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Evaluating the Science and Ethics of Research on Humans Dennis J. Mazur, MD PhD (Department of Veterans Affairs Medical Center)

Evaluating the Science and Ethics of Research on Humans By Dennis J. Mazur, MD PhD (Department of Veterans Affairs Medical Center)

Evaluating the Science and Ethics of Research on Humans by Dennis J. Mazur, MD PhD (Department of Veterans Affairs Medical Center)


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Summary

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.

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Evaluating the Science and Ethics of Research on Humans Summary

Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members by Dennis J. Mazur, MD PhD (Department of Veterans Affairs Medical Center)

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.

Evaluating the Science and Ethics of Research on Humans 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 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

About Dennis J. Mazur, MD PhD (Department of Veterans Affairs Medical Center)

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.

Table of Contents

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

Additional information

CIN0801885027G
9780801885020
0801885027
Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members by Dennis J. Mazur, MD PhD (Department of Veterans Affairs Medical Center)
Used - Good
Paperback
Johns Hopkins University Press
20070402
272
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
This is a used book - there is no escaping the fact it has been read by someone else and it will show signs of wear and previous use. Overall we expect it to be in good condition, but if you are not entirely satisfied please get in touch with us

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