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.
An indispensable guide for both experienced and inexperienced IRB members... I would recommend it to any IRB member.
Mazur's book provides IRB members with essential questions they should ask when reviewing proposed and ongoing studies.
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.
College-level holdings strong in medical and research issues or medical ethics will want this 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.
Every IRB member must read this book so that the participants of clinical trials benefit from it.
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.
The analysis of a study's risk-benefit ratio is especially good.
Contains helpful summaries and checklists throughout based on the author's thirty years of research experience.
Goes beyond basics to provide an excellent resource for any IRB member serious about his or her responsibilities.
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...
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.
Book Details
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
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