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)
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.
"--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.
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)
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)
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.
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)
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)
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)
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)
This study reviews the amount of attention bioethics, health law, and health economics receive in medical school curricula and the background of professors teaching these topic. It concludes that the number of required hours of instruction in bioethics, health law, and health economics in medical schools comprises less than two percent of the medical school curriculum; that time on these subjects is heavily weighted toward the first two years of medical education; and that many instructors have not published on the (...) subjects they are teaching. (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)
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.
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)
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)