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Ethical Issues in Clinical Research

Ethical Issues in Clinical Research PDF Author: Bernard Lo
Publisher: Lippincott Williams & Wilkins
ISBN: 1451152779
Category : Medical
Languages : en
Pages : 300

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Book Description
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.

Ethical Issues in Clinical Research

Ethical Issues in Clinical Research PDF Author: Bernard Lo
Publisher: Lippincott Williams & Wilkins
ISBN: 1451152779
Category : Medical
Languages : en
Pages : 300

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Book Description
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.

Fundamentals of Clinical Trials

Fundamentals of Clinical Trials PDF Author: Lawrence M. Friedman
Publisher: Springer Science & Business Media
ISBN: 1441915869
Category : Medical
Languages : en
Pages : 445

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Book Description
The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.

Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol PDF Author: Evan DeRenzo
Publisher: Academic Press
ISBN: 0123869358
Category : Medical
Languages : en
Pages : 368

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Book Description
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

The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics PDF Author: Ezekiel J. Emanuel
Publisher: OUP USA
ISBN: 0199768633
Category : Medical
Languages : en
Pages : 848

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Book Description
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.

Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol PDF Author: Evan DeRenzo
Publisher: Academic Press
ISBN: 0123869544
Category : Medical
Languages : en
Pages : 370

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Book Description
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

Ethical Issues in Neurology

Ethical Issues in Neurology PDF Author: James L. Bernat
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781790604
Category : Medical
Languages : en
Pages : 552

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Book Description
Written by an eminent authority from the American Academy of Neurology's Committee on Ethics, Law, and Humanities, this book is an excellent text for all clinicians interested in ethical decision-making. The book features outstanding presentations on dying and palliative care, physician-assisted suicide and voluntary active euthanasia, medical futility, and the relationship between ethics and the law. New chapters in this edition discuss how clinicians resolve ethical dilemmas in practice and explore ethical issues in neuroscience research. Other highlights include updated material on palliative sedation, advance directives, ICU withdrawal of life-sustaining therapy, gene therapy, the very-low-birth-weight premature infant, the developmentally disabled patient, informed consent, organizational ethics, brain death controversies, and fMRI and PET studies relating to persistent vegetative state.

Ethical and Policy Issues in International Research

Ethical and Policy Issues in International Research PDF Author: United States. National Bioethics Advisory Commission
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 166

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Book Description


Ethical and Policy Issues in International Research: Report and recommendations of the National Bioethics Advisory Commission

Ethical and Policy Issues in International Research: Report and recommendations of the National Bioethics Advisory Commission PDF Author: United States. National Bioethics Advisory Commission
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages :

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Book Description


Ethics and Regulation of Clinical Research

Ethics and Regulation of Clinical Research PDF 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

Ethical Issues in International Biomedical Research

Ethical Issues in International Biomedical Research PDF Author: James V. Lavery
Publisher: Oxford University Press, USA
ISBN: 0195179226
Category : Medical
Languages : en
Pages : 401

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Book Description
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.