Paul Miller

Private law scholarship is experiencing a reawakening in the United States with the rise of the New Private Law. New Private Lawyers have emphasized our common commitment to the scholarly interest and practical importance held by legal concepts; a belief that private law ought to be analyzed (in part) from an internal point of view; and a conviction that functionalist and conceptual analyses of private law doctrines, procedures and institutions are, or can be, complementary. We are also joined in criticism of aspects of American legal realism and in lament over some of its continuing legacies in private law. However, New Private Law scholars have yet to articulate a scholarly methodology that defines and differentiates our work. I argue that the New Private Law is rooted in a shared—if implicit—new formalist methodology and provide the first programmatic explanation of it. The Article does several things. It provides a clear statement of methodological tenets of the new formalism. It relates these to wider developments in general jurisprudence, with particular attention to scholarship on law and practical reason. It explains the sense in which the new formalism is novel, especially relative to older varieties of legal formalism. It distances the new formalism from foolish and implausible claims prominent in pejorative renderings of legal formalism. It shows how the new formalism is reflected in New Private Law scholarship. And it explains how a clear grasp of new formalist methodology enables reconciliation of the otherwise baffling eclecticism in the New Private Law while promising new and fruitful avenues for its future development.

Most private law theorists claim to analyze private law from an internal point of view; a vantagepoint within which private law doctrine, institutions and procedure enjoy pride of place. Private law theory of a generation ago distinguished the internal from external points of view, valorizing the former and criticizing the latter for ignoring the normativity of private law or for mistaking private law for public law or regulation. The New Private Law, by contrast, asserts the complementarity of internal and external points of view, partly by emphasizing the value of functionalist analyses of legal form. In this article, we canvas leading accounts of the internal point of view in private law (provided by corrective justice and civil recourse theorists, respectively) and identify their shortcomings: notably, their inability to ground assertions about the normative and explanatory priority of the internal point of view, and about its relationship (whether of exclusivity or complementarity) to external points of view. We offer an alternative, and we think better, rendering of the internal point of view, drawing on the work of John Finnis. Amongst other things, our account vindicates the New Private Law’s alluring but elusive promise of perspectival integration, showing how private law may be understood as an interlocking set of practices of public practical deliberation equally concerned with reasoned compliance and behavioral conformity with practically reasonable laws.

For the past several decades, realists and formalists have been deeply at odds. They have, however, mostly been talking past one another, with each side trading in caricature of the other. In this article, I aim to show the benefits of a more tempered approach; in my case, the approach of a formalist to realist thought. I closely examine the unreconstructed legacy of realist thought, focusing on realist ideas that have proven especially influential. Along the way, I uncover some surprising affinities and compatibilities between realist and formalist thought. Acknowledging that it is hard to take the measure of realism, I argue that we can credit it with eight important ideas about law. For each of these, I also locate correlative unsound ideas. That these pairings of ideas—sound and unsound—travel together has made it difficult to understand and to critically evaluate realism. This, in turn, has made it difficult for realists and formalists to join one another in productive debate. It is all too easy for those sympathetic to realism to see only the sound ideas, or to be swayed by rhetorically powerful expression of unsound ones. Likewise, it has been all too easy for formalists to see only the unsound ideas. This article aids in the disentanglement of the many strands of realist thought and hence furnishes a basis for more discriminate assessment of the relative merits of realism and formalism, respectively.

: 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

As we enter the new century, humanity wields increasing power to understand, alter, and control the world in which we live. The mysteries of our genetic code provide remarkable new insights into our unique human characteristics. Rapid developments in information technology provide instant access to limitless data. The information age has taken hold, and the genetic revolution is in full swing. With apologies to Aldous Huxley, we stand at the precipice of a brave new world.It has been just 50 years since James Watson and Francis Crick's groundbreaking discovery of the double helix. Since then, profound developments in the science of genetics have been staggering. More staggering still are the potential benefits, the boundless horizons, the promised and unimagined applications of their work, and the work of the many scientists involved in the sequencing of the human genome. There can be no doubt that a firm and unwavering commitment to the betterment of humankind has fueled this tireless effort.

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

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

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.

: 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

: 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

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.

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.

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.

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.

The existing EELS literature has usefully identified the scope of ethical issues posed by pharmacogenetic and pharmacogenomic research. The time has come for in-depth examination of particular ethical issues. The involvement of racial and ethnic communities in pharmacogenetic and pharmacogenomic research is contentious precisely because it touches upon the science and politics of studying racial and ethnic difference. To date, the ethics literature has not seriously taken account of the fact that such research impinges upon the interests of communities, and that taking such interests seriously requires that we both protect and empower communities in research. We propose a framework that rests upon the recognition that communities are heterogeneous human associations and differing policies are appropriate for differing communities. Community consent and consultation and community consultation alone are neither appropriate nor required for all pharmacogenetic and pharmacogenomic research. Rather, application of these policy protections must take into account particulars of both planned research and the communities involved

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

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

Civil wrongs occupy a significant place in private law. They are particularly prominent in tort law, but equally have a place in contract law, property and intellectual property law, unjust enrichment, fiduciary law, and in equity more broadly. Civil wrongs are also a preoccupation of leading general theories of private law, including corrective justice and civil recourse theories. According to these and other theories, the centrality of civil wrongs to civil liability shows that private law is fundamentally concerned with the expression and enforcement of norms of justice appropriate to interpersonal interaction and association. Others, sounding notes of caution or criticism, argue that a preoccupation with wrongs and remedies has meant neglect of other ways in which private law serves justice, and ways in which private law serves values other than justice. This volume comprises original papers written by a wide variety of legal theorists and philosophers exploring the nature of civil wrongs, their place in private law, and their relationship to other forms of wrongdoing.