Today there are multiple implantable medical devices on the market. The type of implants that interface the body’s tissues has been considered to have particular strong ethical implications. This article describes a development of a novel practice for ethical assessment and reflection within medical device research and development of non-CE marked medical devices, taking the perspective of both the ethicist and the researcher. The research case was an EU funded project where the aim was to develop and compare the efficiency (...) of invasive and non-invasive technological medical devices to create meaningful sensations as a novel therapy for phantom limb pain. An Independent Ethical Advisor with a regulatory and advisory role was assigned to the project, allowing us to investigate the projects deliberate incorporation of ethics. In the article we suggest and applied a novel framework based on action research for combining ethical assessment with building ethical reflection. The case analyse five different activities / elements: 1) the use of informed consent; 2) a survey amongst the research partners; 3) a workshop session; 4) observation of consortium meetings; and 5) an interview with a participating patient. (shrink)

BackgroundThere is a lack of empirical research regarding the outcomes of such clinical ethics support methods as moral case deliberation. Empirical research in how healthcare professionals perceive potential outcomes is needed in order to evaluate the value and effectiveness of ethics support; and help to design future outcomes research. The aim was to use the European Moral Case Deliberation Outcome Instrument instrument to examine the importance of various MCD outcomes, according to healthcare professionals, prior to participation.MethodsA North European field survey (...) among healthcare professionals drawn from 73 workplaces in a variety of healthcare settings in the Netherlands, Norway and Sweden. The Euro-MCD instrument was used.ResultsAll outcomes regarding the domains of moral reflexivity, moral attitude, emotional support, collaboration, impact at organisational level and concrete results, were perceived as very or quite important by 76%–97% of the 703 respondents. Outcomes regarding collaboration and concrete results were perceived as most important. Outcomes assessed as least important were mostly about moral attitude. ‘Better interactions with patient/family’ emerged as a new domain from the qualitative analysis. Dutch respondents perceived most of the outcomes as significantly less important than the Scandinavians, especially regarding emotional support. Furthermore, men, those who were younger, and physician-respondents scored most of the outcomes as statistically significantly less important compared with the other respondents.ConclusionsThe findings indicate a need for a broad instrument such as the Euro-MCD. Outcomes related to better interactions between professionals and patients must also be included in the future. The empirical findings raise the normative question of whether outcomes that were perceived as less important, such as moral reflexivity and moral attitude outcomes, should still be included. In the future, a combination of empirical findings and normative reflection will contribute to the revision of the instrument. (shrink)

Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The (...) aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. (shrink)

Background:Ethics rounds are one way to support healthcare personnel in handling ethically difficult situations. A previous study in the present project showed that ethics rounds did not result in significant changes in perceptions of how ethical issues were handled, that is, in the ethical climate. However, there was anecdotal evidence that the ethics rounds were viewed as a positive experience and that they stimulated ethical reflection.Aim:The aim of this study was to gain a deeper understanding of how the ethics rounds (...) were experienced and why the intervention in the form of ethics rounds did not succeed in improving the ethical climate for the staff.Research design:An exploratory and descriptive design with a qualitative approach was adopted, using individual interviews.Participants and research context:A total of 11 healthcare personnel, working in two different psychiatry outpatient clinics and with experience of participating in ethics rounds, were interviewed.Ethical considerations:The study was based on informed consent and was approved by one of the Swedish Regional Ethical Review Boards.Findings:The participants were generally positive about the ethics rounds. They had experienced changes by participating in the ethics rounds in the form of being able to see things from different perspectives as well as by gaining insight into ethical issues. However, these changes had not affected daily work.Discussion:A crucial question is whether or not increased reflection ability among the participants is a good enough outcome of ethics rounds and whether this result could have been measured in patient-related outcomes. Ethics rounds might foster cooperation among the staff and this, in turn, could influence patient care.Conclusion:By listening to others during ethics rounds, a person can learn to see things from a new angle. Participation in ethics rounds can also lead to better insight concerning ethical issues. (shrink)

BackgroundMoral case deliberation as a form of clinical ethics support is usually implemented in health care institutions and educational programs. While there is no previous research on the use of clinical ethics support on the level of health care regulation, employees of regulatory bodies are regularly confronted with moral challenges. This pilot study describes and evaluates the use of MCD at the Dutch Health Care Inspectorate.The objective of this pilot study is to investigate: 1) the current way of dealing with (...) moral issues at the IGZ; 2) experience with and evaluation of MCD as clinical ethics support, and 3) future preferences and needs regarding clinical ethics support for dealing with moral questions at the IGZ.MethodsWe performed an explorative pilot study. The research questions were assessed by means of: 1) interviews with MCD participants during four focus groups; and 2) interviews with six key stakeholders at the IGZ. De qualitative data is illustrated by data from questionnaires on MCD outcomes, perspective taking and MCD evaluation.ResultsProfessionals do not always recognize moral issues. Employees report a need for regular and structured moral support in health care regulation. The MCD meetings are evaluated positively. The most important outcomes of MCD are feeling secure and learning from others. Additional support is needed to successfully implement MCD at the Inspectorate.ConclusionWe conclude that the respondents perceive moral case deliberation as a useful form of clinical ethics support for dealing with moral questions and issues in health care regulation. (shrink)

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they (...) are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a “bottom-up” perspective might give healthcare personnel opportunities to think and reflect more than a “top-down” perspective. A “bottom-up” approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a “top-down” approach risks removing such moral responsibility. (shrink)

Background:Within oncology and hematology care, patients are sometimes considered to have such a poor prognosis that they can receive a do not resuscitate order from the physician responsible, stipulating that neither basic nor advanced coronary pulmonary rescue be performed in the event of a cardiac arrest. Studies on do not resuscitate decisions within oncology and hematology units, focusing on the specific role of the nurse in relation to these decisions, are scarce.Objective:The aim of this study was to investigate hematology and (...) oncology nurses’ experiences and perceptions of do not resuscitate orders, in order to achieve a deeper understanding of the nurses’ specific role in these decisions.Research design:A qualitative, descriptive methodology with individual semi-structured interviews was used.Participants and research context:A total of 15 nurses from eight hematology/oncology wards in four hospitals in Sweden were interviewed individually.Ethical considerations:In accordance with national regulations, an ethical review was not required for this study. The research followed international guidelines for empirical research, as outlined in the Helsinki Declaration.Findings:The nurses strived for good nursing care through balancing harms and goods and observing integrity and quality of life as important values. Experienced hindrances for good care were unclear and poorly documented decisions, uninformed patients and relatives, and disagreements among the caregivers and family. The nurses expressed a need for an ongoing discussion on do not resuscitate decisions, including all concerned parties.Conclusion:In order to provide good nursing care, nurses need clear and well-documented do not resuscitate orders, and patients and relatives need to be well informed and included in the decisions. To increase the understanding for each other’s opinions within the medical team, regular ethical discussions are required. (shrink)

BackgroundIn paediatric oncology, healthcare professionals face moral challenges. Clinical ethics support services, such as moral case deliberation, aim to assist them in dealing with these challenges. Yet, healthcare professionals can have different expectations and goals related to clinical ethics support services.MethodsIn this study, the perceptions held by healthcare professionals regarding the importance of possible outcomes of MCDs, prior to implementation of MCDs, were investigated. A multisite, cross-sectional, quantitative study was performed at all six Paediatric Oncology Centres in Sweden. Healthcare professionals (...) answered the Euro-MCD instrument with 26 potential MCD outcomes using a scale from Not important to Very important. Descriptive and comparative statistical analyses were carried out.ResultsAll outcomes were rated high, i.e., between 3.12 and 3.78. More open communication, developing skills to analyse ethically difficult situations, better mutual understanding, and deciding on concrete actions were rated as most important. Understanding of ethical theories and critical examination of policies were rated less important. Most often nursing assistants rated higher and physicians lower than the other professions did. Women and participants without previous experience of MCDs perceived outcomes as more important. There were differences between centres as one centre had significantly higher, and one centre had significantly lower ratings compared to the others.ConclusionIt is clear that healthcare professionals want MCDs to improve teamwork and skills in order to analyse and manage ethically difficult situations. When comparing to previous research about important MCD outcomes, there were similarities in what healthcare professionals consider to be important when handling moral challenges regardless of country and potential differences in healthcare settings and systems, such as paediatric vs. adult care. (shrink)

In spite of the growing interest in nursing ethics, few studies have focused on ethical dilemmas experienced by nurses working with clinical studies as ‘research nurses’. The aim of the present study was to describe and explore ethical dilemmas that Swedish research nurses experience in their day-to-day work. In a qualitative study a purposeful sample of six research nurses from five wards of differing disciplines in four Swedish hospitals was interviewed. The analysis displayed several examples of ethical dilemmas, primarily tensions (...) between the nurses’ obligations to the study and to the patients involved. A guiding moral principle for the nurses was patient-centeredness, where the interest of research must not override the interest of the patient. In situations where tensions between research and patient interests occurred, and doctors and nurses disagreed upon the judgement, the nurses sometimes chose to follow the doctors’ advice, and thus acted against their own moral judgment. Such situations seemed to create feelings of moral distress among the nurses. They described their profession as being ‘invisible’ and as lacking opportunities for ethical competence building. The conclusion is that research nurses frequently experience severe and difficult ethical dilemmas in their daily work. They need to be acknowledged as a particular profession in the health care organisation and encouraged to develop their specific ethical competence. (shrink)

The aim of the present study was to describe and explore the perception of ethical guidelines and their role in ethical competence-building among Swedish physicians and research nurses. Twelve informants were interviewed in depth. The results demonstrated that the informants had a critical attitude towards ethical guidelines and claimed to make little use of them in practical moral judgements. Ethical competence was seen primarily as character-building, related to virtues such as being empathic, honest and loyal to patients. Ethical competence was (...) assumed to be learned through good examples, role models and practical experience, while ethical guidelines were not perceived as valuable in this process. In order to improve the staff's familiarity with and the usability of ethical guidelines, the workplace needs to provide opportunities for ethical dialogues. In such discussions, argumentation can improve, virtues can be developed and guidelines can be usefully invoked. (shrink)

In Moral Case Deliberation, healthcare professionals discuss ethically difficult patient situations in their daily practice. There is a lack of knowledge regarding the content of MCD and there is a need to shed light on this ethical reflection in the midst of clinical practice. Thus, the aim of the study was to describe the content of healthcare professionals’ moral reasoning during MCD. The design was qualitative and descriptive, and data consisted of 22 audio-recorded inter-professional MCDs, analysed with content analysis. The (...) moral reasoning centred on how to strike the balance between personal convictions about what constitutes good care, and the perceived dissonant care preferences held by the patient. The healthcare professionals deliberated about good care in relation to demands considered to be unrealistic, justifications for influencing the patient, the incapacitated patient’s nebulous interests, and coping with the conflict between using coercion to achieve good while protecting human dignity. Furthermore, as a basis for the reasoning, the healthcare professionals reflected on how to establish a responsible relationship with the vulnerable person. This comprised acknowledging the patient as a susceptible human being, protecting dignity and integrity, defining their own moral responsibility, and having patience to give the patient and family time to come to terms with illness and declining health. The profound struggle to respect the patient’s autonomy in clinical practice can be understood through the concept of relational autonomy, to try to secure both patients’ influence and at the same time take responsibility for their needs as vulnerable humans. (shrink)

An important and supposedly impactful form of clinical ethics support is moral case deliberation. Empirical evidence, however, is limited with regard to its actual impact. With this literature review, we aim to investigate the empirical evidence of MCD, thereby a) informing the practice, and b) providing a focus for further research on and development of MCD in healthcare settings. A systematic literature search was conducted in the electronic databases PubMed, CINAHL and Web of Science. Both the data collection and the (...) qualitative data analysis followed a stepwise approach, including continuous peer review and careful documentation of our decisions. The qualitative analysis was supported by ATLAS.ti. Based on a qualitative analysis of 25 empirical papers, we identified four clusters of themes: 1) facilitators and barriers in the preparation and context of MCD, i.e., a safe and open atmosphere created by a facilitator, a concrete case, commitment of participants, a focus on the moral dimension, and a supportive organization; 2) changes that are brought about on a personal and inter-professional level, with regard to professional’s feelings of relief, relatedness and confidence; understanding of the perspectives of colleagues, one’s own perspective and the moral issue at stake; and awareness of the moral dimension of one’s work and awareness of the importance of reflection; 3) changes that are brought about in caring for patients and families; and 4) changes that are brought about on an organizational level. This review shows that MCD brings about changes in practice, mostly for the professional in inter-professional interactions. Most reported changes are considered positive, although challenges, frustrations and absence of change were also reported. Empirical evidence of a concrete impact on the quality of patient care is limited and is mostly based on self-reports. With patient-focused and methodologically sound qualitative research, the practice and the value of MCD in healthcare settings can be better understood, thus making a stronger case for this kind of ethics support. (shrink)