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

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 unifi ed 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.

The Importance of Formative Assessment in Science and Engineering Ethics Education: Some Evidence and Practical Advice

“…While studies show a positive increase in course and program offerings, they also demonstrate a large variation in content, curricular materials, and instruction (DuBois et al, 2010;Kalichman & Plemmons, 2007;Lehmann, Kasoff, Koch, & Federman, 2004). For example, DuBois et al (2010) conducted an extensive survey of mandated RCR instruction and found that while RCR instruction is widespread (97% of those surveyed), there is "no unified approach (p. 109)"; there exists rather a "significant variation in scope, content, and approaches to RCR instruction (p. 110)". These authors report that programs "lack a coherent plan for RCR instruction."…”

Education in Research Integrity and Governance of Science in the United States, Argentina, and Brazil

“…Reports of research misconduct continue unabated, leading many to doubt that instruction in the responsible conduct of research "works" as a preventive or corrective measure (Hicks 2013). The few studies that have examined US instruction in responsible conduct have found that programs vary greatly and often lack coherence (DuBois et al 2010;Resnick and Dinse 2012). And while perhaps as many as two-thirds of medical schools provide instruction in responsible conduct to trainees without regard to their source of funding, overall many institutions appear to aim their instruction solely at complying with federal requirements (Resnick and Dinse 2012).…”

A Primer on Ethics Education for Stem Cell and Biomedical Scientists

“…Ethics education efforts frequently have unclear goals and vary in quality and effectiveness [2]. How ethics education is incorporated into training programs and the resources available also lack consistency [1,42]. All research ethics courses not only aim to deliver knowledge about principles, practices, and policies but can also teach ethical problem solving skills, ethical sensitivity skills, and may alter behavior (attitudes and values) with the goal of increasing ethicality and motivating ethical action of scientists [31].…”

“…In 2000, the US Office of Research Integrity outlined nine instructional areas of RCR courses: (1) data acquisition, management, sharing, and ownership, (2) mentor/trainee responsibilities, (3) publication practices and responsible authorship, (4) peer review, (5) collaborative science, (6) human subjects, (7) research involving animals, (8) research misconduct, and (9) conflict of interest and commitment [79]. Yet several studies have shown that RCR courses vary significantly in content and best practices [20,42,80,81]. Based on a 2009 Delphi study, expert panelists recommended ORI's nine overarching objectives with the emphasis of two new core areas: the social responsibilities of scientists and current topics [67].…”