The Oxford Textbook of Clinical Research Ethics

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The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
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About the author

Emanuel: Chair, Department of Bioethics, NIH. Grady: Department of Bioethics, NIH. Crouch: Poynter Center for the Study of Ethics, Indiana University. Lie: Department of Bioethics, NIH. Miller: Department of Bioethics, NIH. Wendler: Department of Bioethics, NIH
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Additional Information

Oxford University Press
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Published on
Apr 18, 2008
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Best For
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Medical / Ethics
Medical / Research
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Content Protection
This content is DRM protected.
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Eligible for Family Library

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In Death, Dying, and Organ Transplantation: Reconstructing Medical Ethics at the End of Life, Miller and Truog challenge fundamental doctrines of established medical ethics. They argue that the routine practice of stopping life support technology in hospitals causes the death of patients and that donors of vital organs (hearts, lungs, liver, and both kidneys) are not really dead at the time that their organs are removed for life-saving transplantation. These practices are ethically legitimate but are not compatible with traditional rules of medical ethics that doctors must not intentionally cause the death of their patients and that vital organs can be obtained for transplantation only from dead donors. In this book Miller and Truog undertake an ethical examination that aims to honestly face the reality of medical practices at the end of life. They expose the misconception that stopping life support merely allows patients to die from their medical conditions, and they dispute the accuracy of determining death of hospitalized patients on the basis of a diagnosis of "brain death" prior to vital organ donation. After detailing the factual and conceptual errors surrounding current practices of determining death for the purpose of organ donation, the authors develop a novel ethical account of procuring vital organs. In the context of reasonable plans to withdraw life support, still-living patients are not harmed or wronged by organ donation prior to their death, provided that valid consent has been obtained for stopping treatment and for organ donation. Recognizing practical difficulties in facing the truth regarding organ donation, the authors also develop a pragmatic alternative account based on the concept of transparent legal fictions. In sum, Miller and Truog argue that in order to preserve the legitimacy of end-of-life practices, we need to reconstruct medical ethics.
Since the early 2000s, the field of Responsible Conduct of Research has become widely recognized as essential to scientific education, investigation, and training. At present, research institutions with public funding are expected to have some minimal training and education in RCR for their graduate students, fellows and trainees. These institutions also are expected to have a system in place for investigating and reporting misconduct in research or violations of regulations in research with human subjects, or in their applications to federal agencies for funding. Public scrutiny of the conduct of scientific researchers remains high. Media reports of misconduct scandals, biased research, violations of human research ethics rules, and moral controversies in research occur on a weekly basis. Since the 2009 publication of the 2nd edition of Shamoo and Resnik's Responsible Conduct of Research, there has been a vast expansion in the information, knowledge, methods, and diagnosis of problems related to RCR and the multitude of ethical issues of human subject protections. With the climate surrounding research conduct always shifting, developments in the field make an updated edition a necessity. All chapters have been revised and reflect the most current RCR landscape. New or further-developed topics include social responsibility and misconduct in social sciences, climate-change research, authorship, and peer review. Updates include new information on research involving human subjects or "vulnerable" biological subjects, as well as genetic research. Just like in previous editions, all chapters contain recent case studies and legal examples of various subjects.
Despite the massive scale of global inequalities, until recently few political philosophers or bioethicists addressed their ethical implications. Questions of justice were thought to be primarily internal to the nation state. Over the last decade or so, there has been an explosion of interest in the philosophical issues surrounding global justice. These issues are of direct relevance to bioethics. The links between poverty and health imply that we cannot separate questions of global health from questions about fair distribution of global resources and the institutions governing the world order. Similarly, as increasing numbers of medical trials are conducted in the developing world, researchers and their sponsors have to confront the special problems of doing research in an unjust world, with corresponding obligations to correct injustice and avoid exploitation. This book presents a collection of original essays by leading thinkers in political theory, philosophy, and bioethics. They address the key issues concerning global justice and bioethics from two perspectives. The first is ideal theory, which is concerned with the social institutions that would regulate a just world. What is the relationship between human rights and the provision of health care? How, if at all, should a global order distinguish between obligations to compatriots and others? The second perspective is from non-ideal theory, which governs how people should behave in the unjust world in which we actually find ourselves. What sort of medical care should actual researchers working in impoverished countries offer their subjects? What should NGOs do in the face of cultural practices with which they deem unethical? If coordinated international action will not happen, what ought individual states to do? These questions have more than theoretical interest; their answers are of direct practical import for policymakers, researchers, advocates, NGOs, scholars, and others. This book is the first collection to comprehensively address the intersection of global justice and bioethical dilemmas.
From the era of slavery to the present day, the first full history of black America’s shocking mistreatment as unwilling and unwitting experimental subjects at the hands of the medical establishment.

Medical Apartheid is the first and only comprehensive history of medical experimentation on African Americans. Starting with the earliest encounters between black Americans and Western medical researchers and the racist pseudoscience that resulted, it details the ways both slaves and freedmen were used in hospitals for experiments conducted without their knowledge—a tradition that continues today within some black populations. It reveals how blacks have historically been prey to grave-robbing as well as unauthorized autopsies and dissections. Moving into the twentieth century, it shows how the pseudoscience of eugenics and social Darwinism was used to justify experimental exploitation and shoddy medical treatment of blacks, and the view that they were biologically inferior, oversexed, and unfit for adult responsibilities. Shocking new details about the government’s notorious Tuskegee experiment are revealed, as are similar, less-well-known medical atrocities conducted by the government, the armed forces, prisons, and private institutions.

The product of years of prodigious research into medical journals and experimental reports long undisturbed, Medical Apartheid reveals the hidden underbelly of scientific research and makes possible, for the first time, an understanding of the roots of the African American health deficit. At last, it provides the fullest possible context for comprehending the behavioral fallout that has caused black Americans to view researchers—and indeed the whole medical establishment—with such deep distrust. No one concerned with issues of public health and racial justice can afford not to read Medical Apartheid, a masterful book that will stir up both controversy and long-needed debate.

For years, people have been asking Ezekiel “Zeke” Emanuel, the brash, outspoken, and fiercely loyal eldest brother in the Emanuel clan, the same question: What did your mom put in the cereal? Middle brother Rahm is the mayor of Chicago, erstwhile White House chief of staff, and one of the most colorful figures in American politics. Youngest brother Ari is a Hollywood superagent, the real-life model for the character of Ari Gold on the hit series Entourage. And Zeke himself, whom the other brothers consider to be the smartest of them all, is one of the world’s leading bioethicists and oncologists, and a former special advisor for health policy in the Obama administration. How did one family of modest means produce three such high-achieving kids? Here, for the first time, Zeke provides the answer.
Set amid the tumult of Chicago in the 1960s and 1970s, Brothers Emanuel recounts the intertwined histories of these three rambunctious, hypercompetitive Jewish American boys, each with his own unique and compelling life story. But ultimately, this is the story of the entire Emanuel family: the tough, colorful Old World grandparents; a mischievous, loving father who immigrated to the United States with twenty-five dollars and who enthralled his boys with tales of his adventures in Israel’s war for independence; and a proud, politically engaged mother who took the boys with her to rallies and protests—including a civil rights march through the streets of Chicago led by Martin Luther King himself.
Even as the Emanuels distinguished themselves as individuals, the bond of brotherhood that tied them together was never broken. Brothers Emanuel is a wry, rollicking, and often poignant narrative of how one American family succeeded in raising three extraordinary children.

Praise for Brothers Emanuel
“An endearing, honest and gripping account of an American success story.”—San Francisco Chronicle

“A beautiful portrait of growing up Jewish in an urban environment during an era of profound social change.”—Publishers Weekly
“This delightful memoir is a deeply personal tale of one family, but it’s also about much larger things: America and tribal identity, love and rivalry, and the moral lessons to be learned as you grow up.”—Walter Isaacson
“Fascinating . . . a classic tale of an immigrant family.”—Chicago Tribune
“Mighty entertaining.”—The Hollywood Reporter
“A clear-eyed, candid memoir that is unique and yet quintessentially American.”—BookPage
“A fun read.”—The Forward
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