Ethics In Clinical Research

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 46,9 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

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.

Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller
Publisher : OUP USA
Page : 848 pages
File Size : 43,9 Mb
Release : 2011-02
Category : Medical
ISBN : 9780199768639

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The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller Pdf

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.

Author : Alan Wertheimer
Publisher : Oxford University Press
Page : 369 pages
File Size : 45,5 Mb
Release : 2011
Category : Medical
ISBN : 9780199743513

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Rethinking the Ethics of Clinical Research by Alan Wertheimer Pdf

Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.

Author : Bernard Lo
Publisher : Lippincott Williams & Wilkins
Page : 302 pages
File Size : 50,5 Mb
Release : 2012-03-28
Category : Medical
ISBN : 9781451152777

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Ethical Issues in Clinical Research by Bernard Lo Pdf

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Author : Ezekiel J. Emanuel
Publisher : Unknown
Page : 532 pages
File Size : 49,9 Mb
Release : 2003
Category : Medical
ISBN : UOM:39015058788673

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Ethical and Regulatory Aspects of Clinical Research by Ezekiel J. Emanuel Pdf

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

Author : Evan DeRenzo,Joel Moss
Publisher : Elsevier
Page : 320 pages
File Size : 55,5 Mb
Release : 2005-09-08
Category : Medical
ISBN : 9780080454207

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Writing Clinical Research Protocols by Evan DeRenzo,Joel Moss Pdf

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Author : Jürgen Boomgaarden,Pekka Louhiala,Urban Wiesing
Publisher : Berghahn Books
Page : 152 pages
File Size : 51,5 Mb
Release : 2003
Category : Law
ISBN : 1571816011

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Issues in Medical Research Ethics by Jürgen Boomgaarden,Pekka Louhiala,Urban Wiesing Pdf

With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.

Author : Robert J. Levine
Publisher : Yale University Press
Page : 484 pages
File Size : 53,5 Mb
Release : 1988-01-01
Category : Language Arts & Disciplines
ISBN : 0300042884

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Ethics and Regulation of Clinical Research by Robert J. Levine Pdf

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 : Institute of Medicine,Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies
Publisher : National Academies Press
Page : 286 pages
File Size : 40,8 Mb
Release : 1994-02-01
Category : Medical
ISBN : 9780309049924

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Women and Health Research by Institute of Medicine,Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies Pdf

In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Author : Evan DeRenzo,Eric A. Singer,Joel Moss
Publisher : Academic Press
Page : 370 pages
File Size : 42,5 Mb
Release : 2020-06-12
Category : Medical
ISBN : 9780123869548

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Ethical Considerations When Preparing a Clinical Research Protocol by Evan DeRenzo,Eric A. Singer,Joel Moss Pdf

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations

Author : Jennifer S. Hawkins,Ezekiel J. Emanuel
Publisher : Princeton University Press
Page : 336 pages
File Size : 55,7 Mb
Release : 2008-08-04
Category : Medical
ISBN : 9781400837328

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Exploitation and Developing Countries by Jennifer S. Hawkins,Ezekiel J. Emanuel Pdf

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.

Author : Albert R. Jonsen,Mark Siegler,William J. Winslade
Publisher : McGraw-Hill Companies
Page : 212 pages
File Size : 42,5 Mb
Release : 1992
Category : Medical
ISBN : UOM:39015029194597

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Clinical Ethics by Albert R. Jonsen,Mark Siegler,William J. Winslade Pdf

Clinical Ethics introduces the four-topics method of approaching ethical problems (i.e., medical indications, patient preferences, quality of life, and contextual features). Each of the four chapters represents one of the topics. In each chapter, the authors discuss cases and provide comments and recommendations. The four-topics method is an organizational process by which clinicians can begin to understand the complexities involved in ethical cases and can proceed to find a solution for each case.

Author : Nuria Homedes,Antonio Ugalde
Publisher : Springer Science & Business Media
Page : 301 pages
File Size : 50,7 Mb
Release : 2013-11-29
Category : Medical
ISBN : 9783319013633

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Clinical Trials in Latin America: Where Ethics and Business Clash by Nuria Homedes,Antonio Ugalde Pdf

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region. ​

Author : United States. National Bioethics Advisory Commission
Publisher : Unknown
Page : 388 pages
File Size : 43,9 Mb
Release : 2001
Category : Medical
ISBN : IND:30000080377165

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Ethical and Policy Issues in International Research by United States. National Bioethics Advisory Commission Pdf

Author : James M. Humber
Publisher : Springer Science & Business Media
Page : 645 pages
File Size : 42,8 Mb
Release : 2013-03-09
Category : Philosophy
ISBN : 9781461565611

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Biomedical Ethics and the Law by James M. Humber Pdf

In the past few years, an increasing number of colleges and universities have added courses in biomedical ethics to their curricula. To some extent, these additions serve to satisfy student demands for "relevance. " But it is also true that such changes reflect a deepening desire on the part of the academic community to deal effectively with a host of problems which must be solved if we are to have a health-care delivery system which is efficient, humane, and just. To a large degree, these problems are the unique result of both rapidly changing moral values and dramatic advances in biomedical technology. The past decade has witnessed sudden and conspicuous controversy over the morality and legality of new practices relating to abortion, therapy for the mentally ill, experimentation using human subjects, forms of genetic interven tion, and euthanasia. Malpractice suits abound, and astronomical fees for malpractice insurance threaten the very possibility of medical and health-care practice. Without the backing of a clear moral consensus, the law is frequently forced into resolving these conflicts only to see the moral issues involved still hotly debated and the validity of the existing law further questioned. Take abortion, for example. Rather than settling the legal issue, the Supreme Court's original abortion decision in Roe v. Wade (1973), seems only to have spurred further legal debate. And of course, whether or not abortion is a mo rally ac ceptable procedure is still the subject of heated dispute.