Cancer Genetics Risk Assessment and Counseling (PDQ®): Genetics - Health Professional Information [NCI] - Ethical, Legal, and Social Implications
Privacy and Confidentiality: Disclosure of Patient's Genetic Information
A strong provider-patient relationship is founded on respect for the patient's privacy and confidentiality; therefore, protecting the patient's personal information from third parties is key to building trust.[2,3] Predictive testing for cancer susceptibility presents a challenge because of the hereditary nature of the diseases being tested and the implications of genetic risk for family members. Physicians are faced with a duty to warn or to act to prevent foreseeable harm. One practical suggestion for facilitating family-based communication is providing patients with education and information materials to facilitate disease susceptibility discussions with family members. The next section discusses the legal, legislative, and ethical basis for balancing patient confidentiality with duty to warn.
Disclosure in research
Privacy and confidentiality also applies to research, such as population screening for genetic diseases. The U.S. Department of Health and Human Services authorizes the use of Certificates of Confidentiality to researchers. This certificate, issued by the National Institutes of Health, protects the researcher from having to reveal the identity of any research subject "in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings." The protections offered by the certificate of confidentiality are limited to personally identifiable information collected beginning on the date of issuance and ending on the expiration date, which matches the date of study completion. The NIH Office of Extramural Research policy and guidance on Certificates of Confidentiality notes that any personally identifiable information collected during that time interval is protected in perpetuity. In regard to family-based recruitment strategies, the Cancer Genetics Network Bioethics Committee assembled a group of experts to develop recommendations for researchers to use in approaching family members. Due to the wide spectrum of research strategies, there are different levels of concern. Essential to family-based recruitment strategies is informing potential research participants how their personal information was obtained by the researcher, why the researcher is approaching them, what the researcher knows about them, and for what purpose the information will be used, whether or not they decide to participate.
"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). There are four state case laws that apply to duty to warn. 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.