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)

Pedagogy, power and practice ethics: clinical teaching in psychiatric/mental health settings Often, baccalaureate nursing students initially approach a psychiatric mental health practicum with uncertainty, and even fear. They may feel unprepared for the myriad complex practice situations encountered. In addition, memories of personal painful life events may be vicariously evoked through learning about and listening to the experiences of those diagnosed with mental disorders. When faced with such challenging situations, nursing students often seek counsel from the clinical and/or (...) classroom faculty. Pedagogic boundaries may begin to blur in the face of student distress. For the nurse educator, several questions arise: Should a nurse educator provide counseling to students? How does one best negotiate the boundaries between ‘counselor’, and ‘caring educator’? What are the limits of a caring and professional pedagogic relation? What different knowledges provide guidance and to what differential consequences for ethical pedagogic relationships? This paper offers a comparative analysis of three philosophical stances to examine differences in key assumptions, pedagogic positioning, relationships of power/knowledge, and consequences for professional ethical pedagogic practices. While definitive answers are difficult, the authors pose several questions for consideration in discerning how best to proceed and under what particular conditions. (shrink)

Evaluating clinical ethics support services has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. In this paper, we argue that a first necessary step for progress is to better understand the intervention in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, (...) we introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS. To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS. (shrink)

The American Society for Bioethics and Humanities has created a quality attestation process for clinical ethics consultants; the pilot phase of reviewing portfolios has begun. One aspect of the QA process which is particularly challenging is assessing the interpersonal skills of individual clinical ethics consultants. We propose that using case simulation to evaluate clinical ethics consultants is an approach that can meet this need provided clear standards for assessment are identified. To this end, we developed the Assessing (...) Clinical Ethics Skills tool, which identifies and specifies specific behaviors that a clinical ethics consultant should demonstrate in an ethics case simulation. The aim is for the clinical ethics consultant or student to use a videotaped case simulation, along with the ACES tool scored by a trained rater, to demonstrate their competence as part of their QA portfolio. The development and piloting of the tool is described. (shrink)

Default positions, predetermined starting points that aid in complex decision-making, are common in clinical medicine. In this article, we identify and critically examine common default positions in clinical ethics practice. Whether default positions ought to be held is an important normative question, but here we are primarily interested in the descriptive, rather than normative, properties of default positions. We argue that default positions in clinical ethics function to protect and promote important values in medicine—respect for persons, utility, (...) and justice. Further, default positions in clinical ethics may also guard against harm. Where default positions exist, there are epistemic burdens to overturn them. The person wishing to reject the default position, rather than the person endorsing it, bears this burden. The person who bears the burden of meeting the epistemic requirements must provide evidence proportional to the degree of harm the default position protects against. Default positions that protect against significant harm impose significant epistemic requirements to overturn. This asymmetry not only makes medical decision-making more economical but also serves to promote and protect certain values. The identification and analysis of common and recognizable default positions can help to identify other default positions and the conditions under which their associated epistemic requirements are met. The article concludes with considerations of potential problems with the use of default positions in clinical ethics. (shrink)

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (shrink)

Over the past several decades, medical ethics has gained a solid foothold in medical education and is now a required course in most medical schools. Although the field of medical ethics is by nature eclectic, moral philosophy has played a dominant role in defining both the content of what is taught and the methodology for reasoning about ethical dilemmas. Most educators largely rely on the case‐based method for teaching ethics, grounding the ethical reasoning in an amalgam of theories drawn from (...) moral philosophy, including consequentialism, deontology, and principlism.In this article we hope to make a case for augmenting the focus of education in medical ethics. We propose complementing the traditional approach to medical ethics with a more embedded approach, one that has been described by others as “microethics,” the ethics of everyday clinical practice. (shrink)

Background: The field of clinical ethics is examining ways of determining competency. The Assessing Clinical Ethics Skills (ACES) tool offers a new approach that identifies a range of skills necessary in the conduct of clinical ethics consultation and provides a consistent framework for evaluating these skills. Through a training website, users learn to apply the ACES tool to clinical ethics consultants (CECs) in simulated ethics consultation videos. The aim is to recognize competent and incompetent clinical (...) ethics consultation skills by watching and evaluating a videotaped CEC performance. We report how we set a criterion cut score (i.e., minimally acceptable score) for judging the ability of users of the ACES tool to evaluate simulated CEC performances.Methods: A modified Angoff standard-setting procedure was used to establish the cut score for an end-of-life case included on the ACES training website. The standard-setting committee viewed the Futility Case and estimated the probability that a minimally competent CEC would correctly answer each item on the ACES tool. The committee further adjusted these estimates by reviewing data from 31 pilot users of the Futility Case before determining the cut score.Results: Averaging over all 31 items, the proposed proportion correct score for minimal competency was 80%, corresponding to a cut score that is between 24 and 25 points out of 31 possible points. The standard-setting committee subsequently set the minimal competency cut score to 24 points.Conclusions: The cut score for the ACES tool identifies the number of correct responses a user of the ACES tool training website must attain to “pass” and reach minimal competency in recognizing competent and incompetent skills of the CECs in the simulated ethics consultation videos. The application of the cut score to live training of CECs and other areas of practice requires further investigation. (shrink)

Our aim in this article is to define the difficulties that clinical ethics services encounter when they are asked to demonstrate the value a clinical ethics service (CES) could and should have for an institution and those it serves. The topic emerged out of numerous related presentations at the Un- Conference hosted by the Cleveland Clinic in August 2018 that identified challenges of articulating the value of clinical ethics work for hospital administrators. After a review these talks, (...) it was apparent that the field of clinical ethics may be at a crisis of sorts due to increased pressure to provide explicit measures to healthcare institutions to concretely demonstrate that CESs make a valuable difference in healthcare delivery. In this article, we grapple with how to satisfy the need for demonstrable value in a field in which metrics alone may not capture the scope of clinical ethics practice. We suggest that capturing the value of a CES has been difficult because the benefits of ethics consultation may be overt or attributable to the CES, but are often hidden due to the systems-level and process-oriented nature of clinical ethics work. Part of the difficulty in demonstrating the value of CESs is capturing and conveying all of the ways the integration of a CES throughout an institution positively affects patients, families, visitors, healthcare professionals, administrators, and the institution itself. Our aim is to (1) elucidate the multifaceted value added by a CES, including value that tends to be hidden and (2) suggest how to demonstrate value to others in a way that is not simplistic or reductionistic. (shrink)

BackgroundExisting clinical ethics support (CES) instruments are considered useful. However, users report obstacles in using them in daily practice. Including end users and other stakeholders in developing CES instruments might help to overcome these limitations. This study describes the development process of a new ethics support instrument called CURA, a low-threshold four-step instrument focused on nurses and nurse assistants working in palliative care. MethodWe used a participatory development design. We worked together with stakeholders in a Community of Practice throughout (...) the study. Potential end users (nurses and nurse assistants in palliative care) used CURA in several pilots and provided us with feedback which we used to improve CURA.ResultsWe distinguished three phases in the development process. Phase one, Identifying Needs, focused on identifying stakeholder and end user needs and preferences, learning from existing CES instruments, their development and evaluation, and identify gaps. Phase two, Development, focused on designing, developing, refining and tailoring the instrument on the basis of iterative co-creation. Phase three, Dissemination, focused on implementation and dissemination. The instrument, CURA, is a four-step low-threshold instrument that fosters ethical reflection.ConclusionsParticipatory development is a valuable approach for developing clinical ethics support instruments. Collaborating with end users and other stakeholders in our development study has helped to meet the needs and preferences of end users, to come up with strategies to refine the instrument in order to enhance its feasibility, and to overcome reported limitations of existing clinical ethics instruments. (shrink)

Given the enduring debate over what constitutes quality, and therefore appropriate training, in clinical ethics consultation, it is unsurprising that there is variation in the structure and content of clinical ethics fellowship programs. However, this variation raises questions about the value of fellowship training when the ethicists that emerge from these programs might be quite different. The specifics of fellowship programs are largely internal. As such, the extent of variation and whether such variation is problematic remains unclear. In (...) this article, we summarize lessons learned from discussions between fellows, their mentors and program directors at the 2020 Clinical Ethics UnConference, and outline some possible ways to advance the conversation about variation in fellowship programs and training. We argue for the more open sharing of training specifics in order to help break down the siloed nature of fellowship programs. Greater transparency could, firstly, allow for more robust reflection on and refinement of training practices and, secondly, allow us to better balance professionally appropriate consistency with unavoidable or desirable variation based on local norms, culture and leadership. (shrink)

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

ObjectivesTo explore the objectives and outcomes most appropriate for evaluating clinical ethics support services (CESs) in the USA.MethodsA three-round e-Delphi was sent to two professional medical ethics listservs (Medical College of Wisconsin-Bioethics and American Society for Bioethics and Humanities) as well as 19 individual experts. The survey originally contained 15 objectives and 9 outcomes. In round 1, participants were asked to validate the content of these lists. In round 2, we had 17 objectives and 10 outcomes, and participants were (...) asked to rank them for appropriateness in a top 10 list of objectives and a top 5 list of outcomes.ResultsParticipants came to a high(at least 70%) level of agreement on seven objectives: mediate, educate, develop policy, improve the moral quality of a decision or action, counsel, create a moral space and manage moral distress. Participants came to a moderate (at least 51%) level of agreement on three objectives: empower, awareness of ethics and preventative ethics. Participants also came to a moderate (at least 51%) level of agreement on five outcomes: ethical justification, transformation of institution, improvement of quality of life, principled consensus and satisfaction with the expertise of a CES.ConclusionThis e-Delphi identified 10 objectives and 5 outcomes that are a good starting point for developing outcome measures to evaluate CESs in the USA, while reminding us of the diversity of perspectives still evident in the field. (shrink)

Ethics consultation in institutions of the healthcare system has been given a standard form based on three pillars: education, the development of guidelines and concrete ethics consultation in case conferences. The spread of ethics committees, which perform these tasks on an organizational level, is a remarkable historic achievement. At the same time it cannot be denied that modern ethics consultation neglects relevant aspects of care ethics approaches. In our essay we present an “ethics of care” approach as well as an (...) empirical pilot project—“Ethics from the bottom up”—which organizes ethics consultation based on this focus. Findings and philosophy of the project will be discussed as far as relevant for ethics consultation in the healthcare system. (shrink)

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

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking (...) about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: the specification of exceptional circumstances, the specification of unproven interventions, the goals of interventional research in terms of individual versus collective interests, the place of adaptive trial designs and the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. (shrink)

Being a patient and living a life -- Clinical space and traits of healing -- False starts and frequent failures -- Three journeys : A.'Ibuprofen and love', B. 'Staying tuned up', C. 'We all want the same things' -- Being a patient : the moral field -- Rethinking healthcare ethics : the patient's moral authority.

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

The pace of change and, indeed, the sheer number of clinical ethics committees has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital (...) for Children NHS Foundation Trust v MX, FX and X, [21]–[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK. (shrink)

It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments A and B is to be cognitively indifferent between the statement ‘A is strictly more effective than B’ and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomised assignment to treatments A and B to be beneficent and non‐maleficent and is sufficient for (...) such an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise‐like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent. (shrink)

From their own practices, the authors offer insight into potential ethical dilemmas that may frequently develop in an applied psychology setting in which sport psychology is also being practiced. Specific ethical situations offered for the reader's consideration include confidentiality with coaches, administration, parents, and athlete-clients; accountability in ethical billing practices and accurate diagnosing; identification of ethical boundaries in nontraditional practice settings (locker room, field, rink, etc.); and establishment of professional competence as it relates to professional practice and marketing.

Scholars and professional organizations in bioethics describe various approaches to “quality assessment” in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes “quality” in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in (...) that they represent evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, in this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction. (shrink)

The Arab and Islamic world is in cultural, political and ethical flux. Pressures of globalisation contend with ancient ideas and concepts that permeate cultural frameworks. Health professionals are among the many groups battling to accommodate the rapidly changing conditions. In many predominantly Muslim countries intense debates are underway among clinicians about the impact of the forces of change on their practices. To help understand these forces we conducted a study of the experiences of clinicians in the Hashemite Kingdom of Jordan, (...) a Middle Eastern nation state where the overwhelming majority of the population is Muslim. The sample contained 508 doctors and doctors-in-training, of whom 63% were male and 80% were younger than 40 years of age. It included both a quantitative survey, covering a wide range of issues, and qualitative, free-text written responses. Our results demonstrated high levels of disquiet related to the overall organisation and administration of the health care system, the specific content of ethical decisionmaking, and the impact of changing social, cultural and religious factors. Concerns included overcrowding, widespread corruption and hierarchical, non- democratic, management practices, and tensions relating to traditional and modern approaches to ethics, especially in relation to consent, organ donation, confidentiality, privacy, abortion, and the role of women. The roles of religion and religious authorities, the relative importance of the family, and community and tribal obligations were also areas of contention. The study exposes profound divisions and widely differing perspectives among Jordanian doctors and an abiding sense of uncertainty and instability within the profession. Many doctors express ambivalence in relation to both modern trends and traditional precepts. Three main axes of ethical contention were demonstrated, relating to the tensions between: "conservative" and "pragmatic" styles of decision-making; "traditional" approaches and internationalised standards of ethics; and the role of Islam and pressures to disengage ethical decision- making from religious authority. We speculate that these issues and divisions, and the deep sense of disquiet revealed by our data reflect large-scale forces to which Jordanian society is exposed and to a substantial degree may provide a way to understand the ethical predicament of many other countries in the contemporary Arab world. (shrink)

Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant (...) step on the pathway to an eventual certification process for clinical ethics consultants. (shrink)

The increasing age of the patient population around the globe and in the United States has resulted in a growing number of patients with dementia. In this manuscript, we examined the role of the ethics consultation service in patients who have dementia and associated cognitive and neuropsychiatric sequelae. We addressed a particularly challenging case presenting with behavioral and psychological symptoms of dementia. We discussed the ethical questions and challenges considered by the ethics consultation service and compared these with current suggestions (...) and expectations from the research literature regarding the role of ethics consultation service in dementia management. We demonstrated two potentially useful approaches of clinical ethical analysis, the principalist theorem and Jonsen's four quadrants approach. While the number of consults in patients with behavioral and psychological symptoms of dementia is likely to increase in clinical ethics, the role of the ethics consultation service in this cohort of patients still remains to be determined. There are significant gaps in understanding of the ethics consultation service role in dementia management, and much work remains to be undertaken on the part of regulatory and healthcare systems in clarifying their roles, expectations, and competencies. (shrink)

Continuous sedation until death is an increasingly common practice in end-of-life care. However, it raises numerous medical, ethical, emotional and legal concerns, such as the reducing or removing of consciousness, the withholding of artificial nutrition and hydration, the proportionality of the sedation to the symptoms, its adequacy in actually relieving symptoms rather than simply giving onlookers the impression that the patient is undergoing a painless 'natural' death, and the perception that it may be functionally equivalent to euthanasia. This book brings (...) together contributions from clinicians, ethicists, lawyers and social scientists, and discusses guidelines as well as clinical, emotional and legal aspects of the practice. The chapters shine a critical spotlight on areas of concern and on the validity of the justifications given for the practice, including in particular the doctrine of double effect. (shrink)

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the (...) policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so. (shrink)

This paper argues that the missing voice in clinical ethics is that of informal caregivers. Despite their substantial contribution to care provided to individuals with disabilities, chronic illness or dementia, informal caregivers are rarely thought of as members of the healthcare team and their narratives are rarely listened to and included in clinical and ethical decisions. Addressing this gap, this paper discusses the reasons for the systemic misrecognition of informal caregivers in healthcare systems and argues for their greater (...) narrative inclusion on the clinical, legal and social planes. (shrink)

With the growth and evolution of the field of clinical ethics, the one constant has been its variation. Resolving ethical issues at the bedside is done differently across the country based on one’s...

The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted in Ghana and (...) South Africa with respondents at different stages of involvement in clinical research, ranging from no experience in clinical research to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinical research contributed to the improvement of local health. They went beyond the researcher/participant versus doctor/patient dichotomy, long established in research ethics, and preferred to view participants and investigators as partners working together to find ways to address local health needs. The conceptualization of investigator-participant relations as a partnership reinforced expectations of care, transparency and accountability, which were viewed as necessary expressions of mutuality and respect within equal collaborations. It is important to engage with these views in order to avoid antagonizing societal expectations and to build up long-term public trust, crucial for the continuous operation of clinical research. (shrink)

The UK Genethics Club was established in November 2001 in order to provide a national forum of ethics support for the profession of clinical genetics in the UK. The forum brings together health professionals, medical ethicists and lawyers and support is provided through detailed discussion of cases and sharing of good practice. Clinical genetics professionals had previously voiced concerns about making extremely difficult ethical decisions, with profound implications, in something of a vacuum. Professionals saw a lack of guidance (...) in the area and lack of time for discussion of difficult cases as reasons for this. This paper describes the origins of the group and gives (anonymized) examples of some of the types of issues discussed. (shrink)

The restructuring of the healthcare marketplace has exerted pressure directly and indirectly on clinical ethics programs. The fiscal orientation and emphasis on efficiency, outcome measures, and cost control have made it increasingly difficult to communicate arguments in support of the existence or growth of ethics programs. In the current marketplace, arguments that rely on the claim that ethics programs protect patient rights or assist in the professional formation of practitioners often result in minimal levels of funding and preclude program (...) growth. Where ethics programs could once sustain themselves on goodwill alone and values arguments in an expanding healthcare market they are now encountering—at least by anecdotal reports—cutbacks and even elimination. To respond to these challenges, we offer an economic model that can be used to demonstrate the “value” of an institutionally based ethics program. (shrink)

Despite increased attention to the question of how best to evaluate clinical ethics consultations and emphasis on external evaluation, there has been little sustained focus on how we, as clinicians, make sense of and learn from our own experiences in the midst of any one consultation. Questions of how we evaluate the request for, unfolding of, and conclusion of any specific ethics consultation are often overlooked, along with the underlying question of whether it is possible to give an accurate (...) account of clinical ethics consultants’ experience as experienced by ethics consultants. Before the challenge of submitting one’s accounts or case reports for review and evaluation from others, there is an underlying challenge of understanding and evaluating our own accounts. To highlight this crucial and deeply challenging dimension of actual clinical ethics practice, we present an account of a complex consultation, explicitly constructed to engage the reader in the unfolding experience of the consultant by emphasizing the multiple perspectives unfolding within the consultant’s experience. Written in script format, the three perspectives presented—prototypical clinically descriptive account; didactically reflective and self-evidentiary account often seen in journal presentations; highly self-critical reflective account emphasizing uncertainties inherent to clinical ethics practice—reflect different manners for responding to the ways actual clinical involvement in ethics consultation practice accentuates and refocuses the question of how to understand and evaluate our own work, as well as that of our colleagues. (shrink)

In the rapidly evolving healthcare environment, perhaps no role is in greater flux and redefinition than that of the clinical bioethicist. The discussion of ethics consultation in the bioethics literature has moved from an ambiguous concern regarding its proper place in the clinical milieu to the more provocative question of which methods and theories should best characterize the intellectual and practical work it claims to do. The American Society for Bioethics and Humanities addressed these concerns in its 1998 (...) report, CoreCompetenciesforHealthCareEthicsConsultation. The report tries to answer the question as to what disciplinary training, background experience, and levels of knowledge in ethics the clinical ethics consultant should have, and what specific skills and character traits the clinical ethics consultant should cultivate. In addition to acquiring knowledge of common bioethical issues, theoretical concepts in ethical theory and moral reasoning, and health-related law and policy, the report also recommends that ethics consultants demonstrate knowledge of the health beliefs and perspectives of patients and healthcare providers. In our opinion, this recommendation underscores a crucial aspect of the practice of ethics consultation in the increasingly multicultural settings of healthcare institutions. Clearly, the dynamic of American life and culture is permeated with diversity and variety as new groups suffuse their own beliefs and faith perspectives into the health sector. New immigrant groups force society to question traditional healthcare practices and to accommodate changing medical needs. (shrink)

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...) synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies. (shrink)

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

Ethics and the Clinical Encounter explores the moral dimensions of clinical medicine and the phenomenon of illness, to determine what ethics must be in order to be fully responsive to clinical encounters. Written in a lively and conversational style with minimal technical terminology, and enhanced by actual experience or real clinical situations, this volume lays out a clinical ethics methodology both in practical and theoretical terms. Here's what the experts had to say: Professor Zaner has (...) provided us with a remarkably lucid and trenchant discussion of the interface of philosophy and the field of medicine. He brings into play an extraordinary range of historial knowledge, extensive observations based on firsthand experience with medical practices, and an acute sense of philosophical argumentation. This is a work that will be an exemplary and indispensable text in the philosophy of medicine for years to come. -- Calvin Schrag... it is a highly original contribution usable in a number of fields.... It really has no competition.... The genius of Zaner's approach is to ground ethics from the 'bottom up' and to direct us to the concrete particulars of therapeutic encounters wherein lie moral and ethical matters... meaty, challenging, and ultimately rewarding.... -- Paul R. Dokecki Richard M. Zaner founded the Center for Clinical and Research Ethics at Vanderbilt University Medical Center. Having established Vanderbilt's first Hospital Ethics Committee (1985), he served as co-chair of VUMC's Ethics Committee since its inception in 1990. Zaner has published five original books, edited ten, and translated four more, and has published more than 100 sections of books and professional journals. (shrink)

The year 2013 may someday be seen as the year a new profession was born. Clinical ethics consultation has been practiced in different ways for roughly 30 years, originally initiated by a group of h...

This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up (...) to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. (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 competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two to three fourth-year (bachelor) nursing students conducted 8 to 11 semi-structured interviews each with nurses in ethics committees. The question was what competencies these nurses themselves say they need to participate in such committees. This article reports the (...) aggregate of the 52 interviews in these five studies. Regarding knowledge, the article reports on health law, ethics and professional knowledge. Regarding skills, communication is mentioned, as are professional skills and skills for ‘doing ethics’. An open and respectful attitude towards patients and fellow committee members is required, as well as commitment to patient care, committee work and professional ethics. The right attitude for a nurse in an ethics committee is said to include a reflective and perceptive attitude, along with an awareness of one’s own limitations and convictions. A detailed competency profile for nurses’ participation in ethics committees as outlined in the recommendations may serve nursing education, institutional committees and nurses themselves to meet the demands of nurses’ preparation for clinical ethics consultations. (shrink)

The last two decades have witnessed a crescendo of allegations that clinical translation is rife with waste and inefficiency. Patient advocates argue that excessively demanding regulations delay access to life‐saving drugs, research funders claim that too much basic science languishes in academic laboratories, journal editors allege that biased reporting squanders public investment in biomedical research, and drug companies (and their critics) argue that far too much is expended in pharmaceutical development.But how should stakeholders evaluate the efficiency of translation and (...) proposed reforms to drug development? Effective reforms require an accurate model of the systems they aspire to improve—their components, their proper functions, and their pathologies. However, there is currently no explicit and well‐developed model of translation for evaluating such criticisms.In what follows, we offer an explicit model of clinical translation. Many discussions of clinical translation and its pathologies presume that its main output is tangible: new drugs, vaccines, devices, and diagnostics. We disagree. We argue that the principal output of clinical translation is information—in particular, information about the coordinated set of materials, practices, and constraints needed to safely unlock the therapeutic or preventive activities of drugs, biologics, and diagnostics. To develop this information calls for a process far different from a simple linear progression of clinical trials; it requires exploratory sampling of many different elements in this set. Our model points to some limitations and liabilities of influential proposals for reforming research. It also reveals some underrecognized opportunities for improving the efficiency of clinical translation. (shrink)

BackgroundAmidst expanding roles in education and policy making, questions have been raised about the ability of Clinical Ethics Committees (CEC) s to carry out effective ethics consultations (CECons). However recent reviews of CECs suggest that there is no uniformity to CECons and no effective means of assessing the quality of CECons. To address this gap a systematic scoping review of prevailing tools used to assess CECons was performed to foreground and guide the design of a tool to evaluate the (...) quality of CECons.MethodsGuided by Levac et al’s (2010) methodological framework for conducting scoping reviews, the research team performed independent literature reviews of accounts of assessments of CECons published in six databases. The included articles were independently analyzed using content and thematic analysis to enhance the validity of the findings.ResultsNine thousand sixty-six abstracts were identified, 617 full-text articles were reviewed, 104 articles were analyzed and four themes were identified – the purpose of the CECons evaluation, the various domains assessed, the methods of assessment used and the long-term impact of these evaluations.ConclusionThis review found prevailing assessments of CECons to be piecemeal due to variable goals, contextual factors and practical limitations. The diversity in domains assessed and tools used foregrounds the lack of minimum standards upheld to ensure baseline efficacy.To advance a contextually appropriate, culturally sensitive, program specific assessment tool to assess CECons, clear structural and competency guidelines must be established in the curation of CECons programs, to evaluate their true efficacy and maintain clinical, legal and ethical standards. (shrink)

This book is the result of a long-standing clinical and educational cooperation between a medical psychologist (Bergsma) and a medical ethicist/philosopher (Thomasma). It is thoroughly interdisciplinary in its examination of the difficulties of honoring the patient's and the physician's autonomy, especially in light of the changes in health care worldwide today. Although autonomy has become the primary standard of bioethics, little has been done to link it to the ways people actually behave, nor to its roots in the healing (...) relationship. Combining as it does the disciplines of psychology and philosophy, this book is a step in that direction. (shrink)

Background: The Clinical Ethics Residency for Nurses was offered selectively to nurses affiliated with two academic medical centers to increase confidence in ethical decision-making. Research Question/Aim: To discover how effective the participants perceived the program and if their goals of participation had been met. Research design: A total of 65 end-of-course essays (from three cohorts) were analyzed using modified directed content analysis. In-depth and recursive readings of the essays by faculty were guided by six questions that had been posed (...) to graduates. Ethical considerations: Institutional review board approval was granted for the duration of the program and its reporting period. Confidentiality was maintained via the use of codes for all evaluations including the essays and potentially identifying content redacted. Findings: An umbrella theme emerged: participants had developed ethical knowledge and skills that provided a “moral compass to navigate the many gray areas of decision-making that confront them in daily practice.” Six major themes corresponding to questions posed to the participants included the ability to advocate for good patient care; to support and empower colleagues, patients, and families; they experienced personal and professional transformation; they valued the multimodal nature of the program; and were using their new knowledge and skills in practice. However, they also recognized that their development as moral agents was an ongoing process. Discussion: Findings support that enhancing nurse confidence in their moral agency with a multimodal educational approach that includes mentored practice in ethical decision-making, enhancing communication skills and role-play can mitigate moral distress. A majority found the program personally and professionally transformative. However, they recognized that ongoing ethics discussion involvement and supportive environments would be important in their continued development of ethical agency. Conclusion: Multimodal ethics education programs have potential to be transformative and enhance nurse confidence in their ethical decision-making. (shrink)

BackgroundClinical ethics support aims to support health care professionals in dealing with ethical issues in clinical practice. Although the prevalence of CES is increasing, it does meet challenges and pressing questions regarding implementation and organization. In this paper we present a specific way of organizing CES, which we have called integrative CES, and argue that this approach meets some of the challenges regarding implementation and organization.MethodsThis integrative approach was developed in an iterative process, combining actual experiences in a case (...) study in which we offered CES to a team that provides transgender health care and reflecting on the theoretical underpinnings of our work stemming from pragmatism, hermeneutics and organizational and educational sciences.ResultsIn this paper we describe five key characteristics of an integrative approach to CES; 1. Positioning CES more within care practices, 2. Involving new perspectives, 3. Creating co-ownership of CES, 4. Paying attention to follow up, and 5. Developing innovative CES activities through an emerging design.ConclusionsIn the discussion we compare this approach to the integrated approach to CES developed in the US and the hub and spokes strategy developed in Canada. Furthermore, we reflect on how an integrative approach to CES can help to handle some of the challenges of current CES. (shrink)