Description
Book SynopsisContaining 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.
Trade ReviewA 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 2007 An indispensable guide for both experienced and inexperienced IRB members... I would recommend it to any IRB member. Doody's Review Service 2007 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 2007 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 2007 College-level holdings strong in medical and research issues or medical ethics will want this review. Midwest Book Review 2007 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 2007 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 2008 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 2008 The analysis of a study's risk-benefit ratio is especially good. U.S. Dept. of Energy, Office of Biological and Environmental Research 2007 Contains helpful summaries and checklists throughout based on the author's thirty years of research experience. Issues in Law and Medicine 2008
Table of ContentsPreface
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
