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With the continuous advancement of medical research, the number of multi-center clinical studies has been steadily increasing, bringing about significant challenges to ethical review. Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry. Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials. The promotion of mutual recognition of ethical reviews is both feasible and practically significant; however, progress has been less than ideal. Through conducting surveys, this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province, identify the reasons hindering the implementation of mutual recognition, and propose possible solutions. The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews, the majority remain in a wait-and-see attitude. Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews. [ABSTRACT FROM AUTHOR]

Background: to analyze, at one year, the efficacy and safety of treat-and-extend (T&E) intravitreal (IV) Brolucizumab in patients affected by macular neovascularization (MNV). Both naïve and previously treated (i.e., switched) patients were included, and the data from the two groups were compared. Methods: anatomical (i.e., central subfoveal thickness, CST; presence of fluid), functional (i.e., best corrected visual acuity, BCVA) and treatment-related (i.e., number of IV injections within the study period; number of patients reaching a 12-weeks interval between treatments) data from 41 eyes of 41 subjects (20 naïve and 21 switched) were analyzed. Patients were treated with 3 monthly IV injections followed by a T&E regimen based on a disease activity assessment performed at each scheduled IV treatment. Results: significant CST reduction (from 412.1 ± 115.8 to 273.2 ± 61.6; p < 0.05) and BCVA (mean; p) improvement were observed in the naïve group, while in the switched cohort, both parameters were almost stable. In the naïve and switched groups, 55% and 33.5% of patients, respectively, reached a 12-week IV interval at one year, with a mean of 6.55 ± 1 and 7.43 ± 0.68 IV treatments, respectively. One patient with mild anterior uveitis without sequelae was recorded. Conclusion: In patients with MNV, IV Brolucizumab injections following a T&E regimen demonstrated great efficacy and a good safety profile, with greater anatomical and functional results in naïve patients. Trial registration: This study was approved by the Local Ethics Committee (protocol number 155/2020, general registry number n°11486, InterHospital Ethics Committee, San Luigi Gonzaga Hospital, Orbassano, Italy). [ABSTRACT FROM AUTHOR]

Background: Little is known about the extent to which pediatric palliative care (PPC) clinicians are engaged in ethics consults or how they perceive interactions with ethics consultants. Objective: Describe the extent to which PPC team members serve in pediatric health care ethics (PHCE) consultancy roles and to describe their experiences interacting with pediatric ethic consultant services. Design: Online survey distributed to members of the American Academy of Pediatrics and American Academy of Hospice and Palliative Care pediatric and ethics section and special interest groups in the United States. Results: Eighty-six responses were obtained (response rate 45%) from PPC teams in 70 different children's hospitals located in 34 states. Almost all (97%) reported a functional ethics consult service such that PPC is not expected to meet the ethics need of the institution. A person involved on the PPC team also performed ethics consults in half (49%) of the settings, predominantly the PPC physician. Most respondents who perceive PPC teams engage in ethics-relevant work as part of their everyday PPC work. Formal ethics training was lacking among PPC members involved in ethics consults with few ethics degrees (15%), certifications (6%), or fellowships (2%). Discord (67%), conflict (49%), limitations to treatment (48%), and distress (41%) were cited as the most frequent reasons for which PPC teams consult ethics. PPC respondents identified role clarity, coordinated engagement, timely presence, and open communication as strong PHCE consultant practices. Conclusions: PPC team members performing ethics consults may benefit from additional ethics education and training. Further research is warranted to delineate scope of ethics consultancy relevant to PPC and role clarity. [ABSTRACT FROM AUTHOR]

South African research ethics committees (RECs) faced significant challenges during the COVID-19 pandemic. Research ethics committees needed to find a balance between careful consideration of scientific validity and ethical merit of protocols, and review with the urgency normally associated with public health emergency research. We aimed to explore the views of South African RECs on their pandemic preparedness and response during COVID-19. We conducted in-depth interviews with 21 participants from RECs that were actively involved in the review of COVID-19 related research, at seven academic institutions across South Africa. Interviews were conducted remotely using an in-depth interview guide that included questions regarding REC preparedness and response to COVID-19. Interviews were conducted until data saturation, and audio-recordings were transcribed verbatim and coded. An inductive approach to thematic analysis was used to organise data into themes and sub-themes. This study focused on three main themes: coping during COVID-19, building REC capacity during pandemic times and a consistently cautious approach to mutual recognition of REC reviews. Despite an initial sense of unpreparedness, RECs were able to adapt and maintain careful ethical oversight of both COVID and non-COVID research, and the rigour of REC reviews. Several important lessons for preparedness and response to future pandemics were identified, including heightened awareness of publication, funding and political pressures, the importance of regular training for RECs and researchers, and strategies to enhance moral resilience of REC members. Incremental steps are needed to build trust and authentic partnerships among RECs in inter-pandemic times, to facilitate collaboration during future public health emergencies. [ABSTRACT FROM AUTHOR]

Preimplantation genetic testing for monogenic diseases for adult-onset conditions is ethically permissible for various conditions, including when the condition is fully penetrant or confers disease predisposition. The Committee strongly recommends that a genetic counselor experienced with both preimplantation genetic testing for monogenic diseases and assisted reproductive technology therapies counsel patients considering such procedures. [ABSTRACT FROM AUTHOR]

The article examines the ethical challenges faced by young adults in healthcare settings, highlighting how these issues differ between pediatric and adult care environments. Topics discussed include the common ethical issues in both settings, such as treatment refusal and goals of care, the role of surrogates in decision-making, and the importance of involving ethicists in supporting patient autonomy while balancing family dynamics.

A growing trend in bioethics highlights the importance of using big data science methods to advance normative insight. This has been called the "digital turn" in bioethics by Salloch and Ursin. Automated data processing can, for example, detect significant patterns of correlation that have escaped the attention of human scholars. Although we agree that such technological innovations could bolster existing methods in empirical bioethics (EB), we argue that it should not be conceptualized as a new turn but rather as a revivification, and possibly an amplification of entrenched debates in EB. We begin by highlighting some convergences between EB and digital bioethics that Salloch and Ursin seem to categorize as fundamental differences and end up with elaborating on some risks related to the integration of empirical findings with normative (philosophical) analysis in the digitalization trend. [ABSTRACT FROM AUTHOR]

Clinical ethics consultation services (CECS) can be particularly complex in oncology, and widespread misconceptions exist about their nature. As a result, visibility and accessibility of information regarding CECS is critical. We investigated the availability and content of information regarding CECS on websites of NCI-designated comprehensive cancer centers and cancer centers (CCs). Each website was reviewed for information on CECS and reviewed for benchmarks partially derived from the American Society of Bioethics and Humanities recommendations for CECS. Our analysis revealed that of 70 NCI-designated center websites, 38 had information on CECS, and 17 were found directly on these sites. When CECS information was available, most websites provided a mission statement (71%) and an explanation of what constitutes an ethics consult (74%). Few provided a description of the consult process (45%) or service membership (39%). Our findings reveal a significant gap in CECS visibility on the websites of NCI-designated CCs. [ABSTRACT FROM AUTHOR]

Background: Giving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about how trialists can develop suitable communication materials. There is limited evidence about what research ethics committees think of this issue, and limited guidance about what level of oversight they should have over the proposed communications, or post-consent participant communications generally. We conducted a survey of UK ethics committee members to address these points. Methods: The survey was co-developed by public contributors and trialists who had previously worked together on the communications guidance. We asked respondents if they agreed with the general idea of informing participants who stop taking part, if they had ever been requested to review similar communications, and what level of ethics committee review they might recommend. The survey was primarily conducted online. It was reviewed by three ethics committee members before finalisation and shared directly with all UK ethics committee members. We analysed quantitative questions descriptively and used inductive analysis for open questions to identify common themes. Results: Ninety-one ethics committee members participated (nearly 10% of all UK members). The sample was similar to reported data about all members in terms of several personal characteristics. Most respondents (83%) agreed with our project's rationale. Only 23% of respondents reported having been asked to review an end-of-participation information sheet before. Respondents gave various answers about the level of ethics committee review required, but most supported a relatively proportionate review process. Common concerns were about the risk of coercion or making participants feel pressured. Conclusions: Our survey suggests that ethics committee members generally support providing information to trial participants who stop taking part, if risks to participants are mitigated. We believe our guidance already addresses the main concerns raised. Our respondents' lack of prior experience with end-of-participation information sheets suggests that participants are not getting information they want or need when they stop participating. Our results help clarify how ethics committee should oversee post-consent participant communications, but further guidance from research regulators could be helpful. [ABSTRACT FROM AUTHOR]

The current research ethics review systems are composed of isolated institutional Research Ethics Committees (RECs) that develop their own standard operating procedures (SOPs), templates and so on, with low adoption of digital solutions to manage submission and review processes. This poses several challenges, such as delays, higher costs, and hindering multi-site research. We propose an online national research ethics platform that all RECs can use, with common review processes and documentation requirements following national policy. The system will scale up adoption of digital solutions to all RECs. It will reduce administrative burden and harmonize review procedures. It will also obviate the need for separate and isolated interventions such as national REC registries or clinical trial registries, as these can be generated as transactional outputs of the system. The harmonized procedures and possibility of single submission will facilitate multi-site research. Sharing of resources and expertise among RECs on the platform will enhance resilience. An e-EC system developed in India and a Regional Health research portal developed by the WHO South-East Asia office offer proof of concepts to demonstrate the feasibility of developing and using such systems. The proposed solution is ambitious but feasible. Developing the proposed system will be a vital cost-effective investment in national health infrastructure to strengthen the research ecosystem and accelerate delivery of improved healthcare innovations by reducing unnecessary delays in conducting research. To maximize benefits, concurrent efforts are needed to build researchers' capacity and enhance the quality and efficiency of human reviews of the research proposals by REC. [ABSTRACT FROM AUTHOR]

Background: Nurses' competence in clinical research is a key element in promoting high quality in the discipline of nursing, and the ethical aspects of research are of paramount importance. Therefore, nurses need to have a comprehensive understanding of the ethics associated with clinical research, which is an integral part of safeguarding the safety of subjects, ensuring the quality of nursing clinical research, and improving the ethical standardization of clinical research. Methods: A cross-sectional survey was conducted on 304 nurses in a province of China between April 2023 and September 2023, utilizing convenience sampling. The survey questionnaire comprised two sections: a general information form and a questionnaire focusing on nurses' knowledge and attitudes towards clinical research ethics. Data analysis encompassed descriptive statistics, t-tests, one-way ANOVA, and multiple linear regression. Results: A total of 320 questionnaires were distributed, of which 304 were valid. The ethical attitude of nurses in clinical research was better (91.17 ± 15.96), while the cognitive score was lower (63.08 ± 12.30). The results of multiple linear regression analysis showed that degree, grade of hospital (I, II or III), technical title, number of clinical projects chaired in one year and whether the respondent has ever participated in an ethics training were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P < 0.001, R2 = 18.0%); degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year, whether the hospital has an ethics committee and whether the respondent has ever participated in an ethics training were the six factors affecting ethical attitudes towards clinical research (F = 8.919, P < 0.001, R2 = 17.3%). Conclusions: Nurses in a Chinese province scored low on the cognitive dimension of clinical research ethics, but their attitudes were at a relative high level, with many influencing factors. Degree, technical title, and grade of hospital, all affect cognitive and attitude scores. It is also worth noting that whether the hospital has an ethics committee affects the attitude scores, but has no effect on the cognitive scores.Nursing administrators and educators should consider providing effective and targeted strategies (e.g., ongoing training, scholarly seminars, and scholarly exchanges) to enhance nurses' knowledge and competence in clinical research ethics to protect subject rights as well as to ensure the quality of clinical research. [ABSTRACT FROM AUTHOR]

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID‐19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID‐19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross‐sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple‐choice questions, 10 yes or no questions, and 2 open‐ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID‐19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk‐benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID‐19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID‐19 protocols. RECs in India encountered difficulties while reviewing risk‐benefit analyses, informed consent documents (ICDs), and COVID‐19 protocols and they suggested providing training on these topics. [ABSTRACT FROM AUTHOR]

Background: Stroke causes ethically challenging changes in the lives of individuals with stroke (IwS). However, it is unclear whether the changes are stable or dynamic. In this study, a novel concept 'ethical pathway' is used to describe the potential changes in the perceived realisation of IwS' values in temporal passage post-stroke. Ethical pathway includes three central values of nursing: dignity, privacy and autonomy. Aim of the study was to analyse the perceived ethical pathway of IwS over a non-limited post-stroke period, with the purpose to understand the existence of the IwS' ethical pathway in theoretical level. Design: A descriptive and correlational design. Methods: The volunteer participants were recruited via the Finnish Brain Association. Data were collected with questions of background variables and the Ethical Pathway of Individuals with Stroke (EPIS) instrument and analysed statistically. The Ethics Committee of the University approved the study and permission for data collection was obtained from the association. Results: Sixty-one IwS participated in the study. The ethical pathway varied during the post-stroke time. Of the values, dignity and privacy were realised lower with longer post-stroke time. The life situational factors were associated with the realisation of the values, but not consistently. [ABSTRACT FROM AUTHOR]

There are significant challenges associated with conducting research with a researcher from another institution, in another country or with another culture, and even more challenges when all three factors apply. This paper critically appraises the complexities of a cross-cultural, international and collaborative research project, and identifies the challenges for the researchers and their organisations, and the ways in which these were managed. It evaluates the process of obtaining ethics approval from two organisations in Aotearoa New Zealand and Fiji. This paper presents the perspectives of both the researchers and the organisations providing ethics approval. There is often concern that research conducted by someone from a 'global north' country (here, Aotearoa New Zealand) in a 'global south' country (here, Fiji) will have power asymmetries, and that research will disadvantage the researched community, or not provide any benefit back to them; this project directly addressed these concerns. The research outputs, and research outcomes and impact, need to be considered at the research design stage to ensure they are appropriate for the community in which the research is being conducted. While organisations may be reluctant to approve research conducted in a different culture and country, the risks can be managed and mitigated. [ABSTRACT FROM AUTHOR]

The article focuses on the deficiencies in ethics committee education and orientation processes in hospitals. Topics include the lack of formal orientation and ongoing education for committee members, the need for comprehensive orientation programs to ensure effective ethics consultation, and the role of ethics committees in improving clinical ethics knowledge among members.

Ensemble learning has gotten a lot of interest because of its capacity to increase predictive accuracy by merging numerous models. However, redundant data and a high level of computing complexity frequently plague ensembles. To choose a subset of models while maintaining the accuracy and diversity of the ensemble, ensemble pruning techniques are used to address these problems. Accuracy and diversity must coexist, even though their goals are conflicting. This is why we formulate the issue of ensemble pruning as a dual-objective maximization problem using the idea from information theory. Then, we propose a Comprehensive Ensemble Pruning Framework (CEPF) based on the dual-objective maximization (DOM) trade-off metric. Extensive evaluation of our framework on the exclusively collected PhysioSense dataset demonstrates the superiority of our method compared to existing pruning techniques. PhysioSense dataset was collected after getting approval from the Institutional Human Ethics Committee (IHEC) of Panimalar Medical College Hospital and Research Institute, Chennai, Tamil Nadu (Protocol No: PMCHRI-IHEC-059). The proposed framework not only preserves or improves ensemble accuracy and diversity but also achieves a significant reduction in actual ensemble size. Furthermore, the proposed method provides valuable insights into the dual-objective trade-off between accuracy and diversity paving the way for further research and advancements in ensemble pruning techniques. [ABSTRACT FROM AUTHOR]

Introduction. The aim was to evaluate the effect of preoperative anxiety on the sympathetic block that developed after spinal anesthesia and therefore the duration of motor and sensory blockade. Materials and Methods. After the approval of the ethics committee, 90 patients between the ages of 18 and 55 years who were to be operated under spinal anesthesia were included in the study. Preoperative anxiety of the patients was evaluated with the Spielberger trait and State Anxiety Scale and Visual Analog Scale (VAS). The Bromage scores of the patients were followed up intermittently. Onset time of sensory block, onset time of motor block, and motor block recovery time were recorded. Cases with bradycardia and hypotension were noted. Results. No statistically significant correlation was found between the duration of motor block onset (5.81 ± 4 min), the sensory block onset time (0.89 ± 0.4 min), and the motor block recovery time (92.06 ± 36.9 min) with other variables. VAS (5.81 ± 2.5), STAI‐1 (40.4 ± 9.8), and STAI‐2 (41.69 ± 8.2) values had a statistically significant effect on the occurrence of bradycardia (14.4%). The variables of VAS, STAI‐1, STAI‐2, sensory block onset, motor block onset, and motor block recovery time were statistically significantly higher in women (mean 5.24 ± 2.4, 38.97 ± 9.9, 41.43 ± 8.7, 0.89 ± 0.42, 5.64 ± 3.82, and 88.77 ± 38.74 in males and mean 7.15 ± 2.1, 43.74 ± 8.9, 42.30 ± 7.0, 0.88 ± 0.27, 6.20 ± 4.35, and 99.70 ± 31.70 in females, respectively). Conclusion. It was observed that preoperative anxiety had no effect on motor and sensory block onset and duration. [ABSTRACT FROM AUTHOR]

AbstractTo address the current lack of knowledge about clinical ethics fellowship programs (CEFPs), we surveyed all 36 programs in the U.S. and Canada. The number of CEFPs has grown exponentially over the last 40 years and far exceeds previous estimates. Commonalities among CEFPs include: 88.8% require an advanced degree or rarely accept applicants without one; 91.7% of programs do not restrict applicants to a specific background such as medicine or philosophy; and 88.9% of programs compensate fellows. CEFPs vary widely on numbers of fellows trained in the last 3 years (1–111), numbers of consultations performed by each fellow (0–450), and salaries paid ($0-$95,000). Less than half of programs meet CEFP standards established by ABPD. Nonpaying programs and larger programs tend to have lower admission standards and lower expectations for fellows. We hope these data will help inform CEFP standards that promote quality and consistency without stifling desirable diversity and innovation. [ABSTRACT FROM AUTHOR]

Researching with children and young people on topics that are considered to be 'sensitive', such as family violence, trauma and abuse, continues to be challenging. But there still is not enough evidence on children and young people's own views and experiences of participating in 'sensitive' research. This article reflects on our experience, as a team of young lived experience advocates and a university researcher, of working together on a project to find out what children and young people in Victoria, Australia who have experienced family violence need to support them in their recovery. The project is about learning what is working well, what could be done better, and where the gaps are between what children and young people tell us they need from services, and what services are doing now. This article shares what we have learnt, including how we have set up a Youth Advisory Group and how we have developed an interactive online activity for children and young people to tell us about their experiences of family violence support services. We also discuss challenges we have faced, such as navigating power flows within the project team; embedding co-design into the project; and getting ethics approval to do this research. Finally, we share three guiding principles for collaborative research that puts children and young people's voices, views and experiences at the centre. We hope that others can learn from our experience to promote the rights and participation of children and young people when working with them in research about family violence. [ABSTRACT FROM AUTHOR]

Background: Healthcare workers frequently face ethically demanding situations in their work, potentially leading to stress of conscience. Long-term work intensification (more and more effort demanded year after year), organizational change and COVID-19 may be risk factors concerning stress of conscience. Aims: The main aim was to investigate the relationship between long-term work intensification and stress of conscience among the personnel in a healthcare organization. Organizational change management was considered a mediator and COVID-19-related work stress a moderator in the association between work intensification and stress of conscience. Research design, participants and context: A total of 211 healthcare district employees participated in a longitudinal survey using questionnaires collected in 2019 (major organizational change in the planning stage) and 2021 (organizational change completed). Ethical considerations: The study was implemented according to the guidelines of the Finnish National Board on Research Integrity. The Finnish instructions were that no review by an ethics committee was necessary because participation was voluntary, informed consent was requested, participants were assured that they were free to withdraw from the longitudinal study at any time and no health data were collected. Findings: Long-term work intensification was associated with more severe stress of conscience. Long-term work intensification was partially mediated through change management to stress of conscience. High COVID-19 stress strengthened the association between long-term work intensification and stress of conscience. Conclusions: Long-term work intensification must be addressed to reduce stress of conscience in healthcare, otherwise the healthcare system will be vulnerable to changes and crisis. Extra resources for personnel and management should be allocated because of work intensification during organizational change and health crises like the COVID-19 pandemic to alleviate stress of conscience. [ABSTRACT FROM AUTHOR]

Background: Professional values are important in promoting healthy work environments, patient satisfaction, and quality of care. Magnet® hospitals are recognized for excellence in nursing care and as such, understanding the relationship between nurses' values and Magnet status is essential as healthcare organizations seek to improve patient outcomes. Research question/aim/objectives: The research question is: are there differences in individual values, professional values, and nursing care quality for nurses and nurse managers practicing in Magnet, Magnet journey, and non-Magnet direct patient care settings? Research Design: This descriptive cross-sectional study is guided and informed by the conceptual framework of the Professional Values Model including individual values, professional values, and nursing care quality. Participants and research context: Convenience sampling of registered nurses and nurse managers, responsible for direct patient care, was utilized in a non-profit healthcare system in the Midwest region of the United States. Ethical Considerations: Institutional review board approval was obtained. Participants were informed about the right to self-determine participation and assurance of anonymity. Findings: 827 (n = 827) nurses and nurse managers responded to the survey. Significant differences were identified in individual values sub-scale: self-enhancement (p = 0.38), professional values (p = 0.037), practice environment: participation in hospital affairs (p = 0.00), foundations for quality care (p = 0.016), and resources adequacy (p = 0.012) and in nurse sensitive HCAHPS questions: nurses explained things understandably (p = 0.00), got help as soon as wanted (p = 0.00), and treated with courtesy and respect (p = 0.00). Discussion/Conclusions: Findings indicate that fostering individual and professional values may impact nursing practice, regardless of Magnet designation. Promoting professional values may contribute to improved work environments, enhancing patient satisfaction. Study results offer valuable insights for organizations striving to enhance nursing values, impacting quality of care provided to patients. MeSH Terms: Cross-Sectional Studies, Respect, Ethics Committees, Patient Satisfaction, Nurse Administrators, and Personal Satisfaction. [ABSTRACT FROM AUTHOR]

The ethics in Catholic hospitals are guided by the Ethical and Religious Directives for Catholic Health Care Services, which provide direction on many topics, including family planning. Previous research has demonstrated there is variability in the availability of prohibited family planning services at Catholic hospitals. This study aims to research a potential source of variability in interpretation and application of the directives through interviewing ethics committee members. Participants were recruited from two different hospitals on the east coast with a total sample size of eight. Ethics committee members were asked questions regarding their personal approach to ethics, their hospital's approach to ethics, and the permissibility of specific family planning methods at their hospital. Most ethics committee members stated that the Catholic faith and/or directives were important in their hospitals' approach to ethics. Most participants stated that they had instances in which their personal approach to ethics conflicted with their hospital's approach, citing women's health and end-of-life care as common causes of conflict. All but one ethics committee member stated that hormonal contraception was forbidden under the directives; however, many members stated that this was either a gray area or permissible under certain circumstances. Reproductive health issues rarely came before the ethics committee at either site with one participant referring to them as "black and white issues." This research suggests that ethics committee members did not see the directives governing family planning services to be ambiguous. However, given the low frequency in which these issues come to the attention of the ethics committee, it is difficult to determine whether the opinions expressed by our participants contribute to the variability between Catholic hospitals when it comes to reproductive healthcare provision. An interesting topic for future research would be interviewing executives at Catholic hospitals to determine where this variability arises. [ABSTRACT FROM AUTHOR]

The article focuses on how ethics programs are evaluating their effectiveness through surveys. Topics include the measurement of consult quality and satisfaction at Northwell Health; feedback on consultation processes and issues at SSM Health St. Anthony Hospital in Oklahoma City, Oklahoma; and the challenges ethicists face in addressing clinician expectations and maintaining transparency.

The World Health Organization (WHO) Global Guidance Framework for the Responsible Use of the Life Sciences addresses the governance of biorisks, including dual-use research, for countries. It emphasizes engaging multisectoral stakeholders such as governments, scientific bodies, health and research institutes, standard-setting organizations, funding bodies, and others. Ethics constitutes a key component of the framework. Given the high social impact of such research and the importance of trust, risk, and benefit, national ethics committees could make a valuable contribution by providing ethical guidance in the decisionmaking process. The purpose of this study was to examine the role of national ethics committees in the context of governance and oversight of dual-use research at the national level. We conducted a landscape analysis of the activities of ethics committees in dual-use research oversight. We also searched the WHO database on National Ethics Committees for publications related to dual-use research and/or misuse of life sciences research and gathered additional documentation from national ethics committees websites and through author contacts. Results showed that in the context of the wide range of oversight mechanisms for dual-use research in countries, national ethics committees have contributed to guiding policy and assessing dual-use research risks in only a limited number of countries. Recommendations from those countries include establishing a multistakeholder, coordinated oversight mechanism at the country level; strengthening international linkages to guide, harmonize, and reinforce national and international efforts; and involving ethics committees as an expert resource in the governance and oversight process. [ABSTRACT FROM AUTHOR]

Why are high monetary payments prohibited for certain goods, thereby causing shortages in their supply? I conduct (i) a framed field experiment with a general population sample and (ii) a survey experiment with this sample and with ethics committees. In the experiment, participants can prohibit others from being offered money to register as stem-cell donors. I document that, whereas the majority of participants do not respond to changes in the incentives (63%) or become more in favour of the offer with higher incentives (20%), a minority of 17% prohibit high incentives. I show that this minority wants to protect individuals who are persuaded by high incentives. I also show that a lottery scheme reduces their objections to high incentives. Finally, I document that the public is much more supportive of high incentives than are ethics committees. [ABSTRACT FROM AUTHOR]

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Abstract The current research ethics review systems are composed of isolated institutional Research Ethics Committees (RECs) that develop their own standard operating procedures (SOPs), templates and so on, with low adoption of digital solutions to manage submission and review processes. This poses several challenges, such as delays, higher costs, and hindering multi-site research. We propose an online national research ethics platform that all RECs can use, with common review processes and documentation requirements following national policy. The system will scale up adoption of digital solutions to all RECs. It will reduce administrative burden and harmonize review procedures. It will also obviate the need for separate and isolated interventions such as national REC registries or clinical trial registries, as these can be generated as transactional outputs of the system. The harmonized procedures and possibility of single submission will facilitate multi-site research. Sharing of resources and expertise among RECs on the platform will enhance resilience. An e-EC system developed in India and a Regional Health research portal developed by the WHO South-East Asia office offer proof of concepts to demonstrate the feasibility of developing and using such systems. The proposed solution is ambitious but feasible. Developing the proposed system will be a vital cost-effective investment in national health infrastructure to strengthen the research ecosystem and accelerate delivery of improved healthcare innovations by reducing unnecessary delays in conducting research. To maximize benefits, concurrent efforts are needed to build researchers’ capacity and enhance the quality and efficiency of human reviews of the research proposals by REC.

Scientists’ misconduct in their research activities is an important problem for science in many countries, including Russia. It leads to negative consequences both for the quality of scientific knowledge obtained and for the reputation of researchers and scientific organizations. However, there is still a small number of empirical studies of this problem in Russia. This work is based on a survey method to explore the ideas of young scientists from all federal districts of Russia about research ethics and the situations of ethical dilemmas that they encounter in their work. In accordance with the chosen theoretical framework: ideas about ethics as an action that is situational by nature, determined by sustainable practices and patterns, the survey was conducted in two stages: an open question about situations of ethical choice in research activities, on the basis of which a detailed questionnaire was then created. As a result, it was revealed that the vast majority of young scientists are faced with situations of violation of ethical standards both in scientific publications and communications, and in the processes of organizing research work. Violations of research procedures, data manipulation, falsification of research results – this is a set of violations in the organization of research that almost three-quarters of respondents encountered themselves or heard about such situations from colleagues. However, there are gaps in consensus about the sources of knowledge about ethics and a lack of institutional practices to prevent violations such as the work of ethics committees or ethical standards.

Healthcare disagreements are common, but recognising the causes is essential to reaching a moral consensus. The article describes the challenges associated with resolving the disagreements. Therefore, a systematic and timely team-based discussion, ethics consultation with ethicists and the hospital ethics committee, active participation of all members' discussions, and scheduled debriefings are pragmatic ways to find balance when healthcare professionals disagree. Teams need these attempts to build consensus and make moral decisions. It also fosters harmony, prioritises patient and team interests and, most importantly, keeps the team intact. [ABSTRACT FROM AUTHOR]

Aquinas's Fifth Way argues for God's existence from the perception of goal-directed activity in nature. Its details are difficult to understand. This study interprets the premises and offers background reasoning for them, which Aquinas develops elsewhere in his writings. A major focus is clarifying the scope of finality the Fifth Way invokes. The argument leaves unspecified the kinds of purposive activity in nature Aquinas has in mind. Thus, the discussion first treats types of purposive activity in nature Aquinas recognizes. It then looks at the two reasons the argument gives for final causes in nature. Things tend to act in regular ways and tend toward what is 'best'. Attention then turns to the key premise that goal-directed activity in nonrational beings requires direction by something with intelligence. A final section of the article explores why Aquinas seems to look to a single source of finality in nature and why, in the conclusion, he claims that we call this God. Thus, Aquinas's larger views on finality in nature shed light on his intents in the Fifth Way. [ABSTRACT FROM AUTHOR]

The paper aims to trace the distinctive character of the talk of the soul and to disentangle it from the talk of the mind. The key context will be the way in which we talk about souls that are ailing. As a point of departure, I use the later Wittgenstein's notion of the soul as anti‐dualist and anti‐substantive, which brings it close to Dennett's or Davidson's philosophy of mind, but which Wittgensteinian ethicists have elaborated upon as concerned with matters of good and evil, and beauty. In relation to these concerns, the sense of the ailing soul is different from issues relating to mental health. I then discuss cases of ailments of the soul that would be misleading to analyse as matters of mental health (issues): addiction, racism, and environmental grief. I conclude with a plea for maintaining the talk of the soul as helpful for making sense of existential or beauty‐ or morality‐related ailments, yet as something that does not necessarily subscribe to any doctrine of the soul as a substance. In support, I also use arguments from the spheres of eco‐theology and public theology. [ABSTRACT FROM AUTHOR]

The article focuses on the challenges and methodologies of assessing the effectiveness of ethics consultation services in healthcare institutions, contrasting the data-driven approach required in clinical areas with the less defined metrics in ethics consultations. It emphasizes the importance of documenting consultations and outcomes to improve consistency and provide educational value, showcasing initiatives at institutions like Columbia University Medical Center in the United States.

The article focuses on the evolving landscape of clinical ethics and the potential legal risks faced by ethicists due to their increasing professionalization and role in healthcare decision-making in U.S. It discusses how ethicists, like other healthcare professionals, could be subject to liability claims if their recommendations are perceived to fall short of professional standards.

Background: Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drugs and trial rules-2019, was proposed on March 19, 2019. The purpose of the study was to ascertain whether various stakeholders were reporting in accordance with the evolving SAE criteria. Materials and Methods: Data were retrieved after the Ethics Committee’s approval between August 2014 and December 2021. Data gathered before March 19, 2019, were categorized as “BEFORE” data, while the remaining data were categorized as “AFTER.” Utilizing causality, on-site SAE reporting, and the ethics committee review procedure, we evaluated the compliance. The data were evaluated using descriptive statistics, and the Chi-square or Mann–Whitney tests were used to compare the “BEFORE” and “AFTER” groups. Results: A total of 77 SAEs were reported in 26 clinical trials, where most clinical trials were phase III. Endocrine projects made up 9/26 (34.61%). In the cardiology studies, the greatest SAE distribution was 21 SAEs/89 participants(23.59%) with approximately 48% of these being vascular. The “AFTER” group noticed a decrease in the total number and length of SAE subcommittee meetings. In the “AFTER” group, there was a significantly higher median number of agenda items/meetings (8 [4.5–10.75]) (P < 0.0001). The median interval between the onset of SAE and the first reporting date, however, was just 1 day (interquartile range: 1–5 days). In nondeath SAEs, there was no significant difference in the compensation paid. In the “AFTER” group, there were no discrepancies in reporting SAE. Conclusion: There is acceptable adherence to SAE reporting criteria. [ABSTRACT FROM AUTHOR]

Background: Genetic research can yield information that is unrelated to the study's objectives but may be of clinical or personal interest to study participants. There is an emerging but controversial responsibility to return some genetic research results, however there is little evidence available about the views of genomic researchers and others on the African continent. Methods: We conducted a continental survey to solicit perspectives of researchers, science policy makers and research ethics committee members on the feedback of individual genetic research findings in African genomics research. Results: A total of 110 persons participated in the survey with 51 complete and 59 incomplete surveys received. Data was summarised using descriptive analysis. Overall, our respondents believed that individual genetic research results that are clinically actionable should be returned to study participants apparently because participants have a right to know things about their health, and it might also be a means for research participation to be recognized. Nonetheless, there is a need for development of precise guidance on how to return individual genetic research findings in African genomics research. Discussion: Participants should receive information that could promote a healthier lifestyle; only clinically actionable findings should be returned, and participants should receive all important information that is directly relevant to their health. Nevertheless, detailed guidelines should inform what ought to be returned. H3Africa guidelines stipulate that it is generally considered good practice for researchers to feedback general study results, but there is no consensus about whether individual genomic study results should also be fed back. The decision on what individual results to feedback, if any, is very challenging and the specific context is important to make an appropriate determination. [ABSTRACT FROM AUTHOR]

Aim: With only limited treatment options in acute spinal cord injury (SCI) currently available, we aimed to investigate the effect of progesterone on neurological recovery after acute SCI. Material and Methods: Randomised double-blind placebo-controlled single-centre trial on 128 patients of acute SCI (within 24 hours of injury) was conducted at our institute with the approval of the ethics committee. Eligible patients were allocated to the progesterone or placebo arm. Of 133 eligible patients, one from the placebo arm expired in the acute phase while 4 were lost to follow-up, leaving 128 patients in the study.68 patients remained in the progesterone arm and 60 in placebo. Patients in the progesterone arm received intramuscular progesterone while those in the placebo received intramuscular isotonic saline twice daily for five consecutive days. Neurological assessment was done at baseline, day six, first and sixth months using the American Spinal Injury Association (ASIA) score and motor and sensory actual neural recovery (ANR) scores. Results: Baseline characteristics were comparable between the groups. At the end of six months, significant improvement occurred in motor and sensory ASIA scores in the progesterone arm (p=<0.01). Compared with the placebo, motor scores were significantly higher in the progesterone arm at 6 months while sensory scores were not (p= <0.01 and p= 0.59 respectively). Additionally, at 6 months, motor ANR was significantly higher in the progesterone arm vs placebo (p=<0.01 vs 0.65). Early progesterone administration (within six hours of injury) was associated with significantly higher motor and sensory ASIA scores at 6 months (p= <0.01vs0.04 respectively). Conclusion: Administration of intramuscular progesterone within 24 hours in acute SCI was associated with better neurological recovery. Further multicentric studies are required to shed more light on the strength and consistency of this improved outcome. [ABSTRACT FROM AUTHOR]

The article explores ethical challenges related to deactivating left ventricular assist devices (LVADs), highlighting the need for clear communication with patients and families, the role of palliative care, and conflicts arising from differing views on the benefits and burdens of LVAD therapy.

The article explores the limitations of traditional hospital ethics committees and proposing the professional clinical ethicist-primary (PCE-primary) model as an innovative alternative to enhance the effectiveness of ethical decision-making in healthcare settings.

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. [ABSTRACT FROM AUTHOR]

Background Ethical conflicts generate difficulties in daily clinical activity. Which methods of ethical advice are most frequently used to resolve them among Spanish doctors has not been studied. The objective of this study is to describe what methods hospital internal medicine physicians in Spain use to resolve their ethical doubts and which they consider most useful. Design A cross-sectional observational study was conducted through a voluntary and anonymous survey and distributed through an ad hoc platform of the Spanish Society of Internal Medicine. Measures We measured methods by which to resolve doubts, types of tools sought, frequency of consulting the Clinical Ethics Committees, and satisfaction with resolution of ethical issues. Results Of 261 internists surveyed, 86 per cent resolve their ethical doubts with assistance, the most frequently used method being consultation with colleagues (58.6 per cent), followed by using specific protocols or guides (11.8 per cent) and consultation with experts in bioethics (9.6 per cent). The most preferred tools are the creation of protocols (30.3 per cent) and the establishment of a consultant/expert in bioethics (27.8 per cent). Conclusions Internists in Spain usually seek assistance to resolve their ethical doubts. Consulting colleagues is the most frequently adopted method. The majority regard tools to resolve ethical conflicts as necessary, seeking above all protocols and consultants/experts in bioethics. [ABSTRACT FROM AUTHOR]

The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed and counseled, but consanguineous arrangements or ones that simulate incestuous unions should be prohibited. Adult child-to-parent arrangements require caution to avoid coercion, and parent-to-adult child arrangements are acceptable in limited situations. Programs that choose to participate in intrafamilial arrangements should be prepared to spend additional time counseling participants and ensuring that they have made free, informed decisions. This document replaces the document of the same name, last published in 2017. [ABSTRACT FROM AUTHOR]

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure. [ABSTRACT FROM AUTHOR]

The need to understand the systems that support ethical health research has long been recognized, but there are limited descriptions of actual health research ethics (HRE) systems. Using participatory network mapping methods, we empirically defined Malaysia's HRE system. 13 Malaysian stakeholders identified 4 overarching and 25 specific HRE system functions and 35 actors internal and 3 external to the Malaysian HRE system responsible for those functions. Functions requiring the most attention were: advising on legislation related to HRE; optimizing research value to society; and defining standards for HRE oversight. Internal actors with the greatest potential for more influence were: the national network of research ethics committees; noninstitution-based research ethics committees; and research participants. The World Health Organization, an external actor, had the largest untapped potential for influence overall. In summary, this stakeholder-driven process identified HRE system functions and actors that could be targeted to increase HRE system capacity. [ABSTRACT FROM AUTHOR]

This study presents the importance of the Research Ethics Committees (CEP) in the context of the Brazilian North Region, formed by the Amazon rainforest, which is occupied by traditional populations and those constituted by migratory currents. This study aims to analyze the bioethical implications arising from the activities of CEPs in the ethical evaluation of research projects and their essential role in protecting vulnerable populations. The authors seek to highlight the importance of ethics committees in the Amazon and their importance face the modern bioethical values that can contribute to the preservation of one of the most valuable and diverse environments on earth. [ABSTRACT FROM AUTHOR]

The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants. [ABSTRACT FROM AUTHOR]