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.

Over a decade ago the field of bioethics was established in response to the increased control over the design of living organisms afforded by both medical genetics and biotechnology. Since its introduction, bioethics has become established as an academic discipline with journals and professional societies, is covered regularly in the media, and affects people everyday around the globe. In response to the increasing need for information about medical genetics and biotechnology as well as the ethical issues these fields raise, Sheed & Ward proudly presents the Readings in Bioethics Series. Edited by Thomas A. Shannon, the series provides anthologies of critical essays and reflections by leading ethicists in four pivotal areas: reproductive technologies, genetic technologies, death and dying, and health care policy. The goal of this series is twofold: first, to provide a set of readers on thematic topics for introductory or survey courses in bioethics or for courses with a particular theme or time limitation. Second, each of the readers in this series is designed to help students focus more thoroughly and effectively on specific topics that flesh out the ethical issues at the core of bioethics. The series is also highly accessible to general readers interested in bioethics. This volume collects critical essays by leading scholars on the definition of death, consciousness, quality of life, tube feeding, pallative care, physician-assisted suicide and the debate on euthanasia. Included in this volume are works by Paul B. Bascom, David DeGrazia, Ezekiel J. Emanuel, Kathleen Foley, Herbert Hendin, Michael Panicola, Stephen G. Post, Thomas A. Shannon, Charles F. von Gunten, Susan W. Tolle.

When is clinical research in developing countries exploitation? Exploitation is a concept in ordinary moral thought that has not often been analyzed outside the Marxist tradition. Yet it is commonly used to describe interactions that seem morally suspect in some way. A case in point is clinical research sponsored by developed countries and carried out in developing countries, with participants who are poor and sick, and lack education. Such individuals seem vulnerable to abuse. But does this, by itself, make such research exploitative?

"Exploitation and Developing Countries" is an attempt by philosophers and bioethicists to reflect on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation in such circumstances. These reflections should interest clinical researchers, since locating the line between appropriate and inappropriate use of subjects--the line between exploitation and fair use--is the central question at the heart of research ethics. Reflection on this rich and important moral concept should also interest normative moral philosophers of a non-Marxist bent.

In addition to the editors, the contributors are Richard J. Arneson, Alisa L. Carse, Margaret Olivia Little, Thomas Pogge, Andrew W. Siegel, and Alan Wertheimer.

Global health is at a crossroads. The 2030 Agenda for Sustainable Development has come with ambitious targets for health and health services worldwide. To reach these targets, many more billions of dollars need to be spent on health. However, development assistance for health has plateaued and domestic funding on health in most countries is growing at rates too low to close the financing gap. National and international decision-makers face tough choices about how scarce health care resources should be spent. Should additional funds be spent on primary prevention of stroke, treating childhood cancer, or expanding treatment for HIV/AIDS? Should health coverage decisions take into account the effects of illness on productivity, household finances, and children's educational attainment, or just focus on health outcomes? Does age matter for priority setting or should it be ignored? Are health gains far in the future less important than gains in the present? Should higher priority be given to people who are sicker or poorer? Global Health Priority-Setting provides a framework for how to think about evidence-based priority-setting in health. Over 18 chapters, ethicists, philosophers, economists, policy-makers, and clinicians from around the world assess the state of current practice in national and global priority setting, describe new tools and methodologies to address establishing global health priorities, and tackle the most important ethical questions that decision-makers must consider in allocating health resources.

What does innovation mean to and in India? What are the predominant sites of activity where Indians innovate, and under what situations do they work or fail? This book addresses these all-important questions arising within diverse Indian contexts: informal economy, low-cost settings, large business groups, entertainment and copyright industries, an evolving pharma sector, a poorly organized and appallingly underfunded public health system, social enterprises for the urban poor, and innovations-for-the-millions. Its balanced perspective on India's promises and failings makes it a valuable addition for those who believe that India's future banks heavily on its ability to leapfrog using innovation, as well as those sceptical of the Indian state's belief in the potential of private enterprise and innovation. It also provides critical insights on innovation in general, the most important of which being the highly context-specific, context-driven character of the innovation project.

Can the ethical mission of health care survive among organizations competing for survival in the marketplace? On this question hinges not only the future of health care in the US, but that of the health care systems of all advanced countries. This book presents both an analytic framework and a menu of pragmatic answers. The team of authors, physician-ethicists from Harvard Medical School and the National Institutes of Health, worked with a consortium of health care organizations to explore some of the most challenging dilemmas in health care today: How can health plans determine medical necessity in a way that ensures quality care, controls costs, and builds trust with patients and physicians? What are the strategies for caring for vulnerable populations that meet their special neds without dramatically increasing costs? To answer these and other similar questions the authors blend ethical analysis with real-world example. The outcome is a rich analysis of the ethical challenges facing health care organizations, combined with tangible examples of exemplary methods to address these challenges. This book will help health care leaders, regulators, and policy makers incorporate exemplary practices, and the underlying themes they embody, into the very heart and soul of health care organizations.

Ezekiel Emanuel, trained as both a physician and a political theorist, rejects the claim that most of today's dilemmas of medical ethics are created by advances in medical technology. He maintains that the seemingly endless debates are the inevitable consequence of liberal political values. He proposes an alternative ideology, a liberal communitarianism that imagines a federation of political communities dedicated to democratic deliberations to guide the formulation of laws and policies.