Ethical approval must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee, while the others had to apply to various regional ECs and/or individual hospital institutional research boards. The time between applying for (...) EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries. (shrink)

In this analysis we discuss the change in criteria for triage of patients during three different phases of a pandemic like COVID-19, seen from the critical care point of view. Availability of critical care beds has become a hot topic, and in many countries, we have seen a huge increase in the provision of temporary intensive care bed capacity. However, there is a limit where the hospitals may run out of resources to provide critical care, which is heavily dependent on (...) trained staff, just-in-time supply chains for clinical consumables and drugs and advanced equipment. In the first phase, we can still do clinical prioritisation and decision-making as usual, based on the need for intensive care and prognostication: what are the odds for a good result with regard to survival and quality of life. In the next, the resources are mostly available, but the system is stressed by many patients arriving over a short time period and auxiliary beds in different places in the hospital being used. We may have to abandon admittance of patients with doubtful prognosis. In the last phase, usual medical triage and priority setting may not be sufficient to decrease inflow and there may not be enough intensive care unit beds available. In this phase different criteria must be applied using a utilitarian approach for triage. We argue that this is an important transition where society, and not physicians, must provide guidance to support triage that is no longer based on medical priorities alone. (shrink)

How should modern medicine's dramatic new powers to sustain life be employed? How should limited resources be used to extend and improve the quality of life? In this collection, Dan Brock, a distinguished philosopher and bioethicist and co-author of Deciding for Others (Cambridge, 1989), explores the moral issues raised by new ideals of shared decision making between physicians and patients. The book develops an ethical framework for decisions about life-sustaining treatment and euthanasia, and examines how these life and death (...) decisions are transformed in health policy when the focus shifts from what is best for a patient to what is just for all patients. Professor Brock combines acute philosophical analysis with a deep understanding of the realities of clinical health policy. This is a volume for philosophers concerned with medical ethics, health policy professionals, physicians interested in bioethics, and undergraduate courses in biomedical ethics. (shrink)

Neither of the two central moral and political obstacles to human embryonic stem cell research survives critical scrutinyThis paper argues that neither of the two central moral and political obstacles to human embryonic stem cell research survives critical scrutiny: first, that derivation of HESCs requires the destruction of human embryos which are full human persons or are at least deserving of respect incompatible with their destruction; second, that creation of HESCs using somatic cell nuclear transfer or cloning is immoral. First, (...) different sources of HESCs are distinguished and the distinct moral objections that might apply to each. Second, it is argued that none of the properties plausibly conferring personhood on an entity is possessed by human embryos, and then shown how destruction of an embryo for research with the prospect of important medical benefits can be compatible with respecting it. Third, it is shown that the main objection to human cloning is only to reproductive cloning and that the objection to creating human beings with the intention of destroying them does not apply to SCNT. Finally, the concern that acquiring human eggs for SCNT would involve exploiting women donors is addressed, and it is shown how that can be avoided.Human embryonic stem cell research has become one of the more politically and morally controversial issues of our time. There is wide variability in what HESC research, if any, is permitted in countries around the world. Within the United States HESC research was a major issue in the last presidential election and some states, such as California, are devoting substantial public monies to fund this research while others prohibit it. In this paper I will explore some of the main obstacles to reaching consensus on this issue in the hope of at least narrowing the disagreement …. (shrink)

This article references the following linked citations. If you are trying to access articles from an off-campus location, you may be required to first logon via your library web site to access JSTOR. Please visit your library's website or contact a librarian to learn about options for remote access to JSTOR.

In lieu of an abstract, here is a brief excerpt of the content:The Ideal of Shared Decision Making Between Physicians and PatientsDan W. Brock (bio)IntroductionShared treatment decision making, with its division of labor between physician and patient, is a common ideal in medical ethics for the physician-patient relationship.1 Most simply put, the physician's role is to use his or her training, knowledge, and experience to provide the patient with facts about the diagnosis and about the prognoses without treatment and (...) with alternative treatments. The patient's role in this division of labor is to provide the values—his or her own conception of the good—with which to evaluate these alternatives, and to select the one that is best for himself or herself. As a rough guide to practice, this is a reasonable conception; most of the time it is likely to produce sound treatment decisions. However, as an ideal it is too simplistic, and is subject to several challenges that I will explore in this paper.Some challenges relate to the physician's role. This facts/values division of labor seems to assume that the physician can and should provide the facts about treatment alternatives in a value-neutral form. But some have questioned whether the sciences on which medicine is based are, or can be, value free. Moreover, the concepts of health and disease, and of the normal and pathological, are held by many to be value laden. And even if it is possible for physicians to provide only value-neutral facts to the patient, should the physicians' role be restricted in this way?Other challenges that I will present in the paper are to the patient's role [End Page 28] as provider of the values for the evaluation of the different treatment alternatives. One defense of this role is based on the claim that physicians are not in a position to know reliably what is in a patient's best interests (Buchanan, forthcoming). I believe at least as influential—even if often not explicitly stated—is an extreme subjectivism about values that assumes that the patient's own ultimate values, which define his or her own conception of the good, are incorrigible. By incorrigible, I mean they cannot be mistaken. In the standard case in which treatment is pursued for the patient's benefit, this extreme subjectivism is thought to support the patient's values guiding treatment decision making and treatment. I will explore this incorrigibility claim and will argue that on each of the main philosophical conceptions of the good for persons it is indefensible and should not be the basis for shared treatment decision making.Underlying this view of the physician-patient division of labor are assumptions and beliefs about the nature and relation of facts and values, and science and ethics, that are largely the legacy of a logical positivism that has long since been rejected by most philosophers. It is time that these unstable foundations for our normative ideal of the physician-patient relation were finally removed and replaced with more defensible underpinnings.Two Models of the Physician-Patient RelationshipPositivists insisted on a relatively sharp distinction between descriptive or empirical claims and science, on the one hand, and evaluative claims and ethics, on the other.2 Descriptive statements and the claims of science were to be true or false according to whether they in fact correctly described and explained the world. By remaining properly descriptive or empirical, science could, at least in principle, be entirely value neutral or value free.In its more extreme versions, positivism held that ethical judgments lacked cognitive content, but were instead expressions of emotions or attitudes, and as such could be neither true nor false, correct or mistaken. Because no evaluative statements were held to be logically entailed by any descriptive or empirical statements, moral reasoning was thought to be properly understood not as reasoning but as attempts at nonrational persuasion.3 Many drew from this an extreme subjectivism in ethics along the lines of what I have called above the incorrigibility thesis—there is no meaningful sense in which an individual's ultimate values defining his or her own conception of the good life could be mistaken, false, or unfounded.These... (shrink)

Some medical services have long generated deep moral controversy within the medical profession as well as in broader society and have led to conscientious refusals by some physicians to provide those services to their patients. More recently, pharmacists in a number of states have refused on grounds of conscience to fill legal prescriptions for their customers. This paper assesses these controversies. First, I offer a brief account of the basis and limits of the claim to be free to act on (...) one’s conscience. Second, I sketch an account of the basis of the medical and pharmacy professions’ responsibilities and the process by which they are specified and change over time. Third, I then set out and defend what I call the “conventional compromise” as a reasonable accommodation to conflicts between these professions’ responsibilities and the moral integrity of their individual members. Finally, I take up and reject the complicity objection to the conventional compromise. Put together, this provides my answer to the question posed in the title of my paper: “Conscientious refusal by physicians and pharmacists: who is obligated to do what, and why?”. (shrink)

The Human Genome Project will produce information permitting increasing opportunities to prevent genetically transmitted harms, most of which will be compatible with a life worth living, through avoiding conception or terminating a pregnancy. Failure to prevent these harms when it is possible for parents to do so without substantial burdens or costs to themselves or others are what J call “wrongful handicaps”. Derek Parfit has developed a systematic difficulty for any such cases being wrongs — when the harm could be (...) prevented only by preventing the existence of the individual who would have a worthwhile life even with the handicap, then bringing him into existence with the handicap does not make him worse off and so does not wrong him. I argue that a non “person‐affecting” principle requiring the avoidance of suffering and limited opportunity correctly accounts for cases of wrongful handicaps without requiring that the individuals with the handicap have been made worse off and therefore wronged. It is an advantage, not a difficulty, of this account that it does not imply that the person with the handicap has been wronged or is a victim with a special moral complaint. (shrink)

Recent EEG studies on the early postmortem interval that suggest the persistence of electrophysiological coherence and connectivity in the brain of animals and humans reinforce the need for further investigation of the relationship between the brain’s activity and the dying process. Neuroscience is now in a position to empirically evaluate the extended process of dying and, more specifically, to investigate the possibility of brain activity following the cessation of cardiac and respiratory function. Under the direction of the Center for Healthy (...) Minds at the University of Wisconsin-Madison, research was conducted in India on a postmortem meditative state cultivated by some Tibetan Buddhist practitioners in which decomposition is putatively delayed. For all healthy baseline and postmortem subjects presented here, we collected resting state electroencephalographic data, mismatch negativity, and auditory brainstem response. In this study, we present HB data to demonstrate the feasibility of a sparse electrode EEG configuration to capture well-defined ERP waveforms from living subjects under very challenging field conditions. While living subjects displayed well-defined MMN and ABR responses, no recognizable EEG waveforms were discernable in any of the tukdam cases. (shrink)

In this paper I will address whether the restriction on the creation of human embryos solely for the purpose of research in which they will be used and destroyed in the creation of human stem cell lines is ethically justified. Of course, a cynical but perhaps accurate reading of the new Obama policy is that leaving this restriction in place was done for political, not ethical, reasons, in light of the apparent public opposition to creating embryos for use in this (...) research. But the issue of whether the restriction is ethically justified remains important, even if only for another day in the policy arena. (shrink)

Book reviewed in this article: Life and Death: Philosophical Essays in Biomedical Ethics. By Dan W. Brock.

The Human Genome Project will produce information permitting increasing opportunities to prevent genetically transmitted harms, most of which will be compatible with a life worth living, through avoiding conception or terminating a pregnancy. Failure to prevent these harms when it is possible for parents to do so without substantial burdens or costs to themselves or others are what J call “wrongful handicaps”. Derek Parfit has developed a systematic difficulty for any such cases being wrongs — when the harm could be (...) prevented only by preventing the existence of the individual who would have a worthwhile life even with the handicap, then bringing him into existence with the handicap does not make him worse off and so does not wrong him. I argue that a non “person‐affecting” principle requiring the avoidance of suffering and limited opportunity correctly accounts for cases of wrongful handicaps without requiring that the individuals with the handicap have been made worse off and therefore wronged. It is an advantage, not a difficulty, of this account that it does not imply that the person with the handicap has been wronged or is a victim with a special moral complaint. (shrink)

Exploring the Illusion of Free Will and Moral Responsibility is an edited collection of new essays by an internationally recognized line-up of contributors. It is aimed at readers who wish to explore the philosophical and scientific arguments for free will skepticism and their implications.

There are substantial data establishing that surrogates are often mistaken in predicting what treatments incompetent patients would have wanted and that supplements such as advance directives have not resulted in significant improvements. Rid and Wendler’s Patient Preference Predictor (PPP) proposal will attempt to gather data about what similar patients would prefer in a variety of treatment choices. It accepts the usual goal of patient autonomy and the Substituted Judgment principle for surrogate decisions. I provide reasons for questioning sole reliance on (...) autonomy when surrogates, not patients, are deciding and for giving some independent weight to patient well-being. Moreover, that family members, typical surrogates, will know best what the patient if incompetent would have wanted is not the only reason why they are chosen. The more pressing problem is that the PPP would fail to remove the more serious mistakes that empirical psychology over the last few decades has shown to infect such decision making. (shrink)

This chapter contains sections titled: An Ethical Framework for Treatment Decision‐making Futile Treatment Ordinary and Extraordinary Treatment Killing and Allowing to Die Treating Pain and the Doctrine of Double Effect Conclusion References Further reading.

In 1990 the landmark Americans with Disabilities Act (ADA) became federal law with the express purpose to “establish a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities."l The act includes separate titles prohibiting discrimination on the basis of disability in employment, public services, transportation and public accommodations. Since it prohibits discrimination on the basis of disability in both public and private services and programs, in health care “it applies to programs provided by the government, (...) benefits provided by employers, and services pro- ”2 vided by physicians.Moreover, the ADA defines disability broadly to include “any.. (shrink)

This book, written by four internationally renowned bioethicists and first published in 2000, was the first systematic treatment of the fundamental ethical issues underlying the application of genetic technologies to human beings. Probing the implications of the remarkable advances in genetics, the authors ask how should these affect our understanding of distributive justice, equality of opportunity, the rights and obligations as parents, the meaning of disability, and the role of the concept of human nature in ethical theory and practice. The (...) book offers a historical context to contemporary debate over the use of these technologies by examining the eugenics movement of the late nineteenth and early twentieth centuries. The questions raised in this book will be of interest to any reflective reader concerned about science and society and the rapid development of biotechnology, as well as to professionals in such areas as philosophy, bioethics, medical ethics, health management, law, and political science. (shrink)

John Kleinig, Paternalism Totowa, NJ: Rowman & Allanheld, 1984, xiii + 242 pp.

It is widely recognized that prioritizing health care resources by their relative cost-effectiveness can result in lower priority for the treatment of disabled persons than otherwise similar non-disabled persons. I distinguish six different ways in which this discrimination against the disabled can occur. I then spell out and evaluate the following moral objections to this discrimination, most of which capture an aspect of its unethical character: it implies that disabled persons' lives are of lesser value than those of non-disabled persons; (...) it constitutes “double jeopardy” or violates Frances Kamm's non-linkage principle; it conflicts with equality of opportunity; it conflicts with fairness, which requires ignoring (some/most) differential impacts of treatment; it wrongly gives lower priority to disabled persons for equally effective treatment; it conflicts with giving all persons an equal chance to reach their full potential; and, it is in conflict with giving priority to the worse off. (shrink)

In this paper I address the relation between just claims to health care and severe cognitive impairment from dementia. Two general approaches to justice in allocation of health care are distinguished – prudential allocation and interpersonal distribution. First, I analyze why a patient who has died has no further claims to health care. Second, I show why prudential allocators would not provide for health care treatment should they be in a persistent vegetative state. Third, I argue that the destruction of (...) personal identity from severe dementia implies that only claims to palliative, but not life-sustaining, health care remain. Finally, I argue that the prudential allocator approach is indeterminate regarding life-sustaining care for the moderately demented and that social policy should not deny that care to patients. Keywords: elderly, health care, the severely-demented, justice CiteULike Connotea Del.icio.us What's this? (shrink)

In the months preceding the writing of this review, bioethics has been in the news a great deal. In congressional and public policy debates surrounding stem cell research, human cloning, and the Human Genome Project, bioethics and bioethicists have gained national attention and been subject to public scrutiny. Commentators have asked who these self-appointed moral experts are to tell us what is right and wrong.

Our purpose in this essay is twofold: to explore John Deely’s “semiotic” or “contextualized animal” as also a “contextualizing animal”, one that not only responds in context but one that changes first the context so as later to change itself—as all living things do; and to explore how this context-shifting “semiotic animal” has caused to emerge the very “signs upon which”, as Deely writes, “the whole of life depends”. Environmental ethics are inseparable from personal ethics, then, because (1) we are (...) in fact ourselves environments for others, (2) we carry models of our environments within us (our genetic / ontogenetic selves), and (3) even our free will (the basis of ethical choice) is an “environmental” phenomenon, as Martin Heisenberg argues in Nature (14 May 2009: 164–165) and as Deely writes in Semiotic Animal: “signs do not fall strictly among the things objectified by perceptions of sense but act prior to that perception to enable it to reconstruct the physical environment along objective lines that are meaningful to the species” (Semiotic Animal: A Postmodern Definition of Human Being Transcending Patriarchy and Feminism [2010]: 119). (shrink)

: Bioethics has focused principally on ethical issues arising in clinical medicine. When it has addressed justice or equity, it has focused on access to health care and on defending a general moral right to health care. This dual focus on establishing a right to health care and on health care rather than health has left bioethics largely silent on two issues of fundamental importance for a full account of justice and health. First, the focus on establishing a right to (...) health care has contributed to a failure to address difficult issues in developing ethical standards for equitably prioritizing limited resources in health care. Second, the focus on inequalities in access to health care has ignored the much greater impact of social determinants of health, in particular socioeconomic class and inequality, on health and health inequalities. Bioethics must broaden its agenda. (shrink)

Rationing is the allocation of a good under conditions of scarcity, which necessarily implies that some who want and could be benefitted by that good will not receive it. One reflection of our ambivalence towards health care rationing is reflected in our resistance to having it distributed in a market like most other goods—most Americans reject ability to pay as the basis for distributing health care. They do not view health care as just another commodity to be distributed by markets. (...) Despite this widespread view, we are the only developed country without some form of universal health insurance, and so for the 46 million Americans without health insurance their access to health care often does depend on their ability to pay for it. Rationing largely remains a topic that the public, their elected leaders, and many health care professionals prefer to avoid. Ever-growing costs of health care will increasingly force the practice and issue of health care resource prioritization and rationing into the open for public, professional, and political attention. This paper explores some of the features of those practices and issues that make them especially ethically and politically difficult. Those issues will not be easily resolved, but avoiding them will not avoid the need or reality of rationing, it will only mean that it will go on covertly and unexamined. That will lead neither to better or more legitimate prioritization and rationing decisions. (shrink)

Competent adults should be permitted to determine the course of their own lives. We may try to influence them. We may ask them, perhaps even implore them, to change their minds. But in the end, they are in charge of their lives. They get to choose their careers, whether and whom to marry, whether to exercise, and whether to have surgery.This emphasis on respect for patients’ autonomy may seem to imply that allowing patients to make their own decisions should always (...) take precedence over other considerations. Given this presumption, there has been almost no discussion in the medical literature or elsewhere about how important this value is and whether it should sometimes be balanced against and give way to other values. This absence of guidance is especially problematic in cases where respect for patient autonomy conflicts with promoting patients’ clinical interests. (shrink)