Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members (Hardback)
  • Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members (Hardback)

Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members (Hardback)

Hardback 272 Pages / Published: 05/02/2007
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Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research-institutional review boards, or IRBs-is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas-drugs, medical devices, and genetic information-Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.

Publisher: Johns Hopkins University Press
ISBN: 9780801885013
Number of pages: 272
Weight: 476 g
Dimensions: 229 x 152 x 21 mm

A well-written and informative narrative of the inner workings of IRBs. It is a must-read for those who are (or will be) members of an IRB and for those who need to submit a proposal. -- Maura Pilotti, Ph.D. * Metapsychology *
An indispensable guide for both experienced and inexperienced IRB members... I would recommend it to any IRB member. * Doody's Review Service *
Mazur's book provides IRB members with essential questions they should ask when reviewing proposed and ongoing studies. -- Karen J. Maschke * New England Journal of Medicine *
The book contains an interesting perspective and a wealth of knowledge. It contains quite a lot of information for any single audience, but those who serve on IRBs can benefit greatly from reading and referring to Mazur's work. -- Alice Z. Frohna * JAMA *
College-level holdings strong in medical and research issues or medical ethics will want this review. * Midwest Book Review *
There is much to like about Evaluating the Science and Ethics of Research on Humans; its depth and sophistication... Not just Mazur's experience but the overall evolution of research administration is reflected in this volume. -- Kenneth A. DeVille * Journal of Legal Medicine *
Every IRB member must read this book so that the participants of clinical trials benefit from it. -- Sanjay A. Pai * Indian Journal of Medical Ethics *
The author applies extensive experience to illustrate the depth of ethical reflection that research proposals can generate and provides guidance on how reflection can be directed to decision making... Checklists in the text and appendices afford IRB members and officers the comfort of knowing that little, if anything, has been overlooked in discharging ethics review. -- Bernard M. Dickens, PhD * Annals of Internal Medicine *
The analysis of a study's risk-benefit ratio is especially good. * U.S. Dept. of Energy, Office of Biological and Environmental Research *
Contains helpful summaries and checklists throughout based on the author's thirty years of research experience. * Issues in Law and Medicine *
Goes beyond basics to provide an excellent resource for any IRB member serious about his or her responsibilities. -- Norman M. Goldfarb * Journal of Clinical Research Best Practices *
Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members goes beyond the basics to provide an excellent resource for any IRB member serious about his or her responsibilties. Along with a readable and compact presentation of the information one would expect in a handbook for IRB members, the book addresses [many] subtleties... * Journal of Clinical Research Best Practices *

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