INFORMED CONSENT FOR GENETIC RESEARCH ON STORED TISSUE SAMPLES
INFORMED CONSENT FOR GENETIC RESEARCH ON STORED TISSUE SAMPLES
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DOI：
10.1001/jama.274.22.1786
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发表时间：
1995-12-13
影响因子：
120.7
通讯作者：
WEISS, JO
中科院分区：
文献类型：
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作者：
CLAYTON, EW;STEINBERG, KK;WEISS, JO
目的。-制定建议，以便将来在收集可用于遗传研究的组织样本时获得充分的知情同意，并确定如果将现有的组织样本用于此类研究，则在什么情况下需要获得进一步的同意。参与者。-由国家人类基因组研究中心和疾病控制与预防中心选出的代表广泛意见的科学家、伦理学家、律师和消费者。证据。-有关法律和法规的法规、法规以及案例和文章。伦理学。共识过程。-最初的研讨会，随后分发本文件的几份草稿，研讨会参与者和其他人有机会发表评论，以及有不同观点的参与者参与的小型会议。结论。-使用储存的组织样本进行基因研究给个人、研究人员和社会带来一系列好处和风险，因此，研讨会参与者得出结论：(1)使用可链接样本的所有基因研究都需要知情同意，除非满足限制或放弃的条件； (2) 使用匿名样本进行基因研究不需要知情同意，但如果要从当前可链接样本中删除标识符，则可以考虑知情同意； (3) 机构审查委员会可以有效地审查所有提议使用样本进行基因研究的方案； (4) 有必要就这些问题开展进一步的工作。
Objective.-To develop recommendations for obtaining adequate informed consent in the future when gathering tissue samples that may be used for genetic studies and defining the circumstances under which it is necessary to obtain further consent if tissue samples already in hand are to be used for such research.Participants.-Scientists, ethicists, lawyers, and consumers selected by the National Center for Human Genome Research and the Centers for Disease Control and Prevention to represent a wide array of opinions.Evidence.-Statutes, regulations, and cases and articles on law and ethics.Consensus Process.-Initial workshop, followed by circulation of several drafts of this document with opportunities for comment by workshop participants and others as well as smaller meetings involving participants with widely differing views.Conclusions.-Genetic research using stored tissue samples poses an array of benefits and risks to individuals, researchers, and society, As a result, the workshop participants conclude that (1) informed consent is required for all genetic research using linkable samples unless conditions for limitation or waiver are met; (2) informed consent is not required for genetic research using anonymous samples but may be considered if identifiers are to be removed from currently linkable samples; (3) institutional review boards could usefully review all protocols that propose to use samples for genetic research; and (4) further work regarding these issues is warranted.