Educational Approaches to the Responsible Conduct of Clinical Research: An Exploratory Study

Academic Medicine 82(1): 32-39, 2007

Posted: 3 Aug 2014 Last revised: 5 Sep 2014

See all articles by Debra DeBruin

Debra DeBruin

University of Minnesota - Minneapolis

Stacy Scholder

University of Minnesota - Minneapolis

Jeffrey P. Kahn

Johns Hopkins Berman Institute of Bioethics

Anna C. Mastroianni

University of Washington - School of Law; University of Washington, Dept. of Health Services, School of Public Health; University of Washington, Dept. of Pediatrics and Department of Bioethics and Humanities, School of Medicine

Mary Faith Marshall

Independent; University of Virginia - School of Medicine

John Lantos

University of Chicago

Jeremy Sugarman

Independent; Johns Hopkins University

Date Written: 2007

Abstract

Purpose: To identify best practices in education related to the responsible conduct of clinical research (RCCR).

Method: American Society for Bioethics and Humanities (ASBH) members involved with teaching RCCR were asked to complete an online survey, followed by an in-depth telephone interview. The online survey asked about respondents’ RCCR teaching, trainees, and institutional context. The phone interview involved discussions about teaching strategies, institutional context, and needs. The study was conducted between 2003 and 2005.

Results: Forty-eight respondents to the online survey indicated a breadth of topics being covered in RCCR curricula; 35 respondents indicated that their RCCR teaching applied toward institutional RCCR requirements. Among the 21 instructors interviewed, many described a wide variety of teaching responsibilities. Recommended teaching strategies included fostering interactive discussion, using skills-based exercises such as designing IRB applications, accommodating students’ individual interests in curriculum design, involving experienced researchers, involving trainees early in their careers as well as requiring continuing education, and designing a curriculum with a clear view of educational objectives. Interviewees described the institutional supports they needed, and they noted that insufficient support sometimes undermines RCCR teaching goals. Participants generally agreed that RCCR education should be required.

Conclusions: Strong agreement among participants concerning recommended strategies for teaching RCCR provides useful, if provisional, guidance to instructors and institutions charged with providing such training. The study suggests a need for substantial investments in RCCR training, studying outcomes, and developing mechanisms to ensure the quality of instruction.

Keywords: education, best practices, clinical research

Suggested Citation

DeBruin, Debra and Scholder, Stacy and Kahn, Jeffrey P. and Mastroianni, Anna C. and Marshall, Mary Faith and Lantos, John and Sugarman, Jeremy, Educational Approaches to the Responsible Conduct of Clinical Research: An Exploratory Study (2007). Academic Medicine 82(1): 32-39, 2007, Available at SSRN: https://ssrn.com/abstract=2475253

Debra DeBruin

University of Minnesota - Minneapolis ( email )

110 Wulling Hall, 86 Pleasant St, S.E.
308 Harvard Street SE
Minneapolis, MN 55455
United States

Stacy Scholder

University of Minnesota - Minneapolis

110 Wulling Hall, 86 Pleasant St, S.E.
308 Harvard Street SE
Minneapolis, MN 55455
United States

Jeffrey P. Kahn

Johns Hopkins Berman Institute of Bioethics ( email )

1809 Ashland Ave
Baltimore, MD 21205
United States
410-614-5679 (Phone)

Anna C. Mastroianni (Contact Author)

University of Washington - School of Law ( email )

William H. Gates Hall
Box 353020
Seattle, WA 98105-3020
United States

HOME PAGE: https://www.law.washington.edu/directory/profile.aspx?ID=144

University of Washington, Dept. of Health Services, School of Public Health ( email )

Seattle, WA 98103
United States

University of Washington, Dept. of Pediatrics and Department of Bioethics and Humanities, School of Medicine ( email )

Seattle, WA 98195
United States

Mary Faith Marshall

Independent ( email )

University of Virginia - School of Medicine ( email )

United States

John Lantos

University of Chicago ( email )

1101 East 58th Street
MacLean Center for Clinical Medical Ethics
Chicago, IL 60637
United States
(773) 363-3700, x 372 (Phone)

Jeremy Sugarman

Independent ( email )

Johns Hopkins University ( email )

Baltimore, MD 20036-1984
United States

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