In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in (...) bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. (shrink)

BackgroundMany studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.MethodsThe data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total (...) of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.ResultsThe researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.ConclusionThe written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. (shrink)

BackgroundResearch on genomics has increased while the biobank activities are becoming more common in different countries. In the mental health field, the questions concerning the potential participants’ vulnerability as well as capacity to give the informed consent can cause reluctancy in recruiting persons with mental health problems, although the knowledge and understanding of mental health problems has remarkable changed, and practice is guided with inclusive approaches, such as recovery approach.AimThe aim of this study was to describe the current knowledge of (...) informed consent practices in the context of genomic research on mental health from the nurses’ viewpoint.MethodsAn integrative review was conducted with search from seven international databases. Data consist 14 publications which were analyzed with thematic analysis.Ethical considerationsEthical requirements were respected in every phase of the research process.FindingsMost of the papers were published in USA and between 2000–2010. Eight reports were categorized as discussion papers, four qualitative studies and one quantitative study. The thematic analysis provided information on five themes: complexity with the capacity to consent, mixed emotions towards participation, factors influencing the decision to participate, nurses’ informed consent process competence and variations between consent procedures.DiscussionIn the informed consent practices, there are various aspects which may affect both the willingness to participate in the study and the informed consent process itself. Implications for practice, education, research, and policies are discussed.ConclusionThere is a need for more updated international research on the topic in the context of different international and national guidelines, legislation, and directives. This study provided a viewpoint to the more collaborative research activities with people with lived experiences also in this field of research following the ideas of recovery approach. (shrink)

Patient’s duties are a topical but little researched area in nursing ethics. However, patient’s duties are closely connected to nursing practice in terms of autonomy, the best purpose of care and rethinking from the patient’s perspective. This article is a metasynthesis (N = 11 original articles) of patient’s duties, aimed to create a tentative model. In this article, a tentative model called ‘right-based duties of a patient’ was constructed. With its aid, a coherent structure of patient’s duties within different roles (...) and objects of a patient can be defined. In addition, the ethical basis, prerequisites, outcomes and risks of patient’s duties can be named. In conclusion, so-called right-based duties of a patient constitute the basic argument. Patient’s duties are not unambiguous for all patients, and the global perspective to duties has been challenged. However, due to both conceptual and practical reasons, rethinking of patient’s duties is needed. (shrink)

Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that (...) is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders’ perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research. Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research. (shrink)

Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.

Background:Medical research involving human subjects must be evaluated by a research ethics committee before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant.Methods:The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies (...) with other invasive interventions, studies with non-invasive physical procedures, and non-physical procedures only.Results:In clinical drug trials, the REC posed queries more frequently about the risk–benefit ratio and less frequently about study methods and participant-related issues in comparison with other study types. Relative to other studies, those with non-physical procedures were subject to more frequent queries related to reliability of the study... (shrink)

We do not know how much clinical physicians carrying out clinical trials in oncology and haematology struggle with ethical concerns. To our knowledge, no empirical research exists on these questions in a Nordic context. Therefore, this study aims to learn what kinds of ethical challenges physicians in Sweden, Denmark and Finland face when caring for patients in clinical trials; and what strategies, if any, they have developed to deal with them. The main findings were that clinical cancer trials pose ethical (...) challenges related to autonomy issues, unreasonable hope for benefits and the therapeutic misconception. Nevertheless, some physicians expressed that struggling with such challenges was not of great concern. This conveys a culture of hope where health care professionals and patients uphold hope and mutually support belief in clinical trials. This culture being implicit, physicians need opportunities to deliberately reflect over the characteristics that should constitute this culture. (shrink)

Touching is an integral part of human behaviour; from the moment of birth until they die, people need to be touched and to touch others. Touching is an intimate action that implies an invasion of the individual's personal, private space. In ethical terms, the ques tion of touching is closely related to the patient's right to integrity and inviolability. The purpose of this study was to describe touching as it is experienced by elderly patients and nurses in long-term care. Touching (...) was approached as a form of commu nication and as an important part of nursing practice. The participants, 25 patients and 30 nurses, were interviewed using a semistructured schedule. The data were analysed using the method of content analysis. The patients experienced touching by nurses as gentle, comforting and important. The nurses, for their part, experienced touching by patients as easy and natural. The patients rarely touched nurses more than was neces sary. In some cases, nurses had to cope with violent touching by patients. Some women nurses interpreted touches by male patients as having a sexual nature and as annoying. This had taught male patients to avoid touching nurses. On the other hand, friendly and grateful touches by patients were very important to nurses. When used for emotional purposes only, touching presupposed a good relationship between nurses and their patients. Although touching is extremely common in nursing practice, there has been very little research into its meaning. More work is therefore needed to explore the role and meaning of touching in nursing. (shrink)

Healthcare ethics is neglected in clinical practice in LMICs such as Nepal. The main objective of this study was to assess the current status of knowledge, attitude and practi...

A necessary and sufficient condition for linear aggregation of SSB utility functionals is presented. Harsanyi's social aggregation theorem for von Neumann–Morgenstern utility functions is shown to be a corollary to this result. Two generalizations of Fishburn and Gehrlein's conditional linear aggregation theorem for SSB utility functionals are also established.

Background: A small minority of nurses are investigated when they fail to meet the required professional standards. Unprofessional conduct does not just affect the nurse but also patients, colleagues and managers. However, it has not been clearly defined. Objective: The objective was to identify unprofessional conduct by registered nurses by examining disciplinary decisions by a national regulator. Design: A retrospective document analysis. Data and research context: Disciplinary decisions delivered to 204 registered nurses by the Finnish national regulatory authority from 2007 (...) to 2016. The data were analysed with quantitative statistics. Ethical consideration: The study received permission from the Finnish National Supervisory Authority for Welfare and Health and used confidential documents that were supplied on the basis of complete anonymity and confidentiality. Findings: The mean age of the registered nurses who were disciplined was 44 years and 81% were female. Two-thirds had worked for their employer for 5 years or less, 53% had two or more employers and 18% had a criminal history. All the decisions included a primary reason for why the nurses were investigated, but there were also 479 coexisting reasons. In most cases, unprofessional conduct was connected to substance abuse. In addition, stealing of medicine, a decreased ability to work and neglect of nursing guidelines were reported. Discussion: We found that the nurses were investigated for unprofessional conduct for complex combinations of primary and coexisting reasons. Our study highlighted that more attention needs to be paid to the key markers for unprofessional conduct. Conclusion: Unprofessional conduct is a complex phenomenon that is connected to nurses’ individual and working backgrounds and has an impact on their work performance. More research is needed to identify how nursing communities can detect, manage and limit the serious effects and consequences of unprofessional conduct. (shrink)

This article is based on the assumption that the researcher cannot detach from his or her own view in phenomenological research. The researcher is assumed to be able to understand the experiences of an individual only through the points of departure created by the researcher's own view. The goal of this article is to describe practical aspects and their theoretical grounds that are of crucial importance in overcoming a researcher's views in data gathering and analysis. Its purpose is to clarify (...) the authenticity and ethical standards concerning the views of the researcher in phenomenological research. (shrink)

Background Professional values create a basis for successful collaboration and person-centred care in integrated care and services. Little is known about how different health and social care workers assess their professional values. Research aim To describe and compare professional value orientation among different health and social care workers in Finland. Research design A quantitative cross-sectional study. Participants and research context We carried out an online survey of health and social care workers from 8 March to 31 May 2022, using the (...) Finnish version of the Nurses’ Professional Values Scale-3. The data were analysed using descriptive and advanced statistics. Ethical considerations Permission was received from all participating organizations and those who completed the survey provided informed consent. Results A total of 1823 health and social care workers, representing seven professional groups and students, took part. The overall level of professional values among the participants was relatively high. Commitment to providing patients and clients with equal care was more important than engaging with society and professional responsibilities in the work environment. Professional values were strongest among professionals with higher educational degrees and training in professional ethics. The same was true for workers who received organizational support for ethical practice, were satisfied with their work and had shorter work experience. Discussion Our results showed shared professional values among different health and social care workers and students. These results are meaningful for integrated care and services. At the same time, a clear need for strengthening engagement with society and professional responsibilities for developing work environments were identified. Conclusions Health and social care workers and students need training in professional ethics and organizational support for ethical practice and work satisfaction to maintain their professional values at different stages of their career. (shrink)

Patient and public involvement is widely thought to be important in the improvement of health care delivery and in health equity. Purpose: The article examines the role of experiential knowledge in service co-production in order to develop opiate substitution treatment services (OST) for high-risk opioid users. Method: Drawing on social representations theory and the concept of social identity, we explore how experts’ by experience and registered nurses’ understandings of OST contain discourses about the social representations, identity, and citizenship of the (...) participants and the effects these may have on developing or hindering inclusive and bottom-up forms of patient and public involvement. Results: The meeting sessions that potentially offer room for creativity and problem-solving fail to provide any new propositions for fixing the system. The health care professionals primarily identify themselves as regulators who protect the correctness of their actions and show little interest in considering experiential knowledge on opioid addiction. Conclusion: The participation of patients has been one of the prominent reforms implemented in health care. The goal of client-centered thinking is often emphasised; however, the implementation is not simple due to the strongly institutionalised knowledge and related working patterns and practices in health care. (shrink)

In light of the interrelation between motor and cognitive development and the predictive value of the former for the latter, the secular decline observed in motor coordination ability as early as preschool urges identification of interventions that may jointly impact motor and cognitive efficiency. The aim of this study was twofold. It (1) explored the outcomes of enriched physical education, centered on deliberate play and cognitively challenging variability of practice, on motor coordination and cognitive processing; (2) examined whether motor coordination (...) outcomes mediate intervention effects on children’s cognition, while controlling for moderation by lifestyle factors as outdoor play habits and weight status. Four hundred and sixty children aged 5-10 years participated in a 6-month group randomized intervention in physical education, with or without playful coordinative and cognitive enrichment. The weight status and spontaneous outdoor play habits of children (parental report of outdoor play) were evaluated at baseline. Before and after the intervention, motor developmental level (Movement Assessment Battery for Children) was evaluated in all children, who were then assessed either with a test of working memory (Random Number Generation task), or with a test of attention (from the Cognitive Assessment System, CAS). Children assigned to the ‘enriched’ intervention showed more pronounced improvements in all motor coordination assessments (manual dexterity, ball skills, static/dynamic balance). The beneficial effect on ball skills was amplified by the level of spontaneous outdoor play and weight status. Among indices of executive function and attention, only that of inhibition showed a differential effect of intervention type. Moderated mediation showed that the better outcome of the enriched physical education on ball skills mediated the better inhibition outcome, but only when the enrichment intervention was paralleled by a medium-to-high level of outdoor play. Results suggest that specifically tailored physical activity games provide a unique form of enrichment that impacts children’s cognitive development through motor coordination improvement, particularly object control skills, which are linked to children’s physical activity habits later in life. Outdoor play appears to offer the natural ground for the stimulation by designed physical activity games to take root in children’s mind. (shrink)

BackgroundHealthcare ethics is neglected in clinical practice in LMICs such as Nepal. The main objective of this study was to assess the current status of knowledge, attitude and practice of healthcare ethics among resident doctors and ward nurses in a tertiary teaching hospital in Nepal.MethodsThis was a cross sectional study conducted among resident doctors and ward nurses in the largest tertiary care teaching hospital of Nepal during January- February 2016 with a self-administered questionnaire. A Cramer’s V value was assessed to (...) ascertain the strength of the differences in the variables between doctors and nurses. Association of variables were determined by Chi square and statistical significance was considered if p value was less than 0.05.ResultsOur study demonstrated that a significant proportion of the doctors and nurses were unaware of major documents of healthcare ethics: Hippocratic Oath, Nuremberg code and Helsinki Declaration. A high percentage of respondents said that their major source of information on healthcare ethics were lectures, books, and journals. Attitude of doctors and nurses were significantly different in 9 out of 22 questions pertaining to different aspects of healthcare ethics. More nurses had agreement than doctors on the tested statements pertaining to different aspects of healthcare ethics except for need of integration of medical ethics in ungraduate curricula,paternalistic attitude of doctor was disagreed more by doctors. Notably, only few doctors stood in support of physician-assisted dying.ConclusionsSignificant proportion of doctors and nurses were unaware of three major documents on healthcare ethics which are the core principles in clinical practice. Provided that a high percentage of respondents had motivation for learning medical ethics and asked for inclusion of medical ethics in the curriculum, it is imperative to avail information on medical ethics through subscription of journals and books on ethics in medical libraries in addition to lectures and training at workplace on medical ethics which can significantly improve the current paucity of knowledge on medical ethics. (shrink)

This article is based on a qualitative longitudinal study that followed the subjective experiences of both people living with dementia and their family members during the early stages of the illness. The purpose of this article is to describe and reflect on the ethical and methodological issues that occurred during data collection. The article focuses on the situation of the person with dementia and the family member and the role of the researcher when conducting the research interviews. Based on the (...) results of this study, conducting research interviews with people with dementia and their family members poses several ethical and methodological challenges that must be addressed. In doing so, ethically sound dementia-specific research methods will be actively developed enhancing our understanding of living with dementia and providing new insights into the care of people with dementia and their family members. (shrink)

The purpose of the research was to study Finnish people's attitudes towards biomedical research and whether the research sponsor makes a difference to those attitudes. A survey questionnaire was sent to a random sample of 25-64 years old. Respondents had a positive attitude towards biomedical research and there were only small variations by population group. When asked whether one's own clinical blood samples could be used in scientific biomedical research, 84 per cent of the respondents would allow it. The most (...) important reasons for giving routinely collected samples to a biobank were altruistic. Attitudes were strongly dependent on the sponsor of the research. Domestic research was looked at more positively than international research. Whether research was made by a public or private actor had less impact. The results suggest that people want to be research participants to help such research of their own free will, and to choose whom they help. This has an impact on the way participants are informed, on the criteria used by ethics committees and other research regulators, and also on transparency and access to research results. (shrink)

The purpose of the research was to study Finnish people's attitudes towards biomedical research and whether the research sponsor makes a difference to those attitudes. A survey questionnaire was sent to a random sample of 25-64 years old. Respondents had a positive attitude towards biomedical research and there were only small variations by population group. When asked whether one's own clinical blood samples could be used in scientific biomedical research, 84 per cent of the respondents would allow it. The most (...) important reasons for giving routinely collected samples to a biobank were altruistic. Attitudes were strongly dependent on the sponsor of the research. Domestic research was looked at more positively than international research. Whether research was made by a public or private actor had less impact. The results suggest that people want to be research participants to help such research of their own free will, and to choose whom they help. This has an impact on the way participants are informed, on the criteria used by ethics committees and other research regulators, and also on transparency and access to research results. (shrink)