Ethical and Regulatory Aspects of Clinical Research
Author: Ezekiel J. Emanuel
Publisher:
Published: 2003
Total Pages: 532
ISBN-13:
DOWNLOAD EBOOK →Professionals in need of such training and bioethicists will be interested.
Lanterna Rally
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Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2004-07-09
Total Pages: 445
ISBN-13: 0309133386
DOWNLOAD EBOOK →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.
Ethics and Regulation of Clinical Research
Author: Robert J. Levine
Publisher: Yale University Press
Published: 1988-01-01
Total Pages: 484
ISBN-13: 9780300042887
DOWNLOAD EBOOK →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
Ethical Issues in Clinical Research
Author: Bernard Lo
Publisher: Lippincott Williams & Wilkins
Published: 2012-03-28
Total Pages: 302
ISBN-13: 1451152779
DOWNLOAD EBOOK →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.
Principles and Practice of Clinical Research
Author: John I. Gallin
Publisher: Elsevier
Published: 2011-04-28
Total Pages: 447
ISBN-13: 0080489567
DOWNLOAD EBOOK →The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
The Oxford Textbook of Clinical Research Ethics
Author: Ezekiel J. Emanuel
Publisher: OUP USA
Published: 2011-02
Total Pages: 848
ISBN-13: 0199768633
DOWNLOAD EBOOK →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.
Clinical Trials in Neurology
Author: Felipe Fregni
Publisher: Humana Press
Published: 2018-07-31
Total Pages: 616
ISBN-13: 9781493978793
DOWNLOAD EBOOK →This volume provides in-depth descriptions and discussion of clinical trial designs based on novel data analysis of high-quality trials for 11 different neurological conditions in order to ultimately improve the quality of care in neurology. Some of the conditions discussed in this book are stroke, traumatic brain injury, Alzheimer’s disease, epilepsy, and tumors of the central nervous system. In Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your research center and clinical investigation. Thorough and comprehensive, Clinical Trials in Neurology is a valuable guide for individuals in the research, education, and clinical practice fields, specifically in the fields of medicine, physical therapy, occupational therapy, nursing, and public health. This volume is also an important resource for clinicians aiming to improve their understanding in methodology of clinical trials.
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:
DOWNLOAD EBOOK →Clinical Research and the Law
Author: Patricia M. Tereskerz
Publisher: John Wiley & Sons
Published: 2012-05-07
Total Pages: 295
ISBN-13: 1405195673
DOWNLOAD EBOOK →This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.
Reviewing Clinical Trials
Author: Chinese University of Hong Kong
Publisher:
Published: 2010
Total Pages: 153
ISBN-13: 9789881904119
DOWNLOAD EBOOK →The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
