Department of Medicine, Center for Clinical Research Ethics at Washington University School of Medicine and Albert Gnaegi Center for Health Care Ethics at Saint Louis University, Missouri, USA.
Clin Transl Sci. 2010 Jun;3(3):109-11. doi: 10.1111/j.1752-8062.2010.00193.x.
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.
美国国立卫生研究院（NIH）要求将负责任的研究行为（RCR）作为任何临床与转化科学奖（CTSA）的组成部分进行教学。NIH CTSA 联盟临床研究伦理关键职能委员会（CRE-KFC）的教育材料小组对截至 2009 年 1 月获得 CTSA 资助的 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。我们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任发送了一份 8 项内容的调查问卷。我们从 38 个 CTSA 中收到了 78 份完整的调查问卷（100%）。我们发现，CTSA 之间的 RCR 培训方法并不统一，许多项目缺乏连贯的 RCR 教学计划，而且大多数 CTSA 尚未针对临床和转化科学家的需求开发独特的教学材料。我们建议 CTSA 之间以及 CTSA 关键职能委员会之间进行合作，以解决这些问题。我们还要求机构通过 CTSpedia 网站向 CTSA 发送原始 RCR 培训材料的电子副本，以实现资源共享。20 家机构提交了至少一个教育产品。CTSpedia 现在包含了 90 多个 RCR 资源。
