The fiduciary relationship model for managing clinical genomic "incidental" findings.
The fiduciary relationship model for managing clinical genomic "incidental" findings.
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DOI：
10.1111/jlme.12177
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发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Lázaro-Muñoz G
中科院分区：
文献类型：
--
作者：
Lázaro-Muñoz G
医患关系有着悠久的历史和深厚的传统，但它是社会上许多最具创新性的技术进步的主要目的地之一。基因组测序等科学创新的实施迫使医患关系不断面临伦理和法律的难题。医患关系对实施基因组学的反应方式是这些技术作为改善人类健康的催化剂取得成功的一个关键方面。因此，重要的是要确定框架，可以指导基因组学在临床护理中的可持续实施。一个有希望的替代方案是应用法律的信托原则来指导临床中基因组信息的产生、使用和处理。法院、立法机构、学者和医疗组织都应用信托原则来定义或描述医患关系的不同方面。最近，美国医学遗传学和基因组学学院（ACMG）和生物伦理问题研究总统委员会（PCSBI）发布的报告称，在临床护理中订购基因组测序测试时，临床医生是受托人。[1]然而，在这些报告中，应用信托原则的含义往往不明确，这可能导致临床医生应如何行事的不确定性，或者一些信托原则在没有考虑其他原则的情况下被应用，这导致实际上与信托法原则相冲突的建议。本文探讨了信托关系的概念，作为一个框架，定义临床医生的责任和患者的权利时，订购全基因组/外显子组测序（WGS/WES）在临床和管理潜在的基因组“偶然”2或次要目标的结果。在这方面，信托原则的适用临床医生的诚信义务（如忠诚义务、注意义务、告知义务和在职权范围内行事的义务）起源于信托法和代理法，产生了至少四种具体的临床医生诚信义务，这些临床医生诚信义务包括：（1）提供有关次要靶基因组状况的材料预测试信息，这些信息可以在订购WGS/WES时进行分析和报告;（2）给予患者选择退出任何次要目标基因组状况的分析和报告的机会;（3）提供WGS/WES和次要目标状况的检查，即使患者不希望检查所有次要目标状况;（4）尊重患者的“不知道”次要目标基因组信息的权利。
The physician-patient relationship has a long history and is rich in deeply held traditions, yet it is one of the principal destinations for many of society’s most innovative technological advances. The implementation of scientific innovations, such as genomic sequencing, forces the physician-patient relationship to continuously confront difficult ethical and legal dilemmas. The way the physician-patient relationship responds to the implementation of genomics is a crucial aspect of the success of these technologies as catalysts for the improvement of human health. Therefore, it is important to identify frameworks that can guide the sustainable implementation of genomics in clinical care. One promising alternative is to apply legal fiduciary principles to guide the generation, use, and handling of genomic information in the clinic. Courts, legislatures, scholars, and medical organizations have applied fiduciary principles to define or describe different aspects of the physician-patient relationship. Recently, the American College of Medical Genetics and Genomics (ACMG) and the Presidential Commission for the Study of Bioethical Issues (PCSBI) released reports that refer to clinicians as fiduciaries when ordering genomic sequencing tests in clinical care. 1 However, in these reports the implications of applying fiduciary principles were often not made explicit, which can lead to uncertainty about how clinicians should act or some fiduciary principles were applied without considering others, which led to recommendations that are actually in conflict with the principles of fiduciary law. This article examines the concept of fiduciary relationships as a framework for defining clinicians’ duties and patients’ rights when ordering whole genome/exome sequencing (WGS/WES) in the clinic and managing potential genomic “incidental” 2 or secondary target findings. In this context, the application of fiduciary principles (eg, duty of loyalty, duty of care, duty to inform, and the duty act within the scope of authority), which have their origins in trust and agency law, gives rise to at least four specific clinician fiduciary duties.These clinician fiduciary duties include the duty to:(1) provide material pretest information about secondary target genomic conditions that may be analyzed and reported when WGS/WES is ordered;(2) give patients the opportunity to opt-out of the analysis and report of any secondary target genomic condition;(3) offer WGS/WES and the examination of secondary target conditions, even if patients do not want all secondary target conditions examined;(4) respect patients’“right not to know” secondary target genomic information.
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DOI：
10.1038/gim.2013.73
发表时间：
2013-07
期刊：
Genetics in medicine : official journal of the American College of Medical Genetics
影响因子：
--
作者：
通讯作者：
--
影响因子：
8.8
作者：
Clayton, Ellen Wright;Haga, Susanne;Burke, Wylie
通讯作者：
Burke, Wylie
影响因子：
9.8
作者：
Chervenak, FA;McCullough, LB
通讯作者：
McCullough, LB
DOI：
10.1038/gim.2013.11
发表时间：
2013-05
期刊：
Genetics in medicine : official journal of the American College of Medical Genetics
影响因子：
--
作者：
Evans JP;Berg JS;Olshan AF;Magnuson T;Rimer BK
通讯作者：
Rimer BK
影响因子：
158.5
作者：
Green, Robert C.;Roberts, J. Scott;Farrer, Lindsay A.
通讯作者：
Farrer, Lindsay A.