Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group
Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group
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DOI：
10.1161/circgenetics.110.958827
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发表时间：
2010-12-01
影响因子：
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通讯作者：
Burke, Gregory L.
中科院分区：
文献类型：
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作者：
Fabsitz, Richard R.;McGuire, Amy;Burke, Gregory L.
2009年1月，美国国家心脏、肺和血液研究所召集了一个由28名成员组成的多学科工作组，以更新2004年美国国家心脏、肺和血液研究所工作组的建议，重点是遗传研究结果返还指南。在这5年中，遗传和社会景观的变化提出了许多问题和挑战。专家组注意到，由于技术和生物信息学的进步，人们有可能获得关于个人的大量信息，而这在十年前是不可能的。虽然未能就若干问题达成共识，但工作组提出了5项建议。工作组提出了2项建议，分别涉及确定何时应该和可以将遗传结果返还给研究参与者的必要标准。此外，建议设立时限，限制调查人员返还遗传研究结果的义务期限。该小组建议建立一个或多个中央机构，就基因研究结果何时与足够的风险相关并已确定临床效用以证明其返回研究参与者提供指导。最后一项建议敦促调查人员在与可识别的社区打交道时，让更广泛的社区参与进来，就总体和个人研究成果的回报向他们提供咨询意见。成立一个负责向机构审查委员会、调查人员、研究机构和研究赞助者提供指导的实体，将对现有数据进行严格审查，促进有关遗传研究结果返还的研究政策标准化，并使研究者和研究参与者能够澄清和分享对处理这些越来越有价值的信息的期望，同时适当尊重他们的权利和需求。参与者(Circ心血管遗传学。2010;3：574-580）。
In January 2009, the National Heart, Lung, and Blood Institute convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004 National Heart, Lung, and Blood Institute Working Group focused on Guidelines to the Return of Genetic Research Results. Changes in the genetic and societal landscape over the intervening 5 years raise multiple questions and challenges. The group noted the complex issues arising from the fact that technological and bioinformatic progress has made it possible to obtain considerable information on individuals that would not have been possible a decade ago. Although unable to reach consensus on a number of issues, the working group produced 5 recommendations. The working group offers 2 recommendations addressing the criteria necessary to determine when genetic results should and may be returned to study participants, respectively. In addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. The group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. The final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. Creation of an entity charged to provide guidance to institutional review boards, investigators, research institutions, and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants. (Circ Cardiovasc Genet. 2010;3:574-580.)