Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs
Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs
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DOI：
10.1111/j.1752-8062.2010.00193.x
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发表时间：
2010-06-01
影响因子：
3.9
通讯作者：
Kon, Alexander A.
中科院分区：
文献类型：
--
作者：
DuBois, James M.;Schilling, Debie A.;Kon, Alexander A.
美国国立卫生研究院(NIH)要求将负责任的研究行为(RCR)指导作为任何临床和翻译科学奖(CTSA)的组成部分。NIH CTSA联盟临床研究伦理关键职能委员会(CRE-KFC)的教育材料组对截至2009年1月持有CTSA资金的38家机构进行了一项调查，以确定它们如何满足RCR培训要求。通过电子邮件向临床研究伦理、教育和职业发展以及监管知识核心的主管发送了一份由8个项目组成的问卷。我们收到了来自38个CTSA的78份已完成的调查(100%)。我们发现，跨CTSA的RCR培训没有统一的方法，许多项目缺乏连贯的RCR教学计划，大多数CTSA没有开发出适合临床和翻译科学家需求的独特教学材料。我们建议CTSA之间和CTSA关键职能委员会之间进行合作，以解决这些弱点。我们还要求各机构通过CTSpedia网站发送原始RCR培训材料的电子副本，供CTSA共享。20家机构至少提交了一份教育产品。CTSpedia现在包含90多个RCR资源。
The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.