Ethical and Regulatory Aspects of Clinical Research PDF Download
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Author: Ezekiel J. Emanuel
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 532
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Book Description
Professionals in need of such training and bioethicists will be interested.
Author: Ezekiel J. Emanuel
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 532
Get Book Here
Book Description
Professionals in need of such training and bioethicists will be interested.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445
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Book Description
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: Samiran Nundy
Publisher: Springer Nature
ISBN: 9811652481
Category : Medical
Languages : en
Pages : 475
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Book Description
This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.
Author:
Publisher: DIANE Publishing
ISBN: 1428910654
Category :
Languages : en
Pages : 436
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Book Description
Author: Jürgen Boomgaarden
Publisher: Berghahn Books
ISBN: 9781571816016
Category : Law
Languages : en
Pages : 152
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Book Description
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: Kenneth W. Goodman
Publisher: Cambridge University Press
ISBN: 9780521469050
Category : Computers
Languages : en
Pages : 196
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Book Description
New technology always raises compelling ethical questions. As those in medicine increasingly depend on computers and other intelligent machines, the intersection of ethics, computing and the health professions grows much more complex and significant. This book attempts systematically to identify and address the full range of ethical issues that arise when intelligent machines are used in medicine, nursing, psychology, and allied health professions. It maps and explores a variety of important issues and controversies, including ethics and evaluation in computational medicine, patient and provider confidentiality, responsibility for use of computers in medicine, appropriate use of decision support systems, outcomes of research and computational prognosis (including mortality predictions), and computer-based biomedical research - especially meta-analysis. This book is accessible to participants in the fields of bioethics and medical informatics. It is appropriate for physicians, nurses, administrators, ethicists, health attorneys, advanced undergraduates and graduate students.
Author: Kenneth A. Richman
Publisher: MIT Press
ISBN: 9780262264341
Category : Medical
Languages : en
Pages : 244
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Book Description
Explores the philosophical and practical ethical implications of a definition of health as a state that allows us to reach our goals. Definitions of health and disease are of more than theoretical interest. Understanding what it means to be healthy has implications for choices in medical treatment, for ethically sound informed consent, and for accurate assessment of policies or programs. This deeper understanding can help us create more effective public policy for health and medicine. It is notable that such contentious legal initiatives as the Americans with Disability Act and the Patients' Bill of Rights fail to define adequately the medical terms on which their effectiveness depends. In Ethics and the Metaphysics of Medicine, Kenneth Richman develops an "embedded instrumentalist" theory of health and applies it to practical problems in health care and medicine, addressing topics that range from the philosophy of science to knee surgery. "Embedded instrumentalist" theories hold that health is a match between one's goals and one's ability to reach those goals, and that the relevant goals may vary from individual to individual. This captures the normative implications of the term health while avoiding problematic relativism. Richman's embedded instrumentalism differs from other theories of health in drawing a distinction between the health of individuals as biological organisms and the health of individuals as moral agents. This distinction illuminates many difficulties in patient-provider communication and helps us understand conflicts between promoting health and promoting ethically permissible behavior. After exploring, expanding, and defending this theory in the first part of the book, Richman examines its ethical implications, discussing such concerns as the connection between medical beneficence and respect for autonomy, patient-provider communication, living wills, and clinical education.
Author: Renato D. Lopes
Publisher: McGraw Hill Professional
ISBN: 0071792651
Category : Medical
Languages : en
Pages : 262
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Book Description
A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials
Author: Robert J. Levine
Publisher: Yale University Press
ISBN: 9780300042887
Category : Language Arts & Disciplines
Languages : en
Pages : 484
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Book Description
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: Noortje Jacobs
Publisher: University of Chicago Press
ISBN: 0226819310
Category : Medical
Languages : en
Pages : 305
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Book Description
How liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science. Ethics boards have become obligatory passage points in today’s medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC, and it has been popular as a practice since the early modern period. Yet in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until at least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case study, historian Noortje Jacobs shows how the authority of physicians to make decisions about clinical research in this period gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of the growing international wariness of medical research in the decades after World War II and was meant to solidify a new way of reasoning together in liberal democracies about medicine and science. But what reasoning together meant, and who was invited to participate, changed drastically over time. In detailing this history, Jacobs shows that research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality and intensify the use of new clinical research methods. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee is an important contribution to our understanding of the randomized controlled trial and the history of research ethics and bioethics more generally.
