IRB practices and policies regarding the secondary research use of biospecimens.
IRB practices and policies regarding the secondary research use of biospecimens.
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DOI：
10.1186/s12910-015-0020-1
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发表时间：
2015-05-08
影响因子：
2.7
通讯作者：
Rivera SM
中科院分区：
文献类型：
--
作者：
Goldenberg AJ;Maschke KJ;Joffe S;Botkin JR;Rothwell E;Murray TH;Anderson R;Deming N;Rosenthal BF;Rivera SM
随着生物样本的共享和二次研究使用的增加，IRB和研究人员面临着保护和尊重捐赠者的挑战，而没有全面的法规来解决生物库带来的人类受试者保护问题。IRB生物库政策中关于这些问题的变化尚未得到很好的记录。本文报告了来自60个临床和翻译科学奖（CTSA）附属机构的IRB行政主管关于其关于生物标本二次使用和共享的政策和实践的调查数据。具体而言，向IRB AD询问未来使用生物样本的知情同意书、使用生物库样本的研究的风险分配以及生物样本/数据的共享。我们的数据表明，IRB采用不同的方法进行方案审查，风险评估和数据共享，特别是当标本不匿名时。鉴于机构对人类受试者保护的不同要求，IRB之间关于生物标本研究的政策不明确或存在分歧，可能会阻碍遗传学研究的推进和机构间合作。本文的在线版本（doi：10.1186/s12910-015-0020-1）包含补充材料，可供授权用户使用。
As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented. This paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. Specifically, IRB ADs were asked about consent for future use of biospecimens, assignment of risk for studies using biobanked specimens, and sharing of biospecimens/data. Our data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized. Unclear or divergent policies regarding biospecimen research among IRBs may constitute a barrier to advancing genetic studies and to inter-institutional collaboration, given different institutional requirements for human subjects protections. The online version of this article (doi:10.1186/s12910-015-0020-1) contains supplementary material, which is available to authorized users.
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影响因子：
2.1
作者：
Rothstein, MA
通讯作者：
Rothstein, MA
影响因子：
2.1
作者：
Williams, Brett A.;Wolf, Leslie E.
通讯作者：
Wolf, Leslie E.
影响因子：
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作者：
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通讯作者：
Henderson, Gail E.
DOI：
10.1525/jer.2008.3.4.99
发表时间：
2008-12-01
影响因子：
1.3
作者：
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通讯作者：
Lo, Bernard
影响因子：
5.2
作者：
Eriksson, S;Helgesson, G
通讯作者：
Helgesson, G