Meeting the Governance Challenges of Next-Generation Biorepository Research
Meeting the Governance Challenges of Next-Generation Biorepository Research
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DOI：
10.1126/scitranslmed.3000361
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发表时间：
2010-01-20
影响因子：
17.1
通讯作者：
Fryer-Edwards, Kelly
中科院分区：
文献类型：
--
作者：
Fullerton, Stephanie M.;Anderson, Nicholas R.;Fryer-Edwards, Kelly
临床转化研究的进展导致了对基础设施开发和数据共享的兴趣激增，这是由标本的生物储存库和相关的健康信息促成的。这些努力与之前的单中心样本收集有质的不同，并为研究人员和机构带来了大量新的伦理和监管挑战。迫切需要新的研究治理方法，以应对当前和预期的挑战，促进高质量的研究，并为持续的研究参与提供坚实的基础。
Advances in clinical translational research have led to an explosion of interest in infrastructure development and data sharing facilitated by biorepositories of specimens and linked health information. These efforts are qualitatively different from the single-center sample collections that preceded them and pose substantial new ethics and regulatory challenges for investigators and institutions. New research governance approaches, which can address current and anticipated challenges, promote high-quality research, and provide a robust basis for ongoing research participation, are urgently required.