Analysis of state laws on informed consent for clinical genetic testing in the era of genomic sequencing.
Analysis of state laws on informed consent for clinical genetic testing in the era of genomic sequencing.
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基因组测序时代的临床基因检测知情同意的州法律分析。
DOI：
10.1002/ajmg.c.31608
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发表时间：
2018-03
期刊：
影响因子：
--
通讯作者：
Appelbaum PS
中科院分区：
文献类型：
--
作者：
Spector-Bagdady K;Prince AER;Yu JH;Appelbaum PS
本文评估了充分的知情同意，临床基因检测法的基础上，检查15个国家的机构参与了美国国立卫生研究院支持的临床测序探索性研究联盟项目。我们通过法律的搜索引擎确定了相关的法律规定，并纳入了描述临床基因检测的知情同意要求和/或遗传物质、信息或数据保护的法规。我们发现，法定定义通常以有问题的方式受到限制，例如仅关注已知与疾病或负面健康影响相关或与无症状疾病相关的变体。如果适用于基因组技术，一些法规要求复杂的细节，并为目前的使用和未来的访问设定了令人困惑的披露标准。另一些国家则对未来研究用途的知情同意要求有例外，对销毁标本而不是销毁衍生数据的要求有限，或将关键的定义组成部分与不断演变的“可识别性”概念联系起来。需要进一步的改革和研究，以确保国家法律保护的发展速度与他们渴望实现的科学发展速度一样快。
This article assesses the adequacy of informed consent to clinical genetic testing laws based on an examination of 15 states with institutions that had been involved in a National Institutes of Health-supported Clinical Sequencing Exploratory Research Consortium project. We identified relevant statutory provisions through a legal search engine and included statutes that describe the informed consent requirements for clinical genetic testing and/or the protections for genetic material, information, or data. We found that statutory definitions were often limited in problematic ways, such as focusing only on variants known to be associated with disease or negative health effects or associated with asymptomatic disease. Some statutes required complex levels of detail if applied to genomic technologies and set confusing disclosure standards for current use and future access. Others had exceptions from informed consent requirements for future research use, limited requirements for the destruction of specimens as opposed to derived data, or linked key definitional components to the evolving concept of “identifiability.” Further reform and research are needed to ensure that state law protections advance as rapidly as the science they aspire to enable.
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