Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary,Used

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary,Used

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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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Frequently Asked Questions

  • Q: What is the main focus of 'Ethical and Regulatory Aspects of Clinical Research'? A: The book focuses on the ethical and regulatory requirements for clinical research, particularly the training needed for investigators funded by the National Institutes of Health.
  • Q: Who is the author of the book? A: The author of the book is Ezekiel J. Emanuel.
  • Q: How many pages does the book contain? A: The book contains 528 pages.
  • Q: What type of binding does the book have? A: The book is available in paperback binding.
  • Q: When was 'Ethical and Regulatory Aspects of Clinical Research' published? A: The book was published on January 1, 2004.
  • Q: Is this book suitable for students? A: Yes, the book is suitable for undergraduate students in research ethics, as well as for students in medicine and public health.
  • Q: Does the book address conflicts of interest in clinical trials? A: Yes, the book includes chapters that address conflicts of interest, scientific misconduct, and challenges to the Institutional Review Board (IRB) system.
  • Q: What are some key components covered in the book? A: Key components covered include designing clinical trials, recruiting participants, ensuring informed consent, and studying special populations.
  • Q: Are there any supplementary materials included in the book? A: Yes, the appendix provides sample informed consent forms for reference.
  • Q: What condition is this book in? A: The book is listed as 'New'.