Ethical Issues In Clinical Research


Ethical Issues In Clinical Research
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Ethical Issues In Clinical Research


Ethical Issues In Clinical Research
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Author : Bernard Lo
language : en
Publisher: Lippincott Williams & Wilkins
Release Date : 2012-03-28

Ethical Issues In Clinical Research written by Bernard Lo and has been published by Lippincott Williams & Wilkins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-28 with Medical categories.


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.



Issues In Medical Research Ethics


Issues In Medical Research Ethics
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Author : Jürgen Boomgaarden
language : en
Publisher: Berghahn Books
Release Date : 2003

Issues In Medical Research Ethics written by Jürgen Boomgaarden and has been published by Berghahn Books this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Law categories.


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.



Ethical And Policy Issues In International Research


Ethical And Policy Issues In International Research
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Author : United States. National Bioethics Advisory Commission
language : en
Publisher:
Release Date : 2001

Ethical And Policy Issues In International Research written by United States. National Bioethics Advisory Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Medical categories.




Ethical Considerations When Preparing A Clinical Research Protocol


Ethical Considerations When Preparing A Clinical Research Protocol
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Author : Evan DeRenzo
language : en
Publisher: Academic Press
Release Date : 2020-06-12

Ethical Considerations When Preparing A Clinical Research Protocol written by Evan DeRenzo and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-12 with Medical categories.


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 Ethical Challenges Of Human Research


The Ethical Challenges Of Human Research
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Author : Franklin G. Miller
language : en
Publisher: Oxford University Press
Release Date : 2012-06-01

The Ethical Challenges Of Human Research written by Franklin G. Miller and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-01 with Medical categories.


The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involving human subjects requires careful attention to the contextual details of scientific experimentation. This book contains 22 essays by Franklin G. Miller on research ethics written over a 15-year period. With the exception of the first essay, all have been previously published in bioethics and medical journals. The book is arranged into four parts. Part One addresses a general ethical perspective on the protection of human subjects in clinical research, including paternalism in research regulation and acceptable limits to research risks. The essays in Part Two examine ethical issues in study design. It includes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patients who have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data. Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamental norm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model." An abiding theme, developed in many of the essays is that the ethics of clinical research is importantly different from the ethics of medical care.



Ethical And Policy Issues In International Research


Ethical And Policy Issues In International Research
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Author : United States. National Bioethics Advisory Commission
language : en
Publisher:
Release Date : 2001

Ethical And Policy Issues In International Research written by United States. National Bioethics Advisory Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Clinical trials categories.




Ethical And Regulatory Aspects Of Clinical Research


Ethical And Regulatory Aspects Of Clinical Research
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Author : Ezekiel J. Emanuel
language : en
Publisher:
Release Date : 2003

Ethical And Regulatory Aspects Of Clinical Research written by Ezekiel J. Emanuel and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Medical categories.


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



Ethics And Regulation Of Clinical Research


Ethics And Regulation Of Clinical Research
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Author : Robert J. Levine
language : en
Publisher:
Release Date : 1986

Ethics And Regulation Of Clinical Research written by Robert J. Levine and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1986 with Human Experimentation categories.




Ethical Conduct Of Clinical Research Involving Children


Ethical Conduct Of Clinical Research Involving Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2004-07-09

Ethical Conduct Of Clinical Research Involving Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-07-09 with Medical categories.


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.



Clinical Research And The Law


Clinical Research And The Law
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Author : Patricia M. Tereskerz
language : en
Publisher: John Wiley & Sons
Release Date : 2012-05-07

Clinical Research And The Law written by Patricia M. Tereskerz and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-07 with Medical categories.


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.