This paper focuses on the _ethics of how_ to approach the introduction of MAiD as an organizational ethics challenge, a focus that diverges from the traditional focus in healthcare ethics on the _ethics of why_ MAiD is right or wrong. It describes a method co-designed and implemented by ethics and medical leadership at a tertiary hospital to develop a values-based, grassroots response to the decriminalization of assisted dying in Canada. This organizational ethics engagement method embodied core tenants that drew inspiration (...) from a variety of sources, including poetic ones. These tenants are: make the problem bigger; focus on values; cultivate open moral spaces; and trust emergence. The paper describes how these tenants were put into practice in order to create a rigorous and sustainable MAiD program that delivers high-quality care to patients and families while honoring the moral diversity of the hospital workforce. One of the goals in sharing this method is to provide a roadmap for healthcare organizations in Canada and other jurisdictions around the world that are facing the challenge of responding to patient requests for MAiD following the decriminalization of this care option. (shrink)

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...) in research is required. Component analysis provides such a systematic approach. (shrink)

This paper depicts a case study of an organizational strategy for the promotion of ethical practice when introducing a new, high-risk, ethically-charged medical practice like Medical Assistance in Dying (MAiD). We describe the development of an interprofessional program that enables the delivery of high-quality, whole-person MAiD care that is values-based and sustainable. A “care ecology” strategy recognizes the interconnected web of relationships and structures necessary to support a quality experience of MAiD for patients, families, and clinicians. This program exemplifies a (...) care ecology approach that addresses common barriers to entry to MAiD practice, and also meets the needs of a variety of stakeholders through the creation of patient and family resources, team supports, standards of practice, professional development opportunities, organizational infrastructure, and community partnerships. We also describe how a thriving care ecology evolves to remain resilient, and to enable integration as the needs of the organization, team and program change over time. The design and development of this program may be adapted to other jurisdictions and organizations where MAiD is introduced, or where new patient populations become eligible for MAiD. This care ecology model may also be applicable to the creation of sustainable programs that provide other morally controversial or novel clinical services. (shrink)

: When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of (...) honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood as competing concepts. We argue that FE and CE offer separable and, in themselves, incomplete justifications for the conduct of clinical trials. FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed in this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns. (shrink)

Following an initial study of the needs of healthcare providers (HCP) regarding the introduction of Medical Assistance in Dying (MAiD), and the subsequent development of an assisted dying program, this study sought to determine the efficacy and impact of MAiD services following the first two years of implementation. The first of three aims of this research was to understand if the needs, concerns and hopes of stakeholders related to patient requests for MAiD were addressed appropriately. Assessing how HCPs and families (...) perceived the quality of MAiD services, and determining if the program successfully accommodated the diverse needs and perspectives of HCPs, rounded out this quality evaluation. This research implemented a mixed-methods design incorporative of an online survey with Likert scale and open-ended questions, as well as focus groups and interviews with staff and physicians, and interviews with MAiD-involved family members. There were 356 online surveys, as well as 39 participants in six focus groups with HCP, as well as fourteen interviews with MAiD-involved family members. Participants indicated that high-quality MAiD care could only be provided with enabling resources such as policies and guidelines to ensure safe, evidence-based, standardized care, as well as a specialized, trained MAiD team. Both focus group and survey data from HCPs suggest the infrastructure developed by the hospital was effective in delivering high-quality MAiD care that supports the diverse needs of various stakeholders. This study may serve as a model for evaluating the impact and quality of services when novel and ethically-contentious clinical practices are introduced to healthcare organizations. (shrink)

This study assessed the attitudes and needs of physicians and health professional staff at a tertiary care hospital in Canada regarding the introduction of physician assisted dying (PAD) during 2015–16. This research aimed to develop an understanding of the wishes, concerns and hopes of stakeholders related to handling requests for PAD; to determine what supports/structures/resources health care professionals (HCP) require in order to ensure high quality and compassionate care for patients requesting PAD, and a supportive environment for all healthcare providers (...) across the moral spectrum. This study constituted a mixed methods design with a qualitative descriptive approach for the study’s qualitative component. A total of 303 HCPs working in a tertiary care hospital completed an online survey and 64 HCPs working in hospital units with high mortality rates participated in 8 focus group discussions. Both focus group and survey data coalesced around several themes to support the implementation of PAD following the decriminalization of this practice: the importance of high quality care; honoring moral diversity; supporting values (such as autonomy, privacy, beneficence); and developing resources, including collaboration with palliative care, education, policies and a specialized team. This study provided the foundational evidence to support the development of the PAD program described in other papers in this collection, and can be a model for gathering evidence from stakeholders to inform the implementation of PAD in any healthcare organization. (shrink)

Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject.

Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in (...) moral and legal theory of the physician-researcher's duty of care to the patient-subject. We have repeatedly suggested that the requisite foundation is in the ethics of trust and the law of fiduciaries.Curiously, despite the absence of a published thorough exposition of our position, some have preemptively criticized our suggestion that the relationship between physician-researcher and patient-subject is fiduciary. Others have offered their own accounts of the implications of fiduciary law for the relationship. (shrink)

In this collection of provocative essays, historians and literary theorists assess the influence of Michel Foucault, particularly his History of Sexuality, on the study of classics. Foucault's famous work presents a bold theory of sexuality for both ancient and modern times, and yet until now it has remained under-explored and insufficiently analyzed. By bringing together the historical knowledge, philological skills, and theoretical perspectives of a wide range of scholars, this collection enables the reader to explore Foucault's model of Greek culture (...) and see how well his interpretation accounts for the full range of evidence from Greece and Rome. Not only do the essays bring to light the assumptions, ideas, and practices that constituted the intimate lives of men and women in the ancient Mediterranean world, but they also demonstrate the importance of the History of Sexuality for fields as diverse as Greco-Roman antiquity, women's history, cultural studies, philosophy, and modern sexuality. The essays include "Situating The History of Sexuality" (the editors), "Taking the Sex Out of Sexuality: Foucault's Failed History" (Joel Black), "Incipit Philosophia" (Alain Vizier), "The Subject in Antiquity after Foucault" (Page duBois), "This Myth Which Is Not One: Construction of Discourse in Plato's Symposium" (Jeffrey S. Carnes), "Foucault's History of Sexuality: A Useful Theory for Women?" (Amy Richlin), "Catullan Consciousness, the 'Care of the Self,' and the Force of the Negative in History" (Paul Allen Miller), "Reversals of Platonic Love in Petronius' Satyricon" (Daniel B. McGlathery), and an essay from Dislocating Masculinity (Lin Foxhall). (shrink)

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...) ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances. (shrink)

Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it (...) is wanting in several respects. (shrink)

(2002). Avoiding a Jekyll-And-Hyde Approach to the Ethics of Clinical Research and Practice. The American Journal of Bioethics: Vol. 2, No. 2, pp. 14-17.

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) (...) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their patients; (4) address the challenges posed by research containing a mixture of interventions and (5) define ethical standards according to which the risks and potential benefits of research may be consistently evaluated. This response argues that the net risks test meets none of these criteria and concludes that it is not a viable alternative to component analysis. (shrink)

A twenty‐person working group convened to discuss the ethical and policy considerations of the controversial intervention called “growth attenuation,” and if possible to develop practical guidance for health professionals. A consensus proved elusive, but most of the members did reach a compromise.

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)

The surge in genetic research and technology, fuelled in large part by the Human Genome Project, has resulted in the continuing expansion of the range of genetic tests and other genetic information available to physicians, insurance companies, employers, and the general public.’ Genetic tests can provide presymptomatic medical information about an individual, including information about an individual's increased risk of future disease, disability, or early death. These tests can reveal information about an individual's carrier status, that is, the likelihood of (...) parents passing on to their children a genetic condition, and about the health of the individual's family members. Although genetic information provides the promise of early detection and treatment of certain illnesses and disorders, it also poses risks. As a result of the increase in genetic testing and information, legal issues regarding employment discrimination on the basis of genetic information are emerging. (shrink)

A twenty‐person working group convened to discuss the ethical and policy considerations of the controversial intervention called “growth attenuation,” and if possible to develop practical guidance for health professionals. A consensus proved elusive, but most of the members did reach a compromise.

: In response to the preceding commentary by Jerry Menikoff in this issue of the Journal , the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself (...) does not supplant ill subjects' rights to personalized judgment and care embodied in Fried's equipoise. (shrink)

The surge in genetic research and technology, fuelled in large part by the Human Genome Project, has resulted in the continuing expansion of the range of genetic tests and other genetic information available to physicians, insurance companies, employers, and the general public.’ Genetic tests can provide presymptomatic medical information about an individual, including information about an individual's increased risk of future disease, disability, or early death. These tests can reveal information about an individual's carrier status, that is, the likelihood of (...) parents passing on to their children a genetic condition, and about the health of the individual's family members. Although genetic information provides the promise of early detection and treatment of certain illnesses and disorders, it also poses risks. As a result of the increase in genetic testing and information, legal issues regarding employment discrimination on the basis of genetic information are emerging. (shrink)

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)

The elegy flared into existence, commanded the cultural stage for several decades, then went extinct. This book accounts for the swift rise and sudden decline of a genre whose life span was incredibly brief relative to its impact. Examining every major poet from Catullus to Ovid, Subjecting Verses presents the first comprehensive history of Latin erotic elegy since Georg Luck's. Paul Allen Miller harmoniously weds close readings of the poetry with insights from theoreticians as diverse as Jameson, Foucault, Lacan, and (...) Zizek. In welcome contrast to previous, thematic studies of elegy--efforts that have become bogged down in determining whether particular themes and poets were pro- or anti-Augustan--Miller offers a new, "symptomatic" history. He asks two obvious but rarely posed questions: what historical conditions were necessary to produce elegy, and what provoked its decline? Ultimately, he argues that elegiac poetry arose from a fundamental split in the nature of subjectivity that occurred in the late first century--a split symptomatic of the historical changes taking place at the time. Subjecting Verses is a major interpretive feat whose influence will reach across classics and literary studies. Linking the rise of elegy with changes in how Romans imagined themselves within a rapidly changing society, it offers a new model of literary theory that neither reduces the poems to a reflection of their context nor examines them in a vacuum. (shrink)

Diotima at the Barricades argues that the debates that emerged from the burgeoning of feminist intellectual life in post-modern France involved complex, structured, and reciprocal exchanges on the interpretation and position of Plato and other ancient texts in the western philosophical and literary tradition. Paul Allen Miller shows how individual works of Anglo-American figures such as Toril Moi, Judith Butler, and Kaja Silverman, as well as movements such as queer theory, are rooted in feminist theoretical debates that began in the (...) sixties in France and have continued right up to the present day. (shrink)

This paper examines Foucault's reading of Plato and ancient philosophy as part of his continuing dialogue and debate with Derrida. It contends that this debate not only in part motivates Foucault's turn to antiquity, but also is directly revelatory of the most basic differences between Foucault's and Derrida's conceptions of philosophy.

Special moral, regulatory, and scientific questions surround the inclusion of children in health-related research. These questions arise from a fundamental moral tension between the obligation to expose children to research participation to ensure that they share in the benefits that arise from it and the obligation to protect them from the harms associated with their inappropriate involvement in research. This tension is felt in the development of moral and regulatory frameworks for the protection of child research subjects and in the (...) implementation and interpretation of these frameworks by institutional review boards. (shrink)

: The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "pulling the plug" on clinical equipoise.

This chapter attempts to derive, define, and specify norms governing the relationship between physician-researcher and patient-subject, and to explore their interconnection. It argues that rooting the relationship between physician-researcher and patient-subject in a normative theory of trust is promising. It enables the derivation, definition, and specification of norms governing the relationship and appreciation of their interconnection.

Fiduciary law is one of the most important areas of private law, governing a wide range of relationships that affect people in their daily lives. These new and innovative essays explore the foundations of fiduciary relationships and the duties fiduciaries owe to their beneficiaries.

Fiduciary law is one of the most important areas of law, governing a wide range of relationships that affect people in their daily lives. These new and innovative essays explore the foundations of fiduciary relationships and the duties of loyalty fiduciaries owe to their beneficiaries.

Examines interrelated topics in Medieval and Renaissance Latin literature: the status of women as writers, the status of women as rhetorical figures, and the status of women in society from the fifth to the early seventeenth century.

IÂ’m only talking about commercial big time music in the United States. Of course music is gloriously seething in odd corners of the planet as it should. I can team up with some compatible friends and we can go find or make our own music in any of a number of accommodating environments- on the net, in the forest, or in some dank club late at night.

Bringing together leading theorists to analyse critically important philosophical questions at the intersection of contract and fiduciary law, Contract, Status, and Fiduciary Law demonstrates that these two areas of law, while distinctive, are deeply intertwined.