Faculty of Medicine, Human Genetics Department, McGill University, Montreal, Quebec, Canada.
Genet Med. 2012 Apr;14(4):484-9. doi: 10.1038/gim.2012.13. Epub 2012 Feb 16.
Managers of genomic biobanks constantly face ethical and legal challenges ranging from issues associated with the informed consent process to procedural concerns related to access by researchers. Yet, with the availability of next-generation sequencing technologies, one topic is emerging as the focus of ongoing debate: the return of individual research results and incidental findings to participants. This article examines this topic from an international perspective, where policies and guidelines discussing the matter in the context of genomic biobanks and genomic research are analyzed and commented. This approach aims to highlight the shortcomings of these international norms, mainly the danger arising from both the therapeutic misconception and the conflation of research results with incidental findings. This article suggests some elements to consider in order to complement available guidance at the international level.
基因组生物样本库的管理者经常面临着各种伦理和法律挑战,这些挑战涉及从知情同意过程中出现的问题到与研究人员获取相关的程序问题。然而,随着下一代测序技术的出现,一个话题成为了正在进行的争论的焦点:向参与者返还个体研究结果和偶然发现。本文从国际视角审视了这一话题,分析和评论了基因组生物样本库和基因组研究背景下讨论这一问题的政策和准则。这种方法旨在强调这些国际规范的缺陷,主要是治疗误解和将研究结果与偶然发现混为一谈所带来的危险。本文提出了一些需要考虑的要素,以便在国际层面上补充现有的指导意见。