• Open Access

Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs

Authors

  • James M. DuBois D.Sc., Ph.D.,

    1. 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
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  • Debie A. Schilling A.A.,

    1. Clinical and Translational Science Center, University of California Davis, Sacramento, California, USA
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  • Elizabeth Heitman Ph.D.,

    1. Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, USA
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  • Nicholas H. Steneck Ph.D.,

    1. Michigan Institution for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan, USA
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  • Alexander A. Kon M.D.

    1. Department of Pediatrics and Program in Bioethics, University of California Davis, Sacramento, California, USA
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JM DuBois (duboisjm@slu.edu)

Abstract

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.

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