Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members

by Dennis J. Mazur MD PhD

Overview

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.

Product Details

ISBN-13:	9780801885013
Publisher:	Johns Hopkins University Press
Publication date:	02/05/2007
Pages:	272
Product dimensions:	6.00(w) x 9.00(h) x 0.82(d)
Age Range:	18 Years

About the Author

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

What People are Saying About This

From the Publisher

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

Thomas May

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.

Editorial 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

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

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 . . .
—Journal of Clinical Research Best Practices

From the Publisher

Every IRB member must read this book so that the participants of clinical trials benefit from it.

Indian Journal of Medical Ethics - Sanjay A. Pai

The analysis of a study's risk-benefit ratio is especially good.

Office of Biological and Environmental Research U.S. Dept. of Energy

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.

Metapsychology - Maura Pilotti

Goes beyond basics to provide an excellent resource for any IRB member serious about his or her responsibilities.

Journal of Clinical Research Best Practices - Norman M. Goldfarb

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.

Journal of Legal Medicine - Kenneth A. DeVille

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 . . .

Journal of Clinical Research Best Practices

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.

JAMA - Alice Z. Frohna

Reviewer: Erica Rangel, BA (Saint Louis University)
Description: This is a comprehensive and practical guide to the central issues and questions facing both new and veteran IRB members. By explaining the central scientific components and evaluating the ethical concepts involved in IRB membership, the book recognizes the importance of protecting human participants and promoting quality study design in human subjects research. The author summarizes the central roles and responsibilities of the IRB member, offers insight into the process of reviewing scientific protocols, and confronts the challenges facing IRBs.
Purpose: The purpose is to provide IRB members a resource that will help them better understand the issues and tasks implicated in reviewing human subjects research. It offers a clear overview of some of the key areas of research on humans. As a handbook for IRB members, the book is organized for both easy reference and deep analysis of central concepts.
Audience: It is directed to new IRB members, as much of the information it provides would likely already be acquired by veterans. However, as a quick reference guide, it is useful to all IRB members.
Features: The first of the book's three parts covers the general roles and concepts involved in IRB membership, the second presents an examination of the process of reviewing scientific protocols and informed consent forms, and the final part provides a pragmatic look at the challenges of IRB membership. Some of the concepts examined include informed consent, recruitment, protocol prescreening, and participant privacy. The author's sophisticated discussion of risk is a particularly valuable chapter. Each chapter offers helpful boxes highlighting a condensed and easily accessible version of the concepts discussed in the chapter. In addition, the appendixes supply two useful checklists for reviewing scientific protocols and reviewing informed consent forms.
Assessment: As an easily accessible and broad overview of the concepts involved in reviewing human subjects research, this book is an indispensable guide for both experienced and inexperienced IRB members. While it does not offer a deep analysis of the philosophical underpinnings of the ethics of human subjects research, the book does equip the reader with a solid understanding of the basic concepts of research ethics and many useful tips for practical application in the IRB setting. I would recommend it to any IRB member.

Doody's Review Service

Contains helpful summaries and checklists throughout based on the author's thirty years of research experience.

Issues in Law and Medicine

Mazur's book provides IRB members with essential questions they should ask when reviewing proposed and ongoing studies.

New England Journal of Medicine - Karen J. Maschke

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.

Annals of Internal Medicine - Bernard M. Dickens

College-level holdings strong in medical and research issues or medical ethics will want this review.

Midwest Book Review