Impact and Assessment of Research Integrity Teaching: A Systematic Literature Review.

Presented here is a systematic literature review of what the academic literature asserts about: (1) the stages of the ethical decision-making process (i.e. awareness, reasoning, motivation, and action) that are claimed to be improved or not improved by RI teaching and whether these claims are supported by evidence; (2) the measurements used to determine the effectiveness of RI teaching; and (3) the stage/s of the ethical decision-making process that are difficult to assess. Regarding (1), awareness was the stage most claimed to be amenable to improvement following RI teaching, and with motivation being the stage that is rarely addressed in the academic literature. While few, some sources claimed RI teaching cannot improve specific stages. With behaviour (action) being the stage referenced most, albeit in only 9% of the total sources, for not being amenable to improvement following RI teaching. Finally, most claims were supported by empirical evidence. Regarding (2), measures most frequently used are custom in-house surveys and some validated measures. Additionally, there is much debate in the literature regarding the adequacy of current assessment measures in RI teaching, and even their absence. Such debate warrants caution when we are considering the empirical evidence supplied to support that RI teaching does or does not improve a specific stage of the decision-making process. Regarding (3), only behaviour was discussed as being difficult to assess, if not impossible. In our discussion section we contextualise these results, and following this we derive some recommendations for relevant stakeholders in RI teaching.

Training needs of health researchers in research ethics in Cameroon: a cross-sectional study.

BACKGROUND: Researchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon. METHODS: It was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants' exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants. RESULTS: Of 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants' protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31-7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant's protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles. CONCLUSION: The coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.

Teaching broader impacts of science with undergraduate research.

Science plays an important role in most aspects of society, and scientists face ethical decisions as a routine part of their work, but science education frequently omits or segregates content related to ethics and broader impacts of science. Undergraduate research experiences have the potential to bridge traditional divides in education and provide a holistic view of science. In practice, these experiences can be inconsistent and may not provide the optimal learning environment. We developed a course that combines seminar and independent research elements to support student learning during undergraduate research, makes ethical and societal impacts of science clear by relating them to the students' own research projects, and develops students' ethical decision-making skills. Here, we describe the course and provide resources for developing a similar course.

Evolution of research ethics in a low resource setting: A case for Uganda.

BACKGROUND: The globalization of clinical research in the last two decades has led to a significant increase in the volume of clinical research in developing countries. As of 2016, Uganda was the third largest destination for clinical trials in Africa. This requires adequate capacity and systems to facilitate ethical practice. METHODS: This was a retrospective study involving review of laws, guidelines, policies and records from 1896 to date. RESULTS: Modern medicine evolved from 1896 and by the time of Uganda's independence in 1962, a 1500 bed national referral hospital was in place and a fully-fledged medical school was established at the Makerere University. As the practice of medicine evolved in the country, so did medical research that addressed priority health issues. The growth in modern medicine was not matched with development of research infrastructure and regulatory systems. The first documented regulation of research activities was in 1970 while the first research ethics committee established in 1986 was to facilitate review of research related to the HIV/AIDs pandemic. In 1990 an Act of Parliament was passed to facilitate development and implementation of policies, hence the development of the national guidelines in 1997, training, establishment and accreditation of research ethics committees, conferences and research site monitoring. CONCLUSION: Over the past 120 years, the implementation and structural aspects of research ethics in Uganda have evolved through 70 years of no regulation, followed by 30 years of rudimentary regulation while the last 20 years have shown significant growth in the regulatory system associated with supportive laws, institutionalization of regulatory and training processes.

Ethics for Laboratory Medicine.

BACKGROUND: Laboratory medicine, like other areas of medicine, is obliged to adhere to high ethical standards. There are particular ethical issues that are unique to laboratory medicine and other areas in which ethical issues uniquely impact laboratory practice. Despite this, there is variability in ethics education within the profession. This review provides a foundation for the study of ethics within laboratory medicine. CONTENT: The Belmont Report identifies 3 core principles in biomedical ethics: respect for persons (including autonomy), beneficence (and its corollary nonmalfeasance), and justice. These core principles must be adhered to in laboratory medicine. Informed consent is vital to maintain patient autonomy. However, balancing patient autonomy with the desire for beneficence can sometimes be difficult when patients refuse testing or treatment. The use of leftover or banked samples is fundamental to the ability to do research, create reference intervals, and develop new tests, but it creates problems with consent. Advances in genetic testing have created unique ethical issues regarding privacy, incidental findings, and informed consent. As in other professions, the emergence of highly contagious and deadly infectious diseases poses a difficult ethical dilemma of helping patients while protecting healthcare workers. CONCLUSIONS: Although many clinical laboratorians do not see or treat patients, they must be held accountable to the highest ethical and professional behavior. Recognition and understanding of ethical issues are essential to ethical practice of laboratory medicine.

Purple Dragons and Yellow Toadstools a Versatile Exercise for Introducing Students to Negotiated Consensus.

An activity called Purple Dragons and Yellow Toadstools, originally reported in 1987 as a training activity for jurors, was adapted as a priming exercise for a unit on teaching research ethics with undergraduate students. In this activity, learners develop skills for building negotiated consensus. The procedure involves individuals' ranking 10-15 moral transgressions and/or legal violations followed by a small group discussion in order to arrive at an agreed-upon ranking by the team. The framework has proved to be quite flexible, adaptable to different subject areas and with different populations of students.

Using Student Engagement to Relocate Ethics to the Core of the Engineering Curriculum.

One of the core problems with engineering ethics education is perceptual. Although ethics is meant to be a central component of today's engineering curriculum, it is often perceived as a marginal requirement that must be fulfilled. In addition, there is a mismatch between faculty and student perceptions of ethics. While faculty aim to communicate the nuances and complexity of engineering ethics, students perceive ethics as laws, rules, and codes that must be memorized. This paper provides some historical context to better understand these perceptual differences, and suggests that curriculum constraints are important contributing factors. Drawing on the growing scholarship of student engagement approaches to pedagogy, the paper explores how students can be empowered to effect change in the broader engineering curriculum through engineering ethics. The paper describes a student engagement approach to pedagogy that includes students as active participants in curriculum design-a role that enables them to critically reflect about why ethics is a requirement. Including students in the process of curriculum design leads students to reframe ethics as an integrative tool with the capacity to bring together different engineering departments and build bridges to non-engineering fields. This paper argues that students can and should play an active and important role in relocating ethics from the periphery to the core of the engineering curriculum.

A New Method for a Virtue-Based Responsible Conduct of Research Curriculum: Pilot Test Results.

Drawing on Pennock's theory of scientific virtues, we are developing an alternative curriculum for training scientists in the responsible conduct of research (RCR) that emphasizes internal values rather than externally imposed rules. This approach focuses on the virtuous characteristics of scientists that lead to responsible and exemplary behavior. We have been pilot-testing one element of such a virtue-based approach to RCR training by conducting dialogue sessions, modeled upon the approach developed by Toolbox Dialogue Initiative, that focus on a specific virtue, e.g., curiosity and objectivity. During these structured discussions, small groups of scientists explore the roles they think the focus virtue plays and should play in the practice of science. Preliminary results have shown that participants strongly prefer this virtue-based model over traditional methods of RCR training. While we cannot yet definitively say that participation in these RCR sessions contributes to responsible conduct, these pilot results are encouraging and warrant continued development of this virtue-based approach to RCR training.

Ethics Across the Curriculum: Prospects for Broader (and Deeper) Teaching and Learning in Research and Engineering Ethics.

The movements to teach the responsible conduct of research (RCR) and engineering ethics at technological universities are often unacknowledged aspects of the ethics across the curriculum (EAC) movement and could benefit from explicit alliances with it. Remarkably, however, not nearly as much scholarly attention has been devoted to EAC as to RCR or to engineering ethics, and RCR and engineering ethics educational efforts are not always presented as facets of EAC. The emergence of EAC efforts at two different institutions-the Illinois Institute of Technology and Utah Valley University (UVU)-provide counter examples. The remarkably successful UVU initiative gave birth to EAC as a scholarly movement and to the associated Society for Ethics Across the Curriculum. EAC initiatives at the Colorado School of Mines, however, point up continuing institutional resistances to EAC. Finally, comparative reflection on successes and failures can draw some lessons for the future. One suggestion is that increasing demands for accountability and pedagogical research into what works in teaching and learning offers special opportunities.

Beyond the Belmont Principles: A Community-Based Approach to Developing an Indigenous Ethics Model and Curriculum for Training Health Researchers Working with American Indian and Alaska Native Communities.

Individuals responsible for carrying out research within their diverse communities experience a critical need for research ethics training materials that align with community values. To improve the capacity to meet local human subject protections, we created the research Ethics Training for Health in Indigenous Communities (rETHICS), a training curriculum aligned within American Indian and Alaska Native (AI/AN) context, culture, and community-level ethical values and principles. Beginning with the Belmont Report and the Common Rule that defines research with human subjects (46 CFR 45), the authors convened three different expert panels (N = 37) to identify Indigenous research values and principles common across tribal communities. The resulting culturally grounded curriculum was then tested with 48 AI/AN individuals, 39 who also had recorded debriefing interviews. Using a thematic analysis, we coded the qualitative feedback from the expert panel discussions and the participant debriefings to assess content validity. Participants identified five foundational constructs needed to ensure cultural-grounding of the AI/AN-specific research training curriculum. These included ensuring that the module was: (a) framed within an AI/AN historical context; (b) reflected Indigenous moral values; (c) specifically linked AI/AN cultural considerations to ethical procedures; (d) contributed to a growing Indigenous ethics; and (e) provided Indigenous-based ethics tools for decision making. Using community-based consultation and feedback from participants led to a culturally grounded training curriculum that teaches research ethical principles and procedures for conducting research with AI/ANs. The curriculum is available for free and the community-based process used can be adapted for other cultural groups.

Research Ethics: Researchers Consider How Best to Prevent Misconduct in Research in Malaysian Higher Learning Institutions Through Ethics Education.

The purpose of this study is to encourage and highlight discussion on how to improve the teaching of research ethics in institutions of higher education in Malaysia. Drawing on semi-structured interviews with 21 academics in a research-intensive university in Malaysia, interviewees agreed on the importance of emphasizing the subject of research ethics among students, as well as academics or researchers. This study reveals that participants felt that there is an urgent need to improve the current awareness and knowledge of issues related to misconduct in research among students and academics. The results of this study indicate a need for better teaching on the subject of research ethics in order to prevent misconduct in research. Finally, it concludes with suggestions that there should be a clear definition of research misconduct, to include consequences when engaging in misconduct; a separate research ethics syllabus for pure and social sciences should be conducted; research ethics should be implemented as a core subject, and there should be an early intervention and continuous learning of research ethics, with an emphasis on ethics training.

Teaching Responsible Research and Innovation: A Phronetic Perspective.

Across the European research area and beyond, efforts are being mobilized to align research and innovation processes and products with societal values and needs, and to create mechanisms for inclusive priority setting and knowledge production. A central concern is how to foster a culture of "Responsible Research and Innovation" (RRI) among scientists and engineers. This paper focuses on RRI teaching at higher education institutions. On the basis of interviews and reviews of academic and policy documents, it highlights the generic aspects of teaching aimed at invoking a sense of care and societal obligation, and provides a set of exemplary cases of RRI-related teaching. It argues that the Aristotelian concept of phronesis can capture core properties of the objectives of RRI-related teaching activities. Teaching should nurture the students' capacity in terms of practical wisdom, practical ethics, or administrative ability in order to enable them to act virtuously and responsibly in contexts which are often characterized by uncertainty, contention, and controversy.

Responsible Conduct of Human Subjects Research in Islamic Communities.

In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award (R25) to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills in varied research ethics topics, including research with human subjects. The program provides a master's level curriculum, including practicum experiences. In this article we describe a practicum project to modify an existing introduction to human subjects research for a US audience to be linguistically and culturally appropriate to Arabic-speaking-Islamic communities. We also highlight key differences that guided the conversion of an English version to one that is in Arabic. And finally, as Institutional Review Boards follow the ethical principles of the Belmont Report in evaluating and approving biomedical and behavioral human subjects research proposals, we provide observations on the conformity of the three ethical principles of the Belmont Report with Islam.