Best Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary by The Johns Hopkins University Press

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms.

This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.

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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. It 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 will be 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

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Best The Human Use of Animals: Case Studies in Ethical Choice

The Human Use of Animals: Case Studies in Ethical Choice by Oxford University Press, USA




The first set of case studies on animal use, this volume offers a thorough, up-to-date exploration of the moral issues related to animal welfare. Its main purpose is to examine how far it is ethically justifiable to harm animals in order to benefit mankind. An excellent introduction provides a framework for the cases and sets the background of philosophical and moral concepts underlying the subject.
Sixteen original, previously unpublished essays cover controversies associated with the human use of animals in a broad range of contexts, including biomedical, behavioral, and wildlife research, cosmetic safety testing, education, the food industry, commerce, and animal use as pets and in religious practices. Scientific research is accorded the closest scrutiny. The authors represent a wide range of expertise within their specialized areas of research--physiology, public policy, ethics, philosophy, law, veterinary science, and psychology. The careful analysis of each case makes it possible to elevate the discourse beyond over-simplified positions, and to demonstrate the complexity of the issues. The Human Use of Animals will be welcomed by students and faculty in law, philosophy, ethics, public policy, religion, medicine, and veterinary medicine. It will also interest activists in the animal protection movement, and members of animal protection organizations and Institutional Animal Care and Use Committees.Read more The Human Use of Animals: Case Studies in Ethical Choice

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Resolving Ethical Dilemmas: A Guide for Clinicians Best Reviews

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Every day clinicians encounter ethical dilemmas that have a direct impact on patient care. This timely Fourth Edition gives you expert guidance in approaching a wide range of ethical dilemmas and developing an action plan even when competing points of view have equal merit. Most chapters include real-life sample cases that the author walks through, discussing the salient issues and how to approach them.

Highlights of this edition include:

• A new chapter on ethical issues in cross-cultural medicine
• New material addressing conscientious objection by physicians, with particular reference to reproductive health and caring for underserved populations
• Revised sections on disclosure of errors to patients, gifts to physicians from drug companies, involuntary psychiatric treatment, genomic medicine, and ethical issues during public health emergencies such as pandemics
• Updates on organ transplantation including increasing the donor pool and non-heart beating donors
• Updated references throughout
• A summary of key points at the end of each chapter

A companion Website includes instant fully searchable text. This useful resource is a must-read for medical students and practicing professionals at every level of experience.

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The Ethical Conduct of Clinical Research Involving Children 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.

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This is the second edition of a highly successful and well-received textbook on the responsible conduct of biomedical and health science research. It is aimed at faculty and graduate students in health science and biomedical science programs. In addition, those on National Institute of Health research grants, administrators at universities, and academic health centers will find it a useful resource. The major changes include new chapters providing overviews of each topic, several new published articles added to the readings, revised case studies as well as further readings and web addresses.

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