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
Preface
Introduction: What Can the New IRB Member Expect?
Part I: The IRB, Its Work, and Its Challenges
1. What Is an IRB, and What Does It Do?
2. Basic Terms and Concepts Used in IRB Work
3. What Is Risk?
Part II: The Scientific Protocol and the Informed Consent
Form
4. Prescreening of Proposals
5. The Scientific Protocol
6. The Informed Consent Form
7. Recruitment, Selection, and Compensation of Study
Participants
8. Research involving Questionnaires and Surveys
9. Protection of Participants' Privacy in Research Dataand
Specimens
Part III: The Continuing Work of the IRB
10. The Ethical Issues of Informed Consent
11. Continuing Review, Communication, and Feedback
12. Where Are IRBs Making Mistakes, and How Can We Minimize
Mistakes?
13. Strategies for Managing the IRB Workload and Supporting IRB
Decision Making
14. Decision-Making Capacity and Accountability in Research
Summary: The IRB's Key Role
Appendix 1: A Check List for Reviewing a Scientific Protocol
Appendix 2: A Check List for Reviewing an Informed Consent Form
Notes
Website References for Cited Documents
Index
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.
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
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