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Ethical Issues In Clinical Research
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Book Synopsis Ethical and Regulatory Aspects of Clinical Research by : Ezekiel J. Emanuel
Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.
Book Synopsis Ethical Issues in Clinical Research by : Bernard Lo
Download or read book Ethical Issues in Clinical Research written by Bernard Lo and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Writing Clinical Research Protocols by : Evan DeRenzo
Download or read book Writing Clinical Research Protocols written by Evan DeRenzo and published by Elsevier. This book was released on 2005-09-08 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Issues in Medical Research Ethics by : Jürgen Boomgaarden
Download or read book Issues in Medical Research Ethics written by Jürgen Boomgaarden and published by Berghahn Books. This book was released on 2003 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Oxford Textbook of Clinical Research Ethics by : Ezekiel J. Emanuel
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Women and Health Research by : Institute of Medicine
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Ethics and Regulation of Clinical Research by : Robert J. Levine
Download or read book Ethics and Regulation of Clinical Research written by Robert J. Levine and published by Yale University Press. This book was released on 1988-01-01 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Rethinking the Ethics of Clinical Research by : Alan Wertheimer
Download or read book Rethinking the Ethics of Clinical Research written by Alan Wertheimer and published by Oxford University Press. This book was released on 2011 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Ethical Challenges of Human Research by : Franklin G. Miller
Download or read book The Ethical Challenges of Human Research written by Franklin G. Miller and published by Oxford University Press. This book was released on 2012-11-15 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains 22 essays on the ethics of research involving human subjects written over a 15-year period. Topics addressed include the ethics of clinical trials, controversial study designs, and informed consent.
Book Synopsis Ethical Issues in International Biomedical Research by : James V. Lavery
Download or read book Ethical Issues in International Biomedical Research written by James V. Lavery and published by . This book was released on 2007 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.
Book Synopsis Ethical and Policy Issues in International Research by : United States. National Bioethics Advisory Commission
Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Book Synopsis Casebook on Ethical Issues in International Health Research by : World Health Organization
Download or read book Casebook on Ethical Issues in International Health Research written by World Health Organization and published by World Health Organization. This book was released on 2009 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: I. Defining "research"--II. Issues in study design . -- III. Harm and benefit -- IV. Voluntary informed consent -- V. Standard of care -- VI. Obligations to participants and communities -- VII. Privacy and confidentiality -- VIII. Professional ethics.
Book Synopsis Clinical Trials in Vulnerable Populations by : Milica Prostran
Download or read book Clinical Trials in Vulnerable Populations written by Milica Prostran and published by BoD – Books on Demand. This book was released on 2018-05-09 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Book Synopsis Ethical Challenges in Oncology by : Colleen Gallagher
Download or read book Ethical Challenges in Oncology written by Colleen Gallagher and published by Academic Press. This book was released on 2017-06-23 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Challenges in Oncology: Patient Care, Research, Education, and Economics covers a wide variety of topics and viewpoints about ethical issues that arise in oncology throughout the full cancer care continuum. This book provides a holistic view on oncology ethics, incorporating the knowledge and expertise of authors from various departments and oncology specialties within the University of Texas MD Anderson Cancer Center. The first section focuses on the ethical issues associated with treating cancer patients. Next, the ethical challenges associated with oncology research, including funding, regulation, subject selection and the big picture are explored. The third section covers ethical issues associated with education in oncology as it reflects both past and future trends in developing proficient health care providers, patients and even executives. Final sections concentrate on the ethical dilemmas associated with the economic repercussions of oncology, offering thoughts on how to alleviate the ethical consequences that can arise from the global effects of cancer and cancer treatment. Each chapter includes discussion topics, answers pertinent questions and provides an ethical framework for problem- solving in each scenario. The topics uncover the ethical apprehensions and problems associated with oncology research and practice in order to determine best practices as well as provide guidance for all parties involved. Offers a diverse range of topics and viewpoints about ethical issues that arise in oncology Provides direction by bringing real issues to the forefront Contains a truly ethical approach on problems as broad as research, finance, appropriateness of care, and professional education
Book Synopsis Clinical Research and the Law by : Patricia M. Tereskerz
Download or read book Clinical Research and the Law written by Patricia M. Tereskerz and published by John Wiley & Sons. This book was released on 2012-04-24 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: CLINICAL RESEARCH AND THE LAW The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including: standards and duty of care conflicts of interest establishing clinical trials informed consent research contracts the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.
