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Biorepository Regulatory Considerations: A Detailed Topic Follow-Up to the Blueprint for the Development of a Community-Based Hospital Biorepository

机译：生物存储库监管注意事项：基于社区的医院生物存储库发展蓝图的详细主题跟进

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摘要

Human specimen and associated clinical data are crucial resources for uncovering new biomarkers as well as identifying factors in the pathogenesis of disease. As tissue banking becomes more widespread in response to increased researcher demand, the need for specific guidance documents and standards to be developed and/or updated becomes more urgent. This article discusses 4 aspects of current regulation and guidance considerations. First is the application of the Common Rule and the Privacy Rule to the Institutional Review Board review process. Second is the honest broker concept, which supports the further protection of donor confidentiality and allows for future updates to data. The third consideration discusses the regulatory approval process. Finally, inconsistencies between regulatory bodies are identified and possible ways to reconcile those inconsistencies are suggested.
机译：人体标本和相关的临床数据是发现新生物标记以及鉴定疾病发病机理的关键资源。随着组织银行业务随着研究者需求的增加而变得越来越广泛，对开发和/或更新特定指导文件和标准的需求变得更加迫切。本文讨论了当前法规和指南注意事项的4个方面。首先是在机构审查委员会的审查过程中应用通用规则和隐私规则。第二是诚实的经纪人概念，它支持进一步保护捐赠者的机密性，并允许将来对数据进行更新。第三个考虑因素讨论了监管审批流程。最后，确定监管机构之间的不一致之处，并提出调和这些不一致之处的可能方法。

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