Quaid Kimberly A, Jessup Nenette M, Meslin Eric M
Indiana University Center for Bioethics, Indianapolis, IN 46202-3297, USA.
Genet Test. 2004 Fall;8(3):347-55. doi: 10.1089/gte.2004.8.347.
The rapid expansion of information and knowledge of genetics has implications for the question of whether, and under what circumstances, information discovered in the course of genetic research should be conveyed to research participants and/or their relatives. The aim of this paper is to propose an ethically defensible solution to a specific case example illustrating this problem. To do this we reviewed the literature to find answers to the following three questions: (1) What do current regulations, guidelines, and commentary say about the disclosure of genetic risk information obtained through research to research participants? (2) What do current regulations, guidelines, and commentary say about the disclosure of genetic risk information obtained through research to the relatives of research subjects? and (3) What do current regulations, guidelines, and commentary say about the disclosure of genetic risk information obtained through research about former research participants who are now deceased? Our conclusion is that current U.S. federal guidelines governing the use of human subjects in research, as well as much of the current literature, do not adequately address the familial dimension inherent in genetic research, are virtually silent on the issue of sharing information of relevance to family members, and do not protect the deceased. It is our belief that this omission needs to be corrected and that explicit guidance on this issue needs to be provided to institutional review boards and researchers alike.
遗传学信息和知识的迅速扩展，引发了这样一个问题：在基因研究过程中发现的信息是否以及在何种情况下应传达给研究参与者和/或他们的亲属。本文的目的是针对一个说明该问题的具体案例，提出一个在伦理上站得住脚的解决方案。为此，我们查阅了文献，以寻找以下三个问题的答案：（1）当前的法规、指南和评论对于将通过研究获得的基因风险信息披露给研究参与者有何说法？（2）当前的法规、指南和评论对于将通过研究获得的基因风险信息披露给研究对象的亲属有何说法？以及（3）当前的法规、指南和评论对于将通过研究获得的基因风险信息披露给现已去世的 former 研究参与者有何说法？我们的结论是，美国当前关于研究中使用人类受试者的联邦指南以及当前的许多文献，都没有充分解决基因研究中固有的家族层面问题，在与家庭成员相关信息共享问题上几乎没有提及，也没有保护死者。我们认为这种遗漏需要得到纠正，并且需要向机构审查委员会和研究人员提供关于这个问题的明确指导。
