This article is an attempt at a ‘political’ reading of Kafka’s The Castle, as an ironical, radical critique - from a libertarian perspective - of the despotism of the modern bureaucratic apparatus. This reading is not self-evident. Like all Kafka’s unfinished novels, Das Schloss is a strange and fascinating literary document that creates perplexity and inspires various contradictory and/or dissonant interpretations. And like The Trial it has been the object of very many religious and theological readings. Michael Löwy concludes by (...) arguing that commentators have neglected the character of Amalia, one of the most impressive female figures in Kafka’s work, who is at the heart of the libertarian individualism of the Prague writer. (shrink)
The Progress of the Left in Latin America: Governments, Social Movements, the Struggles of the Amerindian Populations Gérard Duménil and Michaël Löwy here interview Michel Lemoine about the nature of the governments currently in office in Argentina, Brazil, Uruguay, Bolivia and Venezuela. What contribution can these governments make to the task of establishing an anti-imperialist front? What are the specific features of the Latin American resistance to neo-liberalism, in view of the articulation between this resistance and the struggles of the (...) Amerindian populations? How is one to assess the manner in which Chavez defines and attempts to implement his project of a “socialism for the twenty-first century”. These are the principal questions addressed here. (shrink)
On Marx et Marxisms. In response to the questions addressed by Jacques Bidet and Bruno Tinel, Gérard Duménil, Michael Löwy and Emmanuel Renault here outline the approach they adopted in their two recently published books on Marx, and on Marxisms . The questions raised here mainly hinge on the articulation between the political, the philosophical and the economic dimension of Marx’s writings, and the way these can be mobilised within contemporary debates.
Allocation of very scarce medical interventions such as organs and vaccines is a persistent ethical challenge. We evaluate eight simple allocation principles that can be classiﬁed into four categories: treating people equally, favouring the worst-oﬀ, maximising total beneﬁts, and promoting and rewarding social usefulness. No single principle is suﬃcient to incorporate all morally relevant considerations and therefore individual principles must be combined into multiprinciple allocation systems. We evaluate three systems: the United Network for Organ Sharing points systems, quality-adjusted life-years, and (...) disability-adjusted life-years. We recommend an alternative system—the complete lives system—which prioritises younger people who have not yet lived a complete life, and also incorporates prognosis, save the most lives, lottery, and instrumental value principles. (shrink)
The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...) current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)
This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. But what sorts of (...) "use" are morally permissible? What is it to exploit people? Suppose that a trial conducted in a developing country would not be ethically permissible in the developed world. Can we automatically conclude from this that the trial is unethical, that some sort of morally problematic double standard is in operation? Or might the differences in the two settings justify differences in trial design? This collection of philosophical essays examines these important questions about what exploitation is and when clinical research counts as exploitative. -/- "This is an outstanding contribution to the growing literature on the ethics of research with human subjects and a fine example of what bioethics can offer at its best. Anyone with a serious interest in these issues will need to read this book from start to finish." -Daniel Wikler, Harvard School of Public Health "This book contributes significantly to the literature on exploitation in clinical research conducted in the developing world."--Patricia Marshall, Case Western Reserve University . (shrink)
1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.
We consider an ethical dilemma in global health: is it ethically acceptable to provide some patients cheaper treatments that are less effective or more toxic than the treatments other patients receive? We argue that it is ethical to consider local resource constraints when deciding what interventions to provide. The provision of cheaper, less effective health care is frequently the most effective way of promoting health and realizing the ethical values of utility, equality, and priority to the worst off.
Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...) in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. Results and Discussion This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal. (shrink)
Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of (...) possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research. (shrink)
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the (...) trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)
Current challenges in medical practice, research, and administration demand physicians who are familiar with bioethics, health law, and health economics. Curriculum directors at American Association of Medical Colleges-affiliated medical schools were sent confidential surveys requesting the number of required hours of the above subjects and the years in which they were taught, as well as instructor names. The number of relevant publications since 1990 for each named instructor was assessed by a PubMed search.In sum, teaching in all three subjects combined (...) comprises less than two percent of the total hours in the American medical curriculum, and most instructors have not recently published articles in the fields they teach. This suggests that medical schools should reevaluate their curricula and instructors in bioethics, health law, and health economics. (shrink)
The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical (...) appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research?social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants. (shrink)
We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
Many guidelines for international research require that studies be responsive to host community health needs or health priorities. Although responsiveness possesses great intuitive and rhetorical appeal, existing conceptions are confusing and difficult to apply. Not only are there few examples of what research the responsiveness requirement permits and what it rejects, but its application can lead to contradictory results. Because of the practical difficulties in applying responsiveness and the danger that misapplying responsiveness could harm the interests of developing countries, we (...) argue that responsiveness should be refocused in three ways: in terms of (1) who enforces it, (2) under what standard, and (3) in what cases. We conclude that responsiveness should be applied by host country officials at the policy level with the exercise of judgment when externally funded research threatens to displace scarce local resources. (shrink)
The 2010 Patient Protection and Affordable Care Act was designed to increase health insurance coverage in the United States. Its most controversial feature is the requirement that US residents purchase health insurance. Opponents of the mandate argue that requiring people to contribute to the collective good is inconsistent with respect for individual liberty. Rather than appeal to the collective good, this Viewpoint argues for a duty to buy health insurance based on the moral duty individuals have to reduce certain burdens (...) they pose on others. When some people have a duty to rescue, others may have a duty to take rescue precautions, in this case, to purchase health insurance to cover acute and emergency care needs. Requiring that individuals meet this obligation is consistent with respect of individual liberty. (shrink)
The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached (...) 139 volunteers to participate, and 138 completed the questionnaire . The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study. (shrink)
As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may (...) be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed. (shrink)
This paper focuses on the role of regulation in the shaping new scientific facts. Fleck chose to study the origins of a diagnostic test for a disease seen as a major public health problem, that is, a ‘scientific fact’ that had a direct and immediate influence outside the closed universe of fundamental scientific research. In 1935, when Fleck wrote his book, Genesis and development of a scientific fact, he believed that the tumultuous early history of the Wassermann reaction had come (...) to an end, and that this reaction was successfully stabilized through the standardization of laboratory practices and thanks to the rise of a specific professional segment—the serologists. He could not have predicted that in the 15 years that followed the publication of his book, regulatory measures—barely metioned in his historical narrative—would play a key role in the destabilization of the original meaning of this reaction. The introduction of mass screening for syphilis—mainly via legislation that introduced obligatory premarital tests and promoted the testing of pregnant women—weakened in fine the link between Wassermann serology and infection by the etiological agent of syphilis, the bacterium Treponema pallidum. Fleck elected to study the Wassermann reaction because of its novelty, its complexity, and because it became the focus of a controversy regarding its origins. However, the Wassermann reaction was also one the first examples of a medical technology regulated by the state and incorporated into legal dispositions. It may therefore be seen as an exemplary case of the close intertwining of scientific investigations, their practical applications and regulatory practices. (shrink)
The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.
Commentators often claim that medical research subjects are coerced into participating in clinical studies. In recent years, such claims have appeared especially frequently in ethical discussions of research in developing countries. Medical research ethics is more important than ever as we move into the 21st century because worldwide the pharmaceutical industry has grown so much and shows no sign of slowing its growth. This means that more people are involved in medical research today than ever before, and in the future (...) even more will be involved. However, despite the pressing need for reflection on research ethics, it is important to carefully identify the concerns we have about research. Otherwise we run the risk that the moral language we use, and which we hear other people use, may do our moral thinking for us. We argue that many recent claims about the occurrence of coercion in medical research are misguided and misuse the word "coercion." We try to identify the real problems, and urge people to attend carefully to the implications of their descriptions of moral problems in research. (shrink)
Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)
Suppose a meeting had been called among chief medical officers, chief administrative officers, and other leaders from a range of health-related institutions in this country. The question posed for this meeting was simple but unusual: Arethestructuresofourorganizations,systems,andinstitutionsethical? Though it was a question reminiscent for a few of the focus some time before on whether the conduct of individuals in their organization was ethical, this question seemed more demanding. Is it reasonable to consider structures or arrangements as ethical or not; or in (...) other words, is ethics an applicable attribute of organizations? And if it is reasonable to speak of an ethics of organizations, by what method might one discern any kind of an answer? And what of the informal connections that link different organizations … how can they be evaluated? (shrink)
In this short response to Kerstein and Bognar, we clarify three aspects of the complete lives system, which we propose as a system of allocating scarce medical interventions. We argue that the complete lives system provides meaningful guidance even though it does not provide an algorithm. We also defend the investment modification to the complete lives system, which prioritizes adolescents and older children over younger children; argue that sickest-first allocation remains flawed when scarcity is absolute and ongoing; and argue that (...) Kerstein and Bognar are mistaken to base their allocation principles on differences in personhood. (shrink)
The debate about justice and health care has occurred largely at a remove from the institutions it concerns; it has been about our most general moral principles, and about what things we value. This debate has foundered. But if the debate is turned in another direction, toward some moral principles that are widely accepted within those institutions, and toward principles that have to do with control over allocation decisions rather than with actually how to make those decisions, agreement may be (...) nearer at hand. (shrink)