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“广泛”同意、同意的例外情况以及将生物样本用于与初始收集目的不同的研究目的的问题。

"Broad" consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose.

机构信息

Bioethics Unit-Office of the President, Istituto Superiore di Sanità, Roma, Italy.

出版信息

Soc Sci Med. 2010 Jan;70(2):217-20. doi: 10.1016/j.socscimed.2009.10.004. Epub 2009 Oct 21.

Abstract

An important ethical issue regarding biological samples stored in biobanks is unforeseen future sample use, when no or limited subject consent is obtained. Biobanks of biological samples have significant future research potential, but may cause conflicts of interest regarding the consent obtained. Indeed, ethics, deontology, and jurisprudence generally advise that consent must be specific and circumstantiated. However, it is not possible to foresee all of the future circumstances in which the samples might be useful, nor is it possible to re-contact all subjects in order to gain consent for a new use. The main arguments for the use of "broad" consent are presented with a brief discussion of the conditions where it may be legitimate not to obtain consent. Particular attention is given to the expressed positions of national and international bioethics bodies.

摘要

生物样本库中储存的生物样本的一个重要伦理问题是,在没有获得或仅有限地获得主体同意的情况下,对未来无法预见的样本使用。生物样本库具有重大的未来研究潜力,但可能会引起与所获得的同意相关的利益冲突。实际上,伦理学、道德学和法学一般都建议同意必须具体和具体说明。但是,无法预见将来可能有用的所有情况,也不可能重新联系所有对象以获得对新用途的同意。提出了使用“广泛”同意的主要论点,并简要讨论了在何种情况下可以合法地不获得同意。特别关注国家和国际生物伦理机构的明确立场。

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