This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the (...) class='Hi'>research, we used a deductive qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour (...) discussion at a European level.Methods: A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models. (shrink)

Personal data protection is an ethical issue. In this study we analyzed how research ethics committees (RECs) and data protection officers (DPOs) handle personal data protection issues in research protocols. We conducted a mixed-methods study. We included heads (or delegated representatives) of RECs and DPOs from universities and public research institutes in Croatia. The participants provided information about data protection issues in research and their mutual collaboration on those issues through structured interviews that contained closed (...) and open-ended questions. Qualitative description was used to analyze open-ended questions. The results showed that 55% of the REC representatives were not aware who was DPO in their institution. Among RECs, 65% never contacted the DPO. There were 61% of RECs who reported that they received no training from the organization on personal data protection. When asked about barriers to personal data protection in their institutions, 26% of REC members highlighted the lack of a clear protocol for assessing personal data protection issues, while 30% of DPOs mentioned lack of knowledge among researchers about personal data. In conclusion, we found that when it came to protecting personal data in research protocols, RECs and DPOs hardly ever worked together. When developing future personal data protection policies for academic and scientific research institutions, it is essential that RECs and DPOs should collaborate and both continue to expand/update their knowledge on personal data protection procedures. (shrink)

The establishment of a Research Ethics Committee (REC) is a significant step to ensure the standard procedures in ethics review process that protect human participants. However, in instances when RECs are not yet established, surrogate activities are practiced by some institutions. The objective of this study was to identify prevailing research ethical practices of research directors and faculty researchers in the absence of a research ethics committee in their respective academic institutions. Specifically, it (...) aimed to explore the participants’ 1) experiences in research subject protection and 2) challenges when there is no existing REC in the institution. Participants were selected from universities in Manila City whose institutions did not have RECs at the time of the conduct of this study. Key informant interviews and focus group discussions were used as approaches for data collection. The authors used NVivo to organize data from the transcribed audio-recorded interviews and were analyzed utilizing a basic interpretive qualitative approach. Based on the results, surrogate practices of participants involved (1) providing “informed consent forms” to target participants and the (2) roles of different personalities in the evaluation/conduct of the research paper. Implications of this study and recommendations were likewise discussed in this paper. (shrink)

Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them (...) better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)

The National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject to regulatory oversight, requiring institutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference (...) work for the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementing regulatory oversight. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, (...) and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

Prior researches have highlighted challenges and variations arising from the requirements of research ethics committees and ethics governance systems across diverse research fields. This emphasizes the need to investigate how universities convey and implement research ethical practices. Research ethics plays a pivotal role in guiding the integration of ethical principles throughout all stages of research starting from its inception and planning to its completion and the dissemination of results. These practices encompass a (...) range of considerations, reviews, guidelines, and processes aimed at safeguarding the rights, dignity, health, safety, and privacy of research participants. Using the content analysis technique, this paper aims to analyse research ethical practices information on universities’ websites from three developed countries and developing countries respectively using the isomorphism conception. The findings suggest that the coercive, normative, and mimetic isomorphic pressures explain the research ethics governance practices. The ethical practices information was disclosed more on university websites of the developed countries. Suggestions to improve the university’s research ethics governance system for the post-COVID-19 era were provided in the paper. (shrink)

Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during (...) review processes. We collected every instance (N = 4,195) of feedback made on N = 197 ‘low-risk’ protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research. (shrink)

Ethical conduct is a maxim in scholarly research as well as scholarly endeavour generally. In the case of research involving humans, few if any question the necessity for ethics approval of procedures by ethics boards or committees. However, concerns have been raised about the appropriateness of ethics approval processes for social science research arguing that the orientation of ethics boards and committees to biomedical and experimental scientific research, institutional risk aversion, and other (...) factors lead to over-protection of research participants and overly restrictive processes that delay and sometimes prevent important social science research. This is particularly significant when social science research is required to respond to social, environmental, or health emergencies and in contract research projects for the reasons explained. This analysis of an ethics approval case study adds to increasing concerns that ethics approval processes can have perverse effects in the social sciences. While a single case study does not provide generalizable findings, in-depth analysis of a significant case can identify issues that need to be further explored. Recommendations offer pathways for facilitating social science research including in emergency situations in which timeliness is important and in collaborative approaches such as participatory action research, while maintaining high ethical standards. (shrink)

In calling for the transformation of military medical education and training, the 2005 Base Realignment and Closure Commission recommended relocating basic and specialty enlisted medical training to a single site to take advantage of economies of scale and the opportunity for joint training. As a result, a joint medical education and training campus (METC) has been established at Fort Sam Houston, Texas. Two of METC's primary long-term goals are to become a high-performing learning organization and to seek accreditation as (...) a community college. Such goals require a clear model of organizational improvement with well-defined metrics for measuring its performance and using research and evaluation to assess and improve that performance. Lessons learned from a review of practices at institutions with similar missions -- such as community colleges, corporate universities, the UK's Defence Medical Education and Training Agency, and other federal agencies, such as the Veterans Health Administration -- establish a clear need for an office of institutional research to help METC attain its organizational goals. They also provide useful recommendations regarding the METC office's structure, scope, and governance. (shrink)

This book is a small handbook designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. The chapters of this book are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee (...) meetings. (shrink)

This research examines the current status of clinical ethics consultation (CEC) in Japan through a nationwide study conducted with chairs of ethics committees and clinical ethics committees among 1028 post-graduate clinical teaching hospitals. We also qualitatively analyzed their viewpoints of the CEC’s benefits and problems related to hospital consultation services to identify the critical points for CEC and inform the development of a correctly functioning system. The questionnaire included structured questions about hospital CEC organization and (...) service purpose and operation and open-ended questions about the benefits and problems of initiating CEC. The questionnaire comprised the presence/absence of an ethics committee, CEC services and membership when services were implemented, users, and the number of cases handled since inception. In addition, the respondents also provided their impressions of the CEC system’s impact on their hospital by describing (a) the benefits of CEC services and (b) the ineffectual or harmful aspects of the CEC system. Qualitative data were examined using qualitative content analysis to determine the impact of establishing a CEC and the difficulties of practice. One hundred twenty-five questionnaires were returned from either the chair of the ethics committee or clinical ethics committee in teaching hospitals. Of these, 90 (72%) reported they provided CEC services. Additionally, 36 respondents (34.6%) reported that their existing research and clinical ethics committees had conducted CEC services, and 35 (33.7%) reported having a newly established clinical ethics committee conducting CEC services. Three positive effects of establishing and four challenges in managing CEC were also identified. (shrink)

To determine factors affecting successful research and publication among medical students, a cross-sectional survey study was carried out at four Thai medical schools during 2018–2022. Medical students who had previously performed research under research advisors’ supervision and their research advisors were included. There were 120 participants, 78 medical students and 42 research advisors. The most common problems reported by the students were student’s lack of knowledge of research design (78%) and research topic (53%), (...) while the most common problems reported by the advisors were student’s lack of knowledge of research topic (55%) and how to prepare documents for ethics committee approval (48%). The promoting factors for research success commonly reported by the students and advisors were “an advisor helps with protocol writing and reviewing the manuscript”, “research teaching in the curriculum”, “provision of an example of a written ethics committee protocol”, and “arranging a special session so that advisors can talk to students about their research of interest”. Among the 78 participating students, 20 (26%) had successfully published their research in journals. These 20 students were more likely than those without publications to be from an institute that had a special research project or conference for medical students (20% vs. 0%,) and to suggest that teaching protocol writing helped in promoting research success (70% vs. 43%). These findings suggest that teaching research, a special research project or conference for medical students, and faculty development of research advising could potentially increase the success rate of students’ research publications. (shrink)

Background Morality is a fundamental component of nurses’ daily work. Nurses’ cognitive tendencies toward moral disengagement in high-stress work environments can easily lead them to engage in counterproductive work behaviors that are not conducive to the organization. However, there is limited research on how to mitigate the impact of moral disengagement on counterproductive work behavior. Objective The objective was to explore the impact of moral disengagement on counterproductive work behavior, as well as the reverse regulatory mechanism of moral (...) identity on the relationship between moral disengagement and counterproductive work behavior. Research design This was a quantitative, cross-sectional study. Participants and research context From September to October 2023, nurses from emergency departments of major hospitals in Hunan Province were recruited, and 500 questionnaires were distributed and collected using the WeChat app Credamo Seeing Numbers. Ethical consideration All study procedures were approved by the Ethics Committee of Hunan Normal University (No. 2023-388). Findings Moral disengagement had a positive effect on counterproductive work behavior directed at the organization (CWB-O) as well as counterproductive work behavior directed at individuals (CWB-I). Moral identity was not significant in moderating the relationship between moral disengagement and CWB-O. Moral identity had an inverse moderating effect on the mechanism of action between moral disengagement and CWB-I. Conclusion Counterproductive work behavior guided by moral disengagement is detrimental to organizations, and moral identity can inhibit the effect of moral disengagement on CWB-I. Nursing administrators should focus on improving nurses’ moral identity and improving the healthcare workplace environment so that moral identity can better exert its inhibitory effect on counterproductive work behavior among nurses. (shrink)

Background The wide proliferation of Covid-19 has impacted billions of people all over the world. This catastrophic pandemic outbreak and ostracism at work have posed challenges for all healthcare professionals, especially for nurses, and have led to a significant increase in the workload, several physical and mental problems, and a change in behavior that is more negative and counterproductive. Therefore, leadership behaviors that are moral in nature serve as a trigger and lessen the adverse workplace effects on nurses’ conduct. Aim (...) this research is directed to explore the impact of post-COVID-19 workplace ostracism on nurses’ counterproductive behavior and examine the role of moral leadership as a mediating factor in post-COVID-19 workplace ostracism and nurses’ counterproductive behavior. Ethical consideration Ethical review and approval Was received from Ethical Committee at the Faculty of Nursing, Alexandria University, Egypt. Methods A cross-sectional and correlation study was implemented in all units of medical, surgical, critical and intensive care units by using three tools; moral leadership questionnaire, Workplace Ostracism Instrument (WOS), and Counterproductive Work Behaviors Questionnaire (CWBs). A convenient sample of 340 from 699 bedside nurses was granted. Results This study revealed that nurses’ perceived moderate mean percent (55.49 ± 3.46) of overall workplace ostracism and counterproductive behavior (74.69 ± 6.15). However, they perceived a low mean percentage of moral leadership. There was a significant positive correlation between workplace ostracism and counterproductive behavior. Otherwise, a significant negative correlation was found between moral leadership, workplace ostracism and counterproductive behavior. Also, this study proved the mediating effect of moral leadership in decreasing workplace ostracism by 79.3% and counterproductive behavior by 36.7%. Conclusion Hospital administrators need to be aware of the significance of moral leadership and apply integrity in the clinical setting to reduce the drawback of isolation on nurses' conduct and increase value for the organization as a whole and nurses in particular. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 53-64 [Access article in PDF] Incentives for Providing Organs Patricia Milmoe McCarrick and Martina Darragh After a contentious debate at its 2002 annual meeting, the American Medical Association's House of Delegates voted to endorse the opinion of its Council on Ethical and Judicial Affairs that the impact of financial incentives on organ donation should be studied (Josefson 2002). The shortage of (...) organs for transplantation has been an ongoing problem for more than 20 years. In June1981, Representative Philip Crane (R-IL) introduced legislation in the U.S. House of Representatives proposing a $25,000 income tax deduction and a $25,000 estate tax exclusion for donating an organ (Tax Incentives 1981). Still the National Organ Transplant Act enacted in October 1984 prohibited the offering of any "valuable consideration" in return for organs (United States 1984).The developments of a legal market for tissues in the United States and a black market for organs around the world have raised the question of whether donation without compensation is the only ethically viable option. Some critics of the current system claim reliance on donation actually promotes a black market in organs (Kaserman and Barnett 2002, p. 38; Palmer 1999, p. 36). In addition, a new set of compensation issues has arisen as living kidney donor transplantations begin to rival those performed with cadaveric organs (United States 2001).As a result, current suggestions for incentives go far beyond the traditional death benefit payment to include such ideas as medals of honor for donors, reimbursement for funeral expenses, exchange programs for organ donation, and special medical insurance for living organ donors. Numerous bills introduced into the 107th Congress have proposed such incentives (Delmonico et al. 2002.) In October 2002, the U.S. Department of Health and Human Services awarded $5.2 million in grants to study both clinical and behavioral interventions for increasing organ donations that do not involve incentives. The inspiration for some of the funded proposals comes from the successes of Spain's social services and the United Kingdom's clinical administration of organ procurement programs (Robeznieks 2002). [End Page 53]With a nod to evidence-based medicine, the underlying concern expressed in much of the current literature is that no idea for increasing the supply of organs should be discounted before it is studied. This bibliography provides a short introduction to the range of opinions expressed on the issue of incentives for providing organs.al-Mousawi, M.; Samhan, M.; al-Mezairee I.; Razzak, M.A.; and Khawari, F. Cadaver Organ Procurement in Kuwait. Transplantation Proceedings 31 (8): 3375-76, 1999.The authors describe a protocol that significantly increased cadaveric organ donation and credit it with fostering the expansion of an organ sharing program among the Arab Gulf states. Developed by Kuwaiti neurologists and anesthetists after a continuing education course on transplantation, the protocol places a special emphasis on the role of local transplant coordinators who facilitate the investigation of brain death cases by neurologists.Arnold, Robert; Bartlett, Steven; Bernat, James; et al. [Ethics Committee of the American Society of Transplant Surgeons] Financial Incentives for Cadaver Organ Donation: an Ethical Reappraisal. Transplantation 73 (8): 1361-67, 27 April 2002.To prepare for proposed studies of financial incentives for organ donation, the American Society of Transplant Surgeons convened a panel to develop a methodology for evaluating the ethics of such research. Comprised of organ procurement organization executives, physicians, surgeons, and ethicists, the panel generated a list of nine criteria for use in judging any incentives proposal. While opposed to direct payment or tax incentives for organ donation, a majority of the members support funeral expense reimbursement or charitable contributions as incentives that would not violate or undermine the ideal of altruism.Cameron, J. Stewart, and Hoffenberg, Raymond. The Ethics of Organ Transplantation Reconsidered: Paid Organ Donation and the Use of Executed Prisoners as Donors. Kidney International 55 (2): 724-32, February 1999.After reviewing arguments for and against payment for organ procurement, the authors apply these arguments to the specific case of obtaining organs from executed... (shrink)

Increasingly, scholarly journals have begun retracting published articles for reasons other than those described by advisory organizations such as the Committee on Publication Ethics (COPE). Numerous research articles have been retracted of late due to political concerns. Additionally, some articles have been retracted for behavioral misconduct, which was also the subject of a recent COPE discussion forum. ‘Behavioral misconduct’ denotes harmful or immoral behavior of one or more authors that is unrelated to the article’s findings or content. We (...) investigated whether federally funded research scientists considered behavioral misconduct a valid reason for retracting published findings and whether the type of behavioral misconduct involved, the level of the expected scientific impact of the article in question, or the kind of editorial action taken affected their support of retraction. Of the 464 participants who took our survey, we found that researchers largely oppose retraction of a published article or removing an author when scientists commit behavioral misconduct, regardless of the type of misconduct involved. However, there was greater support for retraction when the misconduct was financial as compared to racial or sexual misconduct. Not surprisingly, researchers were more likely to use the published information in question in their own work when its impact was high. Future studies should investigate the extent to which these findings are moderated by researchers’ editorial experience and other demographic factors. (shrink)