Legal issues in predictive genetic testing programs

This article reviews aspects of predictive genetic testing to which the general law of doctor-patient relations applies and identifies peculiarities of such testing that raise more specialized legal issues. Where testing programs are experimental in character, investigators bear legal responsibilities to inform their subjects adequately and separate duties to submit their proposals to ethical review. Access to routine care and counseling and to specialized testing programs are addressed in the contexts of antidiscrimination laws and patient protection. The law on patients' adequately informed and free decision-making regarding testing is reviewed, with particular attention to reproductive counseling and planning for future inability to make or express decisions about care. Modern perceptions of the legal nature of medical confidentiality are applied to results of predictive genetic testing, and distinctions are illustrated between justified and excusable breaches of confidentiality, particularly with regard to familial disorders. Attention is given to patients' directions that their medical information be made available to third parties and to themselves. Finally, legal issues are considered regarding legal control of tissue samples that patients give for genetic diagnosis.