Managing incidental genomic findings: legal obligations of clinicians

Managing incidental genomic findings: legal obligations of clinicians
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DOI:
10.1038/gim.2013.7
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发表时间:
2013-08-01
影响因子:
8.8
通讯作者:
Burke, Wylie
Burke, Wylie
中科院分区:
医学1区
文献类型:
--
作者:
Clayton, Ellen Wright;Haga, Susanne;Burke, Wylie

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目的:临床全外显子组和全基因组测序将导致广泛的偶然发现,但临床医生识别和披露这些发现的义务是一个有争议的问题。我们寻求法律的情况下,可以提供洞察临床医生的法律的liability.Methods:我们搜索的情况下,偶然的发现相关的原因的诉讼,使用搜索引擎WestLaw,WestLaw Next,Lexis,和Lexis Advance.Results:我们没有发现任何案例法相关的偶然发现基因检测,但确定了8例涉及偶然发现在医学影像。这些病例表明,如果在适用的护理标准下,临床医生未能识别或理解偶然发现的重要性,或者由于疏忽未能将所识别的偶然发现通知其他临床医生和/或患者,则临床医生可能会因未能披露偶然发现而面临责任,这些偶然发现将提供干预措施以改善健康结局的机会。其他情况下,支持责任未能适当地提到一个临床医生与更大的professions.Conclusions:临床医生可能面临的责任,如果他们没有透露偶然的信息,可以告知干预措施,以改善健康结果;缺乏临床actionability的信息可能有较少的进口。
Purpose: Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but clinicians' obligations to identify and disclose such findings are a matter of debate. We sought legal cases that could offer insights into clinicians' legal liability.Methods: We searched for cases in which incidental findings were related to the cause of action, using the search engines WestLaw, WestLaw Next, Lexis, and Lexis Advance.Results: We found no case law related to incidental findings from genetic testing but identified eight cases involving incidental findings in medical imaging. These cases suggest that clinicians may face liability for failing to disclose incidental findings that would have offered an opportunity for interventions to improve health outcome, if under the applicable standard of care, they fail to identify or appreciate the significance of the incidental finding or they negligently fail to notify other clinicians and/or the patient of the identified incidental finding. Other cases support liability for failure to refer appropriately to a clinician with greater expertise.Conclusions: Clinicians may face liability if they fail to disclose incidental information that could inform interventions to improve health outcome; information lacking clinical actionability is likely to have less import.