Ethics in Medical Research: A Handbook of Good Practice / Edition 1

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Overview

This is a comprehensive, practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain, accessible style, this book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to them, and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address ethical issues at an early stage in the design of their studies, helping them to avoid unnecessary delay, and to safeguard the well-being of patients and healthy volunteers. The book will also be extremely useful to members of research ethics committees.

The book contains no figures.

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Editorial Reviews

Doody's Review Service
Reviewer: Robert A. Crouch(University of Virginia)
Description: Handbooks can serve a number of purposes, and this one is no exception. Addressed primarily to medical researchers and to members of Institutional Review Boards (or Research Ethics Committees), the author discusses not only substantive ethical issues that occur in the context of research (such as confidentiality and research with children and fetuses), but also helpfully lays out many of the more basic issues that are involved in research (the function and composition of review boards, and the evaluation of risks and benefits in a study protocol, to name only two).
Purpose: His task for much of the book is to review various national and international research guidelines and to explain what they ethically require of the researcher. By providing this information in manageable handbook format, the author has done the research community a great service. Those who consult his handbook should be able to identify and avoid many of the common problems that are encountered during protocol review.
Audience: This book can serve both to educate researchers and thus to streamline the protocol review process by producing more ethically acceptable research protocols from the start.
Features: The handbook format is at once the book's best and worst feature: what the author provides for the reader in breadth is purchased by a lack of depth.
Assessment: Consulting the book will inform readers of the ethical issues researchers should be aware of, but insights into the ethical reasoning that led to the endorsement of any guideline's requirement are rarely presented. Such a deficiency is problematic because it will leave many in the dark when either extant guidelines change, or novel protocols are submitted (and the ethical implications of these are not obviously dealt with by the author. This is not so much a criticism of this fine book as it is a general criticism of handbooks, but it is nonetheless something the reader should keep in mind.
From the Publisher
"In general, this book provides a significant amount of information on a number of topics in clinical research. I am confident that students of research ethics, particularly those interested in practices in the United States and the United Kingdom, will find this book to be a handy and suitable resource." Teaching and Learning Medicine

"This is a very comprehensive volume on the process of medical research ethics...its value lies in the practical application of the principles of research ethics, which ensures that the price of this text would be money well spent." Nursing Ethics

"This book offers much sensible advice and comment as well as a comprehensive bibliography. It will be useful to researchers who are preparing applications and members of ethical committees." B. Ashworth

Robert A. Crouch(University of Virginia)
Handbooks can serve a number of purposes, and this one is no exception. Addressed primarily to medical researchers and to members of Institutional Review Boards (or Research Ethics Committees), the author discusses not only substantive ethical issues that occur in the context of research (such as confidentiality and research with children and fetuses), but also helpfully lays out many of the more basic issues that are involved in research (the function and composition of review boards, and the evaluation of risks and benefits in a study protocol, to name only two). His task for much of the book is to review various national and international research guidelines and to explain what they ethically require of the researcher. By providing this information in manageable handbook format, the author has done the research community a great service. Those who consult his handbook should be able to identify and avoid many of the common problems that are encountered during protocol review. This book can serve both to educate researchers and thus to streamline the protocol review process by producing more ethically acceptable research protocols from the start. The handbook format is at once the book's best and worst feature: what the author provides for the reader in breadth is purchased by a lack of depth. Consulting the book will inform readers of the ethical issues researchers should be aware of, but insights into the ethical reasoning that led to the endorsement of any guideline's requirement are rarely presented. Such a deficiency is problematic because it will leave many in the dark when either extant guidelines change, or novel protocols are submitted (and the ethical implicationsof these are not obviously dealt with by the author. This is not so much a criticism of this fine book as it is a general criticism of handbooks, but it is nonetheless something the reader should keep in mind.

3 Stars from Doody
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Product Details

  • ISBN-13: 9780521626194
  • Publisher: Cambridge University Press
  • Publication date: 8/28/1999
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 422
  • Product dimensions: 5.43 (w) x 8.50 (h) x 1.10 (d)

Table of Contents

1. The origin of the ethical review of medical research; 2. Medical Research Ethics Committees: protecting patients, researchers and institutions; 3. The researcher and his/her facilities; 4. The importance of informed consent; 5. Evaluating risks and benefits; 6. What kinds of procedure is it acceptable to expose research participants to, and how often?; 7. Confidentiality; 8. Clinical trials; 9. Research with healthy volunteers; 10. Are placebos ethical?; 11. Arrangements for compensation; 12. Research with children, persons with intellectual disability and other vulnerable groups; 13. Research on surplus blood and other tissue; 14. Questionnaire and interview studies; 15. Epidemiological studies; 16. Genetic research: special ethical considerations; 17. Gene therapy; 18. Research on fetuses; 19. Animal to human transplantation; 20. Post approval monitoring of research by ethics committees.

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