With the increasing professionalization of clinical ethics, some hospitals and health systems utilize both ethics committees and professional clinical ethicists to address their ethics needs. Drawing upon historical critiques of ethics committees and their own experiences, the authors argue that, in ethics programs with one or more professional clinical ethicists, ethics committees should be dissolved when they fail to meet minimum standards of effectiveness. The authors outline several criteria for assessing effectiveness, describe the benefits of a model that places primary (...) responsibility for ethics work with professional clinical ethicists—the PCE-primary model, and offer suggestions for alternative ethics program structures that empower healthcare professionals to contribute to ethics work in ways more tailored to their strengths and skills while minimizing the shortcomings of ethics committees. (shrink)

Clinical Ethics Committees (CECs), as distinct from Research Ethics Committees, were originally established with the aim of supporting healthcare professionals in managing controversial clinical ethical issues. However, it is still unclear whether they manage to accomplish this task and what is their impact on clinical practice. This systematic review aims to collect available assessments of CECs’ performance as reported in literature, in order to evaluate CECs’ effectiveness. We retrieved all literature published up to November 2019 in six databases (PubMed, Ovid (...) MEDLINE, Scopus, Philosopher’s Index, Embase and Web of Science), following PRISMA guidelines. We included only articles specifically addressing CECs and providing any form of CECs performance assessment. Twenty-nine articles were included. Ethics consultation was the most evaluated of CECs’ functions. We did not find standardized tools for measuring CECs’ efficacy, but 33% of studies considered “user satisfaction” as an indicator, with 94% of them reporting an average positive perception of CECs’ impact. Changes in patient treatment and a decrease of moral distress in health personnel were reported as additional outcomes of ethics consultation. The highly diverse ways by which CECs carry out their activities make CECs’ evaluation difficult. The adoption of shared criteria would be desirable to provide a reliable answer to the question about their effectiveness. Nonetheless, in general both users and providers consider CECs as helpful, relevant to their work, able to improve the quality of care. Their main function is ethics consultation, while less attention seems to be devoted to bioethics education and policy formation. (shrink)

Empirische Forschungsarbeiten zur Ethik im Gesundheitswesen können entsprechende Implementationsprojekte unterstützen. Inzwischen gibt es eine Vielfalt von Ethikberatungsansätzen und -strukturen, die jedoch noch nicht in allen Gesundheitseinrichtungen genutzt werden. Bedarfserhebungen können wichtige Daten zu Strategie- und Projekterfordernissen darstellen. Die Bedeutung und Gründe für die Einschätzung des Bedarfs an klinischer Ethikberatung werden in der Fachliteratur vielfach diskutiert. Im vorliegenden Beitrag werden die Ergebnisse aus der Literaturanalyse im Hinblick auf vorhandene Erhebungsinstrumente zusammengefasst und ein Konzept zur Entwicklung eines Bedarfserhebungsinstruments beschrieben. Das Konzept beinhaltet (...) Daten zum Erhebungsbereich, zu den Forschungsfragen, zur Zielformulierung und zu den Zielgruppen. Anschließend wird das vorläufig entwickelte Instrument kurz vorgestellt. Ziel des Erhebungsinstruments ist es zunächst, empirische Daten von handelnden Pflegepersonen zu erheben, um so eine Grundlage für den konkreten Unterstützungsbedarf zu erhalten. (shrink)

The Texas Advance Directive Act allows physicians and hospitals to overrule patient or family requests for futile care. Purposefully not defining futility, the law leaves its determination in specific cases to an institutional process. While the law has received several criticisms, it does seem to work constructively in the cases that come to the review process. We introduce a new criticism: While the law has been justified by an appeal to professional values such as avoiding harm to patients, avoiding the (...) provision of unseemly care, and good stewardship of medical resources, it is applied incompletely. It allows physicians and institutional committees to refuse “futile” treatments desired by patients and families while at the same time providing no way of regulating physicians who recommend or even push “futile” treatments in similar cases. In this sense, the TADA is incomplete on its own terms. (shrink)

The aim of the study was to report the results of a systematically conducted literature review of empirical studies about healthcare organizations’ ethics and management or leadership issues. Electronic databases MEDLINE and CINAHL yielded 909 citations. After a two stage application of the inclusion and exclusion criteria 56 full-text articles were included in the review. No large research programs were identified. Most of the studies were in acute hospital settings from the 1990s onwards. The studies focused on ethical challenges, dilemmas (...) in practice, employee moral distress and ethical climates or environments. Study samples typically consisted of healthcare practitioners, operational, executive and strategic managers. Data collection was mainly by questionnaires or interviews and most of the studies were descriptive, correlational and cross-sectional. There is need to develop conceptual clarity and a theoretical framework around the subject of organizational ethics and the breadth of the contexts and scope of the research needs to be increased. (shrink)

Clinical ethics committees (CECs) in the United Kingdom (UK) have developed significantly over the past 15 years. The issue of access to and participation in clinical ethics consultation by patients and family members has, however, gone largely unrecognized. There are various dimensions to this kind of contact, including patient notification, consent and participation. This study reports the first specific investigation of patient contact with UK CECs. A questionnaire study was carried out with representatives from UK CECs. Results suggest that patient (...) participation in clinical ethics consultation is low and unlikely to change significantly in the near future. Attitudes towards patients having a role in clinical ethics consultation are mixed, with a variety of reasons put forward both for and against patient participation. These results are discussed in the light of common themes in the literature and the practical and political context of clinical ethics support in the UK. (shrink)

Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over a period of eight years to two separate (...) samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees. (shrink)

BackgroundFew comparative studies of clinical ethics consultation practices have been reported. The objective of this study was to explore how American and Japanese experts analyze an Alzheimer's case regarding ethics consultation.MethodsWe presented the case to physicians and ethicists from the US and Japan (one expert from each field from both countries; total = 4) and obtained their responses through a questionnaire and in-depth interviews.ResultsEstablishing a consensus was a common goal among American and Japanese participants. In attempting to achieve consensus, the (...) most significant similarity between Japanese and American ethics consultants was that they both appeared to adopt an "ethics facilitation" approach. Differences were found in recommendation and assessment between the American and Japanese participants. In selecting a surrogate, the American participants chose to contact the grandson before designating the daughter-in-law as the surrogate decision-maker. Conversely the Japanese experts assumed that the daughter-in-law was the surrogate.ConclusionOur findings suggest that consensus building through an "ethics facilitation" approach may be a commonality to the practice of ethics consultation in the US and Japan, while differences emerged in terms of recommendations, surrogate assessment, and assessing treatments. Further research is needed to appreciate differences not only among different nations including, but not limited to, countries in Europe, Asia and the Americas, but also within each country. (shrink)

Every healthcare organisation enacts a multitude of policies, but there has been no discussion as to what procedural and substantive requirements a policy writing process should meet in order to achieve good outcomes and to possess sufficient authority for those who are asked to follow it.Using, as an example, the controversy about patient’s refusal of blood transfusions, I argue that a hospital wide policy is preferable to individual decision making, because it ensures autonomy, quality, fairness, and efficiency.Policy writing for morally (...) controversial medical practices needs additional justification compared to policies on standard medical practices and secures legitimate authority for HCO members by meeting five requirements: all parties directed by the policy are represented; the deliberative process encompasses all of the HCO’s obligations; the rationales for the policy are made available; there is a mechanism for criticising, and for evaluating the policy. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Background‘The Clinical Ethics Advisory Group’ (CEAG) is the clinical ethics support body for Newcastle upon Tyne Hospitals National Health Service Foundation Trust. A significant change in CEAG’s way of working occurred over the past 5 years as a result of Court decisions, increasing public expectations and an increase in CEAG’s paediatric case flow.PurposeReview historical data: (a) as a useful benchmark to look for the early impact of significant service changes and (b) to seek possible reference (‘sentinel’) cases for use with (...) a posited practical (casuistic) case-based reasoning model.MethodsAudit of the minutes of the first 22 years’ meetings was undertaken by the two chairs of CEAG over that period of time.Results223 matters discussed: 86 Trust policy issues; 117 clinical cases (84 adult (32 urgent), 33 child (8 urgent)); 12 CEAG procedural issues and 8 UK Clinical Ethics Network ‘round robin’ cases. The range of topic areas was wide. A broad range of ethical structures were deployed, principlism predominated. Quality was subjectively assessed by each reviewer, but different methods were used. This proved highly concordant between the two reviewers. 47% (105/223) of discussions were ‘excellent’ (*A4C4–A4C4) and 70% (156.5/223) ‘good’ or better (*A4C4–A3C3). By meeting the criteria of ‘excellent’ and ‘prospective’, 92/223 (41%) of matters were deemed potentially suitable as sentinel cases.ConclusionsThe audit provides a rich vein of information. There is demand for CEAG’s services, workload is becoming more complex. Formal funding for such services seems justified. (shrink)

BackgroundAs hospitals have grown more complex, the ethical concerns they confront have grown correspondingly complicated. Many hospitals have consequently developed health care ethics programs (HCEPs) that include far more than ethics consultation services alone. Yet systematic research on these programs is lacking.MethodsBased on a national, cross-sectional survey of a stratified sample of 600 US hospitals, we report on the prevalence, scope, activities, staffing, workload, financial compensation, and greatest challenges facing HCEPs.ResultsAmong 372 hospitals whose informants responded to an online survey, 97% (...) of hospitals have HCEPs. Their scope includes clinical ethics functions in virtually all hospitals, but includes other functions in far fewer hospitals: ethical leadership (35.7%), regulatory compliance (29.0%), business ethics (26.2%), and research ethics (12.6%). HCEPs are responsible for providing ongoing ethics education to various target audiences including all staff (77.0%), nurses (59.9%), staff physicians (49.0%), hospital leadership (44.2%), medical residents (20.3%) and the community/general public (18.4%). HCEPs staff are most commonly involved in policy work through review of existing policies but are less often involved in development of new policies. HCEPs have an ethics representative in executive leadership in 80.5% of hospitals, have representation on other hospital committees in 40.7%, are actively engaged in community outreach in 22.6%, and lead large-scale ethics quality improvement initiatives in 17.7%. In general, major teaching hospitals and urban hospitals have the most highly integrated ethics programs with the broadest scope and greatest number of activities. Larger hospitals, academically affiliated hospitals, and urban hospitals have significantly more individuals performing HCEP work and significantly more individuals receiving financial compensation specifically for that work. Overall, the most common greatest challenge facing HCEPs is resource shortages, whereas underutilization is the most common greatest challenge for hospitals with fewer than 100 beds. Respondents’ strategies for managing challenges include staff training and additional funds.ConclusionsWhile this study must be cautiously interpreted due to its limitations, the findings may be useful for understanding the characteristics of HCEPs in US hospitals and the factors associated with these characteristics. This information may contribute to exploring ways to strengthen HCEPs. (shrink)

Empirische Forschungsarbeiten zur Ethik im Gesundheitswesen können entsprechende Implementationsprojekte unterstützen. Inzwischen gibt es eine Vielfalt von Ethikberatungsansätzen und -strukturen, die jedoch noch nicht in allen Gesundheitseinrichtungen genutzt werden. Bedarfserhebungen können wichtige Daten zu Strategie- und Projekterfordernissen darstellen. Die Bedeutung und Gründe für die Einschätzung des Bedarfs an klinischer Ethikberatung werden in der Fachliteratur vielfach diskutiert. Im vorliegenden Beitrag werden die Ergebnisse aus der Literaturanalyse im Hinblick auf vorhandene Erhebungsinstrumente zusammengefasst und ein Konzept zur Entwicklung eines Bedarfserhebungsinstruments beschrieben. Das Konzept beinhaltet (...) Daten zum Erhebungsbereich, zu den Forschungsfragen, zur Zielformulierung und zu den Zielgruppen. Anschließend wird das vorläufig entwickelte Instrument kurz vorgestellt. Ziel des Erhebungsinstruments ist es zunächst, empirische Daten von handelnden Pflegepersonen zu erheben, um so eine Grundlage für den konkreten Unterstützungsbedarf zu erhalten. (shrink)

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, (...) conflict, and ‘outsiders’ are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well‐known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper. (shrink)

The growing prevalence of health care ethics consultation (HCEC) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance, and for the debates surrounding why and how HCEC is evaluated. The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters.

This paper provides a series of reflections on making the case to senior leaders for the introduction of clinical ethics support services within a UK hospital Trust at a time when clinical ethics committees are dwindling in the UK. The paper provides key considerations for those building a case for clinical ethics support within hospitals by drawing upon published academic literature, and key reports from governmental and professional bodies. We also include extracts from documents relating to, and annual reports of, (...) existing clinical ethics support within UK hospitals, as well as extracts from our own proposal submitted to the Trust Board. We aim for this paper to support other ethicists and/or health care staff contemplating introducing clinical ethics support into hospitals, to facilitate the process of making the case for clinical ethics support, and to contribute to the key debates in the literature around clinical ethics support. We conclude that there is a real need for investment in clinical ethics in the UK in order to build the evidence base required to support the wider introduction of clinical ethics support into UK hospitals. Furthermore, our perceptions of the purpose of, and perceived needs met through, clinical ethics support needs to shift to one of hospitals investing in their staff. Finally, we raise concerns over the optional nature of clinical ethics support available to practitioners within UK hospitals. (shrink)

There is an increasing need for quality in ethics consultations, though there have been significant achievements in the United States and Europe. However, fundamental concerns that place the profession in jeopardy are discussed from the perspective of the U.S. in a manner that will be helpful for other countries. The descriptive component of the essay (the first two points) explains the achievements in ethics quality (illustrated by the IntegratedEthics program of the Veterans Health Administration) and the progress on standards and (...) competencies for ethics consultations (represented by the Core Competencies of the American Society for Bioethics and Humanities). Based on these achievements, the analytical component of the essay (the final three points) identifies and seeks to resolve three fundamental concerns (with increasing levels of importance) that compromise quality in ethics consultations: standards of quality; professionalism; and credentialing. The analysis argues for clearer standards of quality in ethics consultation and urges further professionalism by explaining the need for the following: interpreting the ASBH core competencies in a normative manner, developing a Code of Ethics, and clarifying the meaning of best practices. However, the most serious concern that threatens quality in ethics consultations is the lack of a credentialing process. This concern can be resolved effectively by developing an independent Ethics Consultation Accreditation Council to accredit and standardize graduate degree programs, fellowship experiences, and qualifying examinations. This credentialing process is indispensable if we are to strategically enhance quality in ethics consultations. (shrink)

A multiple-case study of four hospital ethics committees in Canada was conducted and data collected included interviews with key informants, observation of committee meetings and ethics-related hospital documents, such as policies and committee minutes. We compared the hospital committees in terms of their structure, functioning and perceptions of key informants and found variation in the dimensions of empowerment, organizational culture of ethics, breadth of ethics mandate, achievements, dynamism, and expertise.

Background: Clinical ethics consultation services have been established in many countries during recent decades. An important task is to discuss concrete clinical cases. However, empirical research observing what is happening during such deliberations is scarce. Objectives: To explore clinical ethics committees’ deliberations and to identify areas for improvement. Design: A pilot study including observations of committees deliberating a paper case, semistructured group interviews, and qualitative analysis of the data. Participants: Nine hospital ethics committees in Norway. Results and interpretations: Key elements (...) of the deliberations included identifying the ethical problems; exploring moral values and principles; clarifying key concepts and relevant legal regulation; exploring medical facts, the patient’s situation, the therapists’ perspective, analogous clinical situations, professional uncertainties, the patient’s and relatives’ perspective, and clinical communication; identifying the involved parties and how to involve them; identifying possible courses of action, and possible conclusion and follow-up. The various elements were closely interwoven. The content and conclusions varied and seemed to be contingent on the committee members’ interpretations, experience and knowledge. Important aspects of a clinical ethics deliberation were sometimes neglected. When the committees used a deliberation procedure and a blackboard, the deliberations tended to become more systematic and transparent. Many of the committees were insecure about how to include the involved parties and how to document the deliberations. Conclusion: Clinical ethics committees may provide an important arena for multidisciplinary discussions of complex clinical ethics challenges. However, this seems to require adequate composition, adoption of transparent deliberation procedures, and targeted training. (shrink)

In 1992, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) passed a mandate that all its approved hospitals put in place a means for addressing ethical concerns.Although the particular process the hospital uses to address such concernsmay vary, the hospital or healthcare ethics committee (HEC) is used most often. In a companion study to that reported here, we found that in 1998 over 90% of U.S. hospitals had ethics committees, compared to just 1% in 1983, and that many (...) have some and a few have sweeping clinical powers in hospitals. (shrink)

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. (shrink)

For more than a decade, Ellen Fox and her colleagues have proclaimed the importance of evaluating ethics consultation services (ECSs). In their article, “Ethics Consultation in United States Hospit...

In den USA haben sich im Wesentlichen drei verschiedene Organisationsformen klinischer Ethikberatung entwickelt: der einzelne Berater, das große Komitee und das Beratungsteam teilweise mit Rückbindung an ein größeres Komitee. Bislang gibt es jedoch weder empirische Daten noch ein Ergebnis der anfänglichen theoretischen Diskussion, ob es ein favorisiertes Modell für die klinische Ethikberatung geben sollte und welches dieses sei. Dieser Artikel argumentiert, dass die Vorzüge, Nachteile und die Erfolgsfaktoren der verschiedenen Organisationsformen in Abhängigkeit von der Zielsetzung klinischer Ethikdienste (KED) bewertet werden (...) müssen. Diese Zielsetzung kann auf einem Spektrum vom „Patientenanwalt“ bis zum „Gewissen der Institution“ angesiedelt sein. Die Zielsetzung bestimmt dabei Aufgabenschwerpunkte, Zusammensetzung, die favorisierte Organisationsform und wünschenswerte Standards. Die Untersuchung stützt sich zum einen auf die Analyse von Interviews mit fünf Vorsitzenden klinischer Ethikkomitees von Harvard Lehrkrankenhäusern in Boston, die jeweils etwa 20 Jahre Erfahrung in klinischer Ethikberatung mit den drei unterschiedlichen Modellen gemacht haben. Zum anderen basiert sie auf der Rezeption der Literatur und empirischen Studien zu KEDs in den USA und Deutschland. Insgesamt scheint das Konsilteam mit Rückbindung an ein Komitee am besten geeignet, die Behandlung einzelner Patienten und das ethische Bewusstsein einer ganzen Organisation zu verbessern. Es vereint die Vorteile der anderen beiden Modelle auf sich, ohne unter deren Schwächen zu leiden. (shrink)

Guidance for Healthcare Ethics Committees edited by D. Micah Hester and Toby Schonfeld is a comprehensive guide for members of ethics committees. The book is designed to address the three essential missions of healthcare ethics committees : Consultation, Policy Writing, and Education. Although there is already significant literature devoted to ethics consultation, the policy writing and education functions of ethics committees get relatively little attention in the literature. It is valuable to have a source that combines all components of the (...) HEC duties. The book addresses a wide range of topics within each area, with the greatest focus on consultation.Guidance for Healthcare Ethics Committees is divided into four parts. The first is an introductory section that gives a broad overview of ethical theories, legal issues affecting ethics committees, and cultural and religious issues that often impact the work of ethics committees. The latter three sections each t .. (shrink)

A growing body of research has demonstrated significant heterogeneity of hospital ethics committee (HEC) size, membership and training requirements, length of appointment, institutional support, clinical and policy roles, and predictors of self identified success. Because these studies have focused on HECs at a single point in time, however, little is known about how the composition of HECs changes over time and what impact these changes have on committee utilization. The current study presents 20 years of data on the evolution of (...) the Massachusetts General Hospital HEC. Between 1993 and 2012, the average number of committee members per year was 38 ± 3 and the average length of membership was 4.8 ± 0.4 years. During that time, the committee performed 934 consults, averaging 47 ± 3 per year. Attendance rates fell from 61.5 to 23.8 % over the study period and were inversely correlated with the total number of members. Between 1993 and 2012, the committee saw substantial growth in the diversity of the professional backgrounds of its members. Multivariate analysis, however, suggests that substantial changes in committee composition did not impact its utilization and that other factors are more likely to explain fluctuations in consultation volume. (shrink)

The proliferation of ethics committees and ethics consultation services has engendered a discussion of the issue of the expertise of those who provide clinical ethics consultation services. In this paper, I discuss two aspects of this issue: the cognitive dimension or content knowledge that the clinical ethics consultant should possess and the practical dimension or set of dispositions, skills, and traits that are necessary for effective ethics consultation. I argue that the failure to differentiate and fully explicate these dimensions contributes (...) to the confusion over the issue of expertise and fuels, at least partly, the controversies about expertise (or authority) in ethics and the legitimacy of the use of ethical knowledge in clinical ethics consultation. (shrink)

There has long been tension between bioethicists whose work focuses on classical philosophical inquiry and those who perform empirical studies on bioethical issues. While many have argued that empirical research merely illuminates current practices and cannot inform normative ethics, others assert that research-based work has significant implications for refining our ethical norms. In this essay, I present a novel construct for classifying empirical research in bioethics into four hierarchical categories: Lay of the Land, Ideal Versus Reality, Improving Care, and Changing (...) Ethical Norms. Through explaining these four categories and providing examples of publications in each stratum, I define how empirical research informs normative ethics. I conclude by demonstrating how philosophical inquiry and empirical research can work cooperatively to further normative ethics. (shrink)

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to (...) benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries. (shrink)

As biomedical research with volunteers was expanded in the United States, the rule of subject selection, constituting scientific and ethical criteria, was generated in 1981 to resolve selection bias in research. Few historical studies, however, have investigated the role of this new hybrid rule in institutional review systems. This paper describes how bioethics commissions and federal agencies have created the subject selection rule based on the concept of justice. I argue that the standardization of this rule as temporal measures, linked (...) with risk-benefit assessment, has reformed the review mechanism, specifically investigators’ modification of research plans, thereby developing justice as balancing. (shrink)

Ethics networks have emerged over the last few decades as a mechanism for individuals and institutions over various regions, cities and states to converge on healthcare-related ethical issues. However, little is known about the development and nature of such networks. In an effort to fill the gap in the knowledge about such networks, a survey was conducted that evaluated the organizational structure, missions and functions, as well as the outcomes/products of ethics networks across the country. Eighteen established bioethics networks were (...) identified via consensus of three search processes and were approached for participation. The participants completed a survey developed for the purposes of this study and distributed via SurveyMonkey. Responses were obtained from 10 of the 18 identified and approached networks regarding topic areas of: Network Composition and Catchment Areas; Network Funding and Expenses; Personnel; Services; and Missions and Accomplishments. Bioethics networks are designed primarily to bring ethics education and support to professionals and hospitals. They do so over specifically defined areas—states, regions, or communities—and each is concerned about how to stay financially healthy. At the same time, the networks work off different organizational models, either as stand-alone organizations or as entities within existing organizational structures. (shrink)

As the field of clinical ethics consultation sets standards and moves forward with the Quality Attestation process, questions should be raised about what ethical issues really do arise in practice. There is limited data on the type and number of ethics consultations conducted across different settings. At Loyola University Medical Center, we conducted a retrospective review of our ethics consultations from 2008 through 2013. One hundred fifty-six cases met the eligibility criteria. We analyzed demographic data on these patients and conducted (...) a content analysis of the ethics consultation write-ups coding both the frequency of ethical issues and most significant, or key, ethical issue per case. Patients for whom ethics consultation was requested were typically male, white, between 50 and 69 years old, of non-Hispanic origin, and of Roman Catholic faith. Nearly half were in the intensive care unit and 44.2 % died in the hospital. The most frequent broad ethical categories were decision-making, goals of care/treatment, and end-of-life. More specifically, capacity, patient’s wishes/autonomy, and surrogate decision maker were the most frequent particular ethical issues. The most common key ethical issues were withdrawing/withholding treatment, patient wishes/autonomy, and capacity. Our findings provide additional data to inform the training of clinical ethics consultants regarding the ethical issues that arise in practice. A wider research agenda should be formed to collect and compare data across institutions to improve education and training in our field. (shrink)

There is growing interest in clinical ethics. However, we still have sparse knowledge about what is actually going on in the everyday practice of clinical ethics consultations. This paper introduces a descriptive evaluation tool to present, discuss and compare how clinical ethics case consultations are actually carried out. The tool does not aim to define ‘best practice’. Rather, it facilitates concrete comparisons and evaluative discussions of the role, function, procedures and ideals inherent in clinical ethics case consultation practices. The tool (...) was developed during meetings of the European Clinical Ethics Network. Based on written reports and participation in the network meetings, the development and the content of the tool and the results of its application in presenting and discussing 10 case consultations are summarized. The tool facilitated understanding of the details of clinical ethics case consultations across individuals and institutions with various experiences and cultures, and comparison between various practices. (shrink)

In den USA haben sich im Wesentlichen drei verschiedene Organisationsformen klinischer Ethikberatung entwickelt: der einzelne Berater, das große Komitee und das Beratungsteam teilweise mit Rückbindung an ein größeres Komitee. Bislang gibt es jedoch weder empirische Daten noch ein Ergebnis der anfänglichen theoretischen Diskussion, ob es ein favorisiertes Modell für die klinische Ethikberatung geben sollte und welches dieses sei. Dieser Artikel argumentiert, dass die Vorzüge, Nachteile und die Erfolgsfaktoren der verschiedenen Organisationsformen in Abhängigkeit von der Zielsetzung klinischer Ethikdienste (KED) bewertet werden (...) müssen. Diese Zielsetzung kann auf einem Spektrum vom „Patientenanwalt“ bis zum „Gewissen der Institution“ angesiedelt sein. Die Zielsetzung bestimmt dabei Aufgabenschwerpunkte, Zusammensetzung, die favorisierte Organisationsform und wünschenswerte Standards. Die Untersuchung stützt sich zum einen auf die Analyse von Interviews mit fünf Vorsitzenden klinischer Ethikkomitees von Harvard Lehrkrankenhäusern in Boston, die jeweils etwa 20 Jahre Erfahrung in klinischer Ethikberatung mit den drei unterschiedlichen Modellen gemacht haben. Zum anderen basiert sie auf der Rezeption der Literatur und empirischen Studien zu KEDs in den USA und Deutschland. Insgesamt scheint das Konsilteam mit Rückbindung an ein Komitee am besten geeignet, die Behandlung einzelner Patienten und das ethische Bewusstsein einer ganzen Organisation zu verbessern. Es vereint die Vorteile der anderen beiden Modelle auf sich, ohne unter deren Schwächen zu leiden. (shrink)

Die Entscheidung für oder gegen lebensverlängernde Behandlungsmaßnahmen geht inzwischen der Hälfte aller Todesfälle in Europa voraus. Sie wird im klinischen Alltag häufig als ethische Herausforderung wahrgenommen, zudem sind unter Klinikern juristische Unsicherheiten und Fragen der korrekten Vorgehensweise verbreitet. Die hier vorgestellte Münchner Leitlinie zu Entscheidungen am Lebensende soll rechtliche Unsicherheit reduzieren, Klinikumsmitarbeiter für die ethische Dimension von Therapieentscheidungen am Lebensende sensibilisieren und ethisch begründete Entscheidungen fördern. Aus organisationsethischer Perspektive soll mit der Leitlinie eine Reflexion und Meinungsbildung zu einem ethisch relevanten (...) Themenbereich erfolgen und ein Beitrag zur Qualitätssicherung der Patientenversorgung und damit auch zur Patientenzufriedenheit geleistet werden. Die Prozesse der Leitlinienentwicklung, -aktualisierung und -implementierung werden vorgestellt. Die wesentlichen inhaltlichen Elemente der Leitlinie mit Darstellung der Rechtslage, der Definition zentraler Begriffe und Klärung medizinischer Entscheidungskriterien werden an Hand eines Entscheidungsalgorithmus dargestellt. Inhalt und Prozess der Leitlinienentwicklung werden auf die folgenden organisationsethischen Qualitätskriterien hin überprüft: deliberativer Prozess, inhaltliche Transparenz, repräsentative Zusammensetzung der Arbeitsgruppe, Implementierung und Evaluation der Leitlinie. Institutionen, die diese Leitlinie übernehmen wollen, sollten diese von einem autorisierten Gremium überprüfen lassen und auf die spezifischen Bedürfnisse ihrer Institution adaptieren. Hierfür ist eine vorgeschaltete Bedarfserhebung hilfreich. In dem Gremium sollten all diejenigen vertreten sein, die in der Folge mit der Leitlinie arbeiten werden. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)