Numerous reports have noted decreasing numbers of antibiotic approvals. To determine the context for this decline, we examined all new molecule entities (NMEs) and new biologic licenses (NBLs) approved by the FDA from 1980–2009, and compared approval rates of the 61 approved antibiotics to trends in other drug classes. We also tracked withdrawals of approved drugs and found more withdrawals for antibiotics than other drug classes. After adjusting for drugs subsequently withdrawn, the record for antibiotic innovation is less dire (...) than previously reported. We also report problems with the quality of the approved antibiotics studied. Future policies providing incentives for new antibiotic development should not be based on simple numerical targets and key provisions should ensure appropriate quality as well as quantity of antibiotic drug innovation. (shrink)

Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI (...) Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies discussed informed consent. Only half of those reported that written informed consent had been obtained; few reported oral consent, and few used other methods such as online consent or completion and return of data collection to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received. Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required. (shrink)

We assume that people have a need to make statements, and construct a model in which this need is the sole determinant of voting behavior. In this model, an individual selects a ballot that makes as close a statement as possible to her ideal point, where abstaining from voting is a possible (null) statement. We show that in such a model, a political system that adopts approval voting may be expected to enjoy a significantly higher rate of participation in (...) elections than a comparable system with plurality rule. (shrink)

In representing a fragmented pluralist polity, the U.S. Congress inevitably exhibits high levels of conflict and disagreement. Increasingly, the American public finds such conflict—the ordinary procedures of legislative democracy—distasteful. As members of Congress pay closer attention to approval ratings and other poll measures, their natural inclination may be to avoid legislating, especially on controversial issues. This response to the preference of the demos has profoundly antidemocratic implications.

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg in 2000 were (...) analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

Resumo: Os processos avaliativos, na universidade, são perpassados por um ethos que prima pela quantificação e pelo ranqueamento. Em decorrência, observa-se cada vez mais a descaracterização da avaliação na sua acepção qualitativa e, consequentemente, formativa. A afirmação desse ethos, na universidade, bem como na sociedade, é facilitada pelos algoritmos de big data, os quais estão na base da constituição da chamada “sociedade métrica”, em que há uma tendência geral para utilizar formas quantitativas para realizar classificações sociais. Neste texto, com respaldo (...) em revisão de literatura, objetiva-se refletir sobre dois processos de avaliação de docentes que atuam no ensino superior e que ultrapassam o espaço acadêmico pela sua dimensão pública espetacularizada: a) o ranqueamento da produção docente, por meio do índice h; e b) a avaliação realizada por estudantes em sites públicos, neste caso específico, o site de avaliação docente ratemyprofessors.com. A partir destas duas estratégias de avaliação, professores, pesquisadores e alunos envolvem-se em uma espécie de certame onde se mostrar, ser visto, monitorado, classificado passa a ser critério de aprovação (percebido) ou, no limite, perda de financiamentos e do próprio trabalho (cancelado). Palavras-chave: Avaliação Docente; Algoritmos; Sociedade Métrica; Cultura Digital. Entre el ranking y el rating: La evaluación digital del profesor en la era de la sociedad métrica Resumen: Los procesos de evaluación en la universidad están impregnados de un ethos que busca la cuantificación y el ranqueo. Como resultado, se observa cada vez más la descaracterización de la evaluación en su sentido cualitativo y, en consecuencia, formativo. La afirmación de este ethos, tanto en la universidad como en la sociedad, se ve facilitada por los algoritmos de big data, que están en la base de la constitución de la llamada “sociedad métrica”, en la que existe una tendencia generalizada a utilizar formas cuantitativas para realizar clasificaciones sociales. En este texto, apoyado en una revisión de la literatura, el objetivo es reflexionar sobre dos procesos de evaluación de profesores que laboran en la educación superior y que van más allá del espacio académico por su dimensión pública espectacularizada: a) el ranking de la producción docente, a través del índice h, b) la evaluación realizada por los estudiantes en los sitios web públicos, en este caso concreto, el sitio web de evaluación del profesorado ratemyprofessors.com. A partir de estas dos estrategias de evaluación, docentes, investigadores y estudiantes se involucran en una especie de certamen en el que mostrarse, ser visto, monitoreado, clasificado se convierte en un criterio de aprobación (percibido) o, en última instancia, pérdida de financiamiento y trabajo propio (cancelado). Palabras-clave: Evaluación Docente; Algoritmos; Sociedad Métrica; Cultura Digital. Between ranking and rating: Digital evaluation of professors in the metric society Abstract: Evaluation processes at universities are permeated by an ethos that emphasizes quantification and ranking. As a result, an increasing discharacterization of the qualitative and thus educational sense of evaluation is observed. The affirmation of this ethos in universities, and in society as a whole, is facilitated by big data algorithms, which are at the foundation of the constitution of the so-called ‘metric society’, in which there is a general trend to use quantitative forms to conduct social classifications. This text, supported by a review of the literature, reflects on two processes of evaluation of professors of higher education that go beyond the academic space because of their spectacularized public dimension: the ranking of professor production, by the “h index” and b) evaluations conducted by students on public online sites, in this case, the ratemyprofessors.com site. Based on these two evaluation strategies, professors, researchers, and students are involved in a dispute in which displaying oneself, being seen, monitored, and classified become criteria for (perceived) approval, or, at the limit, for a loss of financing for one’s work (canceling). Keywords: Evaluation Of Professors; Algorithms; Metric Society; Critical Theory; Digital Culture. Data de registro: 15/04/2022 Data de aceite: 13/12/2022. (shrink)

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to (...) the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (shrink)

Academic engagement describes students’ involvement in academic learning and achievement. This paper reports the psychometric properties of the University Student Engagement Inventory (USEI) with a sample of 3992 university students from nine different countries and regions from Europe, North and South America, Africa, and Asia. The USEI operationalizes a trifactorial conceptualization of academic engagement (behavioral, emotional and cognitive). Construct validity was assessed by means of confirmatory factor analysis and reliability was assessed using Cronbach’s alpha and McDonald’s omega coefficients. Weak measurement (...) invariance was observed for country/region, while strong measurement invariance was observed for gender and area of graduation. The USEI scores showed predictive validity for dropout intention, self-rated academic performance, and course approval rate while divergent validity with student burnout scores was also evident. Overall, the results indicate that the USEI can produce reliable and valid data on academic engagement of university students across the world. (shrink)

The Koizumi Administration got off on the right foot with a high approval rate over 85 % in April 2001, and swept Upper House Election held three months later (Inoguchi, 2002). However, it lost the support of legislators, media, and constituents because of his failure to get the reform process off the ground. Most salient of the legislative records is that the batting average of the cabinet sponsored bills has experienced a dramatic fall in the 153rd (27 September to (...) 7 December 1001) and 154th (21 January to 31 July 2002) sessions, registering the second lowest figure for the last decade. Clearly the Prime Minister's legislative coalition has been significantly weakened (see Table 1; see Table 2 for the distribution of seats by political party). (shrink)

Several vaccines against COVID-19 have now been developed and are already being rolled out around the world. The decision whether or not to get vaccinated has so far been left to the individual citizens. However, there are good reasons, both in theory as well as in practice, to believe that the willingness to get vaccinated might not be sufficiently high to achieve herd immunity. A policy of mandatory vaccination could ensure high levels of vaccination coverage, but its legitimacy is doubtful. (...) We investigate the willingness to get vaccinated and the reasons for an acceptance (or rejection) of a policy of mandatory vaccination against COVID-19 in June and July 2020 in Germany based on a representative real time survey, a random sub-sample (SOEP-CoV) of the German Socio-Economic Panel (SOEP). Our results show that about 70 percent of adults in Germany would voluntarily get vaccinated against the coronavirus if a vaccine without side effects was available. About half of residents of Germany are in favor, and half against, a policy of mandatory vaccination. The approval rate for mandatory vaccination is significantly higher among those who would get vaccinated voluntarily (around 60 percent) than among those who would not get vaccinated voluntarily (27 percent). The individual willingness to get vaccinated and acceptance of a policy of mandatory vaccination correlates systematically with socio-demographic and psychological characteristics of the respondents. We conclude that as far as people’s declared intentions are concerned, herd immunity could be reached without a policy of mandatory vaccination, but that such a policy might be found acceptable too, were it to become necessary. (shrink)

In the Philippines, all transplant centers are mandated by the Department of Health (DOH) to have a Hospital Transplant Ethics Committee (HTEC) to ensure that donations are altruistic, voluntary and free of coercion/commercial transactions. This study was undertaken primarily to describe the organizational and functional profile of existing HTECs and identify areas for improvement. This is a descriptive cross‐sectional study. There was variation in their logistical arrangements (support from hospital, filing systems, office spaces), operations (length and frequency of meetings, number (...) of referrals) and membership (composition, qualifications, occupation, training). The approval rate for donor‐recipient pairs is high with the majority of cases made by living non‐related donors. Appropriate reasons were cited for rejection. The perception of HTECs is that they are competent and confident in their decision‐making. However, there is a need to standardize HTEC composition, provide operating procedures and additional training which can be done by the DOH. (shrink)

In this paper, we analyze how citizens evaluate their president, especially focusing on why voters lower their evaluations at an individual-level perspective. We assert that citizens raise their evaluations of a new president when their expectations are met and lower their opinions when his or her performance disappoints them. Furthermore, the evaluations of the president are not only affected by a government's economic and diplomatic performance, but are also influenced by individual awareness of salient political issues, the contents of the (...) news, and their own perceived influence on politics. We test the theoretical hypotheses using Taiwan's Election and Democratization Study panel survey data. The statistical results support our theoretical hypotheses and show that when President Ma's performance did not meet respondents media exposure and political efficacy are significantly associated with the change in their opinions of Ma. (shrink)

I assume that voters mark ballots exclusively to express their true preferences among parties, leaving aside any considerations about an election’s possible outcome. The paper then analyzes the resulting voting behavior. In particular, it studies how effective different voting systems such as plurality rule, approval voting, and range voting are in fostering high turnout rates of such expressive voters.

The research aims to identify the trends of Palestinian higher educational institutions in Gaza Strip as learning organizations from the perspective of senior management in the Palestinian universities in Gaza Strip. The researchers used descriptive analytical approach and used the questionnaire as a tool for information gathering. The questionnaires were distributed to senior management in the Palestinian universities. The study population reached (344) employees in senior management is dispersed over (3) Palestinian universities. A stratified random sample of (182) employees from (...) the Palestinian universities was selected and the recovery rate was (69.2%). Statistical analysis (SPSS) program was used for analysis and processing the data. The study found the following results: There is an agreement about: the importance of the focus of "organizational structure" with an average approval, the importance of "technological infrastructure" axis with high approval, and the importance of "strategic" with an average approval. The results concluded that the study sample agree on the importance of "organizational dimension" highly. The results showed that the sample believe that the "strategic leadership" level in the universities got medium-approval. There is a fair level agreement about the axis of interest "teams / committees". There is an agreement about the importance of the "human dimension" moderately. The results showed that the sample is highly agreed about the importance of focus of the "knowledge management", and the focus of the "continuing education". They agreed weakly to somewhat about the importance of the focus of "scientific research", moderately agree about the importance of the center of "institutional culture", agree moderately on the importance of "cognitive dimension". The results showed that the sample largely agree on the importance of the focus of "strategic partnerships and alliances". They agree highly on the axis "keep up with the labor market" and on the focus of the importance of "technology incubators". The results showed that the sample moderately agree about the importance of the theme on "consulting and training", the importance of the focus of "social responsibility", and the focus of the "Community dimension". The study found a group of recommendations including: there is a need to provide suitable environment that achieve learning organizations. There is a need to develop the technological infrastructure (hardware, software, networks, databases, and human skills) because of the great advantages that they offer. The universities need to adopt knowledge management in the academic and administrative departments because knowledge is the core of the work of these departments. The establishment of technology incubators in universities to adopt outstanding university research projects, to protect, to supports, and to market them; furthermore, to develop the capabilities and skills of employees in the field of information technology. (shrink)

Several European countries are approving legislative reforms moving to a presumed consent system in order to increase organ donation rates. Nevertheless, irrespective of the consent system in force, family's decisional capacity probably causes a greater impact on such rates. In this contribution we have developed a systematic methodology in order to analyse and compare European organ procurement laws, and we clarify the weight given by each European law to relatives' decisional capacity over individual's preferences (expressed or not while alive) regarding (...) the destination of his or her organs after death. In this sense, the results constitute the first comprehensive and comparative legislative mapping on European transplantation laws. (shrink)

The study aimed to identify the reality of the use of social networks in the technical colleges in Palestine, where the variables of social networks were included. The analytical descriptive method was used in the study. A questionnaire consisting of (12) items was randomly distributed to college workers Technology in the Gaza Strip. The sample of the study consisted of (205) employees of these colleges. The response rate was 74.5%. The results showed a high degree of approval for the (...) dimensions of the social networks and a relative weight (74.15%) according to the perspective of the employees of the technical colleges in the Gaza Strip. The results of the study showed that there is a high level of social networking areas (site management and Website Content) in the technical colleges in the Gaza Strip. The field of site management ranked first with a relative weight of 74.91%, and second and last (Content Site) with a relative weight (73.38%). The results showed that there were differences between colleges in the use of social networks where the results showed that the most common colleges used these networks (UCAS) and the least used is (GTC). The results showed no differences between male and female employees in the use of social networks in technical colleges. The researchers suggest a number of recommendations, including: the need to raise awareness of the importance of Facebook and other social networking sites, through the holding of courses for employees in technical colleges, and to identify the ways to optimize the use of such sites, and the benefits of this use, and reflected positively on technical colleges. And the adoption of dealing with the various social networking sites as a reality, and the Palestinian and Arab technical colleges, use them in accordance with the objectives of technical colleges. Advise the Department of Technical Colleges to devote time to their presence on social networks to follow the public and respond to their queries. There is a need for the attention of decision-makers in technical colleges in social sites, because they are considered an important and effective means of communication, and the link between beneficiaries and decision-makers. There is a need to promote the use of modern electronic means of work and the need to increase the link of customers to the college through electronic services. (shrink)

The study aimed to identify the role of administrative procedures and systems in enhancing the performance of the educational institutions in the Islamic University in Gaza. To achieve the research objectives, the researchers used the analytical descriptive approach to collect information. The researchers used the questionnaire distributed to three categories of employees at the Islamic University (senior management, faculty members, their assistants and members of the administrative board). A random sample of 314 employees was selected and 276 questionnaires were retrieved (...) with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter process and analyze data. The results of the research showed a positive role for the administrative procedures and systems in enhancing the performance of the Islamic University from the point of view of the members (senior management, teaching staff and their assistants and the administrative body), where the relative weight of all the paragraphs (73.728%). The analysis of the results revealed that the administrative procedures at the Islamic University in Gaza are used to an acceptable degree. The relative weight of all the paragraphs is 70%. This indicates a relationship between administrative procedures and regulations and the performance of the Islamic University in the Gaza Strip. The study found that there was a good degree of approval from the sample regarding the administrative procedures and their relationship to the job performance. There exist a sufficient degree of powers to the deans and department managers to carry out their tasks, with the use of plans as control tools. And that there are rules and procedures provided for decision-making in the University Council. It also has full powers to manage the university to improve the teaching and learning environment. The researchers also recommended a number of recommendations, including the need to follow up on the procedures and systems of management and update them continuously in the light of changes that may occur and to ensure the existence of a strong system of electronic information systems within the university. There is a need to provide mechanisms for obtaining information about the surrounding external environment, and effective mechanisms to provide managers with the necessary information in a timely manner. The importance of providing channels of communication that enables staff to communicate information about any violations and breaches. The study also recommended the follow-up, review, procedures and administrative systems, and work to modify them in line with the mission of the university and the objectives that the university seeks to reach. (shrink)

Background The global pandemic raised ethical issues for nurses about caring for all patients, not just those with COVID-19. Italy was the first European country to be seriously affected by the first wave, while Estonia’s infection and death rates were among the lowest in Europe. Did this raise different ethical issues for nurses in these two countries as well? Aim The aim was to describe and compare ethical issues between nurses working during the first wave of the COVID-19 pandemic in (...) Estonia and Italy. Research design A cross-sectional survey study with a self-administered questionnaire. The impact of COVID- 19 emergency on nursing care questionnaire was used. Participants and research context Convenience sampling was used to recruit 1098 nurses working during the first wave of the pandemic in 2020: 162 from Estonia and 936 from Italy. Ethical considerations Research ethics approvals were obtained, and the nurses provided informed consent. Results The most frequent ethical issues for Estonian nurses were professional communication and ensuring access to care for patients without COVID-19, and for Italian nurses, the end-of-life care and the risk of them getting the virus and transmitting it to their loved ones. There were no statistically significant differences in the frequency of ethical issues between Estonian nurses working with patients with and without COVID-19. Italian nurses caring for COVID-19 patients faced statistically significantly more (both p <.001) issues around prioritising patients and end-of-life. Nurses working with patients without COVID-19 in Italy faced more issues about access to care ( p <.001). Conclusions Estonian and Italian nurses, working in different clinical contexts during the first wave of the pandemic, faced different ethical issues. Local contextual aspects need to be considered to support nurses’ ethical decision-making in providing care during future crises and to ensure ethical care for patients. (shrink)

Background:Previous research has linked missed nursing care to nurses’ work environment. Ethical climate is a part of work environment, but the relationship of missed care to different types of ethical climate is unknown.Research objectives:To describe the types of ethical climate in adult in-patient cancer care settings, and their relationship to missed nursing care.Research design:A descriptive correlation design was used. Data were collected using the Ethical Climate Questionnaire and the MISSCARE survey tool, and analyzed with descriptive statistics, Pearson’s correlation and analysis (...) of variance.Participants and research context:All nurses from relevant units in the Republic of Cyprus were invited to participate.Ethical considerations:The research protocol has been approved according to national legislation, all licenses have been obtained, and respondents participated voluntarily after they have received all necessary information.Findings:Response rate was 91.8%. Five types identified were as follows: caring ; law and code ; rules ; instrumental ; and independence. Reported overall missed care was M = 2.51, and this was positively related to instrumental and independence types and negatively related to caring, rules, and law and code.Discussion:The reported levels of missed care and the types of ethical climates present similarities and differences with the relevant literature. All types of ethical climate were related to the reported missed care.Conclusion:Efforts to reduce the influence of instrumental and independence types and fostering caring, law and code, and rules types might decrease missed nursing care. However, more robust evidence is needed. (shrink)

Aim To study the views of people in a largely Muslim country, Kuwait, of the acceptability of a life-ending action such as physician-assisted suicide (PAS). Method 330 Kuwaiti university students judged the acceptability of PAS in 36 scenarios composed of all combinations of four factors: the patient's age (35, 60 or 85 years); the level of incurability of the illness (completely incurable vs extremely difficult to cure); the type of suffering (extreme physical pain or complete dependence) and the extent to (...) which the patient requests a life-ending procedure, euthanasia or PAS (no request, some form of request, repeated requests). In all scenarios, the patients were women who were receiving the best possible care. The ratings were subjected to cluster analysis and analyses of variance. Results Five clusters were found. For 44%, PAS was always very unacceptable, no matter what the circumstances. For 23%, it was unacceptable, but less so if the patient was older or requested it repeatedly. For 16%, it was unacceptable if the patient was young but was acceptable if the patient was elderly. For 5%, it was unacceptable if the patient had extreme pain but was acceptable if completely dependent. For 11%, it was unacceptable if the patient did not request it but acceptable if she did. Conclusion The majority of the Kuwaiti university students opposed PAS either categorically or with a slight variation according to circumstances. Nonetheless, a minority approved of PAS in some cases, particularly when the patient was elderly. (shrink)

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration. An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical evidence justify off-label uses, (...) physicians promote patients’ interests by prescribing products off label.Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”. (shrink)

Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.Objective: To assess training needs for biomedical research ethics evaluation among targeted countries.Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing (...) the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need. (shrink)

Background:Academic ethical awareness is an important aspect especially for nursing students who will provide ethical nursing care to patients in future or try to tread the path of learning toward professional acknowledgement in nursing scholarship.Purpose:The purpose of this study was to explore academic ethical awareness and its related characteristics among undergraduate nursing students.Methods:This study commenced the survey with cross-sectional, descriptive questions and enrolled convenient samples of 581 undergraduate nursing students from three universities in South Korea. It was investigated with structured (...) questionnaires including general characteristics and academic ethical awareness related.Ethical considerations:This study was reviewed and approved by the Institutional Review Board at National University.Findings:Academic ethical awareness was the highest regarding behaviors violating the respect or confidentiality of patients and cheating on exams, while it was the lowest for inappropriate behaviors in class. From the result of general characteristics difference, male students showed higher score than female students in relative; first-year students showed higher score than other year students; the higher score was rated from students who were highly satisfied with their major than the other not satisfied with their major; and students with low academic stress showed higher ethical awareness score than persons with higher stress.Conclusion:Personal behaviors were rated with low ethical awareness in relative, but items related to public rules and actual effects on patients or others were rated with higher score. Nursing satisfaction and academic stress are main factors on ethical awareness. To improve overall ethical awareness level of nursing students, it is required to provide more education about the importance of personal behaviors in class and need to improve the understanding of how it will be connected with future situation and effect. (shrink)

BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus (...) generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent. (shrink)

In Lesotho, the risk of mother-to-child-transmission (MTCT) of HIV is substantial; women of childbearing age have a high HIV prevalence rate (26·4%), low knowledge of HIV status and a total fertility rate of 3·5 births per woman. An effective means of preventing MTCT is to reduce unwanted fertility. This paper examines the unmet need for contraception to limit and space births among HIV-positive women in Lesotho aged 15–49 years, using the 2004 Lesotho Demographic and Health Survey. HIV-positive women have their (...) need for contraception unmet in almost one-third of cases, and multivariate analysis reveals this unmet need is most likely amongst the poor and amongst those not approving of family planning. Urgent action is needed to lower the level of unmet need and reduce MTCT. A constructive strategy is to improve access to family planning for all women in Lesotho, irrespective of HIV status, and, more specifically, integrate family planning with MTCT prevention and voluntary counselling and testing services. Copyright © Cambridge University Press 2008. (shrink)

Deep brain stimulation has been regarded as an efficient and safe treatment for Parkinson’s disease since being approved by the Food and Drug Administration in 1997. It is estimated that more than 150 000 patients have been implanted, with a forecasted rapid increase in uptake with population ageing. Recent longitudinal follow-up studies have reported a significant increase in postoperative survival rates of patients with PD implanted with DBS as compared with those not implanted with DBS. Although DBS tends to increase (...) life expectancy for most patients with PD, this medical benefit does not come without attendant negative consequences. For example, emerging forms of iatrogenic harms are sometimes induced—harms which were not initially expected when clinicians proposed neurosurgery and patients or their guardians consented to the treatment. We report and discuss the clinical case of a patient who was implanted with DBS more than 20 years ago and is now experiencing unexpected stages of PD. This case illustrates how extending the life span without improving quality of life may introduce a burden of harms for patients and families. As well, this case shows why we should prepare for the expanding numbers of PD-implanted patients experiencing a gain of longevity but with severe stages of disease leading to diminution in quality of life. This newly observed effect of DBS treatment requires us to explore ethical questions related to iatrogenic harms, informed consent, end of life and caregivers’ burden. (shrink)

For centuries, the processes of social differentiation associated with Modernity have often been thought to intensify the need for site-specific forms of role training and knowledge production, threatening the university’s survival either through fragmentation or through failure to adapt. Other lines of argument emphasize the extent to which the Modern system creates and relies on an integrated knowledge system, but most of the literature stresses functional differentiation and putative threats to the university. And yet over this period the university has (...) flourished. In our view, this seeming paradox is explained by the fact that modern society rests as much on universalistic cosmological bases as it does on differentiation. The university expands over recent centuries because – as it has from its religious origins – it casts cultural and human materials in universalistic terms. Our view helps explain empirical phenomena that confound standard accounts: the university’s extraordinary expansion and global diffusion, its curricular and structural isomorphism, and its relatively unified structure. All of this holds increasingly true after World War II, as national state societies made up of citizens are increasingly embedded in a world society constituted of empowered individuals. The redefinition of society in global and individual terms reduces nationally bounded models of nature and culture, extends the pool of university beneficiaries and investigators, and empowers the human persons who are understood to root it all. The changes intensify universalization and the university’s rate of worldwide growth. For the university’s knowledge and “knowers,” and for the pedagogy that joins them together, the implications are many. The emerging societal context intensifies longstanding processes of cultural rationalization and ontological elaboration, yielding great expansions in what can and should be known, and in who can and should know. These changes in turn alter the menu of approved techniques for joining knowledge and knower as one. The “knowledge society” that results is distinguished by the extraordinary degree to which the university is linked to society. But it is also distinguished by the degree to which society is organized around the university’s abstracted and universalized understandings of the world and its degree-certified graduates. (shrink)

Refusing consent to organ donation remains unacceptably high, and improving consent rates from family or next-of-kin is an important step to procuring more organs for solid organ transplantation in countries where this approval is sought. We have thus far failed to translate fully our limited understanding of why families refuse permission into successful strategies targeting consent in the setting of deceased organ donation, primarily because our interventions fail to target underlying cognitive obstacles. Novel interventions to overcome these hurdles, incorporating (...) an understanding of cognitive psychology and behavioral change therapy, may be beneficial. One potential intervention is to use the concept of nudge theory, where decision-making is influenced by encouraging positive reinforcement and indirect suggestion. Purposefully nudging families to given consent for organ donation by understanding, and then overcoming, their inherent cognitive biases is novel but also controversial. This article explores the roles of relatives in decisions about organ donation, how nudge theory translates to organ donation and discusses the arguments for and against its application. (shrink)

The ethics of hastened death are complex. Studies on physicians’ opinions about assisted dying exist, but changes in physicians’ attitudes towards hastened death in clinical decision-making and the background factors explaining this remain unclear. The aim of this study was to explore the changes in these attitudes among Finnish physicians. A questionnaire including hypothetical patient scenarios was sent to 1182 and 1258 Finnish physicians in 1999 and 2015, respectively. Two scenarios of patients with advanced cancer were presented: one requesting an (...) increase in his morphine dose to a potentially lethal level and another suffering a cardiac arrest. Physicians’ attitudes towards assisted death, life values and other background factors were queried as well. The response rate was 56%. The morphine dose was increased by 25% and 34% of the physicians in 1999 and 2015, respectively. Oncologists approved the increase most infrequently without a significant change between the study years. Oncological specialty, faith in God, female gender and younger age were independent factors associated with the reluctance to increase the morphine dose. Euthanasia, but not assisted suicide, was considered less reprehensible in 2015. In both years, most physicians withheld cardiopulmonary resuscitation. Finnish physicians accepted the risk of hastening death more often in 2015 than in 1999. The physicians’ specialty and many other background factors influenced this acceptance. They also regarded euthanasia as less reprehensible now than they did 16 years ago. (shrink)

Drug-resistant tuberculosis has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug-resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration in the United States and the Medicines Control Council in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing (...) of the drug is completed. These campaigns raise ethical concerns about whether patients should be offered experimental, unapproved, medicines for the treatment of life-threatening illnesses, and if authorities should approve drugs for life-threatening illnesses when vital questions about safety and efficacy remain outstanding. (shrink)

Three studies test eight hypotheses about (1) how judgment differs between people who ascribe greater vs. less moral relevance to choices, (2) how moral judgment is subject to task constraints that shift evaluative focus (to moral rules vs. to consequences), and (3) how differences in the propensity to rely on intuitive reactions affect judgment. In Study 1, judgments were affected by rated agreement with moral rules proscribing harm, whether the dilemma under consideration made moral rules versus consequences of choice salient, (...) and by thinking styles (intuitive vs. deliberative). In Studies 2 and 3, participants evaluated policy decisions to knowingly do harm to a resource to mitigate greater harm or to merely allow the greater harm to happen. When evaluated in isolation, approval for decisions to harm was affected by endorsement of moral rules and by thinking style. When both choices were evaluated simultaneously, total harm -- but not the do/allow distinction -- influenced rated approval. These studies suggest that moral rules play an important, but context-sensitive role in moral cognition, and offer an account of when emotional reactions to perceived moral violations receive less weight than consideration of costs and benefits in moral judgment and decision making. (shrink)

Background:Prisons are contexts where nurses are required to have specific skills to ensure that, in a setting designed for the expiation of crime, prisoners receive the same type of care as anyone else. But this is not always the case, giving rise to ethical issues.Research questions:‘How do correctional nurses describe their working experience in prisons? What issues emerged?’Methodology:This is a qualitative descriptive study. Following purposive sampling, we conducted five focus groups. Thematic analysis was used to analyse the data.Participants and research (...) context:Our sample included 31 correctional nurses in seven prisons in Northern Italy.Ethical considerations:The scientific merit of this study was recognized by the Academic Board of the University of Genoa. Approval to conduct the study was obtained from the Liguria Regional Government that funded this study and from the Local Health Authority that was the prison nurses’ employer. Formal consent was obtained from all the nurses who volunteered to participate in this study.Findings:Five themes emerged from the focus groups: prisoners’ healthcare needs, negotiation between custody and care, satisfaction of working in prisons, obstacles to quality care and safety. ‘Manipulation’ was a transversal theme that emerged from all the focus groups.Discussion:The problems generated by the clash between prison security and nursing care priorities did not enable nurses to practice autonomously and provide the best possible to care prisoners, giving rise to ethical issues and moral distress. This in turn causes high nursing turnover rates that negatively impact continuum of care.Conclusion:In Italy, correctional nurses urgently require specific education interventions with the participation of all those who work in prisons. Interventions based on the post-modern concept of restorative nursing could offer prison nurses the opportunity to both resolve ethical issues and reduce moral distress. (shrink)

Background Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research. Objective Our aim was to assess whether REC approval and ICP were documented in surgical trials. Study design Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the corresponding (...) author when ethical information was lacking. Results Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP. Conclusions The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines. (shrink)

Objective Having failed to achieve adequate influenza vaccination rates among employees through voluntary programmes, healthcare organisations have adopted mandatory ones. Some programmes permit religious exemptions, but little is known about who requests religious objections or why. Methods Content analysis of applications for religious exemptions from influenza vaccination at a free-standing children’s hospital in Cincinnati, Ohio, USA during the 2014–2015 influenza season. Results Twelve of 15 260 employees submitted applications requesting religious exemptions. Requestors included both clinical and non-clinical employees. All requestors (...) voluntarily identified their religious affiliation, and most were Christian. Content analysis identified six categories of reasons used to justify an exemption: risks/benefits, ethical/political, lack of direct patient contact, providence, purity and sanctity of life. Individuals articulated reasons in 1–5 categories. The most frequently cited category was purity; the vaccine and/or its mode of administration were impure, or receiving the vaccine would make the individual impure. Two individuals asserted that the vaccine contained cells derived from aborted human fetuses. Individuals also volunteered information supporting the sincerity of their beliefs including distress over previous vaccination and examples of behaviour consistent with their specific objection or their general religious commitment. All requests were approved. Conclusions Less than 0.1% of employees requested religious exemptions. Partnering with religious leaders and carefully correcting erroneous information may help address requestors’ concerns. (shrink)

We conducted a survey of attitudes towards the sale of kidneys for transplantation within and without the medical community. Half of those polled received a case of a young man in India whose only chance for survival was to purchase a kidney, the other half a case of a Canadian man who was suffering side-effects from dialysis and had been on the transplant waiting list for three years. We found the percentage of responses allowing the patients to purchase a kidney (...) was similar for the two cases (40 per cent in the Canadian case and 49 per cent in the Indian case). The medical groups had much lower rates of approval of this practice than the public. In all groups those allowing the practice showed similar concerns about regulation. This survey indicates public opinion to be contrary to public policy. (shrink)

Background: High ethical sensitivity positively affects the quality of nursing care; nevertheless, Chinese nurses’ ethical sensitivity and the factors influencing it have not been described. Research objectives: The purpose of this study was to describe ethical sensitivity and to explore factors influencing it among Chinese-registered nurses, to help nursing administrators improve nurses’ ethical sensitivity, build harmony between nurses and patients, and promote the patients’ health. Research design: This was a descriptive, cross-sectional study. Participants and research context: We recruited 500 nurses (...) from several departments in three tertiary hospitals. The Chinese Moral Sensitivity Questionnaire–Revised version and the Jefferson Scale of Empathy-Health Professionals were used to assess the nurses’ ethical sensitivity and empathy ability, respectively. Fifteen sociodemographic variables were included in the questionnaires. Ethical considerations: Informed consent was obtained from the participants regarding participation and data storage and handling. This program has been examined and supported by the research center of medical ethics and professional ethics of Guilin Medical University. The Approval No. was 2016RWYB04. The whole research process is conducted strictly according to ethical requirements. Results: The valid response rate was 84.40%. The total score of Chinese Moral Sensitivity Questionnaire–Revised was 35.82 ± 8.17. The subscale scores of moral responsibility and strength and sense of moral burden were 21.50 ± 4.91 and 14.33 ± 3.98, respectively. Significant differences were found among age groups, gender, years of working, category of profession, and quality of family communication regarding nurses’ ethical sensitivity. Regression analysis showed that the main factors influencing nurses’ ethical sensitivity were gender, years of working, quality of family communication, career satisfaction, and empathic ability. Discussion: Our findings suggest that Chinese nurses’ ethical sensitivity in tertiary hospitals in Guilin is at a medium level. Conclusion: The director of nursing schools and hospitals in China should pay attention to nurses’ ethical sensitivity and should intensify education and training to improve nurses’ ethical sensitivity. Further studies should focus on interventions aimed at improving Chinese nurses’ ethical sensitivity. (shrink)

Abstract— This study aimed to identify the degree of use of the capabilities of decision-support systems in Palestinian institutions higher education, Aqsa University in Gaza - a case study. The study used a analytical descriptive approach, and the researchers used the of questionnaire tool to collect the data, the researchers using stratified random sample distributed (150) questioners to the study population and (126) was obtained back with rate of 84%. The study showed that the most important results are: that senior (...) management supports the existence of decision support systems and that there is approval by the respondents on the paragraphs of the use of the capabilities of decision support systems in general. And that there are no significant differences between the averages of the answers of respondents differences about the degree of use of decision support systems capabilities attributed to personal data. The study also concluded a series of recommendations including: increasing the adoption of the senior management decision support in their decision-making systems. And increased regulatory attention to the potential available to decision support systems directly to the senior management in the Palestinian universities in the Gaza Strip. There is an increased interest in the physical and technical possibilities available for the use of decision support systems. There is an increased interest in human potential available for the use of decision support systems. Investment of information available to universities in building the capacities of integration techniques and other information technology capabilities. The empowerment of human resources in universities and participating in making decisions concerning the construction of the capabilities of information technology. (shrink)

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...) The European Medicines Agency reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells. (shrink)

An investigation of public support for coastal adaptation options and public finance options in Florida evaluated stakeholder judgments and how they changed through a participatory engagement process. The study found that public finance mechanisms that imposed fiscal burdens on those who directly benefit from hazard reduction were rated as more acceptable than others. Significantly, visualisations and data on local economic damage and return on investment of potential adaptation options further increased acceptability ratings. The question of whether a development fee (...) for adaptation or any other public purpose supported by private funds is a legal issue that depends on a test called the rational nexus. One concern of this article is to explore options for such fees to cover adaptation to climate change. This raises issues about the potential conflict with the community-wide and intergenerational nature of long-term adaptation. We also explore the relevance of environmental attitudes using the 'new environmental paradigm' (NEP) scale and political party affiliation. Results have implications for infrastructure improvements that require public approval for financing. (shrink)

Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a descriptive study. The (...) questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (χ 2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. Results The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC. Conclusion In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research. (shrink)

The research aims to identify the learning organizations and their role in achieving organizational excellence in the Palestinian universities in Gaza Strip. The researchers used descriptive analytical approach and used the questionnaire as a tool for information gathering. The questionnaires were distributed to senior management in the Palestinian universities. The study population reached (344) employees in senior management is dispersed over (3) Palestinian universities. A stratified random sample of (182) workers from the Palestinian universities was selected and the recovery rate (...) was (69.2%). Statistical analysis (SPSS) program was used for analysis and processing the data. The research found the following results: there is a fair degree of approval on "cognitive dimension", there is a high approval about the importance of "organizational dimension", there is moderately consent of the importance of "Community dimension", there is a large degree of consent about the importance of axis of the "leadership excellence", there is a large degree of consent about the importance of axis of the "service-excellence", there is a fair degree approval about the importance of the axis of "cognitive excellence", and there is a moderately consent of the importance of "Organizational Excellence". The research found a group of recommendations including: the need to develop appropriate strategies for the University, employ modern technology in information systems, in addition to provide appropriate environment that achieve learning organizations, develop technological infrastructure, adopt universities for knowledge management in the academic and administrative departments because knowledge is the core of the work of these departments, create technological incubators in universities to adopt excellence academic research projects, and protected them, support them, and market them. Establishing of centers of excellence for scientific research in the university.The need for cooperation and coordination between local, Arab and international universities for the exchange of knowledge, information, and participation programs and training courses, as it provides an opportunity to develop the capabilities and skills of personnel and expertise. (shrink)

The purpose of this study was to examine how ethical approval and competing interests are addressed by medical journals in Iran. In a cross-sectional study, 151 journals accredited by the Publications Commission of the Ministry of Health and Medical Education were reviewed. Data collection was carried out by assessing journal guidelines and conducting structured phone interviews with journal managers, focusing on how ethical considerations and conflicts of interest (COI) are addressed. Overall, 135 of the 151 journals (89.4 percent) examined (...) some aspect of ethical considerations of submitted articles. Authors were required to disclose their financial sponsors by 98 journals (64.9 percent), while COI disclosure was required by 67 journals (44.4 percent). We conclude that the rate of addressing ethical considerations is not far from ideal, but the requirement for COI disclosure needs more attention. (shrink)

anonymous tissue samples obtained in hospitals and clinics without donor consent. This can be justified as a response to a public health emergency, but should not be seen as setting a precedent for waiving consent whenever samples are anonymous. The following recommendations grow out of this discussion: (1) Studies using anonymous tissue samples should not be automatically exempt from consent requirements, and consent should not be waived simply to avoid anticipated refusals, low participation rates or self selection bias. (2) The (...) consensus on informed consent favors fulfilling as many of the elements of informed consent as reasonably possible, so studies should be assessed individually to determine if any or all elements of informed consent should be modified or omitted. (3) There is a need for greater regulation of the research use of tissue samples. (4) Investigators seeking approval to waive consent or modify elements of informed consent should document the sort of new findings that they believe would effect their calculations about the benefits and burdens to subjects who are enrolled in the study, and institutional review boards should indicate whether they agree with the investigators' analysis. Keywords: AIDS, Consent, Ethics, HIV, Notification, Privacy, Research, Screening, Surveillance CiteULike Connotea Del.icio.us What's this? (shrink)

Background:Homeless persons in the United States have disproportionately high rates of illness, injury, and mortality and tend to believe that the quality of their end-of-life care will be poor. No studies were found as to whether nurses or nursing students require moral courage to help homeless persons or members of any other demographic complete advance directives.Research hypothesis:We hypothesized that baccalaureate nursing students require moral courage to help homeless persons complete advance directives. Moral courage was defined as a trait of a (...) person or an action that overcomes fears or other challenges to achieve something of great moral worth.Research design:The hypothesis was investigated through a qualitative descriptive study. Aside from the pre-selection of a single variable to study (i.e. moral courage), our investigation was a naturalistic inquiry with narrative hues insofar as it attended to specific words and phrases in the data that were associated with that variable.Participants and research context:A total of 15 baccalaureate nursing students at a public university in the United States responded to questionnaires that sought to elicit fears and other challenges that they both expected to experience and actually experienced while helping homeless persons complete advance directives at a local, non-profit service agency.Ethical considerations:The study was approved by the Internal Review Board of the authors’ university, and each participant signed an informed consent form, which stated that the study involved no reasonably foreseeable risks and that participation was voluntary.Findings:Before meeting with homeless persons, participants reported that they expected to experience two fears and a challenge: fear of behaving in ways that a homeless person would deem inappropriate, fear of discussing a homeless person’s dying and death, and the challenge of adequately conveying the advance directive’s meaning and accurately recording a homeless person’s end-of-life wishes. In contrast, after their meetings with homeless persons, relatively few participants reported having encountered those obstacles. So, while participants required moral courage to assist homeless persons with advance directives, they required greater moral courage as they anticipated their meetings than during those meetings.Discussion:Our study breaks new ground at the intersection of nursing, moral courage, and advance directives. It might also have important implications for how to improve the training that US nursing students receive before they provide this service.Conclusion:Our results cannot be generalized, but portions of our approach are likely to be transferable to similar social contexts. For example, because homeless persons are misunderstood and marginalized throughout the United States, our design for training nursing students to provide this service is also likely to be useful across the United States. Internationally, however, it is not yet known whether our participants’ fears and the challenge they faced are also experienced by those who assist homeless persons or members of other vulnerable populations in documenting healthcare wishes. (shrink)

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (...) and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

Background and objectives Conscientious refusal of abortion has been discussed widely by medical ethicists but little information on practitioners' opinions exists. The American College of Obstetricians and Gynecologists (ACOG) issued recommendations about conscientious refusal. We used a vignette experiment to examine obstetrician-gynecologists' (OB/GYN) support for the recommendations. Design A national survey of OB/GYN physicians contained a vignette experiment in which an OB/GYN doctor refused a requested elective abortion. The vignette varied two issues recently addressed by the ACOG ethics committee—whether the (...) doctor referred and whether the doctor disclosed their objection to the abortion. Participants and setting 1800 OB/GYN randomly selected physicians were asked to complete a mail survey containing the vignette. The response rate was 66% (n=1154) after excluding 40 ineligible cases. Measurement Physicians indicated their approval for the vignette doctor's decision. Main results Overall, 43% of OB/GYN physicians responded that the conscientious refusal exercised by the vignette physician was appropriate. 70% rated the vignette doctor as acting appropriately when a referral was made. This dropped to 51% when the doctor disclosed objections to the patient, and to 12% when the doctor disclosed objections and refused to make a referral. Consistent with previous research, males were more likely to support disclosure and refusal to refer. Highly religious physicians supported non-referral but not disclosure. Conclusion OB/GYN physicians are less likely to support conscientious refusal of abortion if physicians disclose their objections to patients. This is at odds with ACOG recommendations and with some models of the doctor–patient relationship. (shrink)

Background: Nurses, social workers, and medical residents are ethically mandated to engage in policy advocacy to promote the health and well-being of patients and increase access to care. Yet, no instrument exists to measure their level of engagement in policy advocacy. Research objective: To describe the development and validation of the Policy Advocacy Engagement Scale, designed to measure frontline healthcare professionals’ engagement in policy advocacy with respect to a broad range of issues, including patients’ ethical rights, quality of care, culturally (...) competent care, preventive care, affordability/accessibility of care, mental healthcare, and community-based care. Research design: Cross-sectional data were gathered to estimate the content and construct validity, internal consistency, and test–retest reliability of the Policy Advocacy Engagement Scale. Participants and context: In all, 97 nurses, 94 social workers, and 104 medical residents were recruited from eight acute-care hospitals in Los Angeles County. Ethical considerations: Informed consent was obtained via Qualtrics and covered purposes, risks and benefits; voluntary participation; confidentiality; and compensation. Institutional Review Board approval was obtained from the University of Southern California and all hospitals. Findings: Results supported the validity of the concept and the instrument. In confirmatory factor analysis, seven items loaded onto one component with indices indicating adequate model fit. A Pearson correlation coefficient of.36 supported the scale’s test–retest stability. Cronbach’s α of.93 indicated strong internal consistency. Discussion: The Policy Advocacy Engagement Scale demonstrated satisfactory psychometric properties in this initial test. Findings should be considered within the context of the study’s limitations, which include a low response rate and limited geographic scope. Conclusion: The Policy Advocacy Engagement Scale appears to be the first validated scale to measure frontline healthcare professionals’ engagement in policy advocacy. With it, researchers can analyze variations in professionals’ levels of policy advocacy engagement, understand what factors are associated with it, and remedy barriers that might exist to their provision of it. (shrink)

Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union to monitor (...) and prevent incomplete registration of trials and selective reporting of trial results. It further investigated opinions of REC members about the need to update current legislation on this matter. Methods: Web-based survey on members of RECs in 22 European countries. Results: Over 90 percent of respondents agreed that the incomplete publication of trial results had a strong or somewhat negative impact on public health and on healthcare professionals’ trust in the validity of clinical research, yet only 30 percent reported that their REC had some mechanism in place to check that findings of approved studies are published in some form. Less than 10 percent stated that their REC has further specific procedures in place to prevent or minimize selective reporting of study results. Respondents stated variously that their REC did not have the resources to follow up on this matter. Conclusions: The existing legislation to regulate trial registration and encourage complete publication of trial results leaves room for improvement. REC members welcome guidelines to adequately address both problems. The new Regulation EU No. 536/2014 as well as the FDA Amendment Act from 2007 require the reporting of summary results within 1 year after study end. As recent reviews demonstrated, without any systematic approach to monitor the adherence to these regulations, publication rates remain rather low. (shrink)

Background: Dignity is a multidimensional construct that includes perception, knowledge, and emotions related to competence or respect. Attitudes to aging are a comprehensive personal view of the experience of aging over the course of life, which can be influenced by various factors, such as the levels of health and self-sufficiency and social, psychological, or demographic factors. Aim: The purpose of this study was to explore the attitudes to aging of home-dwelling and inpatient older adults, and whether dignity and other selected (...) factors belong among the predictors influencing attitudes to aging in these two different groups of older adults. Research design: Cross-sectional study using a set of questionnaires: Patient Dignity Inventory, Attitudes to Aging Questionnaire, and Barthel Index. Pearson and Spearman correlation analyses and multivariable linear regression were used for statistical processing. Participants and research context: 233 inpatients and 237 home-dwelling older adults participated in the research in two regions of the Czech Republic. Ethical considerations: Institutional Review Board approval was received from the authors’ university. Findings: The inpatients had more negative attitudes to aging. The predictors of their attitudes to aging were gender and dignity. Women and inpatients with poor dignity ratings had more negative attitudes to aging. The predictors for home-dwelling older adults were education, living arrangement, and dignity. More negative attitudes to aging were found in older adults with lower levels of education who lived alone and rated their dignity as low. Discussion and Conclusions: The results of this study add to the understanding that a sense of dignity is an important predictor of attitudes to aging for both home-dwelling older adults and inpatients. (shrink)

The magnitude of public concerns about agricultural innovations has often been underestimated, as past examples, such as pesticides, nanotechnology, and cloning, demonstrate. Indeed, studies have proven that the agricultural sector presents an area of tension and often attracts skepticism concerning new technologies. Digital technologies have become increasingly popular in agriculture. Yet there are almost no investigations on the public acceptance of digitalization in agriculture so far. Our online survey provides initial insights to reduce this knowledge gap. The sample represents the (...) German population in terms of gender, age, education and size of place of residence. Results showed that if the potential of digital farming technologies regarding animal welfare and environmental protection was described, respondents reacted positively. Thus, the general attitudes of respondents toward the benefits of DFT were mostly positive. The approval to increasing adoption rates of particular DFT by providing subsidies was also high. Linear regression models showed that the dominant positive influences on respondents’ attitudes toward the benefits of DFT were a generally positive attitude toward farming and a strong trust in farmers in Germany. Confronting respondents with pictures showing DFT resulted in many spontaneous negative associations and general criticism of agricultural production. The latter holds true for DFT in animal husbandry in particular. However, as agriculture as a whole is criticized by many groups in Germany, it is unlikely that benefits from digitalization will significantly increase the public acceptance of agriculture as a whole. (shrink)