[PDF] The Ethics And Regulation Of Research With Human Subjects eBook

Author : David B. Resnik
Publisher : Springer
Page : 320 pages
File Size : 35,65 MB
Release : 2018-01-09
Category : Philosophy
ISBN : 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.

Author : Nancy M. P. King
Publisher : UNC Press Books
Page : 294 pages
File Size : 40,71 MB
Release : 2005-10-12
Category : Medical
ISBN : 0807876062

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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 relationships between funders and researchers should affect research design, for example, or whether the potential benefits of research can outweigh the importance of its subjects' interests are inadequately addressed by the prevailing, regulation-based research ethics paradigm. This book constitutes a reexamination of research ethics. It combines case studies and commentaries by a multidisciplinary group of scholars and researchers to explore such topics as informed consent, conflict of interest, confidentiality, and research on illegal behavior. All human subjects research takes place within complex social, cultural, and political contexts, the contributors argue. Increased consideration of the relationships between researchers and their subjects, funders, and institutions within these contexts will facilitate research that is sensitive and responsible as well as scientifically fruitful. Beyond Regulations features a keynote essay by Ruth Macklin. Other contributors are Marcela Aracena Alvarez, Jorge Balan, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renee C. Fox, Lara Freidenfelds, Gail E. Henderson, Nancy M. P. King, Loretta M. Kopelman, Ernest N. Kraybill, Barry M. Popkin, Silvina Ramos, Desmond K. Runyan, Jane Stein, Ronald P. Strauss, Keith A. Wailoo, and Cynthia Waszak. Across a broad range of disciplines--in biomedicine, the social sciences, and the humanities--researchers, scholars, administrators, and teachers increasingly struggle with questions of ethics in research with human subjects. All research takes place in complex social, cultural, political, and economic contexts; yet the prevailing principle-based research ethics paradigm does not adequately account for them. This book reexamines research ethics using a new relationships paradigm. Through in-depth cases, commentaries, and essays, a multidisciplinary group of scholars and researchers addresses informed consent, conflict of interest, confidentiality, and other issues, considering questions like: What relationships should researchers have with their subjects' communities? When researchers and subjects have different views about research, who should have control? How should relationships between funders and researchers affect research design? Can research be so potentially beneficial that its importance outweighs the interests of subjects? Examining the relationships between researchers and subjects, communities, funders, and institutions--including considerations of authority and voice--can facilitate human subjects research that is morally sensitive and responsible as well as scientifically fruitful.

Author : Robert J. Levine
Publisher : Yale University Press
Page : 484 pages
File Size : 14,24 MB
Release : 1988-01-01
Category : Language Arts & Disciplines
ISBN : 9780300042887

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The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved. "[Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library."--Norman Fost, M.D., The New England Journal of Medicine "Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history."--Daniel M. Fox, Bulletin of the History of Medicine "You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country."--Alex Paton, British Medical Journal "Should be of wide interest to those keen to see advances in medical research brought into general medical practice."--Gilbert Omenn, Issues in Science and Technology

Author : Carl H. Coleman
Publisher :
Page : pages
File Size : 16,79 MB
Release : 2005
Category : Human experimentation in medicine
ISBN : 9783620400054

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This book provides a set of teaching materials that could be used in an academic course on human subject research in a broad range of professional school settings. In developing these materials, the authors were mindful that their readers would include tomorrow's advisers, managers, and regulators of researchers and research institutions. If students are to be effective in these roles, they must not only understand the history of human subject protection and the relevant ethical and regulatory issues; they must begin to think critically about the existing regulatory system and to consider the desirability of policy reform. This book is largely comprised of primary source documents, including governmental regulations, guidance statements, and court decisions, and excerpts from the voluminous commentary produced by scholars, advisory commissions, and others. These materials are accompanied by extensive notes and questions, which expand on some of the issues raised in the primary readings and ask the reader to think about the gaps, ambiguities, and conflicts those materials raise.

Author : Ezekiel J. Emanuel
Publisher :
Page : 532 pages
File Size : 45,60 MB
Release : 2003
Category : Medical
ISBN :

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Professionals in need of such training and bioethicists will be interested.

Author : Volker Roelcke
Publisher : Franz Steiner Verlag
Page : 370 pages
File Size : 41,93 MB
Release : 2004
Category : History
ISBN : 9783515084550

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Debates on the ethics of human subjects research meet with an increasing interest both within the medical profession and the broader public. Frequently, historical arguments are used to propagate or attack certain positions within these debates. However, there is a tendency to oversimplify the complexities of the past for present day purposes, and at the same time a lack of awareness of the historical dimension implicit in today's value preferences. Twentieth Century Ethics of Human Subjects Research brings together leading historians of medicine to reconstruct and analyse the history of actual experimental practices, the debates on human subjects research, and the attempts to regulate such research during the twentieth century. The volume addresses cases of medical research in France, Britain, Israel, the United States, and Germany, including the Nazi period; the major developments of ethical debates in these and further national contexts, such as the Soviet Union, the Czech Republic, and Japan. It also explores religious views (Catholic, Jewish) on human experimentation, and the origins and contexts of international codes and declarations. "Volker Roelckes Uberblick uber die Geschichte der Menschenversuche im Dritten Reich sei jedem empfohlen, der sich kurz und pragnant uber dieses dustere Kapitel deutscher Geschichte informieren mochte." FAZ.

Author : Adil Shamoo
Publisher : Taylor & Francis
Page : 160 pages
File Size : 50,37 MB
Release : 2021-03-05
Category : Science
ISBN : 1136276033

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Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the media, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.

Author : Institute of Medicine
Publisher : National Academies Press
Page : 445 pages
File Size : 37,87 MB
Release : 2004-07-09
Category : Medical
ISBN : 0309133386

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In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.