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    Cancer Genetics Risk Assessment and Counseling (PDQ®): Genetics - Health Professional Information [NCI] - Ethical, Legal, and Social Implications

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    "Duty to warn": Legal proceedings, federal/state legislation, and recommendations of professional organizations

    "Duty to warn" requires balancing the bioethical constructs of beneficence and autonomy with other factors such as case proceedings, legislation, and professional societies' recommendations. As of September 2008, the National Council of State Legislatures lists the states that have legislation requiring consent to disclose genetic information. The definition of "genetic information" can vary depending on the legal case and the language used in state and federal legislation, and generally includes genetic testing and family history information; however, the definition generally does not apply to current diagnoses. Genetic diagnosis can be done through direct genetic tests (direct mutation analysis) for disorders linked to a specific gene and indirect genetic tests (indirect mutation analysis) for disorders in which the specific genes are not known or there are multiple different genes involved (genetic heterogeneity).[7] There are four state case laws that apply to duty to warn.[8] Two cases deal directly with testing for hereditary cancer predisposition syndromes; one case deals with a psychotherapist's duty to warn a relative of imminent threat, and another with genetic testing as a tool for reproductive decisions. Table 2 summarizes the cases.

    Table 2. State Case Laws That Apply to Duty to Warn

    State Case Law Description Summary
    Tarasoff versus Regents of the University of California[9,10] Establishes moral duty to warn family members of risks unknown to them In 1976, the California court judged that breach of confidentiality would have been justified in order to warn of a foreseeable and serious harm to an identifiable individual.
    Distinct from genetic risk since the mutation is already present (or absent) in family members
    Pate versus Threlkel[8,11,12] Duty to warn family members of hereditary risk of cancer is satisfied by telling the patient to tell his or her family In 1995, the Florida court judged that a physician had a duty to warn the patient that her children were at risk of developing thyroid cancer because the disease could have been detected and cured at an earlier stage.
    Safer versus Estate of Pack[8,13] Physician must take reasonable steps to warn family members of hereditary risk disease In 1996, a New Jersey appellate court defined a physician's duty to warn immediate family members of risk of colon cancer; however, the court ruled in favor of the doctor because the patient had undergone rectal screening as a child, which indicated that she had been warned of the risk.
    Molloy versus Meier[8,14] Physician's duty regarding genetic testing and diagnosis of foreseeable disease risk extends beyond the patient to biological parents In 2004, a Minnesota Supreme Court held that the physician failed to breach confidentiality to warn of hereditary disease risk because he did not inform parents of the diagnosis of fragile X syndrome in their first child. The parents state that this information would have influenced their reproductive decisions.
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