Ethics committees in Catholic health care are responsible for con­sultation, education, and policy development and review. Historically, ethics committees were reactive and had no articulated goals. This article argues that the essential goals of Catholic ethics committees are (1) to promote the human dignity of patients and staff; (2) to promote the common good; (3) to promote institutional identity, integrity, and ethical climate; and (4) to improve quality of care. These goals are most effectively (...) met when ethics committees are proactive and integrated in the institution, embrace systems thinking, and utilize professional ethicists locally or regionally. (shrink)

This paper considers the roles and definitions of expert and lay members of ethics committees, focussing on those given by the National Research Ethics Service which is mandated to review all research conducted in National Health Service settings in the United Kingdom. It questions the absence of a specified position for the ‘professional ethicist’ and suggests that such individuals will often be lay members of ethics committees, their participation being a reflection of their academic interest (...) and expertise. The absence of a specified position for professional ethicists and the concomitant but implicit denial of ethical expertise appear to be an anomalous state of affairs if one considers that the training offered to members of ethics committees is often delivered by academic ethicists. It is suggested that this is based on a misunderstanding of the concept ‘ethical expertise’ and that properly understood the ethicist can assist the work of ethics committees by drawing on their expert knowledge. (shrink)

Since Clinical Ethics Consultation has become important in the public health sector in the last decade in Germany, there are on-going questions about effectiveness. Targets have been established by the Ethics Committees, in regard to assisting patients, families and health care teams at times of ethical conflicts during the decision-making process in medical care. Of all the ethics consultations over the last eight years at Erlangen University Hospital the consultations carried out in the pediatric department were (...) chosen to be reviewed by a pediatrician and an ethicist. These were evaluated on the basis of team formation, interdisciplinary orientation, ethical criteria, completeness and methods of documentation. Results of the analysis of those records show a well-organized consultation team with regard to its personnel composition. Discrepancies with ethical questions posed in the literature are revealed, and also some partially incomplete documentation regarding medical facts and descriptions of the patients' or parents' opinion. (shrink)

Objective Our objective was to evaluate whether those individuals with previous involvement with formal clinical ethics processes differ in their attitudes towards the resolution of prototypical clinical ethics cases than general health care professionals. We hypothesized that those individuals with previous participation in ethics consultation would have significantly different attitudes on the appropriate role of ethics committees in the assessment and resolution of clinical ethical dilemmas than those who have not. Methods We conducted a case-based (...) survey of health care professionals at six US hospitals. We administered the survey to health care professionals in a variety of clinical roles at each center and further sub-categorized these by respondents reporting or not reporting their membership on an ethics committee or participation as an ethics consultant/requestor of ethics consult services. Using the analysis of variance test, we present the variation in attitudes using a 5-point Likert scale with 95% confidence intervals and significance set at p ≤ 0.05. Results A total of 240 respondents completed the survey (response rate: 63.6%) from all six surveyed centers (128 respondents with involvement with ethics consultation, 112 respondents without). Health care professionals not previously involved with formal clinical ethics processes were less likely to view the ethics committee as having a role in resolving the presented clinical ethical dilemmas ( p = 0.01 for analysis of variance comparison). Conclusion In this multi-center survey study, health care providers without previous involvement with formal clinical ethics processes were less likely than those with previous involvement to support a role for ethics committees aiding in ethical case resolution. (shrink)

Much has been written about the role of hospital ethics committees. Ethics committees may have begun in Seattle in the early 1960s, but they were reified in. New Jersey by the Quinlan Court in the 1970s and thrived in the national bioethics movement of the 1980s.In this flurry of ethics activity, several new forms of ethics committees have evolved. New forms of ethics committees include patient care-oriented ethics committees. Many (...) ethicists are familiar with mission-oriented ethics committees. Such committees have taken on new roles, and Include PROs, IPCs, and HREAPs. In general, these committees are regulatory in nature and may often rely on rules and regulations to assess patient cases, research protocols, and health professional practices. (shrink)

This text provides a comprehensive and timely examination of the most pertinent factors affecting institutional ethics committees, for ethicists, trustees, administrators, physicians, clergy, nurses, social workers, attorneys and others with an interest in ethics committees.

In 2002, I wrote an editorial in this Journal arguing that it was time to review the structure and function of ethics committees in the USA, Australia and the UK.1 This followed the deaths of Ellen Roche and Jesse Gelsinger, which were at least in significant part due to the poor functioning of research ethics committees in the USA.2 In the case of Ellen Roche, it was the failure to require a systematic review of the existing (...) literature which led to her death. Iain Chalmers and I had previously documented in 1996 the failure of ethics committees to require systematic review.3 In 1998, at the time of revising the previous guidelines and forming the first Australian National Statement on Research Ethics, I made a public submission to the Australian Health Ethics Committee arguing that the new guidelines for RECs should include a person with skills in conducting systematic reviews of the literature and that the requirement to have a religious representative on the committee be replaced with the requirement to have an ethicist. Neither of these changes was made. I argued, ‘It is time to ask whether institutional RECs should be abandoned in favour of expert committees that cover many institutions—suprainstitutional specialist committees. Supraregional specialist ethics committees could specialise—for example, in genetic research, cancer clinical trials, dermatology, respiratory physiology and each of the specialist areas of medical research. An example of such a committee is provided by the Thoracic Society of Australia and New Zealand research ethics committee, which reviews multicentre trials of respiratory drugs’.4 Around that time, I was involved ‘at the coal face’ as Chair of the Department of Human Services Ethics Committee in Victoria. In a public presentation, I arguedThere are two philosophical views of what ethics review is. On the …. (shrink)

Technology and Ethics. A European Quest for Responsible Engineering, edited by B. Heriard Dubreuil and his team (University Lille) is in many regards an innovative publication. It is the first fully European contribution to the field of engineering ethics and the result of an intensive cooperation between ethicists and engineers from all the member countries of the European Union. The basic structure of the book is both the distinction and interaction between three levels of analysis: personal responsibility (...) of engineers, the institutional level (business organisations) and the impact of technology on society and culture. On the personal level, the book deals with problems such as the role of professional codes and the fact that engineers must cope with flexibility, shorter lines of decision and erosion of the boundaries between private and professional life. On the meso level, the book deals with different aspects of decision making in the context of business organizations, such as quality management, technology assessment procedures, business ethics committees etc... On the macro level, the authors focus on the power of technology. Together with the influences from other social, economic and political actors, the decisions of engineers change the world in a way which is of moral significance. (shrink)

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)

BackgroundThe COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, (...) we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa.MethodsTwenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses.ResultsKenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking.ConclusionsThis study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs. (shrink)

While dramatic medical "breakthroughs" routinely grab headlines, health-care providers know their daily lives center much more frequently on mundane issues that the media ignore, such as how doctors and their patients can form more trusting relationships. This anthology for health-care providers and ethics committee members focuses on just such questions. Essays are divided under headings including care at the end of life; patients, families, and health-care decisions; health law; care for severely compromised newborns; issues in transplantation, managed care, resource (...) allocation, and genetic testing; and clinical integrity and professionalism. Weinberg is a medical ethicist who teaches at Philadelphia College of Osteopathic Medicine. Annotation copyrighted by Book News Inc., Portland, OR. (shrink)

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. (shrink)

Recent political developments and disclosures of serious adverse events in human gene therapy (HGT) with the death of 18‐year old Jesse Gelsinger in the USA have shown that the clinical application of HGT raises some severe ethical issues. These have either been neglected or not yet been discussed to a satisfactory extent. In this paper, we will address this deficiency and develop strategies for a safer application of HGT. Such a study must first look closely at the science of HGT (...) itself. We will evaluate the latest preclinical research, especially data on the viruses that are used as vectors and on modes of administration of vectors. We will put forward new arguments concerning the toxicity assessment of so‐called ‘gene drugs‘, the tissue and cell type specificity of the vectors, and the duration and on‐set of gene expression. Secondly, we will look at procedural aspects of applied research ethics on the way to clinical application of HGT. There, informed consent (IC) and the patient‐researcher relationship are of utmost concern. Furthermore, we will explore the problem of expertise in risk assessment and will show how current regulations foster conflicts of interests that create dilemma situations even for those researchers who act in the best interest of the patients. We will conclude the article with a set of questions for ethicists who have to decide about the quality of HGT protocols. This may contribute to the safety of patients participating in HGT trials and to achieving the aim of efficient application of HGT. (shrink)

The most important issue remains: Whether attorneys should serve on HECs? Will they tend to inhibit the development of other discussions, ethical discussions, regarding the issues brought before the HEC? D. Niemira (17, p. 982) suggests that what a hospital needs is not necessarily an attorney to help in their ethical deliberations, but an ethicist. This suggestion should receive further analysis. What types of ethical deliberations to which attorneys have not been exposed in their legal training are important given the (...) broader attorney-role (beyond giving legal opinion) in HEC discussions?The pro-active attorney faces many challenges, both in the current setting (as cases are brought to the HEC) and as future questions are raised (due to innovations in medical technology). These questions remain unclarified by the courts. The nature of the attorney's role is ever challenging; he or she remains in a key position that is currently needed (regarding the uncharted areas of HEC decisionmaking) and important for the future (as new cases emerge and require extensive deliberations). (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Clinical ethics consultation service remains undeveloped in developing countries. It is recognised that its introduction poses challenges. Malaysia, a multicultural society with diverse religions, values and perceptions further complicate the introduction of formal clinical ethics consultation service. Clinicians attending a national congress workshop completed a Strengths–Weaknesses–Opportunities–Threats analysis. The aim was to gain insight into clinician’s expectations and promote initiatives leading to the introduction of clinical ethics consultation service. Clinicians agree that clinical ethics consultation service can improve (...) quality of care, reduce healthcare costs and advocate for patients and providers. The analysis highlighted constraints in sufficient critical mass of relevant expertise and restricted opportunities for training. The opportunities lie in education, curriculum development and availability of dedicated proponents. Cultural barriers, limited resources, lack of awareness, differenc... (shrink)

In most children’s hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between (...) philosophers and physicians about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children’s hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are ethics committee meetings, Nursing Ethics Forum, ethics Brown Bag workshops, PICU ethics rounds, Grand Rounds, NICU Comprehensive Care Rounds, Palliative Care Team case conferences, multidisciplinary consults in Fetal Health Center, and ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of “core competencies” than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple “moral spaces” in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set out to do than in the role of the typical hospital ethics consultant today. (shrink)

Chaplains who serve in a clinical context often minister to patients representing a wide variety of faiths. In order to offer the best pastoral care possible, the chaplain should first possess a set of personal theological convictions as a foundation for ministry. Second, he or she needs to be sensitive to the beliefs and practices of the patients. Third, it is vital to develop a relationship of acceptance and trust not only with patients under their care, but also with family (...) members and caregivers as well. At times, situations will arise that are purely religious or theological. In a clinical setting, however, the questions and problems that arise more often are both theological and ethical. It is beneficial for the chaplain to be involved in an ethics committee, where the specifics of each case can be discussed, and staff can offer counsel to patients and their families. This study examines issues that chaplains face at the bedside, such as terminal care, life-prolonging treatments, dementia, persistent vegetative state, and euthanasia/assisted suicide. We will discover that those who are involved in clinical pastoral ministry will be called upon to be a comforter, mediator, educator, ethicist, and counselor. (shrink)

Hospitals are places where patients are unwell, where patients and their families may be upset, confused, frustrated, in pain, and vulnerable. The likelihood of these experiences and emotions manifesting in anger and aggressive behaviour is high. In this paper, we describe the involvement of a clinical ethics service responding to a request to discuss family aggression within a rehabilitation department in a large paediatric hospital in Australia. We suggest two key advantages of involving a clinical ethics service in (...) discussions about how to respond to family aggression. First, the process of ethics deliberation provides an opportunity for clinicians to be involved in the solution by articulating their perspectives, tolerance levels, and general concerns about the effects of family aggression towards staff. Second, supporting clinicians to articulate and identify the impact of parental aggression directly counters the disadvantages of the more blunt zero-tolerance policy response, which is necessarily imposed from the top down. (shrink)

The article examines reasons and features of the Italian bioethics movement in itself and in relationship to that in the U.S.A. Research, consultation, teaching are the most requested professional activities. Ethics committees are now established in several places and at different level: national (National Italian Committee for Bioethics), regional (Italy has about twenty regions with some political power), and institutional (research centers, university, main hospitals).

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. (...) Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research. (shrink)

The first ethicists of the 1970s paved the way for the three most familiar models of clinical ethics consultation: (1) a single consultant, (2) a member of a hospital ethics committee, and (3) a member of a subcommittee of a hospital ethics committee. Within the single consultant model there are (A) the lone ethicist (a member of hospital staff, working alone when consulting) and (B) the independent ethicist (a freelance, external consultant, working alone). This article discusses (...) the structure and opportunities offered by the freelance, independent ethicist model, and provides guidance for those who employ freelance, independent ethicists, as well as guidance for ethicists who are considering adopting this practice model. (shrink)

The ever-debated question of triage and allocating the life-saving ventilator during the COVID-19 pandemic has been repeatedly raised and challenged within the ethical community after shortages propelled doctors before life and death decisions. The British Medical Association’s ethical guidance highlighted the possibility of an initial surge of patients that would outstrip the health system’s ability to deliver care “to existing standards,” where utilitarian measures have to be applied, and triage decisions need to maximize “overall benefit” In these emergency circumstances, triage (...) that “grades according to their needs and the probable outcomes of intervention” will prioritize or eliminate patients for treatment, and health professionals may be faced with obligations to withhold or withdraw treatments to some patients in favour of others. This piece is a response and extension to articles published on the manner of involvement for ethics and ethicists in pandemic triage decisions, particularly examining the ability and necessity of establishing triage committees to ameliorate scarce allocation decisions for physicians. (shrink)

The American Society for Bioethics and Humanities promulgated standards for clinical ethics consultants and is currently developing a national Quality Attestation in Clinical Ethics Consultation to assist facilities in ensuring that those performing clinical ethics consultations meet minimum standards. As the field moves towards such professionalization, there is a need to provide access to qualified clinical ethicists at a broad range of medical facilities. Currently, however, there are insufficient numbers of trained clinical ethicists to staff (...) all healthcare facilities, and many facilities lack the necessary resources to hire staff clinical ethicists. In this review, we describe several models for providing expert clinical ethics support to remote facilities that lack access to qualified clinical ethicists. Based on this analysis, we recommend telemedicine as the optimal model providing expert support to local ethics committee members tasked with providing clinical ethics consultation services. (shrink)

The pandemic significantly raised the stakes for the translation of bioethics insights into policy. The novelty, range and sheer quantity of the ethical problems that needed to be addressed urgently within public policy were unprecedented and required high‐bandwidth two‐way transfer of insights between academic bioethics and policy. Countries such as the United Kingdom, which do not have a National Ethics Committee, faced particular challenges in how to facilitate this. This paper takes as a case study the brief career of (...) the Ethics Advisory Board (EAB) for the NHS Covid‐19 App, which shows both the difficulty and the political complexity of policy‐relevant bioethics in a pandemic and how this was exacerbated by the transience and informality of the structures through which ethics advice was delivered. It analyses how and why, after EAB's demise, the Westminster government increasingly sought to either take its ethics advice in private or to evade ethical scrutiny of its policies altogether. In reflecting on EAB, and these later ethics advice contexts, the article provides a novel framework for analysing ethics advice within democracies, defining four idealised stances: the pure ethicist, the advocate, the ethics arbiter and the critical friend. (shrink)

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized by the World (...) Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

The purpose of this article is to clarify both the role of nurses in ethics meetings and the way in which ethics meetings can function as a catalyst for good nursing care. The thoughts presented are practice based; they arose from our practical experiences as nurses and ethicists with ethics meetings in health care organizations in Belgium. Our reflections are written from the perspective of the nurse in the field who is participating in (inter)professional ethical dialogue. (...) First, the difficulties that nurses experience while participating in ethics meetings are described. Then the possibilities for support of nurses in their ethical responsibility are explored. (shrink)

Jake Greenblum and Ryan K Hubbard argue that physicians, nurses, clinical ethicists and ethics committee members should not cite religious considerations when helping patients (or their proxies) make medical decisions. They provide two arguments for this position: The Public Reason Argument and the Fiduciary Argument. In this essay, I show that the Public Reason Argument fails. Greenblum and Hubbard may provide good reason to think that physicians should not invoke their own religious commitments as reasons for a particular (...) medical decision. But they fail to show that it is wrong for physicians to cite the patient’s own religious commitments as reasons for a particular decision. As such, if Greenblum and Hubbard’s thesis is to survive, the Fiduciary Argument (or some unmentioned argument) will have to do the bulk of the work. (shrink)

Background In 2001 a report on the provision of clinical ethics support in UK healthcare institutions identified 20 clinical ethics committees. Since then there has been no systematic evaluation or documentation of their work at a national level. Recent national surveys of clinical ethics services in other countries have identified wide variation in practice and scope of activities. Objective To describe the current provision of ethics support in the UK and its development since 2001. Method (...) A postal/electronic questionnaire survey administered to the chairs of all 82 clinical ethics services registered with the UK Clinical Ethics Network in July 2010. Results Response rate was 62% with the majority of responding services situated in acute trusts. All services included a clinical ethics committee with one service also having a clinical ethicist. Lay members were present in 72% of responding committees. Individual case consultation has increased since 2001 with 29% of chairs spending more than 50% of their time on this. Access to and involvement in the process of case consultation is less for patients and families than for clinical staff. There is wide variation in committee processes and levels of institutional support. Over half of the responding committees undertook some form of evaluation. Conclusion Clinical ethics services in the UK are increasing as is their involvement in case consultation. However, the significant variation in committee processes suggests that further qualitative research is needed to understand how these committees function and the role they play in their institution. (shrink)

The development of ethics case consultation over the past 30 years, initially in North America and recently in Western Europe, has primarily taken place in the secondary or tertiary healthcare settings. The predominant model for ethics consultation, in some countries overwhelmingly so, is a hospital-based clinical ethics committee. In the United States, accreditation boards suggest the ethics committee model as a way of meeting the ethics component of the accreditation requirement for payment by Health Maintenance (...) Organizations, and in some European countries, there are legislatory requirements or government recommendations for hospitals to have clinical ethics committees. There is no corresponding pressure for primary care services to have ethics committees or ethics consultants to advise clinicians, patients, and families on the difficult ethical decisions that arise in clinical practice. (shrink)

Whether practiced by ethics committees or clinical ethicists, medical ethics enjoys a solid foundation in acute care hospitals. However, medical ethics fails to have a strong presence in the primary care setting. Recently, some ethicists have argued that the reason for this disparity between ethics in the acute and primary care setting is that primary care ethics is distinct from acute care ethics: the failure to translate ethics to the primary (...) care setting stems from the incorrect belief that acute care ethics can be applied to the primary care setting. In this paper, I argue that primary care ethics and acute care ethics are species of the same ethical genus, and that the ethical differences are not ones of kind but of circumstance. I do this by appealing to the role obligations that underlie acute care and primary care clinicians’ medical ethical obligations and the shared institutions that ground those obligations. (shrink)

This paper argues that the function of moral education in the biomedical context should be exactly the same as in a general, philosophical framework: it should not provide ready-to-use kits of moral principles; rather, it must show the history, epistemology and conceptual structure of moral theories that would enable those who have to make decisions to be as informed and as responsible as possible. If this complexity cannot be attained, an incomplete product—i.e. bioethics or bioethical principles—should not be seen as (...) a viable substitute. This theoretical position is subsequently illustrated by a case study involving research ethics committees. It is argued that within these committees, that are carefully formed multidisciplinary bodies, what makes competent decision-making possible is not a bioethical theory, nor even a sound philosophical ethics, but the dynamics of the discussion of a number of experts coming from different disciplines. This multidisciplinary expertise is necessary and sufficient to undertake the challenges of complex decisions in the biomedical context. (shrink)

Knowledge of the heterosexual spread of HIV is needed to plan future health-care needs. In December 1989 we gained approval and finance for unlinked anonymous testing of neonatal Guthrie card samples in Scotland. Local ethics committee approval was required before testing could start. Twenty ethics committees were approached in the 15 Scottish health board areas. Nineteen of the committees have agreed, representing 99.6 per cent of births in Scotland. Our method of contacting ethics committees (...) is discussed, as are the points raised. (shrink)

Abstract Gender and Ethics Committees: Where’s the Different Voice? -/- Prominent international and national ethics commissions such as the UNESCO Bioethics Commission rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under-representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women’s bodies, and when such committees claim to derive ‘universal’ standards. Are women missing from many ethics (...) class='Hi'>committees because of relatively straightforward, if discriminatory, demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ‘anti-female’? It has been argued, for example, that there is a ‘different voice’ in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ‘masculine paradigm’ in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women’s representation on ethics committees in Eastern and Western Europe, a critical analysis of the supposed ‘masculinism’ of the principlist approach, and a case example in which a ‘different voice’ did indeed make a difference. (shrink)

Hospital ethics committees (HECs) and ethicists generally describe themselves as engaged in four domains of practice: case consultation, research, education, and policy work. Despite the increasing attention to quality indicators, practice standards, and evaluation methods for the other domains, comparatively little is known or published about the policy work of HECs or ethicists. This article attempts to open the ?black box? of this health care ethics practice by providing two detailed case examples of ethics (...) policy reviews. We also describe the development and application of an evaluation strategy to assess the quality of ethics policy review work, and to enable continuous improvement of ethics policy review processes. Given the potential for policy work to impact entire patient populations and organizational systems, it is imperative that HECs and ethicists develop clearer roles, responsibilities, procedural standards, and evaluation methods to ensure the delivery of consistent, relevant, and high-quality ethics policy reviews. (shrink)

Bioethical and bio‐political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the (...) quality of their work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision‐making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific‐technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision‐making procedures – if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible. (shrink)

This collection of thirty-one cases and commentaries addresses ethical problems commonly encountered by the average health care professional, not just those working on such high-tech specialties as organ transplants or genetic engineering. It deals with familiar issues that are rarely considered in ethics casebooks, including such fundamental matters as informed consent, patient decision-making capacity, the role of the family, and end-of-life decisions. It also provides resources for basic but neglected ethical issues involving placement decisions for elderly or technologically dependent (...) patients, rehabilitation care, confidentiality regarding AIDS, professional responsibility, and organizational and institutional ethics. The authors describe in detail the perspectives of each party to the case, the kind of language that ethicists use to discuss the issues, and the outcome of the case. A short bibliography suggests useful articles for further reading or curriculum development. Easily understood by readers with no prior training in ethics, this book offers guidance on everyday problems from across the broad continuum of care. It will be valuable for health-care professionals, hospital ethics committees, and for students preparing for careers in health-care professions. (shrink)

Philosophers, particularly moral philosophers, are increasingly being involved in public decision‐making in areas which are seen to raise ethical issues. For example, Dame Mary Warnock chaired the ‘Committee of Inquiry into Human Fertilization and Embryology’ in the UK in 1982–4; the Philosophy Department at Auckland was commissioned by the Auckland Regional Authority to report on the ethical aspects of fluoridating the public water supply in 1990; and many of us are serving on ethics committees of various sorts. Not (...) only are philosophers actually being called on or consulted, but many of us would argue that a philosophical contribution in such areas is essential.The involvement of moral philosophers in public policy decisions raises a question of professional ethics, viz, what role should a philosopher's own moral perspective or judgements play in the advice s/he gives, or contribution s/he makes, to public decision‐making on ethical issues. Like most problems in professional ethics, this prompts reflection on the nature of the profession, and in particular on the expertise we take moral philosophy to offer. It also prompts reflection on how processes of public decision making in ethically problematic areas should be understood. I explore these issues in this paper. (shrink)

Long used as a tool for medical compliance and adhering to treatment plans, behavior contracts have made their way into the in-patient healthcare setting as a way to manage the “difficult” patient and family. The use of this tool is even being adopted by healthcare ethics consultants (HECs) in US hospitals as part of their work in navigating conflict at the bedside. Anecdotal evidence of their increasing popularity among clinical ethicists, for example, can be found at professional bioethics (...) meetings and conversations and idea-sharing among practitioners on HEC social media. While there are a handful of papers gesturing toward a bioethical critique of behavior contracts of various types, the use of behavior contracts in the context of interpersonal conflict has not been vetted by bioethicists to determine their ethical legitimacy or efficacy. In this paper, we highlight a set of ethical concerns that we believe must be addressed before continuing or widespread implementation of behavior contracts to manage the “difficult” patient or family. (shrink)

Clinical ethicists encounter the most emotionally eviscerating medical cases possible. They struggle to facilitate resolutions founded on good reasoning embedded in compassionate care. This book fills the considerable gap between current texts and the continuing educational needs of those actually facing complex ethics consultations in hospital settings. 28 richly detailed cases explore the ethical reasoning, professional issues, and the emotional aspects of these impossibly difficult consultations. The cases are grouped together by theme to aid teaching, discussion and professional (...) growth. The cases inform any reader who has a keen interest in the choices made in real-life medical dilemmas as well as the emotional cost to those who work to improve the situations. On a more advanced level, this book should be read by ethics committee members who participate in ethics consultations, individual ethics consultants, clinicians who seek education about complex clinical ethics cases, and bioethics students. (shrink)

The purpose of this article is to highlight ways in which institutional policymakers tend to insufficiently conceptualise their role as ethics practitioners. We use the case of blood product recall notification as a means of raising questions about the way in which, as we have observed it, discourse for those who make institutional ethics policies is constrained by routine balancing of simplified principles to the exclusion of reflexive practices—those that turn ethics reasoning back on itself. The latter (...) allows ethics practitioners with comparatively little formal training to take ownership of traditional parameters, which define their discussions and ultimately ought to make them more insightful when doing ethics. Thus, in the midst of calls for more training to increase the competency of ethics committees, we suggest that an additional problem of how these lay ethicists conceive of their roles also needs to be addressed. (shrink)

New brain-computer interface and neuroimaging techniques are making differentiation less ambiguous and more accurate between unresponsive wakefulness syndrome patients and patients with higher cognitive function and awareness. As research into these areas continues to progress, new ethical issues will face physicians of patients suffering from total locked-in syndrome, characterized by complete loss of voluntary muscle control, with retention of cognitive function and awareness detectable only with neuroimaging and brain-computer interfaces. Physicians, researchers, ethicists and hospital ethics committees should (...) be aware of and prepared to handle ethical issues unique to these totally locked-in patients. Several thought experiments are discussed, to highlight potential ethical dilemmas surrounding surrogate decision-making, autonomy, end-of-life care, and pediatric care, which will be unique to total LIS patients. These, along with other ethical problems especially relevant to total LIS patients, merit further discussion among physicians, researchers, ethicists and hospital ethics committees, to facilitate consensus regarding these issues, and improve patient care. (shrink)

Clinical ethics support services are developing in Europe. They will be most useful if they are designed to match the ethical concerns of clinicians. We conducted a cross-sectional mailed survey on random samples of general physicians in Norway, Switzerland, Italy, and the UK, to assess their access to different types of ethics support services, and to describe what makes them more likely to have used available ethics support. Respondents reported access to formal ethics support services such (...) as clinical ethics committees (23%), consultation in individual cases (17.6%), and individual ethicists (8.8%), but also to other kinds of less formal ethics support (23.6%). Access to formal ethics support services was associated with work in urban hospitals. Informal ethics resources were more evenly distributed. Although most respondents (81%) reported that they would find help useful in facing ethical difficulties, they reported having used the available services infrequently (14%). Physicians with greater confidence in their knowledge of ethics (P = 0.001), or who had had ethics courses in medical school (P = 0.006), were more likely to have used available services. Access to help in facing ethical difficulties among general physicians in the surveyed countries is provided by a mix of official ethics support services and other resources. Developing ethics support services may benefit from integration of informal services. Development of ethics education in medical school curricula could lead to improved physicians sensititity to ethical difficulties and greater use of ethics support services. Such support services may also need to be more proactive in making their help available. (shrink)

BackgroundClinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.FindingsIn Zimbabwe the parental informed consent document for children participating (...) in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.ConclusionThe challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. (shrink)

The study of low penetrance gene variants in a complex genetic disorder such as stroke does not pose the same risks and benefits as a study of highly penetrant mutations.1 Because of the nature of their disease, however, stroke patients may not understand the information given when they are asked for consent to participate in research and are potentially vulnerable subjects. In a systematic review of publications on ischaemic stroke genetics, we assessed the way in which informed consent and (...) class='Hi'>ethics committee approval are reported.MethodsWe searched the MEDLINE database for stroke genetics studies published in English between January 2000 and January 2002, using the medical subject heading term “cerebrovascular disorders, genetics of” plus the text words “ischaemic” and “stroke.”2 We included only original clinical trials and observational studies of human genetic risk factors for ischaemic stroke.Both authors independently reviewed every article. We used standardised forms to record whether an explicit statement described informed consent and institutional review board procedures. We also recorded whether …. (shrink)

A 1999–2000 national study of U.S. hospitals raised concerns about ethics consultation (EC) practices and catalyzed improvement efforts. To assess how practices have changed since 2000, we administered a 105-item survey to “best informants” in a stratified random sample of 600 U.S. general hospitals. This primary article details the methods for the entire study, then focuses on the 16 items from the prior study. Compared with 2000, the estimated number of case consultations performed annually rose by 94% to 68,000. (...) The median number of consults per hospital was unchanged at 3, but more than doubled for hospitals with 400+ beds. The level of education of EC practitioners was unchanged, while the percentage of hospitals formally evaluating their ECS decreased from 28.0% to 19.1%. The gap between large, teaching hospitals and small, nonteaching hospitals widened since the prior study. We suggest targeting future improvement efforts to hospitals where needs are not being met by current approaches to EC. (shrink)

Erhics committees and ethics consultants are becoming more involved in helping individuals make decisions and in advising institutions and legislatures about drafting policy. The role of these committees and consultants has been acknowledged in law, and their function is generally considered salutory and helpful. Ethics consultants and committees, furthermore, play a critical role in educating students and members of the hospital community and the public at large. More over, many ethicists engage in scholarky activities (...) to expand the boundaries of our understanding and, in turn, facilitate our capacity for helping. The role of the ethicist and of the ethics committee is thus manifold. Ethics committees and ethics consultants somehow “in competition” is a mistaken notion: when ethics committees, ethics consultants, and the community work smoothly together, much good can be accomplished. (shrink)