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. (shrink)

Volume 20, Issue 4, May 2020, Page 114-116.

What should be the role of an institutional ethics committee in resolving conflict concerning patient care decisions in the neonatal intensive care unit? This question takes on added importance in light of recent court decisions which suggest that IEC deliberations may serve as persuasive evidence in court, of proposed state regulations that would establish an IEC as an alternative to judicial review, and of recent Joint Commission on Accreditation of Healthcare Organizations guidelines that require an institutional policy on limitation or (...) withdrawal of treatment to include a specified mechanism for resolving conflict. Unfortunately, despite these developments, prospective case consultation remains one of the most controversial and poorly understood aspects of IEC functions. Questions and concerns persist about the relation the IEC has and should have to actual decisions in specific cases.We briefly examine the clinical, organizational, and regulatory complexity of the NICU environment and suggest five potential sources of uncertainty, disagreement, and conflict among parent and NICU staff. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 14-16, June 2011.

What should be the role of an institutional ethics committee in resolving conflict concerning patient care decisions in the neonatal intensive care unit? This question takes on added importance in light of recent court decisions which suggest that IEC deliberations may serve as persuasive evidence in court, of proposed state regulations that would establish an IEC as an alternative to judicial review, and of recent Joint Commission on Accreditation of Healthcare Organizations guidelines that require an institutional policy on limitation or (...) withdrawal of treatment to include a specified mechanism for resolving conflict. Unfortunately, despite these developments, prospective case consultation remains one of the most controversial and poorly understood aspects of IEC functions. Questions and concerns persist about the relation the IEC has and should have to actual decisions in specific cases.We briefly examine the clinical, organizational, and regulatory complexity of the NICU environment and suggest five potential sources of uncertainty, disagreement, and conflict among parent and NICU staff. (shrink)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood—the standard treatment for hemorrhagic shock—is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page W1-W3, August 2011.

The debate about the ethics of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) often focuses on the assumptions made by the different parties involved, failing to note the lack of a necessary connection between those assumptions and the main criticism of the study—that the parents appear to have been poorly informed. The fact that the target ranges of oxygen saturation (SpO2) used in SUPPORT were within the range recommended as an appropriate “standard of care” does not mean that (...) the infants randomized to one of two restricted SpO2 ranges received the same treatment they would have received outside of the trial. The corresponding observation that randomization altered the potential harms to which an individual infant was exposed does not mean that the risks of being in SUPPORT were greater than or in addition to the risks associated with usual care. The argument that parents should have been better informed about these potential harms does not entail the (incorrect) assumption that neonatal clinicians make individualized treatment decisions rather than follow a standardized protocol when adjusting the level of oxygen a preterm infant receives. The fact that parents are unaware of the trade‐off clinicians make between these potential harms when establishing such a protocol does not justify the failure to adequately inform parents about the purpose of SUPPORT and the risks and harms that were involved. (shrink)

A response to “What Counts as Equipoise?” by Henry J. Silverman and Didier Dreyfuss.

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The (...) model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care. (shrink)

Determining whether a research risk meets or exceeds a regulatory standard of risk acceptability is difficult. Recently a framework called the systematic evaluation of research risks (SERR) has been proposed as a method of comparing research risks with predetermined standards of acceptability. SERR purports to offer a systematic and largely determinate (definite) way to compare risks and say whether a specific research risk falls below or above an acknowledged standard of acceptable risk. Here the authors review some philosophical problems with (...) this framework, which they take to be representative of determinate approaches to risk comparison, and conclude that it should not be used in a stand-alone or determinate fashion. Instead, the authors suggest that a deliberative approach may be a more viable candidate for future development. Such an approach could be informed by methods such as SERR without being rigidly bound to them. (shrink)

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...) of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood - the standard treatment for hemorrhagic shock - is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards. (shrink)

Book reviewed in this article: Animal Experimentation: The Moral Issues. Edited by Robert M. Baird and Stuart E. Rosenbaum.

Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent has been theparadigm for (...) assessing capacity to give assent.This method leaves the youngest, leastcognitively mature children vulnerable towaiver of assent and forced researchparticipation. Voluntariness can also becompromised by the influence of authorityfigures who can exert undue influence andcoerce children to participate in research. This paper discusses factors that may influencethe decision to give assent/permission,potential parent-child conflict in theassent/permission process and how it isresolved, and potential parental undueinfluence on research participation. Theseissues are illustrated with quotations drawnfrom a larger qualitative study of parentalpermission and child assent (data notpresented). We suggest a developmentalapproach, viewing assent as a continuum rangingfrom mere affirmation in the youngest childrento the equivalent of the informed consentprocess in the mature adolescent. (shrink)

Our objective is to understand how parents and children perceive their roles in decision making about research participation. Forty-five children (ages 4-15 years) with or without a chronic condition and 21 parents were the participants. A semistructured interview assessed perceptions of up to 4 hypothetical research scenarios with varying levels of risk, benefit, and complexity. Children were also administered the Peabody Picture Vocabulary Test, Third Edition, to assess verbal ability, as a proxy for the child's cognitive development. The audiotaped interviews (...) were transcribed and analyzed for themes related to parent and child decision-making roles. Both parents and children varied in their perceptions of decision-making roles. Child perceptions of parental influence on decision making as knowledge-based increased with cognitive development, whereas perceptions of parental influence as power-based decreased. Both children and parents commented that they would collaborate with each other when making decisions. Collaborative decision making appeared to increase with cognitive development. These findings suggest that approaches to child assent and parent permission should consider the parent-child relationship and how children and families typically make decisions. Future research is necessary to explain variation in the process of research decision making across children and families, explore the role of collaboration on children's decision-making skills, and understand developmental trajectories and mechanisms related to research decision making. (shrink)

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs (...) in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission. (shrink)

Discussion of the ethics of forgoing medically provided nutrition and hydration tends to focus on adults rather than infants and children. Many appellate court decisions address the legal propriety of forgoing medically provided nutritional support of adults, but only a few have ruled on pediatric cases that pose the same issue.The cessation of nutritional support is implemented most commonly for patients in a permanent vegetative state ). An estimated 4,000 to 10,000 American children are in the permanent vegetative state, compared (...) to 10,000 to 25,000 adults. Yet the dearth of literature, case reports, and court decisions suggests that physicians and families of pediatric patients stop medically provided nutrition or seek court orders much less frequently. (shrink)

Einheit der Kirche und Einheit der Menschheit, by W. Pannenberg.--Die Menschheit, Israel und die Nationen in hebräischer Überlieferung, by M. Greenberg.--Die Einheit der Menschheit in biblischer Sicht, by C. Maurer.--Einheit und Entfremdung im Islam, by H. Askari.--Die Entdeckung Amerikas und das europäische Menschenbild, by L. González Rodríguez.--Der Einfluss des Kolonialismus auf das asiatische Verständnis vom Menschen, by J. G. Arapura.--Religiöser Pluralismus und die Suche nach menschlicher Gemeinschaft, by S. J. Samartha.--Vom konfuzianischen Edelmann zum neuen chinesischen "politischen Menschen", by D. A. (...) Robinson.--Die Revolution der Wissenschaft und die Einheit der Menschheit, by B. Towers.--Sprache und Kommunikation, by E. A. Nida.--Die Theologie der Tradition als Grundlage der Einheit, by N. A. Nissiotis. (shrink)

Signs of mankind's solidarity, by J. R. Nelson.--Mankind, Israel and the nations in the Hebraic heritage, by M. Greenberg.--Christian insights from biblical sources, by C. Maurer.--Muhammad and all men, by D. Rahbar.--The impact of New World discovery upon European thought of man, by E. J. Burrus.--The effects of colonialism upon the Asian understanding of man, by J. G. Arapura.--Religious pluralism and the quest for human community, by S. J. Samartha.--From Confucian gentleman to the new Chinese 'political' man, by D. (...) A. Robinson.--The scientific revolution and the unity of man, by B. Towers.--Language and communication, by E. A. Nida.--Man and the son of man, by J. Moltmann.--The potentiality of conciliarity: communion, conscience, council, by W. B. Blakemore.--Oneness must mean wholeness, by J. R. Nelson. (shrink)

Patricia Williams made a number of claims concerning the methods and practise of cladistic analysis and classification. Her argument rests upon the distinction of two kinds of hierarchy: a divisional hierarchy depicting evolutionary descent and the Linnean hierarchy describing taxonomic groups in a classification. Williams goes on to outline five problems with cladistics that lead her to the conclusion that systematists should eliminate cladism as a school of biological taxonomy and to replace it either with something that is philosophically coherent (...) or to replace it with pure methodology, untainted by theory (Williams 1992, 151). Williams makes a number of points which she feels collectively add up to insurmountable problems for cladistics. We examine Williams' views concerning the two hierarchies and consider what cladists currently understand about the status of ancestors. We will demonstrate that Williams has seriously misunderstood many modern commentators on this subject and all of her five persistent problems are derivable from this misunderstanding. Some persons believe and argue, on grounds approaching faith it seems to me, that phylogeny comes from our knowledge of evolution. Others have found to their surprise, and sometimes dismay, that phylogeny comes from our knowledge of systematics. Nelson (1989, 67). (shrink)

Aristotelian Actualism is the conjunction of the theses that absolutely everything is actual, that individuals are neither reducible to nor dependent on independently identified properties, and that some individuals are genuine contingent existents. Robert Adams and Gregory Fitch, two prominent proponents of Aristotelian Actualism, have argued that this view has a consequence that any modal logic stronger than M, and so any modal logic in which symmetry and reflexivity are frame conditions, is inadequate. We argue that this is incorrect.

One of our great behavioral scientists, the bestselling author of Behave, plumbs the depths of the science and philosophy of decision-making to mount a devastating case against free will, an argument with profound consequences Robert Sapolsky's Behave, his now classic account of why humans do good and why they do bad, pointed toward an unsettling conclusion: We may not grasp the precise marriage of nature and nurture that creates the physics and chemistry at the base of human behavior, but (...) that doesn't mean it doesn't exist. Now, in Determined, Sapolsky takes his argument all the way, mounting a brilliant (and in his inimitable way, delightful) full-frontal assault on the pleasant fantasy that there is some separate self telling our biology what to do. Determined offers a marvelous synthesis of what we know about how consciousness works-the tight weave between reason and emotion and between stimulus and response in the moment and over a life. One by one, Sapolsky tackles all the major arguments for free will and takes them out, cutting a path through the thickets of chaos and complexity science and quantum physics, as well as touching ground on some of the wilder shores of philosophy. He shows us that the history of medicine is in no small part the history of learning that fewer and fewer things are somebody's "fault"; for example, for centuries we thought seizures were a sign of demonic possession. Yet, as he acknowledges, it's very hard, and at times impossible, to uncouple from our zeal to judge others and to judge ourselves. Sapolsky applies the new understanding of life beyond free will to some of our most essential questions around punishment, morality, and living well together. By the end, Sapolsky argues that while living our daily lives recognizing that we have no free will is going to be monumentally difficult, doing so is not going to result in anarchy, pointlessness, and existential malaise. Instead, it will make for a much more humane world. (shrink)

Arthur W. H. Adkins's writings have sparked debates among a wide range of scholars over the nature of ancient Greek ethics and its relevance to modern times. Demonstrating the breadth of his influence, the essays in this volume reveal how leading classicists, philosophers, legal theorists, and scholars of religion have incorporated Adkins's thought into their own diverse research. The timely subjects addressed by the contributors include the relation between literature and moral understanding, moral and nonmoral values, and the contemporary meaning (...) of ancient Greek ethics. The volume also includes an essay from the late Adkins himself illustrating his methodology in an analysis of the "Speech of Lysias" in Plato's _Phaedrus_. _The Greeks and Us_ will interest all those concerned with how ancient moral values do or do not differ from our own. Contributors include Arthur W. H. Adkins, Stephanie Nelson, Martha C. Nussbaum, Paul Schollmeier, James Boyd White, Bernard Williams, and Lee Yearley. Commentaries by Wendy Doniger, Charles M. Gray, David Grene, Robert B. Louden, Richard Posner, and Candace Vogler. (shrink)

Disagreement about the nature of ‘addiction’, such as whether it is a brain disease, arises in part because the label is applied to a wide range of phenomena. This creates conceptual and definitional confusions and misunderstandings, often leading to researchers talking past one another. Ontologies have been successfully implemented in other fields to help solve these problems by creating unifying frameworks that can accommodate divergence while clarifying the basis for it. We argue that ontologies can help transform the way we (...) think and communicate about addiction as well, providing a basis for a shared understanding of the domain and a shared means for communicating and achieving that understanding. -/- We introduce the use of ontologies in science and medicine and show how they can unify differing perspectives on addiction. We also show how ontologies provide a practical tool for organizing our collective knowledge in this field, even, and especially, when that knowledge is garnered through distinct disciplinary approaches adopting disparate methodologies or perspectives (e.g., neurobiological, psychological, sociological, etc.). In the end, we believe that ontologies can help to avoid letting questions like “Is addiction a brain disease?” divide the field, hamper communication, or otherwise disrupt the ability to make meaningful progress. (shrink)

The problem of evil is one of the most discussed topics in the philosophy of religion. For some time, however, there has been a need for a collection of readings that adequately represents recent and ongoing writing on the topic. This volume fills that need, offering the most up-to-date collection of recent scholarship on the problem of evil. The distinguished contributors include J.L. Mackie, Nelson Pike, Roderick M. Chisholm, Terence Penelhum, Alvin Plantinga, William L. Rowe, Stephen J. Wykstra, John (...) Hick, and Diogenes Allen. Including an introductory essay and a selected bibliography, this comprehensive and completely up-to-date collection is an invaluable guide to current scholarship in this highly debated area of the philosophy of religion. Oxford Readings in Philosophy aims to bring together important recent writings in major areas of philosophical inquiry, selected from a variety of sources, mostly periodicals, which may not be conveniently available. (shrink)

Book reviewed in this article: Animal Experimentation: The Moral Issues. Edited by Robert M. Baird and Stuart E. Rosenbaum.