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.     

Team-Based Learning Instruction for Responsible Conduct of Research Positively Impacts Ethical Decision-Making

Common practices for responsible conduct of research (RCR) instruction have recently been shown to have no positive impact on and possibly to undermine ethical decision-making (EDM). We show that a team-based learning (TBL) RCR curriculum results in some gains in decision ethicality, the use of more helpful metacognitive reasoning strategies in decision-making, and elimination of most negative effects of other forms of RCR instruction on social–behavioral responses. TBL supports the reasoning strategies and social mechanisms that underlie EDM and ethics instruction, and may provide a more effective method for RCR instruction than lectures and small group discussion.     

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.     

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.     

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.     

Research ethics review for the use of anonymized samples and data: A systematic review of normative documents

While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized research, and what the considerations in said ethics review would be. The review of normative documents issued by both national and international level organizations reveals a growing concern over the ability of anonymization procedures to prevent against reidentification. This is particularly true in the context of genomic research where genetic material’s uniquely identifying nature along with advances in technology have complicated previous standards of identifiability. Even where individual identities may not be identifiable, there is the risk of group harm that may not be protected by anonymization alone. We conclude that the majority of normative documents support that the review of an ethics committee is necessary to address the concerns associated with the use of anonymized samples and data for research.     

Qualitative Evaluation Methods in Ethics Education: A Systematic Review and Analysis of Best Practices

Although qualitative research offers some unique advantages over quantitative research, qualitative methods are rarely employed in the evaluation of ethics education programs and are often criticized for a lack of rigor. This systematic review investigated the use of qualitative methods in studies of ethics education. Following a review of the literature in which 24 studies were identified, each study was coded based on 16 best practices characteristics in qualitative research. General thematic analysis and grounded theory were found to be the dominant approaches used. Researchers are effectively executing a number of best practices, such as using direct data sources, structured data collection instruments, non-leading questioning, and expert raters. However, other best practices were rarely present in the courses reviewed, such as collecting data using multiple sources, methods, raters, and timepoints, evaluating reliability, and employing triangulation analyses to assess convergence. Recommendations are presented for improving future qualitative research studies in ethics education.     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Enriching our understanding of vulnerability through the experiences and perspectives of individuals living with mental illness

ABSTRACT

Vulnerability is a central concept in research ethics and typically serves to identify individuals or groups whose participation in research prompts specific concerns or warrants special consideration. While theoretical discussions on vulnerability have contributed valuable insights to discussions of mental health research and care, they have not been enriched thus far by stakeholder perspectives. This oversight has important consequences for the ways in which we frame vulnerability. It misses the far-reaching insights and experiential knowledge of mental health research participants whose experiences this ethics concept ultimately seeks to capture. In view of this gap, our study combines a pragmatist ethics framework and interpretive phenomenological analysis of qualitative interviews to explore user perspectives on the notion of vulnerability through the lived experiences of mental health research participants and patient-advocates. Importantly, these perspectives offer essential clues to address the difficulties of operationalizing concerns for vulnerability in concrete and practical ways. They help refine our understanding of this key ethics concept.     

Whistle blowing and research integrity: Potential remedy for research misconduct in Malaysian institutions of higher education

This study found that less than half of the respondents are willing to blow the whistle. The results reveal that a lack of protection with regard to the whistleblower’s identity, the tedious investigative process, and the notion of avoiding confrontation, which is more apparent in Asian cultures as compared to the West, are among the reasons why individuals who witnessed misconduct chose to remain silent. Adhering to the Asian cultural upbringing where the young must respect the old, those of lower rank must obey those with higher authority, and subordinates do not question the actions of their superior, has become a norm even in the working environment. Therefore, emphasize the need for better protection for whistleblowers including using experienced individuals with a research ethics background to handle allegations from whistleblowers. In addition, established guidelines and procedures for whistleblowers with regard to voicing their allegations against colleagues engaged in research misconduct is still lacking or, to a certain extent, is still unknown to researchers. Thus, the concern indicates a need for institutions to create awareness among researchers regarding the existing platform for whistleblowers, or to develop a systematic and clear procedure which is reliable and independent to promote professionalism in academia.     

Asian Public Concern over the Ethics of Scientists: Predictors and Implications for Research Ethics

The following two research questions were examined in this study: 1) What is the public's level of concern with ethics in science; and 2) Are religious affiliation, religious involvement, and education predictors of that concern in Asia? The sample includes 7,963 men and women between the ages of 20 and 59 from ten Asian countries. An overall low level of relative concern toward ethics in science was reported. Lower educational attainment was associated with lower odds of concern. Christian religious affiliation and moderate religious involvement were also associated with lower odds of concern. This article highlights the importance of more active research into social perspectives on ethics in science.     

On instructional science and instructional technology

Against the background of contemporary new views, approaches and methods of teaching and training, it is assumed that we are faced with the emergence of a new branch of science, a science of instruction, located somewhere between the psychology of learning and educational work. This science of instruction is carefully distinguished from the much discussed technology of education, a term which is reserved for the field of application (praxis) alone.The most characteristic requirement of a science of instruction is that it must provide operational rules, so-called operative precepts with reference to well-defined forms of learning. Another fundamental distinction in the paper is made between operative and normative precepts.Examples of certain types of operative precepts are discussed, which in the main have bearing upon the technology of education called programmed instruction; they belong to a body of operative, instructional precepts, which could be traced to a developing science of instruction.Finally some concepts and functions of instruction are dealt with and it is stressed that this field of application, in order to secure the necessary basis of decision, must be rooted on the one hand in a science of instruction capable of developing operative rules, and on the other hand in a philosophy of education whence it can derive its normative precepts.     

'Text-work' in Research Ethics Review: The significance of documents in and beyond committee meetings

ABSTRACT

This article analyzes how a formal text (the Ethics Review Form) available at National Health Service Research Ethics Committees (NHSRECs) in the United Kingdom was used in meetings. Derived from the work of Dorothy Smith on incorporating texts into institutional ethnography (IE), it proposes the concept of “text work” as a way into understanding more about decision-making in ethics review and describes the extent to which this formal text shaped and influenced review work. The research study used observations of committee meetings, field-notes and interviews to produce an ethnographic mapping of Research Ethics Committees’ (RECs) work. This article draws on one aspect of the research which was the process of isolating a particular, ubiquitous text and analyzing how it worked and was worked on in the meetings. The analysis contributes to contemporary discussion offering an alternative to ongoing debates about idealized ways of conducting ethics review. Finally, some tentative suggestions are made about improving training, based on and starting from the work which reviewers undertake.     

Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e., consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and Institutional Review Board (IRB) requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process.     

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.     

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.     

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.     

RCR Online Course: Build an Online Course to Augment RCR Training Using Evidenced-Based Learning Theory

This article demonstrates how to apply evidenced-based instructional design principles to develop a supplemental, online Responsible Conduct of Research (RCR) course. The supplement RCR course may serve to appropriately augment the National Institutes of Health (NIH) required RCR training. The way to ensure that an online RCR course is effective is to incorporate evidence-based learning theories into the development of the course content. This article specifically demonstrates application of Bloom's taxonomy and Gagne's Nine Instructional Events to a research misconduct course. At the conclusion, the reader will be able to apply evidence-based learning theories to the development of any online course.