Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research. Whether or not T1 has these features, translational research (...) beyond approval is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)

When conducting health and medical research it is important to do the research ethically and to apply for prior ethical approval from the relevant authorities. The latter requirement is true for developed countries as well as developing countries. The authors argue that simply applying for research ethics approval from an institutional review board at a university based in a developed country is not enough to start a health research project in a developing country. The (...) paper also suggests a number of reasons why researchers may fail to seek local research ethics permission in developing countries. The authors use a recent paper reporting research conducted in Nepal and published in an international journal as a case study to highlight the importance of being sensitive to local requirements regarding applying for and registering health and medical research. (shrink)

Confirming multisite studies presents an ongoing challenge for researchers based in England. Those wishing to set up a multisite study must undergo local Research & Development review, in addition...

It is a tale of two Pfizers. In 2018 they abandoned research into the leading cause of dementia, Alzheimer’s Disease (AD) (Hawkes 2018). In 2021, they developed the first vaccine for Covid-19 to re...

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of (...) research regulatory structures, arranging a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)

The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service procedures and the electronic Integrated Research Application System. We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus (...) on the substantive research, and suggest directions for radical system change. We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates. The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation. We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate. (shrink)

The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of (...) products by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems. (shrink)

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals (...) cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval. (shrink)

Objectives—To assess the process involved in obtaining ethical approval for a single-centre study involving geographically dispersed subjects with an uncommon genetic disorder. Design—Observational data of the application process to 53 local research ethics committees (LRECs) throughout Wales, England and Scotland. The Multicentre Research Ethics Committee (MREC) for Wales had already granted approval. Results—Application to the 53 LRECs required 24,552 sheets of paper and took two months of the researcher's time. The median time taken for approval (...) was 39 days with only seven (13%) of committees responding within the recommended 21 days. In at least nineteen cases (36%) a subcommittee considered the application. Thirty-three committees (62%) accepted the proposal without amendments but, of the remainder, four (8%) requested changes outside of the remit of LRECs. Discussion—Difficulties still exist with the system for obtaining ethical approval for studies involving a single centre but with patients at multiple sites, as is often required for genetic observational research. As such studies differ from true multicentre studies, it may be advantageous to develop a separate and specific process of application to ensure that resources are not unnecessarily expended in the quest for ethical approval. (shrink)

University human research ethics application procedures can be complicated and daunting, especially for international students unfamiliar with the process and the language. We conducted focus groups and interviews with four research higher degree and 21 Master’s coursework international students at an Australian university to gain their views on the human ethics application process. We found the most important influences on their experience were: the time it took to do an application; support from supervisors, peers and others; their own (...) language skills; and their lack of familiarity with research ethics procedures. To improve the experience of international students undertaking research involving human research ethics applications, we recommend universities provide guidance on institutional ethics review processes, concepts and terminology, with translations in a range of languages, together with guidance on how to conduct research ethically within and outside the students’ own countries. We also recommend curricula be developed to further students’ understanding of the importance of ethical research practice, and that these curricula be embedded in undergraduate and postgraduate degree programs and reflected in course learning outcomes. (shrink)

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review (...) by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB). (shrink)

We argue that developing a human ethics application is an effective method for refining the intent and design of research studies. Our study aimed to investigate the delivery of end-of-life and palliative care nursing to residents of an aged care unit in a Multi-purpose Service/centre in rural Victoria. We used the ethics application process as a strategy to focus the study, and to refine the data collection and analysis techniques. It is our contention that the process of completing the (...) application and gaining ethics approval is laborious; however, the intellectualising that occurs provides researchers with an opportunity to reflect upon and refine their studies, thus ensuring the ultimate success and timely completion of research investigations. (shrink)

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and efficacy (...) of the drug. While considerable scholarly attention has been devoted to this case, the ethical aspects of the AA regulatory pathway have so far remained relatively unexplored. In this paper, we set out to fill this gap. We illustrate six conditions that should be met for AA to be ethically acceptable: moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency. We discuss such conditions and suggest practical steps to implement them in regulatory and oversight processes. Taken together, our six conditions represent a benchmark for assessing the ethical validity of AA processes and decisions. (shrink)

Antibiotic use triggers evolutionary and ecological responses from bacteria, leading to antibiotic resistance and harmful patient outcomes. Two complementary strategies support long-term antibiotic effectiveness: conservation of existing therapies and production of novel antibiotics. Conservation encompasses infection control, antibiotic stewardship, and other public health interventions to prevent infection, which reduce antibiotic demand. Production of new antibiotics allows physicians to replace existing drugs rendered less effective by resistance.In recent years, physicians and policymakers have raised concerns about the pipeline for new antibiotics, pointing (...) to a decline in the number of antibiotics approved since the 1980s. This trend has been attributed to high research and development costs, low reimbursement for antibiotics, and regulatory standards for review and approval. Professional societies and researchers around the world have called for renewed emphasis on antimicrobial stewardship, while also supporting antibiotic research and development through grants, changes to intellectual property laws to extend market exclusivity periods, and modification of premarket testing regulations to reduce antibiotic development time and expenses. (shrink)

Animals have been and will continue to be used in educational programs, but some concerns about the responsibility for assuring their proper care and humane use need to be discussed. Research animals have been regulated and monitored quite successfully by Institutional Animal Care and Use Committees (IACUC). These Committees are extending their responsibilities to cover animals used in educational programs. Three common roles of these IACUCs are described, including oversight, investigative and training responsibilities. Guidelines developed for faculty using animals (...) at the University of Florida are presented and discussed. (shrink)

Background: Values are the basis of nursing practice, especially in making decisions about complicated ethical issues. Despite their key role in nursing, little information exists on the factors affecting their development and manifestation in nursing students. Objective: This study identifies and describes the facilitators and inhibitors of the development and manifestation of professional values based on the experiences of nursing students and instructors and nurses. Research design: Data were collected through 29 semi-structured interviews and two focus group (...) interviews in 2013–2015 and were analyzed using the conventional content analysis method of Elo and Kyngäs. Participants and research context: In total, 18 nursing undergraduates, five nursing instructors, and five nurses from Shiraz University of Medical Sciences and one of the teaching hospitals in Shiraz were selected through purposive sampling. Ethical considerations: The research was approved by the Ethics Committee of Shiraz University of Medical Sciences and the teaching hospital examined. Findings: The findings consisted of two categories: personal and environmental factors. Personal factors consisted of the two subcategories of personal stimuli (work experience and past relationships, inner beliefs and acting on values, belief in God and a divine worldview) and personal inhibitors (the lack of professional motivation and enthusiasm, negative emotions). Environmental factors consisted of the two subcategories of environmental stimuli (cooperation, order and discipline) and environmental inhibitors (unfavorable work environment, society’s negative attitude toward nursing, the violation of rights). Discussion and conclusion: Given the impact of personal and environmental factors on the development and manifestation of professional values in nursing students, it is upon the education authorities to take account of them in their planning, and nursing managers are also recommended to further address these factors in their development of a proper work environment, provision of standard facilities and removal of barriers. (shrink)

Background: Ethics development is one of the most important aspects of professional practice in health sciences students. Understanding factors affecting ethics development can enhance clinical and professional performance in students. Objective: This study was conducted to explore students’ perceptions about factors affecting professional ethics development. Research design: This study is a conventional content analysis. Data were collected through 20 semi-structured interviews and two focus group interviews (12 students) during 2017–2018. Data were analyzed concurrently with data gathering, (...) using the conventional content analysis approach of Graneheim and Lundman. Participants and research context: In total, 8 students of nursing, 5 medical students, 4 students of anesthesia and 3 operating room students in individual interviews, and 12 students in two focus group interviews from one university in the south of Iran were selected through purposive sampling. Ethical considerations: The research was approved by the Ethics Committee of one university in the south of Iran. Findings: The findings revealed two themes: personal and background factors. Personal factors consisted of the two categories of individual motivation and tendencies and interpersonal interactions. Background factors consisted of the two categories of role and function of teachers and environmental agents. Discussion and conclusions: According to the findings, both background and individual factors affect development of professional ethics in students. Understanding these factors along with reinforcement of educational planning in this field can improve healthcare services. (shrink)

Background: Maintaining patient dignity is an important aspect of nursing care. No instrument is currently available to measure nurses’ behaviours for maintaining patient dignity in clinical care. Objectives: To develop and test an instrument to measure activities nurses perform to maintain patient dignity in clinical care settings, guided by the literature and face-to-face interviews. Research design: A quantitative cross-sectional descriptive survey collected data from the developed scale, which was analysed by descriptive statistics and factor analysis. Participants and research (...) context: Convenience samples of nurses participated in the interviews (n = 40) and examined face validity of the scale (n = 20). A purposive sample of 610 nurses was recruited from four regional hospitals in the northern, southern and eastern areas of Taiwan to test the developed scale. Ethical considerations: Research was approved by the Institutional Review Board of the study hospital. Information about the study was provided to nurses and those willing to participate provided written informed consent prior to data collection. Findings: The 36-item Dignity in Care Scale for Nurses had acceptable content and face validity. Factor analysis identified six factors necessary for maintaining dignity of patient care: communication skills, confidentiality of patient information, prompt response to patient needs, respect for patient’s autonomy, providing a safe environment and protecting the patient’s well-being. The reliability coefficient for the total scale was 0.93; alpha coefficients for the subscales ranged from 0.70 to 0.94. Discussion: The Dignity in Care Scale for Nurses was demonstrated to be a reliable and valid tool for assessing how nurses maintain dignity in care for patients in the clinical setting. The questionnaire can be used to provide feedback to nurses regarding patient dignity. Conclusion: Data gained from this instrument could be used to design nursing education programmes to help nurses enhance their abilities for maintaining patient dignity in clinical practice. (shrink)

Background: Moral courage is required at all levels of nursing. However, there is a need for development of instruments to measure nurses’ moral courage. Objectives: The objective of this study is to develop a scale to measure nurses’ self-assessed moral courage, to evaluate the scale’s psychometric properties, and to briefly describe the current level of nurses’ self-assessed moral courage and associated socio-demographic factors. Research design: In this methodological study, non-experimental, cross-sectional exploratory design was applied. The data were collected (...) using Nurses’ Moral Courage Scale and analysed statistically. Participants and research context: The data were collected from a convenience sample of 482 nurses from four different clinical fields in a major university hospital in Finland for the final testing of the scale. The pilot comprised a convenience sample of 129 nurses. Ethical considerations: The study followed good scientific inquiry guidelines. Ethical approval was obtained from the university ethics committee and permission to conduct the study from the participating hospital. Findings: Psychometric evaluation showed that the 4-sub-scale, 21-item Nurses’ Moral Courage Scale demonstrates good reliability and validity at its current state of development showing a good level of internal consistency for a new scale, the internal consistency values ranging from 0.73 to 0.82 for sub-scales and 0.93 for the total scale, thus well exceeding the recommended Cronbach’s alpha value of >0.7. Principal component analysis and confirmatory factor analysis supported the theoretical construct of Nurses’ Moral Courage Scale. Face validity and expert panel assessments markedly contributed to the relevance of items in establishing content validity. Discussion and conclusion: Nurses’ Moral Courage Scale provides a new generic instrument intended for measuring nurses’ self-assessed moral courage. Recognizing the importance of moral courage as a part of nurses’ moral competence and its assessment offers possibilities to develop interventions and educational programs for enhancement of moral courage. Research should focus on further validation measures of Nurses’ Moral Courage Scale in international contexts. (shrink)

Background: The Clinical Ethics Residency for Nurses was offered selectively to nurses affiliated with two academic medical centers to increase confidence in ethical decision-making. Research Question/Aim: To discover how effective the participants perceived the program and if their goals of participation had been met. Research design: A total of 65 end-of-course essays (from three cohorts) were analyzed using modified directed content analysis. In-depth and recursive readings of the essays by faculty were guided by six questions that had been (...) posed to graduates. Ethical considerations: Institutional review board approval was granted for the duration of the program and its reporting period. Confidentiality was maintained via the use of codes for all evaluations including the essays and potentially identifying content redacted. Findings: An umbrella theme emerged: participants had developed ethical knowledge and skills that provided a “moral compass to navigate the many gray areas of decision-making that confront them in daily practice.” Six major themes corresponding to questions posed to the participants included the ability to advocate for good patient care; to support and empower colleagues, patients, and families; they experienced personal and professional transformation; they valued the multimodal nature of the program; and were using their new knowledge and skills in practice. However, they also recognized that their development as moral agents was an ongoing process. Discussion: Findings support that enhancing nurse confidence in their moral agency with a multimodal educational approach that includes mentored practice in ethical decision-making, enhancing communication skills and role-play can mitigate moral distress. A majority found the program personally and professionally transformative. However, they recognized that ongoing ethics discussion involvement and supportive environments would be important in their continued development of ethical agency. Conclusion: Multimodal ethics education programs have potential to be transformative and enhance nurse confidence in their ethical decision-making. (shrink)

Background: Spiritual development is one of the most important aspects of socialization that has attracted the attention of researchers. It is needed to train nursing student and novice nurses to provide high-quality care for patients. There is ambiguity in the definition of spiritual development and its relations, especially in the eastern countries. Research objectives:: To explore the concept of spiritual development in Iranian nurses. Research design: Qualitative content analysis approach. Data were gathered from semi-structured interviews. (...) Participants and research context: The participants were 17 Iranian Muslim nurses selected using a purposeful sampling. The place of interviews was on their choice. Ethical considerations: Based on the principles of the Helsinki declaration, the focus was on preserving the participants’ autonomy, confidentiality, and anonymity. The participants were told the study purposes and trends, and their rights were emphasized; they were then asked to sign written consent forms. Formal research approval was obtained from Kerman University of Medical Sciences. Ethical approval was granted by the University Ethics Committee before the study was conducted (K/92 etc). Findings: Three themes for spiritual development were defined: obligation to religion, commitment to ethics, and commitment to law. From the results, factors such as connection to the limitless divine power, personal and society-oriented ethical codes, and commitment to the law are proposed. Discussion: There are some differences between these findings and previous study, especially in the relation of the spirituality, religion, and law. Some studies, mostly Iranian, support these findings partially. Conclusion: The results suggest that it is better to teach nursing education based on humanistic principles, ethics, and law to the new generation of nurses to improve community health and development. More studies are needed to examine the relation between these themes. (shrink)

A working party of academics from both professional safeguarding backgrounds and research backgrounds developed and wrote ethical guidelines on safeguarding children in research on behalf of their faculty research ethics committee. The working party encountered a lack of useful precedents while developing the guidelines leading to a lengthy process of debate and consideration of the issues. This paper explores the various issues and dilemmas arising during this process, particularly the tension between safeguarding children from abuse and maintaining (...) research confidentiality. One of the main areas of discussion was how to establish the limits of confidentiality without compromising the research in hand. The role and responsibilities of researchers in supporting children's welfare, and the development of procedures for ensuring that safeguarding is effective are discussed as key elements. In addition, the issues researchers may face when determining thresholds for intervention are considered alongside the uncertainties created by considerations of the extent to which children can give informed consent in research contexts. The paper reflects the process of considering these issues and the conclusions the working party drew as to how best to support children's welfare during research. It also outlines the key elements of the guidelines and the structures developed to ensure researchers could get advice if suspected child abuse became an issue in their research. The paper includes a short version of the guidelines which were eventually approved across the Higher Education Institute. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing (...) countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

The establishment of research ethics committees (REC) in China’s higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in scientific research ethics, as seen in the recent controversies involving a proposed human head transplant and gene-edited babies. At present, the problems for REC in China’s HEI include lack of regulation, informal ethics reviews, lack of supervision and insufficient ethics review capacity. To counteract these problems, suggested measures include (...) mandatory formation of formal ethics committee, administrative support from HEI, ethics approval letter prior to funding application, formulation of regulations and standard operating procedures, selecting and training for members and independent consultants, training for secretaries and staff, ethics training for investigators, and learning from the experience of HEI outside of China, such as the USA and Canada. The establishment of REC in China’s HEI will greatly enhance the overall quality of ethics reviews in China. In addition to better protecting the rights and welfare of human participants, it is also conducive to maintaining the reputation of China’s HEI. (shrink)

Background Developing confident capacity for ethical decision-making is vital in nursing education. However, no tool examines nursing students’ competence in ethical decision-making. Aim This study aimed to develop an Ethical Decision-Making Competence Scale (EDM-CS) to assess ethical care decision-making competencies in nursing students. Participants and research context Original items were obtained by employing a focus group and the Delphi method. A cross-sectional design was used to confirm the items remained on the scale. Additionally, the scale’s reliability and validity were (...) assessed. The EDM-CS was completed by 498 nursing students. An exploratory factor analysis (EFA) was used to examine the factor structure based on data from group 1 ( n = 250). A second-order confirmatory factor analysis (CFA) was used to examine the model’s fitness based on data from group 2 ( n = 248). This study was conducted between August 2022 and July 2023. Ethical considerations The Institutional Review Board of Chung Shan Medical University Hospital approved this study’s design and procedure. Results From the original 34 items, nine were deleted in the EFA. Thus, the EDM-CS had 25 items and a four-factor structure (ethical judgement, ethical sensitivity, ethical motivation, and ethical action), which explained 60.97% of the total variance. A second-order CFA identified a second-order factor termed ‘ethical decision-making competence’ with 18 items (root mean square residual = 0.052). The EDM-CS scores correlated significantly and positively with the scores on the Scale of Protective Factor-24 (r = 0.47, p <.001), which indicated good convergent validity. Cronbach’s alpha coefficient of the final EDM-CS was 0.90 and ranged from 0.73 to 0.80 for the four subscales. Discussion and conclusion The EDM-CS was validated to fit the data adequately. It can be used to evaluate clinical nursing students’ ethical decision-making abilities and to develop education strategies to improve their ethical care competence. (shrink)

Background: In the ever-changing and complex healthcare environment, nurses encounter challenging situations that may involve a clash between their personal and professional values resulting in a profound impact on their practice. Nevertheless, there is a dearth of literature on how nurses develop their personal–professional values. Aim: The aim of this study was to understand how nurses develop their foundational values as the base for their value system. Research design: A constructivist grounded theory methodology was employed to collect multiple data (...) sets, including face-to-face focus group and individual interviews, along with anecdote and reflective stories. Participants and research context: Fifty-four nurses working across various nursing settings in Indonesia were recruited to participate. Ethical considerations: Ethics approval was obtained from the Monash University Human Ethics Committee, project approval number 1553. Findings: Foundational values acquisition was achieved through family upbringing, professional nurse education and organisational/institutional values reinforcement. These values are framed through three reference points: religious lens, humanity perspective and professionalism. This framing results in a unique combination of personal–professional values that comprise nurses’ values system. Values are transferred to other nurses either in a formal or informal way as part of one’s professional responsibility and customary social interaction via telling and sharing in person or through social media. Discussion: Values and ethics are inherently interweaved during nursing practice. Ethical and moral values are part of professional training, but other values are often buried in a hidden curriculum, and attained and activated through interactions during nurses’ training. Conclusion: Developing a value system is a complex undertaking that involves basic social processes of attaining, enacting and socialising values. These processes encompass several intertwined entities such as the sources of values, the pool of foundational values, value perspectives and framings, initial value structures, and methods of value transference. (shrink)

Background: Adolescents’ health choices have been widely researched, but the ethical basis of these choices, namely their rights, duties, and responsibilities, have been disregarded and scale is required to measure these. Objective: To describe the development of a scale that measures adolescents’ rights, duties, and responsibilities in relation to health choices and document the preliminary scale testing. Research design: A multi-phase development method was used to construct the Health Rights Duties and Responsibilities ( HealthRDR) scale. The concepts (...) and content were defined through document analysis, a systematic literature review, and focus groups. The content validity and clarity of the items were evaluated by expert panel of 23 adolescents, school nurses, and researchers. We calculated the content validity index and the content validity ratio at on item and scale levels. Preliminary testing was conducted with 200 adolescents aged 15–16 years. Descriptive statistics, Cronbach’s alpha correlation, and statistics for the item-analysis were calculated. Ethical considerations: Ethical approval and permission were obtained according to national legislation and responsible research practice was followed. Informed consent was obtained from the participants and the parents were informed about the study. Findings: The Health Rights Duties and Responsibilities scale comprises of four sub-scales with 148 items: 15 on health choices, 36 on rights, 47 on duties, and 50 on responsibilities. The items had a 0.93 content validity index and a 0.85 content validity ratio. Cronbach’s alpha correlation coefficient was 0.99 for the total scale and the individual sub-scales scores were health choices (0.93), rights (0.97), responsibilities (0.99), and duties (0.98). Discussion: The findings are discussed in light of the ethical concepts and validity and reliability of the developed scale. Conclusion: The Health Rights Duties and Responsibilities scale defines and understands adolescents’ rights, duties, and responsibilities in relation to health choices and has good content validity. Further testing and refinement of the concepts are needed. (shrink)

Background: Nurses’ collegiality is topical because patient care is complicated, requiring shared knowledge and working methods. Nurses’ collaboration has been supported by a number of different working models, but there has been less focus on ethics. Aim: This study aimed to develop nurses’ collegiality guidelines using the Delphi method. Method: Two online panels of Finnish experts, with 35 and 40 members, used the four-step Delphi method in December 2013 and January 2014. They reformulated the items of nurses’ collegiality identified by (...) the literature and rated based on validity and importance. Content analysis and descriptive statistical methods were used to analyze the data, and the nurses’ collegiality guidelines were formulated. Ethical considerations: Organizational approval was received, and an informed consent was obtained from all participants. Information about the voluntary nature of participation was provided. Results: During the first Delphi panel round, a number of items were reformulated and added, resulting in 32 reformulated items. As a result of the second round, 8 of the 32 items scored an agreement rate of more than 75%, with the most rated item being collegiality means that professionals respect each other. The item with second highest rating was collegiality has a common objective: what is best for patients, followed by the third highest which was professional ethics is the basis of collegiality. Conclusion: Nurses’ collegiality and its content are well recognized in clinical practice but seldom studied. Collegiality can be supported by guidelines, and nurses working in clinical practice, together with teachers and managers, have shared responsibilities to support and develop it. More research in different nursing environments is needed to improve understanding of the content and practice of nursing collegiality. (shrink)

COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that COVID-19 (...) vaccination provides to children, the potential for rare risks to outweigh these benefits and undermine vaccine confidence, and substantial evidence that COVID-19 vaccination confers adequate protection to risk groups, such as older adults, without the need to vaccinate healthy children. We conclude that child COVID-19 vaccination in wealthy communities before adults in poor communities worldwide is ethically unacceptable and consider how policy deliberations might evolve in light of future developments. (shrink)

Introduction: Clinical policies control several aspects of clinical practice, including individual treatment and care, resource management and healthcare professionals’ etiquette. This article presents Clinical Policy Ethics Assessment Tool, an ethical assessment tool for clinical policies that could be used not only by clinical ethics committees but also by policy committees or other relevant groups. Aim: The aim of this study was to find or create a tool to identify ethical issues and/or confirm ethical validity in nursing practice policies, protocols and (...) guidelines. Methodology: The development of Clinical Policy Ethics Assessment Tool involved first a literature review, followed by modification of the Research Protocol Ethics Assessment Tool, which was created to identify research protocols’ ethical issues, and finally, a trial of Clinical Policy Ethics Assessment Tool to ensure its reliability and validity. Ethical consideration: The policies analysed trialling Clinical Policy Ethics Assessment Tool were in the public domain and did not contain any confidential information. Despite that, Clinical Policy Ethics Assessment Tool also had the approval of a research ethics committee. Results: Research Protocol Ethics Assessment Tool was chosen as the template for a Clinical Policy Ethics Assessment Tool, to which several modifications were added to adapt it to work within a nursing practice context. Clinical Policy Ethics Assessment Tool was tested twice, which resulted in a general test–retest reliability coefficient = 0.86, r = 0.84, α1 = 0.817, α2 = 0.824 and interclass correlation coefficient = 0.874. Discussion: Contemporary nursing practice in a developed country is often ruled by clinical policies. The use of Clinical Policy Ethics Assessment Tool could confirm the ethical validity of those clinical practice policies, impacting on nurses’ education, values and quality of care. Conclusion: Clinical Policy Ethics Assessment Tool has the potential to detect ethical issues and facilitate the correction and improvement of clinical policies and guidelines in a structured way. This is especially so as it has shown reliability in detecting issues in clinical policies involving human participants and in encouraging policymakers to consider common ethical dilemmas in nursing practice. (shrink)

The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As a result, researchers came under unprecedented time pressure to develop a vaccine. This case study focuses on the first COVID-19 vaccine, which was approved for use in humans, known as Comirnaty, the BioNTech-Pfizer COVID-19 vaccine or Vaccine BNT162b2. With the benefit of hindsight, we show how close collaboration with regulators and trust-based decisions meant that (...) the race for a COVID-19 vaccine was won without purposefully infecting healthy participants with an infectious agent that can cause severe illness or death and for which no rescue therapy had existed. (shrink)

Background Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. Objective To explore such perceptions and attitudes in Lebanese parents. Study design 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were (...) tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Results Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term ‘randomisation’ hindered parental approval of participation. Conclusion Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus (...) psychosocial) research (P = 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus (...) psychosocial) research (P = 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other hand, a sizeable body of literature has emerged criticising the work of RECs, as, among other things, overly bureaucratic and unresponsive to the needs of disciplines (...) outside the biomedical sciences. This article adopts the format of a debate between a Chair of a university REC and a social science researcher as a vehicle for contrasting different perspectives on research ethics. The fictional debate allows for a productive discussion between the two sides, incorporating key insights from the recent literature and concludes with a synthesis that sketches out some ideas about how university RECs can be made more responsive and accountable. (shrink)

Background: The awareness and development of professional values affect the quality of nursing care. This study is the first interventional study conducted to develop the professional values of nurses in a clinical setting. Objectives: The aim of this study is to determine the effect of a structured Professional Values Development Programme on the development of the professional values of nurses. Research design: This study was a non-randomised controlled trial that measured with pre-test and post-test. Data were (...) collected by using an Individual Identification Form and the Nurses’ Professional Values Scale–Revised. The intervention group was involved in a 12-week programme. Participants in the control group received the programme after all data had been collected. Data collection for both groups was conducted at baseline and a 12-week follow-up. Expert opinions were evaluated by the Kendall Coefficient of Correlation test. Chi-square tests and t-tests were used to evaluate group differences. This study was registered at ClinicalTrials.gov. Participants and research context: This study was conducted with 80 nurses (intervention group = 40, control group = 40). This study was conducted in paediatric clinics in two university hospitals in Turkey. Ethical considerations: In order to conduct this study, ethics committee approval was obtained. This study was performed according to the Helsinki Declaration. Participants were informed verbally and in writing, and informed consent was obtained by giving explanations. indings In the analysis, the two groups were similar in demographic variables. The only significant difference between the groups was between weekly working hours. Participants in the intervention group reported statistically significantly higher levels of professional values ( p = 0.001) than those in the control group. Discussions and conclusions: This study provides evidence of the positive effectiveness of the Professional Values Development Programme in the development of professional values of clinical nurses. It also demonstrated the feasibility of implementing the programme with clinical nurses. (shrink)

Alzheimer’s disease (AD), the devastating and most prevailing underlying cause for age-associated dementia, has no effective disease-modifying treatment. The last approved drug for the relief of AD symptoms was in 2003. The recent approval of sodium oligomannate (GV-971, 2019) in China and the human antibody aducanumab in the USA (ADUHELM, 2021) therefore represent significant breakthroughs, albeit ones that are fraught with controversy. Here, we explore potential scientific ethics issues associated with GV-971 and aducanumab’s development and approval. While (...) these issues may be belied by socioeconomic and political complexities in the heady business of commercial drug development, they are of fundamental importance to scientific integrity and ultimately, welfare of patients. We posit that the push for approval of both AD drugs based on incomplete research and unconvincing marginal effectiveness is ethically unsound. Regardless of how both these drugs shall perform in the market for the years to come, the scientific ethics issues and potentially questionable research practices should therefore be duly noted and lessons learned. (shrink)

Background Moral distress was first described by Jameton in 1984, and has been defined as distress experienced by an individual when they are unable to carry out what they believe to be the right course of action because of real or perceived constraints on that action. This complex phenomenon has been studied extensively among healthcare providers, and intensive care professionals in particular report high levels of moral distress. This distress has been associated with provider burnout and associated consequences such as (...) job attrition, with potential impacts on patient and family care. There is a paucity of literature exploring how middle and late career healthcare providers experience and cope with moral distress. Objectives We explore the experience of moral distress and the strategies and resources invoked to mitigate that distress in mid- and late-career healthcare providers practicing in paediatric intensive care, in order to identify ways in which the work environment can build a culture of moral resilience. Research design An exploratory, qualitative quality improvement project utilizing focus group and semi-structured interviews with pediatric intensive care front-line providers. Participants Mid-and-later career (10 + years in practice) pediatric intensive care front line providers in a tertiary pediatric hospital. Research context This work focuses on paediatric intensive care providers in a single critical care unit, in order to explore the site-specific perspectives of health care providers in that context with respect to moral distress coping strategies. Ethical considerations The study was approved by the Quality Management Office at the institution; consent was obtained from participants, and no identifying data was included in this project. Findings Participants endorsed perspective-building and described strategies for positive adaptation including; active, reflective and structured supports. Participants articulated interest in enhanced and accessible formal supports. Discussion Findings in this study resonate with the current literature in healthcare provider moral distress, and exposed ways in which the work environment could support a culture of moral resilience. Avenues are described for the management and mitigation of moral distress in this setting. Conclusion This exploratory work lays the groundwork for interventions that facilitate personal growth and meaning in the midst of moral crises in critical care practice. (shrink)

Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these (...) features, translational research beyond approval ( T2 : phase IV, health services, and implementation research) is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc., wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration. The new drug is expected to receive FDA approval in 2 or more years. The (...) company decides to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build (...) ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in (...) other low and middle income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees, and developed a template for expediting review of research protocols in epidemic and emergency conditions. (shrink)

Background There is no definition of what constitutes a lie when working with people with moderate to severe dementia. Lies are often defined as therapeutic with no evidence of how therapeutic value is gauged. There is no previous research that observes lies being told or the impact the lies have on people with dementia. Aim The aim was to develop a taxonomy of lies for use when supporting people with moderate to severe dementia and then use this to develop (...) a model, which could be used to explore the impact of lie telling. Research design Ethnography was used, with the researcher observing and recording lies told to people with moderate to severe dementia, by professional caregivers. Data analysis was based on Burnard’s thematic analysis. Ethical consideration Ethical approval for the study was obtained from Northumbria University, the Research Ethics Committee (REC) and the Health Research Authority (HRA) in the United Kingdom. Study number 227508. Findings Six categories of lie were identified; blatant, avoidance, familiarity, props, banter and going along with. Spontaneous and planned lies were observed. Motivation, validation and genuineness were key in terms of how the person with dementia responded. These affective domains were used to develop the Lie ARM (affective reflective model). Discussion Planned and spontaneous lies are an effective intervention for people with moderate to severe dementia. Healthcare professionals need to be aware of their motivation for using lies, as well as the impact they have on patients. Conclusion The taxonomy is an objective way to categorise lies. It supports increased reflection, particularly if used in conjunction with the Lie ARM. The Lie ARM is a useful tool to help staff reflect on practice or to predict whether a proposed lie is likely to be therapeutic. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, are (...) progressing smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

Marion Lee Sanders,1 Anthony James Langone2 1Department of Medicine, Division of Nephrology and Hypertension, University of Iowa, Iowa City, IA, 2Department of Medicine, Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA: Transplantation is the preferred treatment option for individuals with end-stage renal disease. Individuals who undergo transplantation must chronically be maintained on an immunosuppression regimen for rejection prophylaxis to help ensure graft survival. Current rejection prophylaxis consists of using a combination of calcineurin inhibitors, mTOR inhibitors, antimetabolite (...) agents, and/or corticosteroids. These agents have collectively improved the short-term outcomes of renal transplantation, but improvements in late/chronic graft loss and recipient survival have lagged significantly behind challenging the field of transplantation to develop novel prophylactic agents. There have been several clinical trials conducted within the last 5 years in an attempt to bring such novel agents to the commercial market. These trials have resulted in the US Food and Drug Administration approval of extended-release tacrolimus, as well as belatacept, which has the potential to replace calcineurin inhibitors for rejection prophylaxis. Other trials have focused on the development of novel calcineurin inhibitors, costimulation blockade, kinase inhibitors, and inhibitors of leukocyte migration. While these later agents have not been FDA-approved for use in transplantation, they remain noteworthy, as these agents explore pathways not previously targeted for allograft-rejection prophylaxis. The purpose of this review was to consolidate available clinical trial data with regard to the recent developments in rejection prophylaxis in kidney transplantation. Keywords: rejection, prophylaxis, immunosuppression, transplantation. (shrink)

Background: Moral sensitivity is a life-long cognitive ability. It is expected that nurses who work in a professional purpose at “curing human beings” should have a highly developed moral sensitivity. The general opinion is that ethics education plays a significant role in this sense to enhance the moral sensitivity in terms of nurses’ professional behaviors and distinguish ethical violations. Aim: This study was conducted as intervention research for the purpose of determining the effect of the ethics training on fourth-year (...) students of the nursing department recognizing ethical violations experienced in the hospital and developing ethical sensitivity. Methods: The study was conducted with 50 students, with 25 students each in the experiment and control groups. Students in the experiment group were provided ethics training and consultancy services. The data were collected through the data collection form, which consists of questions on the socio-demographic characteristics and ethical sensitivity of the students, Moral Sensitivity Questionnaire, and the observation form on ethical principle violations/protection in the clinic environment. The data were digitized on the computer with the SPSS for Windows 13.0 program. The data were evaluated utilizing number, percentile calculation, paired samples t-test, Wilcoxon test, and the McNemar test. Results: The total Moral Sensitivity Questionnaire pre-test score averages of students in the experiment group were determined to be 93.88 ± 13.57, and their total post-test score averages were determined to be 89.24 ± 15.90. The total pre-test score averages of students in the control group were determined to be 91.48 ± 17.59, and their total post-test score averages were determined to be 97.72 ± 19.91. In the study, it was determined that the post-training ethical sensitivity of students in the experiment group increased; however, this was statistically not significant. Furthermore, it was determined that the number of ethical principle protection/violation observations and correct examples provided by students in the experiment group were higher than the control group and the difference was statistically significant. Ethical considerations: Written permission and ethical approval were obtained from the university where the study was conducted. Written consent was received from students accepting to participate in the study. Conclusion: As a result, ethics education given to students enables them to distinguish ethical violations in a hospital and make a proper observation in this issue. (shrink)

The problem of the research was represented by the lack of interest of many teachers in the use of diversification and change in various exercises, despite the positive role it plays in generalizing the motor program for any fencing skill, even though most of its skills are characterized by difficulty in performing them, which requires providing the largest number of motor programs in order to be The learner has full readiness and preparedness, and the research aims to prepare (...) various exercises to develop sensory perception and accuracy in performing complex attack skills and the stabbing movement. And to identify the effect of various exercises in developing the students’ kinetic awareness and accuracy of combined attack skills and stabbing movements in fencing. Use the researcherthatThe experimental approach with two equal groups. The research sample represented the students of the third stage of the Department of Physical Education and Sports Sciences at the Islamic University for the academic year 2022-2023 AD, and they numbered (50) students. They were selected by a simple random method, and were divided into two groups (experimental and control), and the number of each group was (25). ) student. The experimental group applied the various exercises prepared by the researcherthatAccording to the stages of building the motor program for learning epee skills in fencing, it was included among the educational units approved in colleges of physical education for third-year students, at the rate of one educational unit per week, amounting to (6) educational units. The time of the educational unit was (90/min), and the time of the educational unit was divided into the preparatory section. (15/d), the main section (65/d), and the final section (10/d). The most important conclusions were that there was a significant effect of the various exercises in developing sensory-motor perception and accuracy of performance in learning fencing skills. The most important recommendations are the need to pay attention to various exercises during educational units because they help learners expand their educational awareness and thus reflect on their performance of skills. (shrink)

Background: Some developed countries have recently changed their role in the context of international recruitment, becoming donors due to socio-economical and political factors such as recessions. This is also the case in Italy, where there has been a flow of immigrant nurses out of the country that has been documented over the past several years. In a short time, it has become a donor country to other developed European countries, such as the United Kingdom. Aims: To advance knowledge in the (...) context of human rights conflicts and ethical implications of the decision-making process of nurses who migrate between developed countries, such as from Italy to the United Kingdom, during times of recession. Research design: A case study based on the descriptive phenomenological approach was undertaken in 2014. Participants and research context: A total of 26 Italian newly graduated nurses finding a job in the United Kingdom were interviewed via Skype and telephone. Ethical considerations: The Internal Review Board of the University approved the project. Findings: In accordance with the descriptive phenomenological approach undertaken, three main themes emerged: (1) escaping from the feeling of being refused/rejected in order to be desired, (2) perceiving themselves respected, as a person and as a nurse, in a growth project and (3) returning if the country changes its strategy regarding nurses. Discussion: Ethical implications in the context of human rights, such as autonomy of the decision, social justice and reciprocal obligation, non-maleficence and double effect, have been discussed. Conclusion: The call for investing in nurses and nurses’ care in developed countries facing recession is urgent. Investing in nurses means respecting individuals and citizens who are at risk of developing health problems during the recession. (shrink)

Population-based research is enhanced by biological measures, but biological sampling raises complex ethical issues. The third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3) will estimate the population prevalence of five sexually transmitted infections (STIs) (Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus (HPV), HIV and Mycoplasma genitalium) in a probability sample aged 16–44 years. The present work describes the development of an ethical approach to urine testing for STIs, including the process of reaching consensus on whether to return (...) results. The following issues were considered: (1) testing for some STIs that are treatable and for which appropriate settings to obtain free testing and advice are widely available (Natsal-3 provides all respondents with STI and healthcare access information), (2) limits on test accuracy and timeliness imposed by survey conditions and sample type, (3) testing for some STIs with unknown clinical and public health implications, (4) how a uniform approach is easier to explain and understand, (5) practical difficulties in returning results and cost efficiency, such as enabling wider STI testing by not returning results. The agreed approach, to perform voluntary anonymous testing with specific consent for five STIs without returning results, was approved by stakeholders and a research ethics committee. Overall, this was acceptable to respondents in developmental piloting; 61% (68 of 111) of respondents agreed to provide a sample. The experiences reported here may inform the ethical decision making of researchers, research ethics committees and funders considering population-based biological sampling. (shrink)

Background: Hospitals are experiencing an estimated 16.5% turnover rate of registered nurses costing from $44,380 - $63,400 per nurse—an estimated $4.21 to $6.02 million financial loss annually for hospitals in the United States of America. Attrition of all nurses is costly. Most past research has focused on the new graduate nurse with little focus on the mid-career nurse. Attrition of mid-career nurses is a loss for the profession now and into the future. Research objective: The purpose of the (...) study was to explore relationships of professional values orientation, career development, job satisfaction, and intent to stay in recently hired mid-career and early-career nurses in a large hospital system. Research design: A descriptive correlational study of personal and professional factors on job satisfaction and retention was conducted. Participants and research context: A convenience sample of nurses from a mid-sized hospital in a metropolitan area in the Southwestern United States was recruited via in-house email. Sixty-seven nurses met the eligibility criteria and completed survey documents. Ethical considerations: Institutional Review Board approval was obtained from both the university and hospital system. Findings: Findings indicated a strong correlation between professional values and career development and that both job satisfaction and career development correlated positively with retention. Discussion: Newly hired mid-career nurses scored higher on job satisfaction and planned to remain in their jobs. This is important because their expertise and leadership are necessary to sustain the profession into the future. Conclusion: Nurse managers should be aware that when nurses perceive value conflicts, retention might be adversely affected. The practice environment stimulates nurses to consider whether to remain on the job or look for other opportunities. (shrink)