Implementation of a responsible conduct of research education program at Duke University School of Medicine

Academic medical centers rarely require all of their research faculty and staff to participate in educational programs on the responsible conduct of research (RCR). There is also little published evidence of RCR programs addressing high-profile, internal cases of misconduct as a way of promoting deliberation and learning. In the wake of major research misconduct, Duke University School of Medicine (DUSoM) expanded its RCR education activities to include all DUSoM faculty and staff engaged in research. The program included formal deliberation of the Translational Omics misconduct case, which occurred at Duke. Over 5,000 DUSoM faculty and staff participated in the first phase of this new program, with a 100% completion rate. The article reports on the program’s development, challenges and successes, and future directions. This experience at Duke University illustrates that, although challenging and resource intensive, engagement with RCR activities can be integrated into programs for all research faculty and staff. Formal, participatory deliberation of recent cases of internal misconduct can add a novel dimension of reflection and openness to RCR educational activities.     

Responsible Conduct of Research Measure: Initial Development and Pilot Study

Although much discussion has been focused on research misconduct (RM) and questionable research practices, to date no self-report measures exist to examine this phenomenon. To help fill this void, the authors developed the Responsible Conduct of Research Measure (RCRM) through multiple pilot study waves involving researchers in the social and behavioral sciences. Preliminary results reveal adequate validity and reliability. The authors discuss limitations of the study as well as some possible directions for future research on this topic.     

Emphasizing the experiences of researchers after RCR instructions: Introduction to Responsible Conduct of Research (RCR) in Malaysia

The purpose of this study is to highlight the experiences of individuals who participate in the Responsible Conduct of Research (RCR) training program held at various universities in Malaysia. In response to a mailing request sent to 40 individuals who had undertaken a RCR training program, 15 participants agreed to be interviewed. The results of the study showed that the three main reasons for participating in the training were as follows: anticipation for knowledge gained; personal experience with research misconduct; and establishing a new network of researchers. In terms of the positive effects gained from undertaking the training, the participants highlighted an increased awareness of the issues and problems related to research misconduct; the need to promote integrity in research conduct; a change in the way they conduct their research; and a change in the way they confront and address misconduct. The findings of this study should be valuable for policy makers and those involved in the management of research programs and ethics, as it demonstrated the importance of RCR training in equipping researchers with the necessary knowledge to conduct research responsibly, and to avoid research misconduct.     

Leading for research excellence and integrity: A qualitative investigation of the relationship-building practices of exemplary principal investigators

We conducted semi-structured, telephone interviews with 52 federally funded researchers nominated as exemplars for their integrity and professional conduct, and their scientific achievements. The aim was to identify the practices they report utilizing to build respectful relationships in their teams. We found four practices, holding meetings, providing supervision and guidance, encouraging shared ownership, and expressing values, which were also important to performing high-quality, compliant research, were essential to fostering relationships. The most common practice described for building relationships was actively and deliberately cultivating a positive team environment. Additionally, exemplars described the need to lead by example, tailor their approach to the needs of individuals, address interpersonal conflict, and hire team members cautiously. We also identified practices the exemplars reported as important to managing the demands of their work and found that encouraging shared ownership and tailoring to individuals supported this goal. Additional strategies related to prioritization and planning, seeking advice, engaging in self-care, and managing emotional reactions. Finally, we identified priorities guiding the exemplars’ practices. Key priorities included providing outstanding mentoring, building collaborations and relationships, and engaging in discovery and innovation. Investigators require exceptional leadership skills but receive limited systematic leadership training. Addressing this gap would advance research excellence and integrity.     

Effective Practices in the Delivery of Research Ethics Education: A Qualitative Review of Instructional Methods

In order to delineate best practices for courses on research ethics, the goal of the present effort was to identify themes related to instructional methods reflected in effective research ethics and responsible conduct of research (RCR) courses. By utilizing a qualitative review, four themes relevant to instructional methods were identified in effective research ethics courses: active participation, case-based activities, a combination of individual and group approaches, and a small number of instructional methods. Three instructional method themes associated with less effective courses were also identified: passive learning, a group-based approach, and a large number of instructional methods. Key characteristics of each theme, along with example courses relative to each theme, are described. Additionally, implications regarding these instructional method themes and recommendations for best practices in research ethics courses are discussed.     

Education in the Responsible Conduct of Research in Psychology: Methods and Scope

In this mixed-method study of education in the responsible conduct of research (RCR) in psychology, phase one survey respondents (n?=?141) reported that faculty and students were familiar with RCR standards and procedures to educate them were believed to be adequate. However, educational methods varied widely. In phase two, seven survey respondents completed in-depth interviews assessing RCR training and education and research review procedures. Educational methods through which RCR content was presented included the following ones: traditional (lectures), technical (web-based), and experiential (internships), but RCR was often minimally considered in the formal curriculum. Our results suggest that psychology training programs might benefit from more formal consideration of RCR education and training in the curriculum.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

Effect of impact factor and discipline on journal data sharing policies

Data sharing is crucial to the advancement of science because it facilitates collaboration, transparency, reproducibility, criticism, and re-analysis. Publishers are well-positioned to promote sharing of research data by implementing data sharing policies. While there is an increasing trend toward requiring data sharing, not all journals mandate that data be shared at the time of publication. In this study, we extended previous work to analyze the data sharing policies of 447 journals across several scientific disciplines, including biology, clinical sciences, mathematics, physics, and social sciences. Our results showed that only a small percentage of journals require data sharing as a condition of publication, and that this varies across disciplines and Impact Factors. Both Impact Factors and discipline are associated with the presence of a data sharing policy. Our results suggest that journals with higher Impact Factors are more likely to have data sharing policies; use shared data in peer review; require deposit of specific data types into publicly available data banks; and refer to reproducibility as a rationale for sharing data. Biological science journals are more likely than social science and mathematics journals to require data sharing.     

A Brief History of RCR Education

Responsible conduct of research (RCR) education is now common throughout the United States, primarily in response to federal requirements beginning with the National Institutes of Health in 1989. Despite this long history, RCR education programs remain highly disparate, often with ill-defined content, format, and goals, and minimal evidence for effectiveness. However because it is widely believed that such programs can have value, it is hoped that a review of what is available, and how that came to pass, will highlight what has been done well and where gaps still remain.     

Ethics Instruction Increases Graduate Students' Responsible Conduct of Research Knowledge but not Moral Reasoning

The purpose of this study was to assess the short-term effectiveness of ethics courses in enhancing responsible conduct of research (RCR) knowledge and moral judgment among graduate students in health-related disciplines. Forty-eight graduate students completed a questionnaire about research experience, knowledge and judgments about appropriate research practices, and a standardized test of moral judgment at the beginning and end of a semester-long ethics course. Knowledge about RCR but not moral judgment increased significantly in some areas. The results are discussed in terms of implications for RCR instruction and of future research designed to improve RCR instruction.     

Are antidepressant and antipsychotic drug trials registered? A cross-sectional analysis of registration and reporting of methodologic characteristics

Introduction: In 2005, the International Committee of Medical Journal Editors (ICMJE) proposed that all submitted trials in all 11 member journals must be prospectively registered in order to be considered for publication. Registering drug trials was meant to reduce the likelihood of selective reporting. The aim was to determine the proportion of antipsychotic and antidepressant trials that were registered.

Methods: We searched in Pubmed for all randomized controlled trials of any antidepressant or antipsychotic published between July and December 2014. The primary objective was to determine the proportion of trials that were registered. Secondary objectives included comparing the reporting of methodological details and positive study findings between registered and unregistered trials.

Results: Of the 67 studies identified, 58% were registered. 75% of the antipsychotic trials and 51% of the antidepressant trials were registered, respectively. Registered trials were more likely to report important methodological details associated with risk of bias in RCTs. There was no significant difference in trials reporting positive outcomes for the study intervention between registered and unregistered trials.

Conclusion: Approximately 60% of published antidepressant and antipsychotic drug trials during July to December 2014 were registered. Unregistered trials were less likely to report important methodological details.     

Best Practice to Order Authors in Multi/Interdisciplinary Health Sciences Research Publications

Misunderstanding and disputes about authorship are commonplace among members of multi/interdisciplinary health research teams. If left unmanaged and unresolved, these conflicts can undermine knowledge sharing and collaboration, obscure accountability for research, and contribute to the incorrect attribution of credit. To mitigate these issues, certain researchers suggest quantitative authorship distributions schemes (e.g., point systems), while others wish to replace or minimize the importance of authorship by using “contributorship”—a system based on authors’ self-reporting contributions. While both methods have advantages, we argue that authorship and contributorship will most likely continue to coexist for multiple ethical and practical reasons. In this article, we develop a five-step “best practice” that incorporates the distribution of both contributorship and authorship for multi/interdisciplinary research. This procedure involves continuous dialogue and the use of a detailed contributorship taxonomy ending with a declaration explaining contributorship, which is used to justify authorship order. Institutions can introduce this approach in responsible conduct of research training as it promotes greater fairness, trust, and collegiality among team members and ultimately reduces confusion and facilitates resolution of time-consuming disagreements.     

Making Professional Decisions in Research: Measurement and Key Predictors

The professional decision-making in research (PDR) measure was administered to 400 National Institutes of Health (NIH)-funded and industry-funded investigators, along with measures of cynicism, moral disengagement, compliance disengagement, impulsivity, work stressors, knowledge of responsible conduct of research (RCR), and socially desirable response tendencies. Negative associations were found for the PDR and measures of cynicism, moral disengagement, and compliance disengagement, while positive associations were found for the PDR and RCR knowledge and positive urgency, an impulsivity subscale. PDR scores were not related to socially desirable responding, or to measures of work stressors and the remaining impulsivity subscales. In a multivariate logistic regression analysis, lower moral disengagement scores, higher RCR knowledge, and identifying the United States as one’s nation of origin emerged as key predictors of stronger performance on the PDR. The implications of these findings for understanding the measurement of decision-making in research and future directions for research and RCR education are discussed.     

Research as Profession and Practice: Frameworks for Guiding the Responsible Conduct of Research

Programs in the responsible conduct of research (RCR) vary between institutions, demonstrated by disparate structures and goals. These variations may be attributed to the absence of grounding frameworks within which to examine research and RCR education programs. This article examines research as a practice and a profession, using these frames to draw out defining features of research and the moral obligations entailed. Situating research within virtue ethics can clarify how researchers might cultivate the virtues necessary for meeting its obligations and aims. By elucidating these features, these perspectives can serve to guide the development of RCR education programs.     

Expanding the Scope of Responsible Conduct of Research Instruction

We argue that responsible conduct research (RCR) instruction should be extended beyond students and trainees funded by the National Institutes of Health (NIH) or National Science Foundation (NSF) to include all students, trainees, faculty, and research staff involved in research. Extending the scope of RCR instruction can help institutions develop and maintain an environment that promotes ethical research conduct. Universities and scientific organizations have objected to expanding the scope of RCR instruction on the grounds that it would be a major undertaking that would require the expenditure of additional institutional resources. We argue, however, that expanding the scope of RCR instruction can be done efficiently without placing undue burdens on institutions.     

Cross-Field Comparison of Ethics Education: Golden Rules and Particulars

Research misconduct negatively impacts the scientific community and society in general. Providing training in the responsible conduct of research (RCR) to researchers is one viable approach to minimizing research misconduct. Although recent evidence suggests ethics training can indeed be effective, little empirical work has examined the similarities and differences across fields. In the present study, we analyzed 62 empirical studies in engineering, biomedical science, social science, and mixed fields. The findings suggest certain instructional principles, or “golden rules,” apply generally to all fields. These golden rules include maintaining a field-specific or field-general approach and emphasizing processes in training. The findings also suggest that content areas contributing to instructional effectiveness vary as a function of field. Generally, it appears that all fields may benefit from taking a multi-pronged approach to ethics education wherein the salient field issues are covered. Implications for RCR education are discussed.     

Infusing Research Integrity Principles and Practices into a Regional Master's Degree–Intensive University: A Case Study

The need for institutions of higher education to advance research and scholarly integrity across graduate degree programs involves a strong commitment from each institution to develop a comprehensive approach for promoting responsible conduct of research (RCR). In response to this need, one master's-intensive regional university implemented a three-tier model project (focusing, developing, and evaluating/sustaining) for infusing research integrity principles and practices while promoting RCR. Components of the model and implementation strategies are presented as a case study analysis. Implications of the model for promoting the RCR are projected relative to graduate programs focused on applied research.     

The Responsible Conduct of Bioethics Research

The responsible conduct of research in the biomedical and behavioral sciences has received significant attention since the late 1980s. However, very little has been written about the responsible conduct of bioethics research. Bioethics is an interdisciplinary field and brings together divergent ethical standards and practices which may be the source of tension or conflict. This article argues that bioethicists should reflect more on ethical issues in the responsible conduct of bioethics research through examination of authorship practices and peer review. I also outline three possible approaches to promote research integrity in bioethics.     

Rescuing Responsible Conduct of Research (RCR) Education

Responsible conduct of research (RCR) education requirements, resources, and research have proliferated over the past twenty years, but evidence and experience highlight shortcomings in many domains: goals, audience, content, teaching tools, use of the Internet for instruction, instructors, allocation of responsibility for education, education requirements, and sources of funding. Revised approaches and suggested roles and responsibilities are proposed to meet these challenges. The unifying theme for these recommendations is to shift the focus from RCR education to RCR culture building.