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)
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.
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)
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.
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.
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)
Traditionally, biomedical research has been devoted to improvement in the understanding and treatment or prevention of disease. Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer (Turner et al. 2003; Vastag 2004; Rose 2002). As with other biomedical interventions, research to assess the safety and efficacy of these enhancements in humans should be conducted (...) before their introduction into clinical practice.1 However, various concerns regarding the ethics of enhancement research could be raised. Those who .. (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)
This article examines a fundamental question of justice in global health. Is it ethically preferable to provide a larger number of people with cheaper treatments that are less effective (or more toxic), or to restrict treatments to a smaller group to provide a more expensive but more effective or less toxic alternative? We argue that choosing to provide less effective or more toxic interventions to a larger number of people is favored by the principles of utility, equality, and priority for (...) those worst-off. Advocates are mistaken to demand that medical care provided in low-income and middle-income countries should be the same as in high-income countries. (shrink)
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 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)
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)
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)
Our Viewpoint argues that expanding access to less effective or more toxic treatments is supported not only by utilitarian ethical reasoning but also by two other ethical frameworks: those that emphasise equality and those that emphasise giving priority to the patients who are worst off. The inadequate resources available for global health reflect not only natural constraints but also unwise social and political choices. However, pitting efforts to reduce inequality and better fund global health against efforts to put available resources (...) to their best use mistakes complementary objectives for conflicting ones. (shrink)
Controversy persists over the ethics of compensating research participants and providing posttrial benefits to communities in developing countries. Little is known about residents' views on these subjects. In this study, interviews about compensation and posttrial benefits from a hypothetical HIV vaccine trial were conducted in Uganda’s Rakai District. Most respondents said researchers owed the community posttrial benefits and research compensation, but opinions differed as to what these should be. Debates about posttrial benefits and compensation rarely include residents' views like these, (...) but future ones should. (shrink)
American health care reformers face a number of ethical issues, including familiar debates over the merits of a single-payer system and publicly provided universal health insurance. No matter how these debates are resolved, a further ethical question must be addressed. Both universal coverage and a single-payer system are compatible with permitting some patients to pay more for faster, better, or more health care choices. Should the United States continue to have a two-tier health care system in which wealth grants some (...) patients access to medical services that others with the same needs cannot obtain? Critical evaluation of both principled objections to inequalities and practical objections to anticipated social and medical consequences of a two-tier health care system are needed. (shrink)
This book presents a collection of original essays by leading thinkers in political theory, philosophy, and bioethics on key issues concerning global justice and bioethics. It is the first collection to comprehensively address these pressing theoretical and practical questions about international distributive justice, humans rights, health care and medical research.