Despite the growing body of literature on training in the responsible conduct of research, few studies have examined the effectiveness of delivery formats used in ethics courses. The present effort sought to address this gap in the literature through a meta-analytic review of 66 empirical studies, representing 106 ethics courses and 10,069 participants. The frequency and effectiveness of 67 instructional and process-based content areas were also assessed for each delivery format. Process-based contents were best delivered face-to-face, whereas contents delivered online (...) were most effective when restricted to compliance-based instructional contents. Overall, hybrid courses were found to be most effective, suggesting that ethics courses are best delivered using a blend of formats and content areas. Implications and recommendations for future development of ethics education courses in the sciences are discussed. (shrink)

Increased investment in ethics education has prompted a variety of instructional objectives and frameworks. Yet, no systematic procedure to classify these varying instructional approaches has been attempted. In the present study, a quantitative clustering procedure was conducted to derive a typology of instruction in ethics education. In total, 330 ethics training programs were included in the cluster analysis. The training programs were appraised with respect to four instructional categories including instructional content, processes, delivery methods, and activities. Eight instructional approaches were (...) identified through this clustering procedure, and these instructional approaches showed different levels of effectiveness. Instructional effectiveness was assessed based on one of nine commonly used ethics criteria. With respect to specific training types, Professional Decision Processes Training and Field-Specific Compliance Training appear to be viable approaches to ethics training based on Cohen’s d effect size estimates. By contrast, two commonly used approaches, General Discussion Training and Norm Adherence Training, were found to be considerably less effective. The implications for instruction in ethics training are discussed. (shrink)

The increased focus in recent years on the risks posed by conflicts of interest arising from financial relationships between physician-investigators and the pharmaceutical and medical device industries has led to a variety of measures that can broadly be described as “regulatory” interventions, including new federal and state laws, criminal prosecutions and private lawsuits, requirements attached to government funding, and institutional policies. Studies suggest, however, that physician-investigators have not internalized the message that financial conflicts of interest have the potential to influence (...) their decision making. Simply informing physician-investigators of the content of relevant rules and the consequences of noncompliance — as appears to be the practice in many existing compliance training activities — is unlikely to lead to lasting changes in norms or behavior. Instead, we theorize that, for trainings to be maximally effective, they must appeal to the complex intrinsic and extrinsic motivations that contribute to individuals' willingness to comply with regulatory mandates. In addition, physician-investigators' beliefs that the risks posed by conflicts of interest do not apply to them need to be challenged. Rigorous evaluation of the newly-designed training programs will help determine whether these theories are borne out in fact. (shrink)

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, (...) the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation. (shrink)

German medical students are not sufficiently introduced to the ethical principles and pitfalls of scientific work. Therefore, a compulsory course on good scientific practice has been developed and implemented into the curriculum of medical students, with the goal to foster scientific integrity and prevent scientific misconduct. Students’ knowledge and attitudes towards GSP were evaluated by a pre-post-teaching questionnaire survey. Most participants initially had startling knowledge gaps in the field. Moreover, they were not acquainted with core institutions on GSP, the office (...) of ombudsperson and the nationally binding guidelines on GSP. The pre-post-teaching comparison showed statistically significant improvement in all areas tested; moreover, after the course participants confided more trust in GSP institutions. Applying ethical rules into practice can be challenging; therefore, students need to learn to work independently with guidelines on GSP and should be introduced to institutions providing further guidance. As our study has shown, students are very willing to pursue a scientific career based on integrity and honesty, however, they lack the knowledge how to do so. In light of our results, we therefore recommend to integrate courses on GSP already at an early time into the mandatory curriculum of medical students. (shrink)

German medical schools have not yet sufficiently introduced students to the field of good scientific practice. In order to prevent scientific misconduct and to foster scientific integrity, courses on GSP must be an integral part of the curriculum of medical students. Based on a review of the literature, teaching units and materials for two courses on GSP were developed and tested in a pilot course. The pilot course was accompanied by a pre-post evaluation that assessed students’ knowledge and attitudes towards (...) scientific integrity and scientific misconduct. A syllabus was designed that comprised the following six topics: theoretical foundations of GSP; scientific publishing; empirical data; scientific supervision and teamwork; clinical research; personal interests. The comparison pre versus post-intervention yielded statistically significant changes in regard to the participants’ knowledge and attitude toward all forms of scientific misconduct treated in the course. As the majority of participants was not familiar with the fundamental regulations or guidelines of GSP, it seems crucial to train students in actively applying such norms to real-world conflicts. Students’ unfamiliarity with the fundamentals of GSP can be linked to the fact that many students have already experienced forms of scientific misconduct. Thus, GSP syllabi should be closely adjusted to a student’s realm of experience. All in all, courses on GSP can be seen as a potential means to increase the number of young scholars. (shrink)

We believe that the professional responsibility of bioscience and biotechnology professionals includes a social responsibility to contribute to the resolution of ethically fraught policy problems generated by their work. It follows that educators have a professional responsibility to prepare future professionals to discharge this responsibility. This essay discusses two pilot projects in ethics pedagogy focused on particularly challenging policy problems, which we call “fractious problems”. The projects aimed to advance future professionals’ acquisition of “fractious problem navigational” skills, a set of (...) skills designed to enable broad and deep understanding of fractious problems and the design of good policy resolutions for them. A secondary objective was to enhance future professionals’ motivation to apply these skills to help their communities resolve these problems. The projects employed “problem based learning” courses to advance these learning objectives. A new assessment instrument, “Skills for Science/Engineering Ethics Test”, was designed and administered to measure the success of the courses in doing so. This essay first discusses the rationale for the pilot projects, and then describes the design of the pilot courses and presents the results of our assessment using SkillSET in the first pilot project and the revised SkillSET 2.0 in the second pilot project. The essay concludes with discussion of observations and results. (shrink)