Awareness of publication guidelines and the responsible conduct of research

We have conducted a longitudinal survey of NIH-funded F32 postdoctoral fellows to determine if mandated instruction in the responsible conduct of research (RCR) has measurable effects on awareness of, attentiveness to, and behavioral judgments about research ethics and authorship and publication. Of 418 F32 fellows participating in the study, 50% were aware of and had referred to guidelines on authorship and publication practices while 50% were either unaware of or had not referred to guidelines. Groups were similar with regard to total number of peer-reviewed publications and total number of first author publications, years of research experience, years since completing their doctoral degree, and receipt of RCR training. The equal distribution of guideline awareness and use, and group similarities with regard to career development and achievement provided us with an opportunity to consider whether awareness of and use of guidelines is associated with broader judgments about author roles and responsibilities. The findings suggest that awareness and utilization of guidelines are, at best, only modestly associated with more ethically appropriate judgments and attitudes about author roles and responsibilities among novice F32's.     

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.     

Assessing the educational literature in the responsible conduct of research for core content

To determine core content for RCR instruction, content analysis was conducted using key instructional resources for ORI's nine RCR "core instructional areas". Topics discussed in these key RCR resources were identified and their frequency across resources was tabulated. Topics covered most frequently were judged to be core content. Although key educational resources cited a variety of references, specific topics and issues addressed were generally consistent across the materials examined. Nonetheless, key resources varied in organization and depth of coverage for core instructional areas. Recent resources were more systematic and comprehensive than earlier works. This was particularly evident in materials about human participant research, conflicts of interest, and data management and sharing. Key resources presented additional "non-core" issues, such as scientific values, ethical principles, creativity and objectivity, moral reasoning, genetics, epidemiological issues, and scientists' societal roles, suggesting that ORI's core instructional areas should be reconfigured or expanded. Because educational material available on RCR and professionalism was so comprehensive, we recommend that ORI consider research integrity, not research misconduct, as one core instructional area. We also recommend that compliance with research regulations be restored as a core instructional area to accentuate ethical, financial and legal requirements related to acceptance of federal funding.     

Outcomes assessment of role-play scenarios for teaching responsible conduct of research

We describe the summative assessment of role-play scenarios that we previously developed to teach central topics in the responsible conduct of research (RCR) to graduate students in science and engineering. Interviews with role-play participants, with participants in a case discussion training session, and with untrained students suggested that role-playing might promote a deeper appreciation of RCR by shifting the focus away from wanting to simply "know the rules." We also present the results of a think-aloud case analysis study and describe the development of a behaviorally-anchored rating scale (BARS) to assess participants' case analysis performance.     

Teaching and learning responsible research conduct: influences of prior experiences on acceptance of new ideas

Despite requirements for Responsible Conduct of Research (RCR) training, little is known about how much this training actually influences the thinking and behaviors of participants. Interview-based qualitative research methods were used to study the reactions of Ph.D. students and postdoctoral fellows to what was taught in an RCR course. For trainees with limited prior RCR experience, or who agreed with what was taught, it was relatively easy to influence their attitudes and how they thought they would use the new information in the future. However, if their prior experiences or existing knowledge conflicted with what was taught they resisted and often rejected new ideas that were presented. Interviews also revealed the tremendously complex process trainees must undergo trying to resolve or integrate all of the different perspectives they receive on RCR from other sources. These results revealed the importance of viewing RCR training from the perspective of learning theory and how prior knowledge influences what people learn. The results also support the need for periodic rather than one-time RCR training to counter the often conflicting views and practices young scientists experience in real-life research settings.     

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.     

Mapping responsible conduct in the uncharted field of research-creation: A scoping review

This scoping review addresses the issues of responsible conduct of research (RCR) that can arise in the practice of research-creation (RC), an emergent, interdisciplinary, and heterogeneous field at the interface of academic research and creative activities. Little is yet known about the nature and scope of RCR issues in RC, so our study examined three questions: (1) What are the specific issues in RC in relation to RCR? (2) How does the specificity of RC influence the understanding and practice of RCR? (3) What recommendations could help address the issues highlighted in the literature? To answer these questions, we conducted a scoping review of the academic literature (n = 181 texts) dealing with RCR in RC. We found that researcher-creators faced some very different RCR challenges in comparison with their colleagues in the rest of academia. Addressing these issues is important for both the RCR and RC communities in order to ensure that the rapid development of this field occurs in line with the norms of RCR which, nonetheless, should be adapted to respect the particularities of RC and allow its contributions to the academic world.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Orphan Papers and Ghostwriting: The Case against the ICMJE Criterion of Authorship

Although popular, I argue that the International Committee of Medical Journal Editors (ICMJE) account of authorship is flawed. It inadvertently allows for practices that it was designed to prevent. In addition, it creates a new category of authorless papers—orphan papers. The original World Association of Medical Editors (WAME) criterion is preferable.     

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.     

Linking the university and the social agency in collaborative evaluation research: principles and examples

This paper presents an analysis of components of successful social work evaluation research practice. Among the key obstacles to successful evaluations of social work intervention are the impoverished knowledge base on which many social work interventions are based, the isolation of researchers and practitioners in the conduct of evaluations, and during research implementation failure to cope with the changing field context. To remedy this situation social work needs to invest in university and social agency partnerships focussed on knowledge building for the profession. In such partnerships the traditional roles of the researcher and the practitioner are altered so that shared responsibility for knowledge development is possible. In addition, to deal with changing field contexts the research team needs to be continuously engaged in problem solving and redesign. An initial example of such a partnership is described together with a case study illustrating implementation of a multi-site field experiment evaluation.     

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.     

Results of a survey on research practices,completed by attendees at the third conference on research policies and quality assurance

A survey was conducted to evaluate the responses of attendees at the Third Conference on Research Policies and Quality Assurance, in May, 1993, as to their perceptions of the frequency of questionable research studies, the desirability of good research practices (GRP) guidelines, and whether all research organizations should perform routine data audits. The vast majority of respondents had suspicions or evidence of other researchers performing questionable studies. Most respondents supported the development of GRP guidelines and preferred that they not be in the form of federal regulations. Most respondents also favored routine data audits.     

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.     

Spare the rod and spoil the child: Samoan perspectives on responsible parenting

Abstract

Cultural groups hold different beliefs, values and understandings that shape the way people parent. From a Samoan perspective, raising children as good citizens involves ensuring that children know how to behave appropriately. If necessary, there is a place for reasonable physical discipline. Moreover, many believe that the way western parents and teachers relate to children is socially irresponsible. This paper explores Samoan understandings of responsible parenting. It argues the case for cultural difference in approaches to parenting, and for the emergence of a ‘third space’ in which cultural groups negotiate the globalizing pressures of Western values. The paper draws on an emerging research literature and interviews with students, teachers and parents in Samoa. The study has implications for educators, social workers and policy makers in New Zealand and other Pacific Rim countries where Samoans form a significant proportion of a rapidly growing Pacific population.     

Empathy and socially responsible consumption: an experiment with the vote-with-the-wallet game

Theory and Decision - We study by means of a laboratory experiment the role of individuals’ empathy in the Vote-with-the-Wallet Game. Our main purpose is to analyze the impact of the ability...