Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas 77030, USA;
Genome Res. 2014 May;24(5):719-23. doi: 10.1101/gr.170514.113. Epub 2014 Mar 27.
Genomic researchers increasingly are faced with difficult decisions about whether, under what circumstances, and how to return research results and significant incidental findings to study participants. Many have argued that there is an ethical-maybe even a legal-obligation to disclose significant findings under some circumstances. At the international level, over the last decade there has begun to emerge a clear legal obligation to return significant findings discovered during the course of research. However, there is no explicit legal duty to disclose in the United States. This creates legal uncertainty that may lead to unmanaged variation in practice and poor quality care. This article discusses liability risks associated with the disclosure of significant research findings for investigators in the United States.
在何种情况下，以及如何向研究参与者返还研究结果和重要的偶然发现。许多人认为，在某些情况下，披露重要发现是一种伦理责任——甚至可能是法律义务。在国际层面上，在过去十年中，人们开始认识到在研究过程中发现重要发现后有明确的法律义务予以返还。然而，在美国并没有明确的法律义务来披露这些发现。这造成了法律上的不确定性，可能导致实践中的管理不善和医疗质量下降。本文讨论了与美国研究人员披露重要研究结果相关的法律责任风险。
