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.     

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.     

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.     

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.     

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.     

Authorship and publication practices: evaluation of the effect of responsible conduct of research instruction to postdoctoral trainees

We have studied postdoctoral trainees funded by NIH F32 fellowship awards in order to test the effectiveness of responsible conduct of research (RCR) education in the areas of authorship and publication practices. We used a 3-wave telephone and on-line survey design, conducted over a period of two years, in order to test for individual change before and after completing RCR education. Overall the responses of the subjects suggested a clear awareness of standards and practices in publication. However, our results failed to suggest that RCR education in this group significantly increased the level of ethically appropriate behavioral responses measured in the study. Similarly we saw no significant effect on increasing awareness of or attention to ethical guidelines about authorship and publication practices. Our interpretation of these null findings was influenced by the significant publication experience of our cohort of subjects. We forward possible explanations for these null findings in this context. Most importantly, we do not suggest that our results argue against continued instruction in RCR education. Instead, we believe our data reinforce the importance of careful articulation of course goals and objectives with attention to the background and experience of the student audience when developing RCR curricula.     

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.     

Practice and Outcomes of Multidisciplinary Research for Environmental Sustainability

Since about 1990, when sustainability became a key concept for a wide range of scientific disciplines, the need for multidisciplinary collaboration has increased. We present five illustrative cases from the long-standing environmental research work at the University of Groningen. The projects described are about hazardous materials risk, odor annoyance, energy scenario evaluation, climate decision analysis, and household consumption, respectively. The various case discussions emphasize experiences in research conceptualization, project design and execution, main findings, policy advice and surplus value, and difficulties met. Conclusions and recommendations are presented about the practice of multidisciplinary research. Finally, some challenges for research and development about environmental sustainability are discussed.     

Integrating the teaching,learning and assessment of communication with children within the qualifying social work curriculum

Qualifying social work education must provide students with a variety of experiential, personalized, participatory, didactic and critically reflective learning opportunities across both the taught curriculum and in practice placements if deep learning of the capabilities needed for effective communication with children and young people is to be ensured. At present, programmes in England are not consistent in the curriculum structures, content and pedagogical approaches they are employing to teach and assess this topic. This paper discusses first how current proposals for the reform of qualifying education in England do not address the ambiguities and discretion in regulatory guidance, which have meant that the place and relevance of this topic within the curriculum remain uncertain and contested. It then draws on a model of the sequencing of students' learning and development in qualifying training, developed through the author's recent empirical research, to present an integrated and coherent approach to the teaching, learning and assessment of this topic. It is proposed that this strategy will enable students to develop the generic, ‘child‐focused’ and ‘applied child‐specialist’ capabilities they need for the ‘knowing’, ‘being’ and ‘doing’ of effective communication with children.     

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.     

Outcomes of permanent family placement for children of minority ethnic origin

The paper explores the outcomes of permanent family placement for children of minority ethnic origin, using a sample of 254 placements drawn, in the main, from a cohort of 1165 British children placed between 1980 and 1985. Statistical techniques are used to explore the relationship between 'success' (defined, for the purposes of this paper, as the placement not known to have broken down) and a range of variables, including the characteristics of the child, the birth parents and the adoptive parents, and the type of placement. In most respects, the findings are consistent with those of similar studies. Age at placement is found to have an important effect, with success least likely for children placed in the middle age range. Lack of problem behaviours in the children at the time of placement is also found to be associated with success. Variables which are found to have no effect on the probability of success include ethnic origin of the child, whether it is an adoptive or permanent foster placement, and whether contact with birth parents continued after placement. There was an interesting gender effect in that boys did better in 'transracial' than in 'matched' placements, but the opposite was the case for girls.     

Attitudes towards using animals in research and teaching: opinions from a selected group of female secondary school students

Abstract

This research provides details about a group of young New Zealand women's awareness of, interest in and attitudes towards the use of animals in scientific research and teaching. These findings were compared to a similar survey of the New Zealand public. An adapted, anonymous questionnaire was used to gather data from 90 young women (14–15 years) from an urban secondary school. While nearly half expressed concern about animal use in research (43%), their awareness was not consistent with the reality of animal research in New Zealand, either in terms of its impact on animals or animal species used. They were unconcerned about the use of animals in teaching and associated such use with enhanced learning. Justification for the use of animals in research and teaching was shown to be complex and contextualized, with an instrumental qualifier being used to justify their opinions. Even though many students were unaware of the regulations surrounding animal use in research and teaching, they were mistrustful that these regulations were being followed by scientists. Instead, their trust was placed in the SPCA and in veterinarians.     

Evaluation of Support Groups for Child Abuse Prevention: Outcomes of Four State Evaluations

ABSTRACT

Parent support groups have grown in popularity as a strategy for preventing child maltreatment, but there have been few evaluations of these groups. The purpose of this paper is twofold. One goal is to identify some of the major challenges in the evaluation of parent support groups and to provide strategies for minimizing these potential difficulties. The second goal is to illustrate successful evaluations of parent support groups (i.e., the Circle of Parents® program) in four states. Three of these states used a retrospective pretest method. Outcomes indicated positive performance across all domains of functioning, as measured by a self-report questionnaire. Strengths and limitations of the evaluations are discussed, and recommendations for future evaluations are provided.