Description
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.Reviews
"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 "Offers an introductory handbook for new IRB members and explains the basic concepts behind IRB work and the questions IRB members should be asking. A vital reference for all IRB members."—Thomas May, Ph.D., Medical College of Wisconsin, author of Bioethics in a Liberal Society "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
Author Information
Dennis J. Mazur, M.D., Ph.D., is a professor of medicine and senior scholar at the Center for Ethics in Health Care, Oregon Health and Science University. Dr. Mazur chaired the institutional review board in the Department of Veterans Affairs Medical Center, Portland, Oregon, for over fifteen years, and Dr. Mazur helped develop and continues to chair the VISN 20 northwest regional multi-site institutional review board.
|
Add hardcover to shopping cart
Ethics Consultation: From Theory to Practice