ABSTRACT The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries (LMICs). This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has, for the past six (...) years, partnered with three research institutions in Africa (University of Botswana, Makerere University in Uganda, and the University of Zambia) to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments (the Octagon Model). We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)

Background:The ethics and value bases in healthcare are widely acknowledged. There is a need to improve and raise awareness of ethics in complex systems and in line with competing needs, different stakeholders and patients’ rights. Evidence-based strategies and interventions for the development of procedures and practice have been used to improve care and services. However, it is not known whether and to what extent ethics can be developed using interventions.Objectives:To examine ethics interventions conducted on healthcare professionals and healthcare students to (...) achieve ethics-related outcomes.Research design:A systematic review.Methods:Five electronic databases were searched: CINAHL, the Cochrane Library, Philosopher’s Index, PubMed and PsycINFO. We searched for published articles written in English without a time limit using the keywords: ethic* OR moral* AND intervention OR program OR pre-post OR quasi-experimental OR rct OR experimental AND nurse OR nursing OR health care. In the four-phased retrieval process, 23 full texts out of 4675 citations were included in the review. Data were analysed using conventional content analysis.Ethical consideration:This systematic review was conducted following good scientific practice in every phase.Findings:It is possible to affect the ethics of healthcare practices through professionals and students. All the interventions were educational in type. Many of the interventions were related to the ethical or moral sensitivity of the professionals, such as moral courage and empowerment. A few of the interventions focused on identifying ethical problems or research ethics.Conclusion:Patient-related outcomes followed by organisational outcomes can be improved by ethics interventions targeting professionals. Such outcomes are promising in developing ethical safety for healthcare patients and professionals. (shrink)

Despite the growing body of literature on training in the responsible conduct of research, few studies have examined the effectiveness of delivery formats used in ethics courses. The present effort sought to address this gap in the literature through a meta-analytic review of 66 empirical studies, representing 106 ethics courses and 10,069 participants. The frequency and effectiveness of 67 instructional and process-based content areas were also assessed for each delivery format. Process-based contents were best delivered face-to-face, whereas contents delivered online (...) were most effective when restricted to compliance-based instructional contents. Overall, hybrid courses were found to be most effective, suggesting that ethics courses are best delivered using a blend of formats and content areas. Implications and recommendations for future development of ethics education courses in the sciences are discussed. (shrink)

Drawing on sociological and anthropological studies, the aim of this article is to reconstruct how obstetric technologies contribute to a moral conception of pregnancy and motherhood, and to evaluate that conception from a normative point of view. Obstetrics and midwifery, so the assumption, are value-laden, value-producing and value-reproducing practices, values that shape the social perception of what it means to be a “good” pregnant woman and to be a “good” mother. Activities in the medical field of reproduction contribute to “kinning”, (...) that is the making of particular social relationships marked by closeness and special moral obligations. Three technologies, which belong to standard procedures in prenatal care in postmodern societies, are presently investigated: informed consent in prenatal care, obstetric sonogram, and birth plan. Their widespread application issupposed to serve the moral goal of effecting patient autonomy. A reconstruction of the actual moral implications of these technologies, however, reveals that this goal is missed in multiple ways. Informed consent situations are marked by involuntariness and blindness to social dimensions of decision-making; obstetric sonograms construct moral subjectivity and agency in a way that attribute inconsistent and unreasonable moral responsibilities to the pregnant woman; and birth plans obscure the need for a healthcare environment that reflects a shared-decision-making model, rather than a rational-choice-framework. (shrink)

Increased investment in ethics education has prompted a variety of instructional objectives and frameworks. Yet, no systematic procedure to classify these varying instructional approaches has been attempted. In the present study, a quantitative clustering procedure was conducted to derive a typology of instruction in ethics education. In total, 330 ethics training programs were included in the cluster analysis. The training programs were appraised with respect to four instructional categories including instructional content, processes, delivery methods, and activities. Eight instructional approaches were (...) identified through this clustering procedure, and these instructional approaches showed different levels of effectiveness. Instructional effectiveness was assessed based on one of nine commonly used ethics criteria. With respect to specific training types, Professional Decision Processes Training and Field-Specific Compliance Training appear to be viable approaches to ethics training based on Cohen’s d effect size estimates. By contrast, two commonly used approaches, General Discussion Training and Norm Adherence Training, were found to be considerably less effective. The implications for instruction in ethics training are discussed. (shrink)

In this article I am concerned with reasoning about matters of justice. There is no doubt that justice-reasoning is a significant mode of ethical reasoning and its importance is therefore generally accepted. But there is a considerable debate concerning the role formal justice can play in reasoning about justice. In this paper, I first provide an analysis of formal justice. I then show that the concept of formal justice is identical to one notion of fairness and I illustrate the function (...) of formal justice in reasoning about issues of fairness. In the third section, I argue that formal justice is an essential component of justice tout court and I demonstrate its value for understanding and assessing reasoning about matters of justice. The overall result of this investigation is that formal justice is an important notion that has a special function in moral thinking, which has not been sufficiently appreciated in the literature. (shrink)

Moral theory is an important guide to bioethical decision-making, but it can confuse and mislead those who offer ethical advice to clinicians and researchers, delaying decisions that must be made in a timely fashion. In this paper I examine the ways moral theory can lead bioethicists astray. Absent a sensitivity to the empirical realities of ethical problems, moral theory 1) contributes to the disappearance of the persons caught in an ethical quandary, 2) focuses on the puzzle-solving rather than examining the (...) conditions that generate moral problems, and 3) universalizes ethical dilemmas, overlooking local processes for resolving moral questions. Taken together, empirically informed moral theory and theoretically informed empirical research can help bioethicists transcend the is/ought problem in ethical work. (shrink)

Does responsible conduct of research (RCR) training improve levels of trust between researchers? Using data gathered as part of a survey on the attitudes of master's and doctoral-level students toward RCR, we found that RCR training correlated with a weakened beliefs of students toward their supervisors' ethicality but a stronger belief in the ethicality of their peers. We believe that these findings point to new avenues of research on trust in the academic setting and to needs for curriculum changes in (...) RCR training. (shrink)

Moral theory is an important guide to bioethical decision-making, but it can confuse and mislead those who offer ethical advice to clinicians and researchers, delaying decisions that must be made in a timely fashion. In this paper I examine the ways moral theory can lead bioethicists astray. Absent a sensitivity to the empirical realities of ethical problems, moral theory 1) contributes to the disappearance of the persons caught in an ethical quandary, 2) focuses on the puzzle-solving rather than examining the (...) conditions that generate moral problems, and 3) universalizes ethical dilemmas, overlooking local processes for resolving moral questions. Taken together, empirically informed moral theory and theoretically informed empirical research can help bioethicists transcend the is/ought problem in ethical work. (shrink)

ABSTRACT Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana (UB). We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then (...) assembled Focus Group Discussions (FGDs) to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions. (shrink)

Conventional medical training offers little help to students to resolve the ethical dilemmas they face as healthcare professionals. Public awareness of the ethical behavior of medical practitioners has been growing. Aim of this study was to assess knowledge of, practice in and attitudes of healthcare ethics among medical, dental and physiotherapy postgraduate students. A cross-sectional analysis based on a questionnaire was performed at a hospital and dental institution of the medical college. The present study included 60 postgraduate students. The questionnaire (...) on health care ethics is a 44-point self-administered standardized questionnaire that poses ethical dilemmas in 5 vignettes with closed-ended questions to test awareness, attitude and experience in the area of healthcare ethics. In the first half of the questionnaire, knowledge and attitude were assessed using 5 case scenarios representing ethical dilemmas and the participants answered the questions using the 5 point likert scale. The second half assessed the practice of Ethics in research and clinical practice. The expected time to fill each questionnaire was about 10–15 min. 62 questionnaires were distributed. 60 completed questionnaires were returned. The response rate was 96%. The mean age of the postgraduates was 26.23 ± 2.33. Among the participants 28 were male and 32 female. 20 completed questionnaires from each, medical, dental and physiotherapy postgraduate students were collected. The multiple group comparison showed that the difference in the knowledge scores were statistically significant between dental and physiotherapy and between medical and physiotherapy but no significant difference between medical and dental. Study suggests that abstract knowledge cannot be converted into practical knowledge automatically. There is a major lack of knowledge of the ethics of health care among graduate students. The postgraduate curriculum must include a good mix of both theoretical concepts and practical application of multidisciplinary healthcare ethics ethical principles and guidelines. (shrink)

Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire that was distributed to a convenience sample of post-graduates (...) at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were “fully aware” of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar. (shrink)

Background Despite the implementation of codes and declarations of medical research ethics, unethical behavior is still reported among researchers. Most of the medical faculties have included topics related to medical research ethics and developed ethical committees; yet, in some cases, unethical behaviors are still observed, and many obstacles are still conferring to applying these guidelines. Methods This cross-sectional questionnaire-based study was conducted by interviewing randomly selected 331 Lebanese physicians across Lebanon, to assess their awareness, knowledge and attitudes on practice regarding (...) international and national research ethics guidelines and scientific misconduct and misbehaviors. Results Our results revealed that although majority of participants declared familiar with ethical principles governing research that involves human subjects, the overall mean score achieved on their knowledge questions was 46%. Only 27.4% are aware of the presence of the Lebanese National Consultative Committee on Ethics, with only half of them aware of its functions and only 25.7% know about the charter of ethics and guiding principles of scientific research in Lebanon. Significant higher levels of research ethics knowledge were recorded among Ph.D. degree-holding subjects, higher university positions as in professors, research ethics trainings-attendees, and physicians with prior research experience. A significant correlation was observed between knowledge of research ethics principles and positive attitudes toward research ethics principles. Noteworthy, we found that more than one third of participants have reported witnessing scientific misconduct and misbehaviors at some period of their careers. Conclusions The presence of low mean awareness levels regarding research ethical principles among the study population of physicians and high levels of perception of scientific misconduct raises concern on the importance of implementing proper training for physicians on research ethics. (shrink)

This study examines the historical beginnings of Bioethics in Nigeria and West Africa. Specifically, it highlights the major events that shaped the progress of Bioethics in Nigeria and West Africa, and evaluate the impacts Bioethics has had on the region. In the final analysis, this study makes recommendations regarding how advanced institutes can complement the efforts of bioethicists in West African Countries. West African Bioethics Training Programs have significantly contributed to the pool of competent bioethicists, academics, health professionals and ethics (...) committee members with requisite knowledge to design, evaluate, monitor, conduct and report studies without misconduct. There is still much, however, that remains to be done. Nevertheless, advanced Bioethics and biomedical institutes can take advantage of the accomplishments achieved so far, by helping to strengthen the WAB Training Programs through fellowships, exchange programs or other additional educational programs. (shrink)

Research is increasingly recognised as a key component of medical curricula, offering a range of benefits including development of skills in evidence-based medicine. The literature indicates that experienced academic supervision or mentoring is important in any research activity and positively influences research output. The aim of this project was to investigate the human research ethics experiences and knowledge of three groups: medical students, and university academic staff and clinicians eligible to supervise medical student research projects; at two Australian universities. Training (...) in research ethics was low amongst academic staff and clinicians eligible to supervise medical student research. Only two-thirds of academic staff and students and less than half of clinicians surveyed indicated that specific patient consent was required for a doctor to include patient medical records within a research publication. There was limited awareness of requirements for participant information and consent forms amongst all groups. In the case of clinical trials, fewer clinicians and students than academics indicated there was a requirement to obtain consent. Awareness of the ethics committee focus on respect was low across all groups. This project has identified significant gaps in human research ethics understanding among medical students, and university academic staff and clinicians. The incorporation of research within medical curricula provides the impetus for medical schools and their institutions to ensure that academic staff and clinicians who are eligible and qualified to supervise students’ research projects are appropriately trained in human research ethics. (shrink)

Background. Ethics are rules or standards governing the conduct of a person or members of a profession. Medical research must be regulated to ensure that fundamental human rights are not breached in the quest for knowledge. Nigeria had no laws or specific guidelines to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee, was established. Its function is to ensure ethical conduct in research and to accredit institutional and state health research ethics committees.Objective. (...) To document the current role of HRECs in the ethical practice of health research in Nigeria, 4 years after the establishment of the NHREC.Methods. Functioning of the HRECs was evaluated via interviews of 14 members of state and institutional HRECs chosen from selected geopolitical zones of the country.Results. The HRECs surveyed had between nine and 15 members, with more males than females. Review meetings were held only occasionally owing to the competing interests of members, who receive no incentives for participation, and poor funding. Scientific and ethical reviews are conducted together by the same committee, but few members of the HRECs are trained in research ethics. Monitoring of research after approval is poor.Conclusion. Nigeria now has about 30 institutional HRECs, but their functioning is hampered by a shortage of both money and qualified individuals to serve on them. (shrink)

In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee . A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. (...) The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network and HREC members in Australia. (shrink)

Background: The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one involved development of an online training module (...) based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha. Results: The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively. Conclusion: The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum. (shrink)

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the (...) training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

This paper describes a three‐year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross‐section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research.Following the training, (...) technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana. We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then assembled Focus (...) Group Discussions to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions. (shrink)

HIV prevention is a critical health issue in Nigeria; a country that has one of the worst HIV epidemic profiles in the world. With 270,000 new infections in 2012, Nigeria is a prime site for HIV prevention research. One effect of the HIV epidemic has been to revolutionalise ethical norms for the conduct of research: it is now considered unethical to design and implement HIV related studies without community engagement. Unfortunately, there is very little commensurate effort in building the capacity (...) of local persons to engage actively with researchers, and there is no existing platform to facilitate dialogue between researchers and communities engaged in research in Nigeria. In an effort to address this gap, we undertook a series of three community dialogues and two community-researcher interface meetings in Nigeria. This paper aims to give an empirical account of the dialogue from these community engagement processes and provide a resulting critique of the implementation of research ethics practices in Nigeria. It is anticipated that the outputs will: support researchers in designing community-based research protocols; inform ethics committees of key considerations during research protocol reviews from a community perspective; and inform policy makers and research sponsors about issues of primary concern to communities with respect to HIV research. (shrink)