Principles of human subjects protections applied in an opt-out, de-identified biobank.
Principles of human subjects protections applied in an opt-out, de-identified biobank.
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DOI：
10.1111/j.1752-8062.2010.00175.x
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发表时间：
2010-02
期刊：
影响因子：
--
通讯作者：
Masys DR
中科院分区：
文献类型：
--
作者：
Pulley J;Clayton E;Bernard GR;Roden DM;Masys DR
BioVU（范德比尔特 DNA 数据库）是当地 IRB 和联邦人类研究保护办公室 (OHRP) 确定的少数符合非人类受试者研究资格的生物库之一。 BioVU 收集从常规临床测试剩余的血液中提取的 DNA 样本。该资源链接到从电子病历 (EMR) 系统中提取的去识别化数据版本，称为合成设备 (SD)，其中所有个人标识符都已被删除。因此，记录中没有附加可识别的私人信息。贝尔蒙特报告列举了实践与研究之间界限的重要性，以及三项原则：尊重人、善行和正义，构成了IRB和伦理委员会判断涉及人类受试者的研究的风险和收益的基本伦理框架。 BioVU是通过设计和实施新程序而开发的，之前没有建立过新程序，这与贝尔蒙特报告的原则一致。其中包括特殊的监督和治理、新的信息技术、适应患者偏好的规定，以及广泛的公共教育和沟通部分。 BioVU 实际实施中对核心原则和保护的思考是本文的重点。临床跨科学2010;卷号：1–7
BioVU, the Vanderbilt DNA Databank, is one of few biobanks that qualifies as non‐human subjects research as determined by the local IRB and the federal Office of Human Research Protections (OHRP). BioVU accrues DNA samples extracted from leftover blood remaining from routine clinical testing. The resource is linked to a de‐identified version of data extracted from an Electronic Medical Record (EMR) system, termed the Synthetic Device (SD), in which all personal identifiers have been removed. Thus, there is no identifiable private information attached to the records. The Belmont Report enumerates the importance of the boundary between practice and research, and three principles: Respect for Persons, Beneficence, and Justice, which constitute the essential ethical framework by which IRBs and ethics committees judge the risks and benefi ts of research involving human subjects. BioVU was developed by designing and implementing new procedures, for which there were no previously established methods, which are consistent with the principles of the Belmont Report. These included special oversight and governance, new informatics technologies, provisions to accommodate patients’ preferences, as well as an extensive public education and communications component. Considerations of core principles and protections in the practical implementation of BioVU is the focus of this paper. Clin Trans Sci 2010; Volume #: 1–7
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