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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.

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Institutions that store DNA samples 32 or store the results of genetic tests also differ in the amount of respect they give to autonomy, confidentiality, and privacy. Some share samples with other institutions. Some store samples or information with identifiers attached, rather than anonymously.

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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.

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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 the introduction of ''optical memory cards," a credit card-sized device that stores medical information. 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 , 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. 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.

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. Supreme Court cases dealing with fundamental rights have held that harm in the future is not as compelling a state interest as immediate harm.

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. 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.

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.

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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.

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  7. 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. 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.

    The government has discretion with respect to which infectious diseases it tackles. For example, it can decide to require screening for syphilis but not chlamydia, or to require vaccinations for smallpox but not for diphtheria. Government action with respect to genetic diseases is likely to be regarded much differently, especially with respect to disorders for which an effective treatment does not exist and, consequently, the only medical procedure available is the abortion of an affected fetus.

    Minority groups who have been discriminated against in the past may view a screening program that targets only disorders that occur within their racial or ethnic group as an additional attack, and may view abstention from reproduction or the abortion of offspring based on genetic information as a form of genocide. Those commentators who argue that the infectious disease precedents justify mandatory genetic screening fail to recognize that even in the case of infectious disease, very few medical procedures are mandated for adults.

    Adults are not forced to seek medical diagnosis and treatment even if they have a treatable infectious disease. Laws that required compulsory infectious disease screening prior to marriage e. For example, New York abolished its requirements for premarital gonorrhea and syphilis testing. One of the reasons for the abolition of the requirements was that they were not the most appropriate way to reach the population at risk.

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    Mandating diagnosis and treatment for genetic disorders is particularly problematic when the concept of disease is so flexible. Arno Motulsky has noted that "[t]he precise definition of 'disease' regardless of etiology, is difficult. David Brock similarly noted that most disorders lie between the extremes of Tay-Sachs disease and alkaptonuria; what a physician advises "depends as much on the physician's ethical preconceptions as his medical experience.

    Despite the fact that the public health model does not fit the situation of genetics, the individual rights model should not be seen as absolute. There are certain situations in which the values of autonomy, privacy, confidentiality, and equity should give way to prevent serious harm to others. Determining the exceptions to these general principles is no easy matter, however.

    There may be instances in which harm can be prevented by violating one of these principles, but in which the value of upholding the principles will nonetheless outweigh the chance of averting harm. In each instance, it will be necessary to assess several factors: How serious is the harm to be averted? Is violating one of the principles the best way to avert the harm? What will be the medical, psychological, and other risks of violating the principle?

    What will be the financial costs of violating the principle? The following section addresses the issues raised by the application of these principles—autonomy, privacy, confidentiality, and equity—in the contexts of clinical genetics, other medical practices, genetics research, and so forth. It also provides guidance for determining the appropriate circumstances for exceptions to these principles.

    The chapter concludes with the committee's recommendations on these issues. One important way to ensure autonomy with respect to genetic testing is to provide adequate information upon which a person can make a decision whether or not to undergo testing.

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    A proper informed consent in medicine generally involves the presentation of information about the risks, benefits, efficacy, and alternatives to the procedure being undertaken. In addition, recent cases and statutes have recognized the importance of disclosures of any potential conflicts of interest that the health care professional recommending the test may have, such as a financial interest in the facility to which the patient is being referred.

    In the genetics context, this would include disclosure about equity holdings or ownership of the laboratory, dependence on test reimbursement to cover the costs of counseling, patents, and so forth. It would also include disclosure of any planned subsequent uses of the tissue samples, even if such uses are to be anonymous. Various kinds of information are relevant to people who are attempting to exercise their autonomy by deciding whether or not to undergo genetic testing.

    This includes information about the severity, potential variability, and treatability of the disorder being tested for. If, for example, carrier status testing is being proposed for a pregnant woman or prenatal testing is being proposed for her fetus, she should be told whether the disorder at issue can be prevented or treated, or whether she will be faced with a decision about whether or not to abort see Chapters 2 , 4 , and 5. The proposed informed consent guidelines for research involving genetic testing suggested by the Alliance of Genetic Support Groups provide an excellent starting point for the development of informed consent policies in the genetics area see Chapter 4.

    The potential development of multiplex testing adds another wrinkle to the issue of informed consent for genetic testing. If disorders are tested from the same blood sample, it may be difficult to apply the current model of informed consent in which a health care provider gives information about each disorder and the efficacy of each test to the patient in advance of the testing. The difficulty in applying the traditional mechanisms for achieving informed consent does not provide an excuse for failing to respect a patient's autonomy and need for information, however. New mechanisms may have to be developed to protect these rights.

    It will be possible to have results reported back to the physician and patient only about those tests or types of tests the patient chooses. The choices can be made by the patient, based, for example, on the patient learning through a computer program about the various disorders and the various tests. Or the choices can be made according to general categories—for example, the patient might choose to have multiplex testing but choose not be informed of the results of testing for untreatable or unpreventable disorders 45 see Chapters 1 , 3 , and 4.

    In addition to the recognition that people are entitled to information before they make decisions, a second application of the autonomy principle comes with the recognition that the decision to participate in genetic testing and other genetics services must be voluntary. Voluntariness has been a recognized principle in past recommendations and practices involving genetics.

    This is in keeping with the recognized right of competent adults to refuse medical intervention, as well as the right to refuse even the presentation of medical information in the informed consent context. Mandating such a test, however, would show insufficient respect for the woman's autonomy and would violate her right to make reproductive decisions. The expansion of available tests fostered by the Human Genome Project will present complicated issues with respect to the testing of newborns and other children. Although there are clear legal precedents stating that adults are free to refuse even potentially beneficial testing and treatment, legal precedents provide that children can be treated without their consent and over their parents' refusal to prevent serious imminent harm.

    The U. Supreme Court has said that, while parents are free to make martyrs of themselves, they are not free to make martyrs of their children.