Broad Consent for Research With Biological Samples: Workshop Conclusions
Broad Consent for Research With Biological Samples: Workshop Conclusions
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DOI：
10.1080/15265161.2015.1062162
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发表时间：
2015-09-02
影响因子：
13.4
通讯作者：
Wendler, David
中科院分区：
文献类型：
--
作者：
Grady, Christine;Eckstein, Lisa;Wendler, David
不同类型的同意被用来获取人类生物标本用于未来的研究。这种变化导致了关于允许哪些研究的混乱、对未来研究的无意限制以及未经同意的研究进行。美国国立卫生研究院（NIH）临床中心的生物伦理学系举办了一个研讨会，考虑通过使用广泛的同意来解决这些问题的伦理可接受性，为未来的研究储存的生物标本。多位生物伦理学学者就这些问题进行了写作，讨论了同意的原因，同意策略的范围以及我们理解的差距，并最终提出了一项建议，即广泛的初步同意加上监督，并在可行的情况下，不断向捐赠者提供信息。本文介绍了协议的领域和需要更多研究和对话的领域。鉴于最近对共同规则提出的修改建议，以及关于储存和共享数据和样本的新指南，这是一个重要而及时的主题。
Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.