Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, Tennessee, USA.
Genet Med. 2013 Aug;15(8):624-9. doi: 10.1038/gim.2013.7. Epub 2013 Feb 28.
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.
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.
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.
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.
临床外显子组和全基因组测序将产生广泛的偶然发现,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。我们寻求可以为临床医生的法律责任提供见解的法律案例。
我们使用 WestLaw、WestLaw Next、Lexis 和 Lexis Advance 等搜索引擎,搜索与诉讼原因相关的偶然发现案例。
我们没有发现与遗传测试偶然发现相关的案例法,但确定了涉及医疗成像中偶然发现的八个案例。这些案例表明,如果在适用的护理标准下,临床医生未能识别或认识到偶然发现的意义,或者疏忽地未能通知其他临床医生和/或患者已识别的偶然发现,那么他们可能会因未能披露偶然发现而面临责任,这些偶然发现可能为改善健康结果提供干预机会。其他案例支持因未能适当转介给具有更高专业知识的临床医生而承担责任。
如果临床医生未能披露可能告知干预以改善健康结果的偶然信息,他们可能会面临责任;缺乏临床可操作性的信息可能意义不大。