Common Morality Principles in Biomedical Ethics: Responses to Critics.

After briefly sketching common-morality principlism, as presented in Principles of Biomedical Ethics, this paper responds to two recent sets of challenges to this framework. The first challenge claims that medical ethics is autonomous and unique and thus not a form of, or justified or guided by, a common morality or by any external morality or moral theory. The second challenge denies that there is a common morality and insists that futile efforts to develop common-morality approaches to bioethics limit diversity and prevent needed moral change. This paper argues that these two critiques fundamentally fail because they significantly misunderstand their target and because their proposed alternatives have major deficiencies and encounter insurmountable problems.

The Origins and Drafting of the Belmont Report.

This article describes the origins and drafting of the Belmont Report by members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Lucky Me: The Amiable and Weighty Influences on My Career.

This autobiographical sketch is being published 50 years after I started as an assistant professor at Georgetown University in 1970. In this presentation, I cannot tell the full story of these 50 years. I write only about the formative years both before and after I was hired at Georgetown, and I emphasize two subjects. The first is the importance of the individuals who were massive influences on my intellectual development and aspirations. The second is the great importance of multidisciplinary work. I came from philosophy, a discipline that generally did not emphasize or particularly value multidisciplinary work, but I was transformed by individuals in other disciplines who directed me to this style of work. Almost sheer luck brought each of these influences into my life.

Response to Commentaries.

After expressing our gratitude to the commentators for their valuable analyses and assessments of Principles of Biomedical Ethics, we respond to several particular critiques raised by the commentators under the following rubrics: the compatibility of different sets of principles and rules; challenges to the principle of respect for autonomy; connecting principles to cases and resolving their conflicts; the value of and compatibility of virtues and principles; common morality theory; and moral status. We point to areas where we see common agreement with our commentators and respond to their critical evaluations.

My Path to Bioethics.

In this series of essays, The Road Less Traveled, noted bioethicists share their stories and the personal experiences that prompted them to pursue the field. These memoirs are less professional chronologies and more descriptions of the seminal touchstone events and turning points that led-often unexpectedly-to their career path.

The upper limits of pain and suffering in animal research.

The control of risk and harm in human research often calls for the establishment of upper limits of risk of pain, suffering, and distress that investigators must not exceed. Such upper limits are uncommon in animal research, in which limits of acceptability are usually left to the discretion of individual investigators, institutions, national inspectors, or ethics review committees. We here assess the merits of the European Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes and its accompanying instruments, such as guides and examples. These documents present a body of legislation governing animal research in the European Union. We argue that the directive supplies a promising approach, but one in need of revision. We interpret the directive's general conception of upper limits and show its promise for the establishment of high-quality policies. We provide a moral rationale for such policies, address the problem of justified exceptions to established upper limits, and show when causing harm is and is not wrongful. We conclude that if the standards we propose for improving the directive are not realized in the review of research protocols, loose and prejudicial risk-benefit assessments may continue to be deemed sufficient to justify morally questionable research. However, a revised EU directive and accompanying instruments could have a substantial influence on the ethics of animal research worldwide, especially in the development of morally sound legal frameworks.

Where are we in the justification of research involving chimpanzees?

On December 15, 2011, the Institute of Medicine (IOM) Committee on the Use of Chimpanzees in Biomedical and Behavioral Research issued a final report commissioned by the National Institutes of Health (NIH). It changed the landscape of discussion about the necessity of using chimpanzees in research. The Committee advanced three principles of scientifically warranted research on chimpanzees, but NIH's statement of task provided inadequate opportunity for the Committee to investigate moral problems and their implications for public policy. The IOM Committee's report is a landmark document, but it has weaknesses in its justificatory framework, largely resulting from the Committee's narrow remit from NIH and IOM. We analyze cases mentioned in the report and argue that numerous central ethical issues are neglected, especially ones of justification. Additionally, we consider whether the principles offered by the Committee could be used as criteria governing the use of other animals in biomedical and behavioral research.

Robert Veatch's early career in bioethics, contributions to the field, and career at Georgetown University.

In this essay, I describe Bob Veatch's career from the perspective of a colleague and friend. Bob and I started our professional careers at the same time and quickly came into professional contact. With Bob's move from the Hastings Center to the Kennedy Institute, we became colleagues and worked for almost a decade on our book on death and dying. He was an outstanding co-editor and author. I believe he knew more about the philosophically connected issues in this area of bioethics than anyone publishing in the area, and it was an area of intellectual interest that he pursued throughout his career. Beyond bioethics, Bob and I shared our shared love of contemporary bluegrass music, especially the songs of The Seldom Scene. Bob studied them much as he studied bioethics-with deep knowledge and seriousness. He was just a scholar by nature and with excellent training and experience. If we were to create a Hall of Fame for bioethics, Bob might be the first person elected.

The concept of voluntary consent.

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals' perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research.

Beyond the 3 Rs to a More Comprehensive Framework of Principles for Animal Research Ethics.

We have produced a framework of general moral principles for animal research ethics in a book, Principles of Animal Research Ethics, which is forthcoming with Oxford University Press in fall 2019. This book includes a detailed statement and defense of our framework along with critical commentaries on our work from seven eminent scholars: Larry Carbone, Frans de Waal, Rebecca Dresser, Joseph Garner, Brian Hare, Margaret Landi, and Julian Savulescu. In the present paper, we explain the motivation for our project and present our framework of principles. The first section explains why a new framework is both needed and timely, on the basis of six important developments in recent decades. The second section challenges assertions of an unbridgeable gulf dividing the animal-research and animal-protection communities on the issue of animal research. It does so, first, by indicating common ground in the core values of social benefit and animal welfare and, then, by presenting and briefly defending our framework: three principles of social benefit and three principles of animal welfare. These six principles, we argue, constitute a more suitable framework than any other that is currently available, including the canonical 3 Rs advanced in 1959 by William M. S. Russell and Rex L. Burch.