The Belmont Report

The Belmont Report

Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Publisher:

Published: 1978

Total Pages: 614

ISBN-13:

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The Ethics of Research with Human Subjects

The Ethics of Research with Human Subjects

Author: David B. Resnik

Publisher: Springer

Published: 2018-01-09

Total Pages: 320

ISBN-13: 3319687565

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This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.


The Censor's Hand

The Censor's Hand

Author: Carl E. Schneider

Publisher: MIT Press

Published: 2015-04-10

Total Pages: 293

ISBN-13: 0262028913

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An argument that the system of boards that license human-subject research is so fundamentally misconceived that it inevitably does more harm than good. Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated (often minutely) by federally required and supervised bureaucracies called “institutional review boards” (IRBs). Do—can—these IRBs do more harm than good? In The Censor's Hand, Schneider addresses this crucial but long-unasked question. Schneider answers the question by consulting a critical but ignored experience—the law's learning about regulation—and by amassing empirical evidence that is scattered around many literatures. He concludes that IRBs were fundamentally misconceived. Their usefulness to human subjects is doubtful, but they clearly delay, distort, and deter research that can save people's lives, soothe their suffering, and enhance their welfare. IRBs demonstrably make decisions poorly. They cannot be expected to make decisions well, for they lack the expertise, ethical principles, legal rules, effective procedures, and accountability essential to good regulation. And IRBs are censors in the place censorship is most damaging—universities. In sum, Schneider argues that IRBs are bad regulation that inescapably do more harm than good. They were an irreparable mistake that should be abandoned so that research can be conducted properly and regulated sensibly.


Belmont Revisited

Belmont Revisited

Author: James F. Childress

Publisher: Georgetown University Press

Published: 2005

Total Pages: 300

ISBN-13: 9781589010628

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Research on human subjects has always been a highly controversial topic in the field of bioethics. The book, featuring contributions from a Who's Who of biothics scholars, analyzes the seminal document on the topic in the United States: the 1979 Belmont Report, widely regarded as the single-most influential set of guidelines in the practice of bioethics.The Belmont Report is a 20-page statement that spells out the rationale for ethical research on humans, concluding that three primary principles are at play: respect for persons, beneficence, and justice. Since the publication of Belmont these three principles, spelled out further by philosopher Tom Beauchamp and ethicist James Childress and known as the "Georgetown mantra," have dominated all discussions of research on human subjects--though, as this book will show, not everyone agrees that this is the most helpful way to think about the matter. In fact, this book is both a broad overview of the evolution of the Belmont Report and, more important, 1) an assessment of its shortcomings and 2) a strong call to rethink how hospitals and pharmaceutical companies can conduct research more humanely and more ethically. So while the book looks back to the creation of Belmont, it also looks forward to the future of research. Contributors, in addition to the editors, include Alexander Capron, Ruth Faden, Eric Cassell, Karen Lebacqz, Larry Churchill, Robert Levine, Patricia King (Georgetown), Susan Sherwin, Ezekiel Emanuel, Robert Veach (Georgetown), Henry Richardson (Georgetown), John Evans.


Beyond Regulations

Beyond Regulations

Author: Nancy M. P. King

Publisher: UNC Press Books

Published: 1999

Total Pages: 300

ISBN-13: 9780807847701

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Across a broad range of disciplines_in medicine, social science, and the humanities_researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how r


Silent Partners

Silent Partners

Author: Rebecca Dresser

Publisher: Oxford University Press

Published: 2017

Total Pages: 321

ISBN-13: 0190459271

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The research ethics system was created without the help of people who know what it is like to be a research subject. This is a serious omission. Experts have overlooked ethical issues that matter to subjects. Silent Partners moves subjects to the forefront, giving them a voice in research ethics.


Recovering the Human Subject

Recovering the Human Subject

Author: James Laidlaw

Publisher: Cambridge University Press

Published: 2018-02-15

Total Pages: 207

ISBN-13: 1108424961

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A focused debate on human subjectivity and post-humanism, with a range of theoretical and ethnographic responses to a classic article.


Images of History

Images of History

Author: Richard Eldridge

Publisher: Oxford University Press

Published: 2017-12

Total Pages: 257

ISBN-13: 0190847360

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Human subjects are both formed by historical inheritances and capable of active criticism. Insisting on this fact, Kant and Benjamin each develop powerful, systematic, but sharply opposed accounts of human powers and interests in freedom. A persistent constitutive tension between Kantian and Benjaminan ideals is woven through human life. By examining the two philosophers through this volume, Richard Eldridge attempts to make better sense of the commitment forming, commitment revising, anxious, reflective and acculturated human subjects we are.


Protecting Data Privacy in Health Services Research

Protecting Data Privacy in Health Services Research

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-13

Total Pages: 208

ISBN-13: 0309071879

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The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.