Roberts Jessica L, Foulkes Alexandra L
University of Houston Law Center.
United States District Court for the Western District of Oklahoma.
William Mary Law Rev. 2020 Oct;62(1):143-211.
Most of our genetic information does not change, yet the results of our genetic tests might. Labs reclassify genetic variants in response to advances in genetic science. As a result, a person who took a test in 2010 could take the same test with the same lab in 2020 and get a different result. However, no legal duty requires labs or physicians to inform patients when a lab reclassifies a variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, it offers much-needed guidance to physicians and labs, who may face liability, and to courts, which will hear these cases.
我们的大部分基因信息不会改变,但基因检测的结果可能会变。实验室会根据基因科学的进展对基因变异进行重新分类。因此,一个在2010年做过检测的人,2020年在同一家实验室做同样的检测,可能会得到不同的结果。然而,即使重新分类传达了具有临床可操作性的信息,法律也没有规定实验室或医生有义务在实验室对变异进行重新分类时告知患者。本文探讨了此类义务的必要性及其潜在挑战。在此过程中,它为可能面临责任的医生和实验室以及将审理这些案件的法院提供了急需的指导。