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预测性基因检测项目中的法律问题。

Legal issues in predictive genetic testing programs.

作者信息

Dickens B M

机构信息

Faculty of Law, University of Toronto, Canada.

出版信息

Alzheimer Dis Assoc Disord. 1994;8(2):94-101. doi: 10.1097/00002093-199408020-00006.

DOI:10.1097/00002093-199408020-00006
PMID:8060611
Abstract

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.

摘要

本文回顾了适用于医患关系一般法律的预测性基因检测的各个方面,并确定了此类检测中引发更专门法律问题的特殊性。在检测项目具有实验性质的情况下,研究人员有法律责任充分告知其受试者,并承担将其提案提交伦理审查的单独职责。反歧视法和患者保护的背景下讨论了获得常规护理与咨询以及专门检测项目的问题。审查了关于患者就检测做出充分知情和自由决策的法律,特别关注生殖咨询以及针对未来无法就护理做出或表达决策的规划。现代对医疗保密法律性质的认知被应用于预测性基因检测的结果,并说明了保密正当与可原谅的违规行为之间的区别,特别是在家族性疾病方面。关注患者关于将其医疗信息提供给第三方和他们自己的指示。最后,考虑了关于患者提供用于基因诊断的组织样本的法律控制的法律问题。

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