When a physician and a clinical ethicist collaborate for better patient care

Bioethics is a relatively new addition to bedside medical care in Arab world which is characterized by a special culture that often makes blind adaptation of western ethics codes and principles; a challenge that has to be faced. To date, the American University of Beirut Medical Center is the only hospital that offers bedside ethics consultations in the Arab Region aiming towards better patient‐centered care. This article tackles the role of the bedside clinical ethics consultant as an active member of the medical team and the impact of such consultations on decision‐making and patient‐centered care. Using the case of a child with multiple medical problems and a futile medical condition, we describe how the collaboration of the medical team and the clinical ethics consultant took a comprehensive approach to accompany and lead the parents and the medical team in their decision‐making process and how the consultations allowed several salient issues to be addressed. This approach proved to be effective in the Arab cultural setting and indeed did lead to better patientcentered care.     

APPLYING THE FOUR‐PRINCIPLE APPROACH

The four‐principle approach to biomedical ethics is used worldwide by practitioners and researchers alike but it is rather unclear what exactly people do when they apply this approach. Ranking, specification, and balancing vary greatly among different people regarding a particular case. Thus, a sound and coherent applicability of principlism seems somewhat mysterious. What are principlists doing? The article examines the methodological strengths and weaknesses of the applicability of this approach. The most important result is that a sound and comprehensible application of the four principles is additionally ensured by making use of the organizing meta‐principle of common morality, which is the starting point and constraining framework of moral reasoning.     

Between Relativism and Imperialism: Navigating Moral Diversity in Cross‐Cultural Bioethics

The need for explicit theoretical reflection on cross‐cultural bioethics continues to grow as the spread of communication technologies and increased human migration has made interactions between medical professionals and patients from different cultural backgrounds much more common. I claim that this need presents us with the following dilemma. On the one hand, we do not want to operate according to an imperialist ethical framework that denies and silences the legitimacy of cultural values other than our own. On the other hand, we do not want to backslide into a form of cultural relativism that is unable to critically appraise cultural practices that are harmful, unjust, or oppressive. I examine two prominent attempts – the principlism of Tom Beauchamp and James Childress and the Contractarianism of Robert Baker – to frame cross‐cultural bioethics between these two extremes and argue that both approaches have significant flaws. The principlist approach fails to provide a non‐question begging way to identify cross‐cultural norms that does not already assume the universal legitimacy of moral principles dominant in North American society. Baker's contractarianism cannot grapple with the realities of political power imbalances that often characterize cross‐cultural moral disputes. I suggest that a naturalized feminist framework, though not free of its own theoretical difficulties, provides the best alternative for approaching moral diversity respectfully and critically.     

Research versus practice: The dilemmas of research ethics in the era of learning health‐care systems

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels.     

Implementing shared decision making in routine mental health care

Shared decision making (SDM) in mental health care involves clinicians and patients working together to make decisions. The key elements of SDM have been identified, decision support tools have been developed, and SDM has been recommended in mental health at policy level. Yet implementation remains limited. Two justifications are typically advanced in support of SDM. The clinical justification is that SDM leads to improved outcome, yet the available empirical evidence base is inconclusive. The ethical justification is that SDM is a right, but clinicians need to balance the biomedical ethical principles of autonomy and justice with beneficence and non‐maleficence. It is argued that SDM is “polyvalent”, a sociological concept which describes an idea commanding superficial but not deep agreement between disparate stakeholders. Implementing SDM in routine mental health services is as much a cultural as a technical problem. Three challenges are identified: creating widespread access to high‐quality decision support tools; integrating SDM with other recovery‐supporting interventions; and responding to cultural changes as patients develop the normal expectations of citizenship. Two approaches which may inform responses in the mental health system to these cultural changes – social marketing and the hospitality industry – are identified.     

Health ethics and Indigenous ethnocide

In colonial societies such as Canada the implications of colonialism and ethnocide (or cultural genocide) for ethical decision‐making are ill‐understood yet have profound implications in health ethics and other spheres. They combine to shape racism in health care in ways, sometimes obvious, more often subtle, that are inadequately understood and often wholly unnoticed. Along with overt experiences of interpersonal racism, Indigenous people with health care needs are confronted by systemic racism in the shaping of institutional structures, hospital policies and in resource allocation decisions. Above all, racism is a function of state law – of the unilateral imposition of the settler society law on Indigenous communities. Indeed, the laws, including health laws, are social determinants of the ill‐health of Indigenous peoples. This article describes the problem of Indigenous ethnocide and explores its ethical implications. It thereby problematizes the role of law in health ethics.     

The Ethical and Legal Framework for the Decision Not to Resuscitate

Practicing physicians are frequently faced with the question of whether or not to institute cardiopulmonary resuscitation in case of cardiac or respiratory arrest in a patient in hospital. Medical training has usually not included any systematic analysis of this issue from either an ethical or a legal standpoint. Many physicians may be unaware that ethical and legal principles, as well as professional guidelines, exist to guide such decision making. In practice, physicians make this decision without the benefit of training in ethical analysis. The problem is especially acute in teaching hospitals when young physicians unacquainted with formal ethics or the law must often make decisions emergently. Studies show some discrepancy between ethical and legal principles and the actual decision making by physicians. For this reason, we recommend an approach that will enable physicians to make and implement decisions not to resuscitate that are consistent with current ethical and legal standards.     

Between the individual and the community: the impact of genetics on ethical models

This paper discusses how genetics is influencing ethical frameworks with particular focus on the effectiveness and appropriateness of individual and communal models. It suggests that genetics supports a relational understanding of the person and therefore that genetic ethics requires ethical models which respect both individuals and groups. First, the inadequacy of individualistic frameworks – at conceptual, ethical and practical levels – is outlined. Second, the “communal turn” in genetic ethics in both clinical and population ethics is considered. Third, it is claimed that this communal turn is applicable to genetic ethics in general and to illustrate this two further examples are explored: those of UK Biobank and personalized medicine. The paper concludes that ethical frameworks in genetic ethics must accommodate both group and individual concerns.     

Adjusting the focus: A public health ethics approach to data research

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.     

The use of Ethics Decision‐Making Frameworks by Canadian Ethics Consultants: A Qualitative Study

In this study, Canadian healthcare ethics consultants describe their use of ethics decision‐making frameworks. Our research finds that ethics consultants in Canada use multi‐purpose ethics decision‐making frameworks, as well as targeted frameworks that focus on reaching an ethical resolution to a particular healthcare issue, such as adverse event reporting, or difficult triage scenarios. Several interviewees mention the influence that the accreditation process in Canadian healthcare organizations has on the adoption and use of such frameworks. Some of the ethics consultants we interviewed also report on their reluctance to use these tools. Limited empirical work has been done previously on the use of ethics decision‐making frameworks. This study begins to fill this gap in our understanding of the work of healthcare ethics consultants.     

Teaching Medical Ethics to Meet the Realities of a Changing Health Care System

The changing context of medical practice—bureaucratic, political, or economic—demands that doctors have the knowledge and skills to face these new realities. Such changes impose obstacles on doctors delivering ethical care to vulnerable patient populations. Modern medical ethics education requires a focus upon the knowledge and skills necessary to close the gap between the theory and practice of ethical care. Physicians and doctors-in-training must learn to be morally sensitive to ethical dilemmas on the wards, learn how to make professionally grounded decisions with their patients and other medical providers, and develop the leadership, dedication, and courage to fulfill ethical values in the face of disincentives and bureaucratic challenges. A new core focus of medical ethics education must turn to learning how to put ethics into practice by teaching physicians to realistically negotiate the new institutional maze of 21st-century medicine.     

BEYOND SUN,SAND, AND STITCHES: ASSIGNING RESPONSIBILITY FOR THE HARMS OF MEDICAL TOURISM

Medical tourism (MT) can be conceptualized as the intentional pursuit of non‐emergency surgical interventions by patients outside their nation of residence. Despite increasing popular interest in MT, the ethical issues associated with the practice have thus far been under‐examined. MT has been associated with a range of both positive and negative effects for medical tourists' home and host countries, and for the medical tourists themselves. Absent from previous explorations of MT is a clear argument of how responsibility for the harms of this practice should be assigned. This paper addresses this gap by describing both backward looking liability and forward looking political responsibility for stakeholders in MT. We use a political responsibility model to develop a decision‐making process for individual medical tourists and conclude that more information on the effects of MT must be developed to help patients engage in ethical MT.     

Transnational policy migration,interdisciplinary policy transfer and decolonization: Tracing the patterns of research ethics regulation in Taiwan

Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on ‘principlism’ and committee‐based review were imported from the United States. Professionalisation of research ethics displaced other longer‐standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing discourses associated with asserting Indigenous peoples’ rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move beyond the self‐referential and attend to the social, economic and political context within which regulation operates.     

Law as Clinical Evidence: A New ConstitutiveModel of Medical Education and Decision-Making

Over several decades, ethics and law have been applied to medical education and practice in a way that reflects the continuation during the twentieth century of the strong distinction between facts and values. We explain the development of applied ethics and applied medical law and report selected results that reflect this applied model from an empirical project examining doctors’ decisions on withdrawing/withholding treatment from patients who lack decision-making capacity. The model is critiqued, and an alternative “constitutive” model is supported on the basis that medicine, medical law, and medical ethics exemplify the inevitable entanglement of facts and values. The model requires that ethics and law be taught across the medical education curriculum and integrated with the basic and clinical sciences and that they be perceived as an integral component of medical evidence and practice. Law, in particular, would rank as equal in normative authority to the relevant clinical scientific “facts” of the case, with graduating doctors having as strong a basic command of each category as the other. The normalization of legal knowledge as part of the clinician’s evidence base to be utilized in practice may provide adequate consolation for clinicians who may initially resent further perceived incursions on their traditional independence and discretion.     

Managing ethical challenges around misattributed parentage within the clinical context: Insights from an African moral theory

This study argues the thesis that a set of guidelines ‐ firmly rooted in a particular interpretation of African moral theory, specifically, Ubuntu – will do a better job than current medical ethics frameworks, in addressing ethical challenges around misattributed parentage within the clinical context. Incidental information such as information with significant personal/health implications raises unique challenges for medical professionals. For example, withholding information of misattributed paternity accidentally discovered in clinical interactions may be seen by a patient as a violation of his/her right‐to‐know. Contrarily, disclosure where a patient has not requested information – or where establishing paternity is not the purpose of clinical visit/interaction – may be taken by the patient as a violation of his/her right ‘not‐to‐know’. Resolving these challenges remain a herculean task. African moral theory contains an under‐emphasized value for addressing such ethical challenges around misattributed parentage in the field of transplant. I seek to contribute this knowledge; and enhance clinician‐patient relationship. This study builds off three completed systematic reviews, which aimed to answer the following questions: “what are the ethical challenges regarding information health professionals face within the clinical contest?” and “what core aspects (or common themes) of Ubuntu can be identified in existing literature describing the same?” In this present study, I applied the definition of Ubuntu which captures the core aspects of the theory in ethical literature on the same, to address ethical issues around unsought information of misattributed parentage in the field of transplant.     

The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low‐literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power‐unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research‐related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.     

医学研究伦理学的发展现状与前景

创新技术的开展和转化医学的注重给医学的发展注入了新的活力,但同时,也带来了一系列社会伦理问题和法律问题。生命医学伦理学的兴起和发展催生了医学研究伦理学分支学科形成,目的在于推进解决涉及人体的医学研究的伦理问题。当前,面临的最突出的伦理问题在于,对医学研究合法性、先进性及伦理性的把握,对医学研究伦理审查必要性的认知,对医学研究方案设计与伦理道德的匹配,对医学研究知情同意的告知,对医学研究风险与受益的平衡。逐步与国际接轨,加强伦理委员会制度建设;提高伦理审查能力建设,形成高水平的伦理审查队伍;学术组织和团体共同努力,推进医学研究伦理学的发展,这将助推医学研究伦理学的发展。     

A Not-So-Gentle Refutation of the Defence of Homeopathy

In a recent paper, Levy, Gadd, Kerridge, and Komesaroff attempt to defend the ethicality of homeopathy by attacking the utilitarian ethical framework as a basis for medical ethics and by introducing a distinction between evidence-based medicine and modern science. This paper demonstrates that their argumentation is not only insufficient to achieve that goal but also incorrect. Utilitarianism is not required to show that homeopathic practice is unethical; indeed, any normative basis of medical ethics will make it unethical, as a defence of homeopathic practice requires the rejection of modern natural sciences, which are an integral part of medical ethics systems. This paper also points out that evidence-based medicine lies at the very core of modern science. Particular arguments made by Levy et al. within the principlist medical ethics normative system are also shown to be wrong.     

Ethical Considerations in Clinical Trials: A Critique of the ICH‐GCP Guideline

This article examines issues relating to ethics decision‐making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH‐GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH‐GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH‐GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH‐GCP Guideline in its present form.