are detected in the blood by using the new DNA extraction testing techniques. The issue of confidentiality of genetic information will be underscored with
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Assessing Genetic Risks: Implications for Health and Social Policy the introduction of ''optical memory cards," a credit card-sized device that stores medical information.35 These cards have already been introduced for use in Houston city health clinics. There is sufficient computer memory on the cards to include genetic information about the person and, in the future, to include a person's entire genome. Congressional legislation has been introduced that would require all patients to use optical memory cards. This bill, the Medical and Health Insurance Information Reform Act of 1992, would mandate a totally electronic system of communication between health care providers and insurers. Such a system would be based either on the optical memory card (with a microchip capable of storing data) or on a card similar to an Automated Teller Card (which simply provides access to data stored elsewhere). APPLYING THE PRINCIPLES TO GENETIC TESTING The principles of autonomy, privacy, confidentiality, and equity place great weight on individuals' rights to make personal decisions without interference. This is due, in part, to the importance placed on individuals in our culture and our legal system. However, individual rights are not without bound, and the area of genetics raises important questions of where individual rights end and where responsibilities to a group—such as one's family or the larger society—begin. Medicine is generally practiced within this culture of individual rights (with provisions for patients' right to refuse treatment and right to control the dissemination of medical information about themselves), but there have been circumstances in which the medical model has been supplanted by the public health model, which encourages the prevention of disease—for example, by requiring that certain medical intervention (such as vaccinations) be undertaken and by warning individuals of health risks (e.g., through educational campaigns against smoking or through contact tracing with respect to venereal diseases). Some commentators have suggested that the public health model be applied to genetics,36 with mandatory genetic screening and even mandatory abortion of seriously affected fetuses. A related measure might be warning people of their risk of genetic disorders. There are several difficulties with applying the public health model to genetics, however. Certain infectious diseases potentially put society as a whole at immediate risk since the diseases can be transmitted to a large number of people in a short time. The potential victims are existing human beings who may be total strangers to the affected individual. In contrast to infectious disease, the transmission of genetic diseases does not present an immediate threat to society. Whereas infectious disease can cause rapid devastation to a community, the transmission of genetic disorders to offspring does not necessarily have an immediate detrimental effect, but rather creates a potential risk for a future generation in society.37 U.S.
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Assessing Genetic Risks: Implications for Health and Social Policy Supreme Court cases dealing with fundamental rights have held that harm in the future is not as compelling a state interest as immediate harm.38 Moreover, the very concept of "prevention" does not readily fit most genetic diseases. In the case of newborn screening for PKU, treatment can prevent mental retardation. However, with many genetic diseases today, the genetic disease itself is not being prevented, but rather the birth of a particular individual with the disease is prevented (e.g., when a couple, each of whom is heterozygous for a serious recessive disorder, chooses not to conceive or chooses to terminate the pregnancy of a fetus who is homozygous for the disorder). This sort of prevention cannot be viewed in the same way as preventing measles or syphilis, for example. There is a great variation among people in their view of disability and what constitutes a disorder to be "prevented." Many people will welcome a child with Down syndrome or cystic fibrosis into their family. In addition, some individuals have religious or other personal moral objections to abortion; even mandatory carrier status screening or prenatal screening without mandatory abortion may be objected to because people who object to abortion are concerned that the abortion rate will rise among those in the general population who learn of genetic risks to their fetus. Furthermore, some people with a particular disability or genetic risk may view mandatory genetic testing for that risk or disability as an attempt to eradicate their kind, as a disavowal of their worth. Mandatory genetic testing might also have devastating effects on the individuals who are tested. Unlike infectious disease (which can be viewed as external to the person), genetic disease may be viewed by people as an intractable part of their nature. Persons who learn, against their will, that they carry a defective gene may view themselves as defective. This harm is compounded if they did not choose to learn the information voluntarily. This assault on personal identity is less likely with infectious diseases, although AIDS and genital herpes (for example) can also have a negative impact on self-image. Moreover, most genetic defects, unlike most infectious diseases, generally cannot now be corrected.39 Thus, the unasked-for revelation that occurs through mandatory genetic testing can haunt the person throughout his or her life and can have widespread reverberations in the family, including others who may be at risk or related as partners. The information can serve as the basis for discrimination against the individual. Additionally, policy concerns raised by attempts to stop the transmission of genetic diseases differ from those addressed to infectious diseases because genetic diseases may differentially affect people of different races or ethnic backgrounds. For that reason, some commentators contest the applicability of the infectious disease model to government actions regarding genetic disorders. Catherine Damme notes that "unlike infectious disease which [generally] knows no ethnic, racial, or gender boundaries, genetic disease is the result of heredity"—leaving open the possibility for discriminatory governmental actions.40 The government has discretion with respect to which infectious diseases it tackles. For example, it can decide to require screening for syphilis but not
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Assessing Genetic Risks: Implications for Health and Social Policy relative, or other third party—for example, to an employer—those circumstances should be explained in advance of testing; and, if the patient wishes, the patient should be given the opportunity to be referred to a health care provider who will protect confidentiality. On a broader scale, the committee recommends that: all forms of genetic information be considered confidential and not be disclosed without the individual's consent (except as required by law), including genetic information that is obtained through specific genetic testing of a person as well as genetic information about a person that is obtained in other ways (e.g., physical examination, knowledge of past treatment, or knowledge of a relative's genetic status); confidentiality of genetic information should be protected no matter who obtains or maintains that information, including genetic information collected or maintained by health care professionals, health care institutions, researchers, employers, insurance companies, laboratory personnel, and law enforcement officials; and to the extent that current statutes do not ensure such confidentiality, they should be amended so that disclosure of genetic information is not required. The committee recommends that codes of ethics of those professionals providing genetics services (such as those of the National Society of Genetic Counselors (NSGC), or of geneticists, physicians, and nurses) contain specific provisions to protect autonomy, privacy, and confidentiality. The committee endorses the NSGC statement of a guiding principle on confidentiality of test results: The NSGC support individual confidentiality regarding results of genetic testing. It is the right and responsibility of the individual to determine who shall have access to medical information, particularly results of testing for genetic conditions.125 The committee also endorses the principles on DNA banking and DNA data banking contained in the 1990 ASHG statement. To further protect confidentiality, the committee recommends that patients' consent be obtained before the patient's name is provided to a genetic disease registry and that consent be obtained before information is redisclosed; each entity that receives or maintains genetic information or samples have procedures in place to protect confidentiality, including procedures limiting access on a need-to-know basis, identifying an individual who has responsibility for overseeing security procedures and safeguards, providing written information to each employee or agent regarding the need to maintain confidentiality,
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Assessing Genetic Risks: Implications for Health and Social Policy and taking no punitive action against employees for bringing evidence of confidentiality breaches to light; any entity that releases genetic information about an individual to someone other than that individual ensure that the recipient of the genetic information has procedures in place to protect the confidentiality of the information; any entity that collects or maintains genetic information or samples separate them from personal identifiers and instead link the information or sample to the individual's name through some form of anonymous surrogate identifiers; the person have control over what parts of his or her medical record are available to which people; if an optical memory card is used, this could be accomplished through a partitioning-off of data on the card; and any individual be allowed access to his or her genetic information in the context of appropriate education and counseling, except in the early research phases during the development of genetic testing when an overall decision has been made that results based on the experimental procedure will not be released and the subjects of the research have been informed of that restriction prior to participation. Discrimination in Insurance and Employment In general, the committee recommends that principles of autonomy, privacy, confidentiality, and equity be maintained, and the disclosure of genetic information and the taking of genetic tests should not be mandated. Such a position, however, is in conflict with some current practices in insurance and employment. Although more than half the U.S. population (approximately 156 million people) is covered by some kind of life insurance,126 the use of genetic information in medical underwriting127 decisions about life insurance appears to raise different and somewhat lesser concerns than the use of genetic information in health insurance underwriting. More of life insurance has historically been medically underwritten. Complaints of genetic discrimination in life insurance have been made.128 Apparently, fewer Americans believe that life insurance is a basic right. In contrast, the Canadian Privacy Commission believes that life insurance is a basic right, and recommends that Canadians be permitted to purchase up to $100,000 in basic life insurance without genetic or other restrictions; underwriting for larger amounts of life insurance could be subject to a variety of life-style and health restrictions, including the use of genetic information.129 Most of the committee agrees with the spirit of the Canadian Commission's recommendation that a limited amount of life insurance be available to everyone without regard to health or genetic status. However, health insurance was considered a much more pressing ethical, legal, and social issue.
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Assessing Genetic Risks: Implications for Health and Social Policy The committee recommends that legislation be adopted so that medical risks, including genetic risks, not be taken into account in decisions on whether to issue or how to price health care insurance. Because health insurance differs significantly from other types of insurance in that it regulates access to health care, an important social good, risk-based health insurance should be eliminated. A means of access to health care should be available to every American without regard to the individual's present health status or condition, including genetic makeup. Any health insurance reform proposals need to be evaluated to determine their effect on genetic testing and the use of genetic information in health insurance (see Chapter 7). The committee recommends that the unfair practices highlighted by the McGann case be prevented. Such situations could be eliminated by Congress in three ways. First, the antidiscrimination provision of the Employee Retirement Income Security Act (ERISA, see Chapter 7), section 510, could be amended to prohibit various types of employer conduct. For example, the legislation could prohibit: (1) the alteration of benefits or the alteration of benefits without a certain notice period; (2) the reduction of coverage for only a single medical condition; (3) the reduction of benefits after a claim for benefits already had been submitted, and so forth. At the very least, the committee recommends that an amendment be adopted making those practices illegal. A second way of legislatively preventing McGann-type situations would be to amend the ERISA preemption provision, section 514. By amending this section to limit the preemptive effect of ERISA (e.g., that permits ERISA provisions to override state insurance regulations) or to eliminate ERISA preemption entirely, the result would be to allow the states to regulate self-insured employer benefits in the same way that state insurance commissions regulate commercial health insurance benefits. Although state regulation may be preferable to no regulation, it could lead to the burdensome multiplicity of state regulations that ERISA was intended to eliminate. For this reason, the committee believes that federal prohibition of the type of conduct in the McGann case would be preferable. A third way to eliminate discrimination in employee health benefits by selfinsured employers would be to amend section 501 of the ADA. The ADA is essentially neutral on the issue of health benefits; clauses on preexisting conditions, medical underwriting, and other actuarially based practices, to the extent permitted by state law, do not violate the ADA. Thus, the ADA could be amended to prohibit differences in health benefits that result in discrimination against individuals with disabilities. Amending the ADA in this manner would, in effect, mandate uniform coverage (although it is not clear what conditions would be covered) at community rates for employees. If Congress wanted to mandate that all employers offer a package of health benefits, a good argument could be made that it ought to do so separately and not via amendments to the ADA. The committee recommends that legislation be adopted so that genetic information cannot be collected on prospective or current employees unless it
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Assessing Genetic Risks: Implications for Health and Social Policy is clearly job related. Sometimes employers will have employees submit to medical exams to see if they are capable of performing particular job tasks. The committee recommends that if an individual consents to the release of genetic information to an employer or potential employer, the releasing entity should not release specific information, but instead answer only yes or no regarding whether the individual was fit to perform the job at issue. The committee recommends that the EEOC recognize that the language of the Americans with Disabilities Act provides protection for presymptomatic people with a genetic profile for late-onset disorders, unaffected carriers of disorders that might affect their children, and people with genetic profiles indicating the possibility of increased risk of a multifactorial disorder. The committee also recommends that state legislatures adopt laws to protect people from genetic discrimination in employment. In addition, the committee recommends an amendment to the ADA (and adoption of similar state statutes) limiting the type of medical testing employers can request or the medical information they can collect to that which is job related. Ultimately, new laws on a variety of other topics may also be necessary to protect autonomy, privacy, and confidentiality in the genetics field, and to protect people from inappropriate decisions based on their genotypes.130 The ability of genetics to predict health risks for asymptomatic individuals and their potential offspring presents challenges in the ethical and social spheres. The committee recommends that careful consideration be given to the development of policies for the implementation of genetic testing and the handling of genetic test results. NOTES 1. March of Dimes Birth Defects Foundation, Genetic Testing and Gene Therapy: National Survey Findings 18 (September 1992). New York. 2. See, e.g., Satz v. Perlmutter, 362 So.2d 160 (Fla. App. 1978) aff'd 379 So.2d 359 (Fla. 1980). 3. See, e.g., Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 154 Cal. App. 2d 560, 317 P.2d 170 (1957); Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert. denied, 409 U.S. 1064 (1972). 4. Gates v. Jensen, 92 Wash.2d 246, 595 P.2d 919 (1979). 5. Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 154 Cal. App. 2d 560, 317 P.2d 170 (1957). 6. Kogan v. Holy Family Hospital, 95 Wash.2d 306, 622 P.2d 1246 (1980). 7. See, e.g., Becker v. Schwartz, 46 N.Y.2d 401, 386 N.E.2d 807, 413 N.Y.S.2d 895 (1978). For a review of relevant cases, see Lori B. Andrews, ''Torts and the Double Helix: Liability for Failure to Disclose Genetic Risks," 29 U. Houston L. Rev. 143 (1992). 8. L. Andrews, "My Body, My Property," 16(5) Hastings Center Report 28 (1986). See also Moore v. Regents of the University of California. 9. The federal regulations governing informed consent in the context of human experimentation provide that informed consent is not necessary for research on pathological or diagnostic specimens "if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects." 45 C.F.R. § 46.101(b)(5) (1991). Similarly, some state human experimentation laws do not seem to extend their coverage to
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Assessing Genetic Risks: Implications for Health and Social Policy research on removed parts. In Virginia, for example, the law does not cover "the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice." Va. Code Ann. § 37.1-234(1) (1984). Under the New York law, human research is defined to exclude "studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice." N.Y. Public Health Law § 2441(2) (McKinney 1977). 10. Office of Technology Assessment (OTA), U.S. Congress, Human Gene Therapy 72 (Washington, D.C.: U.S. Government Printing Office, 1984). 11. Ferdinand D. Schoeman, "Privacy: Philosophical Dimensions of the Literature," in Philosophical Dimensions of Privacy: An Anthology, ed., Ferdinand D. Schoeman (New York: Cambridge University Press, 1984). 12. See Judith Jarvis Thomson, "The Right to Privacy," Philosophy and Public Affairs 4(summer):315-333, (1975). 13. See, e.g., Griswold v. Connecticut, 381 U.S. 479 (1965); Roe v. Wade, 410 U.S. 113 (1973); Planned Parenthood v. Casey,__U.S.__, , 112 S.Ct. 2791 (1992). 14. Lifchez v. Hartigan, 735 F. Supp. 1361 (N.D. III. 1991), affd without opinion sub. nom.; Scholber v. Lifchez, 914 F.2d 260 (7th Cir. 1990), cert. denied, 111 S.Ct. 787 (1991). 15. Carter v. Broadlawn Medical Center, 667 F. Supp. 1269, 1282 (S.D. Iowa 1987). In that case, the court held that the privacy of patient records in a county hospital is protected by the Fourteenth Amendment's concept of personal liberty. See also Whalen v. Roe, 429 U.S. 589, 599 n. 23 (1977). 16. Horne v. Patton, 291 Ala. 701, 287 So.2d 824 (1973); MacDonald v. Clinger, 84 A.D.2d 482, 444 N.Y.S.2d 801 (1982). 17. Privacy Act of 1974, 5 U.S.C. § 552a (1991). 18. For further discussion of these arguments (and others in this section), see Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 3rd ed. (New York: Oxford University Press, 1989, chap. 7). 19. Mark Siegler, "Confidentiality in Medicine—A Decrepit Concept," N. Engl. J. Med. 307:1518-1521 (1982). 20. Research has found that people who are told that their answers would not be confidential provide less intimate information. Woods and McNamara, "Confidentiality: Its Effect on Interviewee Behavior," 11 Prof. Psychology 714, 719 (1980). 21. See, e.g., Horne v. Patton, 291 Ala. 701, 287 So.2d 824 (1973); MacDonald v. Clinger, 84 A.D.2d 482,444 N.Y.S.2d 801 (1982). See W. Prosser and W.P. Keeton, Prosser and Keeton on Torts 856-863 (1984). See also S. Newman, "Privacy in Personal Medical Information: A Diagnosis," 33 U. Fla. L. Rev. 394-424 (1981). According to the latter article, the tort of invasion of privacy has been rejected only in Rhode Island, Nebraska and Wisconsin. Id. at 403. However, two of these states now recognize it by statute. R.I. Gen. Laws § 9-1-28 (1984); Wisc. Stat. § 895.50 (1985-86). 22. Norman Daniels, "Insurability and the HIV Epidemic: Ethical Issues in Underwriting," 68 The Milbank Quarterly 497-515 (1990). See also Mark A. Rothstein, "The Use of Genetic Information in Health and Life Insurance." In Friedman, T. (ed.) Molecular Genetic Medicine (New York: Academic Press, 1993). 23. On the natural lottery, see H. Tristram Engelhardt, Jr., Foundations of Bioethics (New York: Oxford University Press, 1986). 24. Id. 25. See Gene Outka, "Social Justice and Equal Access to Health Care," Journal of Religious Ethics 2 (1974). See also President's Commission for the Study of Ethical Problems in Biomedical and Behavioral Research, Securing Access to Health Care, Vol. 1: Report (Washington, D.C.: U.S. Government Printing Office, 1983). 26. Normal Daniels, "Equity of Access to Health Care: Some Conceptual and Ethical Issues," Milbank Memorial Fund Quarterly/Health and Society 60 (1982). See also Norman Daniels, Just Health Care (New York: Cambridge University Press, 1985).
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Assessing Genetic Risks: Implications for Health and Social Policy 27. President's Commission for the Study of Ethical Problems in Biomedical and Behavioral Research, Securing Access to Health Care, Vol. 1: Report (Washington, D.C.: U.S. Government Printing Office, 1983), p. 42. 28. Rothstein, "Genetic Discrimination in Employment and the American with Disabilities Act," 29 Houston L Rev. 23, 31 (1992). See also the discussion infra in this chapter, "Discrimination." 29. Office of Technology Assessment (OTA), U.S. Congress, Genetic Witness: Forensic Uses of DNA Tests (Washington, D.C.: U.S. Government Printing Office, 1990). 30. D. C. Wertz and J.C. Fletcher, Ethics and Human Genetics: A Cross-Cultural Perspective (New York: Springer-Verlag, 1989); and D.C. Wertz and J.C. Fletcher, "An International Survey of Attitudes of Medical Geneticists Toward Mass Screening and Access to Results," 104 Public Health Reports 35-44 (1989). 31. G. Geller, E. Tambor, G. Chase, K. Hofman, R. Faden, N. Holtzman. "How Will Primary Care Physicians Incorporate Genetic Testing: Directiveness in Communication," 31 Medical Care 625-631 (1993). 32. There are several reasons why institutions store DNA samples, rather than just information from samples. The first is for future potential clinical benefit, such as when a new test may be developed that could provide a more accurate diagnosis. The second is for litigation purposes, so that the sample can be retested if the results are challenged. The third is for research purposes, to use the DNA for the development of additional tests. 33. Philip Reilly, Presentation to Ethical, Legal, and Social Implications Program Committee, January 1991. 34. Yoichi Matsubara, Kuniaki Narisawa, Keiya Tada, Hiroyuki Ikeda, Yao Ye-Qi, David M. Danks, Anne Green, Edward R.B. McCabe, "Prevalence of K329E Mutation in Medium-Chain AcylCoA Dehydrogenase Gene Determined from Guthrie Cards," 338 Lancet 552-553 (1991). 35. Joe Abernathy, "City Health Clinics Unveil Controversial 'Smart Card'," Houston Chronicle, October 11, 1992, sec. A, p. 1. 36. See, e.g., M. Shaw, "Conditional Prospective Rights of the Fetus," 5 J. Legal Med. 63 (1989). 37. Moreover, it should be noted that this risk (transmission of genetic disease to offspring) is one that society has always lived with, and seems to have flourished despite that risk. 38. For example, in The New York Times v. United States, 403 U.S. 713 (1971), the U.S. Supreme Court, in a per curiam opinion held that the government had not met its "heavy burden" of proving that national security required that the Pentagon Papers be suppressed. The logic of the case was explained further in the concurrences; the right of free speech is to be infringed by a prior restraint only when disclosure "will surely result in direct, immediate, and irreparable damage to our Nation or its people." Id. at 730 (Stewart, J., concurring). Or when there is "governmental allegation and proof that publication must inevitably, directly, and immediately cause the occurrence of an event kindred to imperiling the safety of a transport already at sea ..." during wartime. Id. at 726-727 (Brennan, J., concurring). The standard of irreparability for granting an injunction against protected speech is an absolute, not a comparative standard. Even if the speech could cause great harm, that would not be sufficient. As Justice White pointed out in his concurrence in New York Times, it is not sufficient that there may be "substantial damage to public interests." Id. at 731 (White, J., concurring). Similarly, Justice Stewart said "I am convinced that the Executive is correct with respect to some of the documents involved [i.e., they should not, in the national interest, be published]. But I cannot say that disclosure of any of them will surely result in direct, immediate, and irreparable harm to our Nation or its people. That being so, there can under the First Amendment be but one judicial resolution of the issue before us." Id. at 730 (White, J., concurring). Even if irreparable harm were a possibility, New York Times indicates that an injunction should not be issued against the press unless such harm would come about directly and immediately. The term "immediately" is easy enough to understand; it requires a present, not future, harm. The term "directly" relates to the lack of intervening influences during that time period. The irreparable harm would not occur directly if another important influence would or could intervene. Another way of
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Assessing Genetic Risks: Implications for Health and Social Policy expressing the immediacy and directness that is necessary is by saying the harm is "inevitable"—it will occur within a short period of time during which nothing will or could change it or stop it. Even when a prior restraint is not at issue, high standards are required for showing a compelling state interest when a fundamental right is at issue. Also in the First Amendment area, speech that is not false should not be the basis for subsequent punishment unless it provided an immediate threat of serious harm. (See, e.g., Bridges v. California, 314 U.S. 252, 263 (1941) ("the substantial evil must, be extremely serious and the degree of imminence extremely high before utterances can be punished").) 39. AIDS, of course, is an infectious disease that cannot be cured and that is strongly identified with certain minority groups (e.g., homosexuals). It is interesting to note that for many of the same reasons that are applicable to mandatory genetic screening, mandatory AIDS screening has not been adopted. Instead, anonymous voluntary screening has been the model. 40. C. Damme, "Controlling Genetic Disease Through Law," 15 U. Cal. Davis L. Rev. 801, 807 (1982). 41. Such charges were leveled by blacks when mandatory sickle cell carrier screening was put into place. 42. L. Andrews, Medical Genetics: A Legal Frontier 233 (1987). 43. A. G. Motulsky, "The Significance of Genetic Disease," 59, 61 in B. Hilton, D. Callahan, M. Harris, P. Condliffe, B. Berkley, eds., Ethical Issues in Human Genetics: Genetic Counseling and the Use of Genetic Knowledge (Fogarty International Proceedings No. 13, 1973). 44. Statement of D. Brock in B. Hilton et al., eds., id. at 90. 45. The idea of choosing by category was discussed by Alta Charo, J.D., at the committee's June 1992 workshop. 46. e.g., Cobbs v. Grant, 8 Cal.3d 829, 104 Cal. Rptr. 505, 502 P.2d 1, 12 (1972). Some states' informed consent statutes explicitly recognize a right to refuse information. Alaska Stat. § 09.55.556(b)(2) (1983); Del. Code Ann. tit. 18, § 6852(b)(2) (Supp. 1984); N.H. Rev. Stat. Ann. § 507-C:2(II)(b)(3) (1983); N.Y. Public Health Law § 2805-d(4)(b) (McKinney 1985); Or. Rev. Stat. § 677.097(2) (1985); Utah Code Ann. § 78-14-5(2)(c) (1977); Vt. Stat. Ann. tit. 12, § 1909(c)(2) (Supp. 1991); Wash. Rev. Code Ann. § 7.70.060(2) (Supp. 1991). 47. Prince v. Massachusetts, 321 U.S. 158, 170 (1944). 48. In re Green, 448 Pa. 338, 292 A.2d 387, 392 (1972). See also Brown and Truit, "The Right of Minors to Medical Treatment," 28 DePaul L. Rev. 289, 299 (1979). 49. Jehovah's Witnesses v. King County Hospital 278 F. Supp. 488 (W.D. Wash. 1967), 390 U.S. 598 (1968), denied, 391 U.S. 961 (1968). 50. D.C. Code Ann. § 6-314(3) (1989); Md. Health-Gen. Code Ann. § 13-102(10) and 109(e)(f) (1982). 51. Iowa Admin. Code § 641-4.1 (136A) (1992); Mich. Comp. Laws Ann. § 333.5431(1) (West 1992); Mont. Code Ann. § 50-19-203(1) (1991); W. Va. Code Ann. § 16-22-3 (Supp. 1992). 52. Mo. Ann. Stat. § 191.331(5) (Vernon 1990); S.C. Code § 44-37-30(B) (1991). 53. Council of Regional Networks for Genetic Services (CORN), Newborn Screening: 1990, Final Report (February 1992). New York. 54. R. R. Faden, A. J. Chwalow, N. A. Holtzman, and S. Horn, "A Survey to Evaluate Parental Consent As Public Policy for Neonatal Screening," 72 Am. J. Pub. Health 1347 (1982). 55. "Consensus Statement Proposed for Routine Newborn Genetic Screening." Based on October 1989 conference in Quebec, Canada. Reported in Bartha Maria Knoppers and Claude M. LaBerge (eds.), "Genetic Screening: From Newborns to Data Typing," Excerpta Medica 382 (1990). 56. Currently, Colorado and Wyoming include cystic fibrosis testing as a part of their mandatory newborn screening program; Wisconsin includes cystic fibrosis in newborn screening as part of an experimental research protocol. 57. Neil A. Holtzman, "What Drives Neonatal Screening Programs," 325 New Engl. J. Med. 802809 (Sept. 12, 1991), referring to K.B. Hammond, S.H. Abman, R.J. Sokol, F.J. Accurso, "Efficacy of
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Assessing Genetic Risks: Implications for Health and Social Policy Statewide Newborn Screening for Cystic Fibrosis by Assay of Trypsinogen Concentration, 325 New Engl. J. Med. 769-74 (1991). 58. Id. 59. Id., citing P. Farrell, personal communication. 60. Norm Fost presentation, June 1992 committee workshop. 61. Statement of Claude LaBerge at June 1992 committee meeting. 62. See T. McNeil, B. Harty, T. Thelin, E. Aspergren-Jansson, T. Sveger, "Identifying Children at High Somatic Risk: Long-Term Effects on Mother-Child Interactions," Acta-Psychiatrica Scandinavica 74(6):555-562 (December 1986). 63. Ellen Wright Clayton, "Screening and Treatment of Newborns," 29 Houston L. Rev. 85 (1992). 64. The federal regulations governing informed consent in the context of human experimentation provide that informed consent is not necessary for research on pathological or diagnostic specimens "if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects." 45 C.F.R. § 46.101(b)(4)(1991). Similarly, some state human experimentation laws do not seem to extend their coverage to research on removed parts. In Virginia, for example, the law does not cover "the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice." Va. Code Ann. § 37.1-234(1) (1990). Under the New York law, human research is defined to exclude "studies exclusively utilizing tissue or fluids after removal or withdrawal from a human subject in the course of medical practice." Some researchers argue that blood and urine left over after a patient's tests are done should be available without requiring the patient's informed consent. However, the issue is not as straightforward as it might seem. Research surreptitiously done on a patient's blood might generate information that could be damaging to the patient. If a cystic fibrosis test were being developed with excess blood from a PKU test, and the blood tested positive for cystic fibrosis, it could be argued that, depending on how reliable the test seemed, the infant's parents should be informed. But if the result ultimately turned out to be a false positive, the family may have been harmed by unnecessary worry. With respect to research on leftover blood from adults, if testing is being developed for a potentially stigmatizing disorder (such as AIDS) or a disorder that might influence employment or other opportunities for the person (such as Huntington disease) the risks to the patient if confidentiality were compromised might be so high that it would seem unethical not to solicit the individual's consent before the research is undertaken. 65. ASHG Ad Hoc Committee on Individual Identification by DNA Analysis, "Individual Identification by DNA Analysis: Points to Consider," Am. J. Hum. Genet. 46:631-634 (1990). 66. Id. at 632. 67. Nancy Wexler, "The Tiresias Complex: Huntington's Disease as a Paradigm of Testing for Late-Onset Disorders," FASEB Journal 6:2820-2825 (1990). 68. See, e.g., Skillings v. Allen, 143 Minn. 323, 173 N.W. 663 (1919); Davis v. Rodman, 147 Ark. 385, 227 S.W. 612 (192 1). For a more recent case, regarding a duty to warn third parties of communicable diseases, see Gammill v. U.S., 727 F.2d 950 (10th Cir. 1984). 69. Tarasoffv. Regents of the University of California, 131 Cal. Rptr. 14, 17 Cal. App. 3d 425, 551 P.2d 334 (1976). 70. Id. 71. Collins v. Howard, 156 F. Supp. 322, 325 (S.D. Ga. 1957) (dicta). 72. The individual generally asks that his or her spouse be informed as well. Statement of J. Lejeune in B. Hilton, D. Callahan, M. Harris, P. Condliffe, B. Berkeley, eds., Ethical Issues in Human Genetics: Genetic Counseling and the Use of Genetic Knowledge, 70 (Fogarty International Proceedings No. 13, 1973). In a March of Dimes-sponsored national public opinion survey, 71 percent of respondents said that if a doctor of a woman who plans to have children finds through testing that her children might
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Assessing Genetic Risks: Implications for Health and Social Policy inherit a serious or fatal genetic disease, the doctor has an obligation to tell her husband. March of Dimes Birth Defects Foundation, Genetic Testing and Gene Therapy: National Survey Findings 7 (New York, September 1992). However, in some instances, an individual may or may not want personal genetic information disclosed to his or her spouse. 73. Berry v. Moensch, 8 Utah 2d 191, 331 P.2d 814 (1958); Curry v. Corn, 52 Misc.2d 1035, 277 N.Y.S.2d 470 (1966) (during marriage, each has the right to know the existence of any disease that may have bearing on the marital relation). 74. See, e.g., Simonsen v. Swenson 104 Neb. 224, 177 N.W. 831 (1920). 75. The man whose nonpaternity is shown through prenatal screening might argue that, in addition to its relevance to his future childbearing plans, the information that he is not the father of his wife's child has an immediate financial implication since he might not wish to support the child. However, state paternity statutes preserve that a child born during a marriage is the husband's child and require him to support the child, even if it could conceivably be shown through genetic testing that he was not the biological father of the child. The logic behind such cases is that there is a societal interest in the integrity of the family. 76. Eisenstadt v. Baird, 405 U.S. 438 (1972). 77. Planned Parenthood v. Danforth, 428 U.S. 52 (1976). 78. Planned Parenthood v. Casey,__ U.S. , 112 S.Ct. 2791 (1992). 79. Id. 80. If a patient is the carrier of the gene for a serious autosomal recessive disorder, his or her relatives might also argue that they would be harmed by not knowing that they, too, are at risk of having children with that disorder. However, the risk to future offspring may be too remote to warrant breaching confidentiality, as it is in the case of a spouse. 81. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Screening and Counseling for Genetic Conditions 6 (1983). 82. See, e.g. Simonsen v. Swenson, 104 Neb. 224, 177 N.W. 831 (1920). 83. In one instance, for example, a woman was denied disability insurance when her father's medical records were released to the insurer. 84. Office of Technology Assessment, U.S. Congress, Medical Testing and Health Insurance 73 (1988). 85. S. Rep. 100-360, 100th Cong., 1st Sess. 20 (1988). 86. Report of Committee on Employer-Based Health Benefits, citing Seeman (1993). 87. McGann v. H. & H. Music Co., 946 F.2d 401 (5th Cir. 1991 ), cert. denied sub nom.; Greenberg v. H. & H. Music Company,__U.S.__ 112 S.Ct. 1556 (1992). 88. Eric Zicklin, "More Employers Self-Insure Their Medical Plans, Survey Finds," Business and Health 74 (April 1992). 89. Mark Rothstein, "The Use of Genetic Information in Health and Life Insurance," in Molecular Genetic Medicine, ed., Ted Friedman (New York: Academic Press, 1993). 90. According to American Healthline, Briefing on Health Insurance, November 17, 1992, more than half of Americans would not accept a job that did not provide health insurance. 91. "EEOC Said Ready to 'Fast Track' Complaints of Insurance Caps under Title I of the ADA," 7 No. 18 AIDS Policy & Law 1-2 (October 2, 1992). 92. N. Kass, "Insurance for the Insurers," Hastings Center Report, 6-11 (November-December 1992). 93. Institute of Medicine (IOM), National Academy of Sciences, M. Field and D. H. Shapiro (eds.) Employment and Health Benefits: A Connection at Risk. Committee on Employer-Based Health Insurance (Washington, D.C.: National Academy Press, 1993). 94. OTA, 1992a, p. 180. 95. OTA, 1992b. 96. See, e.g., P.R. Billings, M.A. Kohn, M. de Cuevas, J. Beckwith, J.S. Alper, M.R. Natowicz, "Discrimination as a Consequence of Genetic Testing," 50 Am. J. Hum. Genet. 476-482 (1992).
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Assessing Genetic Risks: Implications for Health and Social Policy 97. U.S. Congress, Office of Technology Assessment, Cystic Fibrosis and DNA Tests: Implications of Carrier Screening (Washington, D.C.: U.S. Government Printing Office, 1992a). 98. The disorders included adult polycystic kidney disease, Huntington disease, neurofibromatosis, Marfan syndrome, Down syndrome, Fabray disease. 99. The conditions included a balanced translocation. 100. The disorder was cystic fibrosis. 101. Kass, 1992. 102. Id. at 10. 103. Report of Institute of Medicine Committee on Employer-Based Health Benefits. 104. See Kass, 1992 for descriptions of these plans. 105. P. Reilly, Genetics, Law and Social Policy 62-86 (Cambridge, Mass.: Harvard University Press, 1977). 106. Fla. Stat. Ann. § 626.9706(1) (West 1984); La. Rev. Stat. Ann. § 22:652.1(D) (West Supp. 1992). 107. 22 Fla. Stat. Ann. § 626.9707(1) (West 1984); La. Rev. Stat. Ann. § 22:652. 1(D) (West Supp. 1992). 108. Fla. Stat. Ann. § 626.9706(2) (West 1984) (life insurance), § 626.9707(2) (West 1984) (disability insurance); La. Rev. Stat. Ann. § 22:652.1(D) (West Supp. 1992). 109. This same law appears in three places in the Florida statutes: Fla. Stat. Ann. § 448.076 (West 1981); § 228.201 (West Supp. 1989); and § 63.043 (West 1985). 110. Fla. Stat. Ann. § 448.075 (West 1981); N.C. Gen. Stat. § 95-28. 1(1989); La. Rev. Stat. Ann. § 23:1002(A) (West 1985). 111. La. Rev. Stat. Ann. § 23:1002(C)(I) (West 1985). 112. Cal. Ins. Code § 10143 (West Supp. 1992). 113. 1991 Wisc. Act 269, codified as Wisc. Stat. Ann. § 631.89. 114. Council on Ethical and Judicial Affairs, "Use of Genetic Testing by Employers," 266 JAMA 1827 (1991). 115. Id. at 1828. 116. Id. at 1828. 117. N.J. Stat. Ann. § 10:5-12(a) (West Supp. 1992). 118. N.Y. Civ. Rights Law § 48 (McKinney 1992). 119. 1992 Iowa Legis. Serv. 93 (West); Or. Rev. Stat. § 659.227 (1991); 1991 Wis. Laws 117. 120. 104 Stat. 327 (1991). For sections of the Americans With Disabilities Act relating to employment, see 42 U.S.C.A. § 12101-12117 (Supp. 1992). 121. L. Gostin and W. Roper. "Update: The Americans with Disabilities Act," Health Affairs 11(3):248-258. 122. Alaska Stat. § 18.80.220(a)(1) (1991); Cal. Gov't Code § 12940(d) (West Supp. 1991); Colo. Rev. Stat. § 24-34-402(1)(d) (1988); Kan. Stat. Ann. § 44-1009(a)(3) (Supp. 1991); Mich. Comp. Laws Ann. § 37.1206(2) (West 1985); Minn. Stat. Ann. § 363.02(1)(8)(i) (West Supp. 1991); Mo. Ann. Stat. § 213.055.1(1)(3) (Vernon Supp. 1992); Ohio Rev. Code Ann. § 4112.02(E)( 1) (Anderson 1991); 43 Pa. Cons. Stat. Ann. § 955(b)(1) (1991); R.I. Gen. Laws § 28-5-7(4)(A) (Supp. 1991); Utah Code Ann. § 34-35-6(1)(d) (Supp. 1991). 123. Office of Technology Assessment (OTA), U.S. Congress, Genetic Screening in the Workplace, OTA-BA-456 (Washington, D.C.: U.S. Government Printing Office, 1990). 124. See, e.g., Simonsen v. Swenson, 104 Neb. 224, 177 N.W. 831 (1920); Tarasoff v. Regents of the University of California, 131 Cal. Rptr. 14, 17 Cal. App. 3d 425, 551 P.2d 334 (1976). 125. National Society of Genetic Counselors (NSGC), "Guiding Principles," Perspectives on Genetic Counseling (October 1991). 126. American Council on Life Insurance, 1992 Life Insurance Fact Book 19 (1992). 127. Medical underwriting is the evaluation of a person's insurability, usually assessed through a combination of answers to a written questionnaire and physical examination to identify certain condi
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Assessing Genetic Risks: Implications for Health and Social Policy tions determined by medical underwriters (and underwriting manuals) to reduce life expectancy below actuarial norms. Standards for medical underwriting vary substantially by insurance company, and underwriting decisions are considered crucial business decisions by insurers and are thus considered "trade secrets." 128. Paul Billings, "Testimony Before Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations," U.S. House of Representatives, 102nd Congress, July 23, 1992. 129. Canadian Privacy Commission, Genetic Testing and Privacy (Ottawa, 1992). 130. Neil A. Holtzman and Mark A. Rothstein, "Invited Editorial: Eugenics and Genetic Discrimination," 50 Am. J. Hum. Genet. 457-459 (1992).
Representative terms from entire chapter: