[Theoretical foundations of clinical ethics consultation in psychiatry]. / Theoretische Grundlagen der klinischen Ethikberatung in der Psychiatrie.

BACKGROUND: Clinical ethics consultants support mental health professionals in identifying and analyzing moral problems in clinical practice. OBJECTIVE: Presentation of key ethical concepts and normative theories that are relevant for clinical ethics consultation in mental healthcare. MATERIAL AND METHODS: Conceptual and ethical analyses. RESULTS: After distinguishing between morality, ethics and law, moral problems are differentiated from other types of problems encountered in clinical practice. Subsequently, key ethical concepts and the concept of moral distress are clarified. In relation to the normative framework a distinction is made between philosophical ethical theories and medical ethical theories, such as principlism and the ethics of care. Finally, justification tests for ethical decision-making in situations of danger to self or others based on the harm principle and soft paternalism are proposed. CONCLUSION: Knowledge of key ethical concepts and normative theories is important for the identification and analysis of moral problems in mental healthcare and should be given greater weight in the training of clinical ethics consultants.

The Structure of Clinical Ethical Decision-Making: A Hospital System Needs Assessment.

Bioethical dilemmas can emerge in research and clinical settings, from end-of-life decision-making to experimental therapies. The COVID-19 pandemic raised serious ethical challenges for healthcare organizations, highlighting the need to conduct needs assessments of the bioethics infrastructures of healthcare organizations. Clinical ethics committees (CECs) also create equitable policies, train staff on ethics issues, and play a consultative role in resolving the difficulty of complex individual cases. The main objective of this project was to conduct a needs assessment of the bioethics infrastructure within a comprehensive hospital system. A cross-sectional anonymous online survey, including quantitative and qualitative formatted questions. The survey was sent to five key leaders from the organization's hospitals. Survey questions focused on the composition, structure, function, and effectiveness of their facilities' bioethics infrastructure and ethics-related training and resources. Positive findings included that most facilities have active CECs with multidisciplinary membership; CECs address critical issues and encourage team members to express clinical ethics concerns. Areas of concern included uncertainty about how CECs function and the process for resolving clinical ethics dilemmas. Most reported no formal orientation process for CEC members, and many said there was no ongoing ethics education process. The authors conclude that if CECs are a critical institutional resource where the practice of medicine and mission intersect, having well-functioning ethics committees with trained and oriented members demonstrates an essential commitment to the mission. The survey revealed that more needs to be done to bolster the bioethics infrastructure of this institution.

Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.

RESEARCH QUESTION AND AIM: Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC's implementation, to increase knowledge about CEC's implementation strategy. RESEARCH DESIGN: We collected quantitative data related to number and characteristics of CEC activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC's development and implementation process. PARTICIPANTS AND RESEARCH CONTEXT: The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. ETHICAL CONSIDERATIONS: The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. FINDINGS: In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC's impact on clinical practice. CONCLUSION: Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially.

Psychiatric Hospital Ethics Committee Discussions Over a Span of Nearly Three Decades.

Various types of health settings use clinical ethics committees (CEC) to deal with the ethical issues that confront both healthcare providers and their patients. Although these committees are now more common than ever, changes in the content of ethical dilemmas through the years is still a relatively unexplored area of research. The current study examines the major topics brought to the CEC of a psychiatric hospital in Israel and explores whether there were changes in their frequency across nearly three decades. The present paper reports on a thematic analysis of the written verbatim transcripts from 466 ethical topics brought to the CEC between the years 1991 and 2016. The following major topics related to ethical dilemmas were identified: confidentiality (30%), patient autonomy (23%), health records (14%), dual relationship (12%), allocation of resources (11%), inappropriate professional and personal conduct (9%), and multicultural sensitivity (1%). Topics related to confidentiality increased significantly over the years, as did inappropriate professional and personal conduct. In addition, the analysis showed that the content of the ethical cases and the resolutions suggested by the CEC also varied over the years. In conclusion, although most ethical topics have remained relatively stable over time, the discourse around them has evolved, requiring a dynamic assessment and reflection by the mental health practitioners serving as members of a CEC.

Establishing Clinical Ethics Committees in Primary Care: A Study from Norwegian Municipal Care.

Would primary care services benefit from the aid of a clinical ethics committee (CEC)? The implementation of CECs in primary care in four Norwegian municipalities was supported and their activities followed for 2.5 years. In this study, the CECs' structure and activities are described, with special emphasis on what characterizes the cases they have discussed. In total, the four CECs discussed 54 cases from primary care services, with the four most common topics being patient autonomy, competence and coercion; professionalism; cooperation and disagreement with next of kin; and priority setting, resource use and quality. Nursing homes and home care were the primary care services most often involved. Next of kin were present in 10 case deliberations, whereas patients were never present. The investigation indicates that it might be feasible for new CECs to attain a high level of activity including case deliberations within the time frame. It also confirms that significant, characteristic and complex moral problems arise in primary care services.

Ethical issues in oncology practice: a qualitative study of stakeholders' experiences and expectations.

BACKGROUND: Clinical Ethics Support Services (CESS) have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders' expectations about a potential CESS to be implemented within the Institution. METHODS: The study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders' professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory. RESULTS: Twenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases. CONCLUSIONS: The interviewees showed a limited degree of 'ethical awareness': despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while  complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients.

Implementing clinical ethics committees as a complex intervention: presentation of a feasibility study in community care.

BACKGROUND: How should clinical ethics support services such as clinical ethics committees (CECs) be implemented and evaluated? We argue that both the CEC itself and the implementation of the CEC should be considered as 'complex interventions'. MAIN TEXT: We present a research project involving the implementation of CECs in community care in four Norwegian municipalities. We show that when both the CEC and its implementation are considered as complex interventions, important consequences follow - both for implementation and the study thereof. Emphasizing four such sets of consequences, we argue, first, that the complexity of the intervention necessitates small-scale testing before larger-scale implementation and testing is attempted; second, that it is necessary to theorize the intervention in sufficient depth; third, that the identification of casual connections charted in so-called logic models allows the identification of factors that are vital for the intervention to succeed and which must therefore be studied; fourth, that an important part of a feasibility study must be to identify and chart as many as possible of the causally important contextual factors. CONCLUSION: The conceptualization of the implementation of a CEC as a complex intervention shapes the intervention and the way evaluation research should be performed, in several significant ways. We recommend that researchers consider whether a complex intervention approach is called for when studying CESS implementation and impact.

[The clinical ethic committee: aims, structure, and tasks of clinical ethics]. / Das Klinische Ethikkomitee: Ziele, Strukturen und Aufgaben Klinischer Ethik.

Advances in medical technology as well as developments in society as a whole, such as the scarcity of resources in the healthcare system or the so-called "Pflegenotstand," increasingly require a professional approach to ethical issues in patient care. Therefore, more and more hospitals develop ethical structures. In the US, this development goes back to the 1960s. In Germany, it started about 30 years later. Essentially, clinical ethics intend to promote the possibilities of a qualified exchange on ethical subjects in everyday care. It covers more than only the support of solving ethical conflicts that may arise in the care of individual patients. In addition, the corresponding organizational structures are taken into account. The structural implementation of clinical ethics often takes place by clinical ethic committees. Key tasks include the clinical ethics consultation, training, and the development of ethical policies and their organizational penetration. In this way, clinical ethics can help make ethical negotiation an integral part of the corporate culture.This article presents the core tasks of clinical ethics and the resulting implementation options. In addition, it places a special emphasis on the importance of organizational relationships.

Evaluation of a paediatric clinical ethics service.

AIM: To evaluate a paediatric clinical ethics service incorporating both normative and empirical analysis. METHODS: Section 1: Review of consensus guidelines to identify emerging standards for clinical ethics services (CES) and evaluation of the service in relation to these. Section 2: Description of service activity data. Section 3: Feedback from clinical staff involved in clinical ethics consultations was collected using a web-based survey. RESULTS: Four guideline documents were reviewed, and clear emerging consensus standards were identified. Our service fulfils identified knowledge and skill core competencies and at least partially fulfils all of the identified service-level standards. Clinicians report that clinical ethics consultation decreases their moral distress. CONCLUSIONS: There is emerging consensus for staff competencies and service-level standards for CES. The role of CES in staff well-being needs to be explored. Collaborative, multi-modal research to develop standards and evaluate CES is needed.

Ethical challenges assessed in the clinical ethics Committee of Psychiatry in the region of Southern Denmark in 2010-2015: a qualitative content analyses.

BACKGROUND: The aim of this article is to give more insight into what ethical challenges clinicians in mental healthcare experience and discuss with a Clinical Ethics Committee in psychiatry in the Region of Southern Denmark. Ethical considerations are an important part of the daily decision-making processes and thereby for the quality of care in mental healthcare. However, such ethical challenges have been given little systematic attention - both in research and in practices. METHODS: A qualitative content analysis of 55 written case-reports from the Clinical Ethics Committee. The Committee offers clinicians in mental healthcare structured ethical analyses of ethical challenges and makes a thorough written case-report. RESULTS: The ethical challenges are grouped into three overarching topics: 1. Clinicians and their relation to patients and relatives. 2. Clinicians and institutional aspects of mental healthcare 3. Clinicians and mental healthcare in a wider social context. Through presentation of illustrative examples the complexity of daily clinical life in mental healthcare becomes evident, as well as typical interests, values and arguments. CONCLUSIONS: This qualitative study indicates that difficult ethical challenges are an inherent part of mental healthcare that requires time, space and competence to be dealt with adequately.

Roles and responsibilities of clinical ethics committees in priority setting.

BACKGROUND: Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees (CECs) be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. METHOD: Descriptions of activities involving priority setting in annual reports from Norwegian CECs (2003-2015) were studied and categorized through qualitative content analysis. RESULTS: Three hundred thirty-nine reports from 38 CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. DISCUSSION: In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs' work further. CONCLUSIONS: The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests.

Discussing End-of-Life Decisions in a Clinical Ethics Committee: An Interview Study of Norwegian Doctors' Experience.

With disagreement, doubts, or ambiguous grounds in end-of-life decisions, doctors are advised to involve a clinical ethics committee (CEC). However, little has been published on doctors' experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors' experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients' relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs' discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs' discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians.

Clinical Ethics Consultation in Japan: What does it Mean to have a Functioning Ethics Consultation?

This research examines the current status of clinical ethics consultation (CEC) in Japan through a nationwide study conducted with chairs of ethics committees and clinical ethics committees among 1028 post-graduate clinical teaching hospitals. We also qualitatively analyzed their viewpoints of the CEC's benefits and problems related to hospital consultation services to identify the critical points for CEC and inform the development of a correctly functioning system. The questionnaire included structured questions about hospital CEC organization and service purpose and operation and open-ended questions about the benefits and problems of initiating CEC. The questionnaire comprised the presence/absence of an ethics committee, CEC services and membership when services were implemented, users, and the number of cases handled since inception. In addition, the respondents also provided their impressions of the CEC system's impact on their hospital by describing (a) the benefits of CEC services and (b) the ineffectual or harmful aspects of the CEC system. Qualitative data were examined using qualitative content analysis to determine the impact of establishing a CEC and the difficulties of practice. One hundred twenty-five questionnaires were returned from either the chair of the ethics committee or clinical ethics committee in teaching hospitals. Of these, 90 (72%) reported they provided CEC services. Additionally, 36 respondents (34.6%) reported that their existing research and clinical ethics committees had conducted CEC services, and 35 (33.7%) reported having a newly established clinical ethics committee conducting CEC services. Three positive effects of establishing and four challenges in managing CEC were also identified.

Implementation of an Ethics Committee in a University Mental Health Clinic.

Mental disorders in university students are very frequent, therefore higher education institutions have established in-campus mental healthcare centres. These clinics have particular characteristics that differ from other mental health centres, as they report to and represent an educational institution, while at the same time looking after the interests and well-being of patients requesting assistance, thus generating unique bioethical conflicts. Ethics Committees are useful tools to offer support to mental health professionals in making ethical decisions. In order to respond to these issues, it was decided that an Ethics Committee would be created in the mental health clinic of a private university in Mexico City. This article describes the implementation process for this Committee, its duties and scope, as well as the case work and review methodology. A list of the most frequent ethical conflicts is attached, jointly with the ethical analysis of the cases treated throughout the year and a half or work by the Committee.

[Medical-ethical decision-making-contribution of the clinical ethics committee by ethics consultation and development of ethical guidelines]. / Medizinisch-ethische Entscheidungsfindung ­ Beitrag des Klinischen Ethik-Komitees durch Ethikberatung und Erstellung ethischer Leitlinien.

Medical-ethical decision-making ranges between the poles of the medical indication on the one hand and the will of the informed and advised patient on the other, which do not necessarily have to coincide. Even if the definitive choice of action is made by the attending physician/the treatment team, it is particularly helpful in problematic conflicting situations to set up the corresponding decision-making as broadly as possible, with the result that ultimately an appropriate, acceptable, and well-founded decision is made for all parties involved. The clinical ethics committee (CEC) can perform the task of providing the most comprehensive and structured support possible in decision-making and problem-solving in a medical-ethical context with all its instruments of ethics consultation as well as by the development of "ethical guidelines". The CEC is not a decision-making body that makes unilateral decisions on its own authority and relieves the directly treating persons of the decision-making responsibility, but an advisory and supporting authority. For recurring, similar ethically sensitive questions, ethical guidelines can be created by the CEC of an institution with the aim of facilitating decision-making in a corresponding ethical problem situation. An ethical guideline provides orientation that can increase the quality of decision-making and relieve decision-makers ethically and legally. In doing so, the ethical guideline grants the decision-maker a range of possibilities by specifying a meaningful corridor for action, from which, in justified cases, deviations can also be made after individual evaluation.

Role of a Clinical Ethics Committee in Residential Aged Long-Term Care Settings: A Systematic Review.

OBJECTIVES: To conduct a systematic review of literature examining the establishment and operation of clinical ethical committees (CECs) in long-term care (LTC). DESIGN: Systematic review. SETTING AND PARTICIPANTS: LTC recipients/family or staff. METHODS: Five databases (Ovid Medline, Ovid Cochrane Library, Ovid PsycINFO, Ovid EMBASE, and CINAHL via EbscoHost) were systematically searched from their inception to May 8, 2020. The initial search was conducted on August 22, 2017, and updated on May 8, 2020, to identify peer-reviewed studies, commentaries, or editorials. The quality of studies was assessed using the Mixed Methods Appraisal Tool. RESULTS: Thirty-three articles were identified for inclusion, of which 13 were primary studies. Most articles were set in the United States. The purpose of establishing a CEC in LTC was typically to assist in dealing with ethical issues and improve the quality of care. The articles described the roles of CECs to include prospective case consultation, case review, policy development, and ethics education. Articles rarely reported whether the CEC was required by or enshrined in law. Membership of CECs was between 4 and 20 members and most commonly included nursing staff, physicians, and directors/administrators. The rationale behind the membership was rarely described. For case consultation, articles described that CECs were typically convened upon referral. The resident issues which a CEC could address included end-of-life care decisions, autonomy/self-determination, and medical treatment decisions. The staff issues addressed by CECs included medical treatment decisions, end-of-life care decisions, and decision-making issues. The decision-making process followed by CECs varied. The outcome of a CEC meeting was typically a recommendation, whereas the implementation of CEC recommendations and decisions were rarely reported. CONCLUSIONS AND IMPLICATIONS: This systematic review identifies how CECs operate in the LTC setting. CECs have the potential to provide valuable support in addressing complex ethical issues in LTC; however, empirical research is required to determine their efficacy in the LTC setting.

Uncertainty about effects is a key factor influencing institutional review boards' approval of clinical studies.

PURPOSE: To investigate factors, which influence institutional review boards' (IRBs') decision to approve or not approve clinical studies, a nationwide vignette-based online survey of IRB members was conducted. METHODS: A factorial design was used, whereby seven aspects of each hypothetical study were randomly varied in 15 phrases in each vignette to produce unique vignettes. Participants indicated the degree of study approval and described factors influencing approval decision. Qualitative responses were thematically content analyzed. RESULTS: Sixteen themes were obtained from 208 participants from 42 institutions. Uncertainty, adherence, study design, and harms were frequently and intensely cited to influence study approval. Analysis of two extreme subgroups (approvers vs. nonapprovers) showed that uncertainty influenced approval decisions, odds ratios (OR) = 3.5 (95% confidence interval [CI], 1.3-9.8) and OR = 3.2 (95% CI, 1.1-8.9), respectively, based on theme frequency and theme intensity, ignoring multiple observations per person. Taking into consideration multiple observations per person, similar results were obtained for uncertainty: OR = 8.9 (95% CI, 0.93-85.4). CONCLUSIONS: Perceived uncertainty about benefits and harms of a proposed intervention is a key driver in IRB members' approval of clinical trials. This, in turn, calls for improved standardization in the communications of information on benefits and harms in the research protocols considered by the IRBs.

Implementação de comitês de bioética em hospitais universitários brasileiros: dificuldades e viabilidades / Implementación de comités de bioética en hospitales universitarios brasileños: dificultades y viabilidades / Implementation of bioethics committees in Brazilian university hospitals: difficulties and viability

Este artigo objetiva apresentar e discutir o processo de implantação e funcionamento de comitês de bioética clínica no complexo hospitalar de uma universidade pública brasileira, na qual quatro de seus hospitais são dotados dessas comissões, em diferentes etapas de estruturação: um hospital geral, um psiquiátrico, um hospital infantil e uma maternidade. Para isso, são discutidos meios, dificuldades e viabilidade para sua implantação, além de recomendações práticas em forma de etapas, com relatos de experiências no Brasil e no mundo. Com o presente texto busca-se contribuir para a reflexão bioética sobre os crescentes desafios éticos decorrentes dos desenvolvimentos científicos da biomedicina, que se materializam na atenção em saúde nas instituições. Busca-se, ainda, fomentar um importante passo para o desenvolvimento de comitês de bioética em nosso país e a apreciação crítica desse importante dispositivo de deliberação ética...

El objetivo de este artículo es presentar y discutir el proceso de implantación y funcionamiento de comités de bioética clínica en el complejo hospitalario de una universidad pública brasileña, con cuatro de sus hospitales poseyendo dichos comités, en diferentes etapas de estructuración: un hospital general, uno psiquiátrico, un hospital infantil y un pabellón de maternidad. Para esto, son discutidos medios, dificultades y viabilidad para su implantación, además de recomendaciones prácticas en forma de etapas, con relatos de experiencias en Brasil y en el mundo. Con el presente relato se busca contribuir a la reflexión bioética sobre los crecientes desafíos éticos derivados de los desarrollos científicos de la biomedicina, que se materializan en la atención a la salud en las instituciones. Se busca también fomentar un importante capítulo del campo que es el futuro desarrollo de comités de bioética en nuestro país y la apreciación crítica de este importante dispositivo de deliberación ética...

The objective of this article is to present and discuss the process of implementation and functioning of clinical bioethics committees in the hospital complex of a Brazilian public university, with four of its hospitals having these commissions in different structuring stages: a general hospital; a psychiatric hospital; a children's hospital and a maternity ward. For this, alternatives, difficulties, as well as the viability, are discussed for their implementation, in addition to practical recommendations in the form of steps, with accounts of experiences in Brazil and around the world. The aim of this report is to contribute to the bioethical reflection regarding the increasing ethical challenges arising from scientific developments in biomedicine. It is also the aim of this report to encourage the future development of bioethics committees in our country and the critical appraisal of this important item of ethical deliberation...