The Ethics Police?: The Struggle to Make Human Research Safe

by Robert Klitzman

Overview

Research on human beings saves countless lives, but has at times harmed the participants. To what degree then should government regulate science, and how? The horrors of Nazi concentration camp experiments and the egregious Tuskegee syphilis study led the US government, in 1974, to establish Research Ethics Committees, known as Institutional Review Boards (IRBs) to oversee research on humans. The US now has over 4,000 IRBs, which examine yearly tens of billions of dollars of research — all studies on people involving diseases, from cancer to autism, and behavior. Yet ethical violations persist.

At the same time, critics have increasingly attacked these committees for delaying or blocking important studies. Partly, science is changing, and the current system has not kept up. Since the regulations were first conceived 40 years ago, research has burgeoned 30-fold. Studies often now include not a single university, but multiple institutions, and 40 separate IRBs thus need to approve a single project. One committee might approve a study quickly, while others require major changes, altering the scientific design, and making the comparison of data between sites difficult.

Crucial dilemmas thus emerge of whether the current system should be changed, and if so, how. Yet we must first understand the status quo to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation. Robert Klitzman thus interviewed 45 IRB leaders and members about how they make decisions. What he heard consistently surprised him.

This book reveals what Klitzman learned, providing rare glimpses into the conflicts and complexities these individuals face, defining science, assessing possible future risks and benefits of studies, and deciding how much to trust researchers — illuminating, more broadly, how we view and interpret ethics in our lives today, and perceive and use power.

These committees reflect many of the most vital tensions of our time - concerning science and human values, individual freedom, government control, and industry greed. Ultimately, as patients, scientists, or subjects, the decisions of these men and women affect us all.

Product Details

ISBN-13:	9780199364602
Publisher:	Oxford University Press
Publication date:	04/13/2015
Pages:	432
Product dimensions:	6.20(w) x 9.30(h) x 1.50(d)

About the Author

Robert Klitzman, MD, is a Professor of Clinical Psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health, and the Director of the Masters of Bioethics Program at Columbia University. He has conducted research and written about a variety of bioethical issues, and has authored or co-authored over 100 articles, and seven books, including Am I My Genes?: Confronting Fate and Family Secrets in the Age of Genetic Testing; When Doctors Become Patients; Mortal Secrets: Truth and Lies in the Age of AIDS; Being Positive; A Year-long Night: Tales of a Medical Internship; The Trembling Mountain: A Personal Account of Kuru, Cannibals, and Mad Cow Disease; and In a House of Dreams and Glass: Becoming a Psychiatrist. His work has appeared in JAMA, Science, and elsewhere, and also has written for the New York Times, Newsweek, The Nation, and other publications. He has received several awards for his work, including fellowships from the Guggenheim Foundation, the Russell Sage Foundation, the Aaron Diamond Foundation, the Robert Wood Johnson Foundation, the Rockefeller Foundation and the Commonwealth Fund. He is a gubernatorial appointee to the NY State Stem Cell Commission, and is member of the Research Ethics Advisory Panel of the US Department of Defense.

Table of Contents

Part I: Introduction
Chapter 1: Protecting the People We Experiment On

Part II: Who IRBs Are
Chapter 2: "Inside the Black Box": Becoming and Being IRB Members

Part III: What IRBs Do: The Contents of IRB Decisions
Chapter 3: Weighing Risks and Benefits and Undue Inducement
Chapter 4: Defining Research and How Good It Needs To Be
Chapter 5: What to Tell Subjects: Battles Over Consent Forms
Chapter 6: From "Nitpicky" to "User-Friendly": Inter-IRB Variations and Their Causes

Part IV: IRBs vs. Institutions: The Contexts of Decisions
Chapter 7: Federal Agencies vs. Local IRBs
Chapter 8: The Roles of Industry
Chapter 9: The Local Ecologies of Institutions

Part V: IRBs vs. Researchers
Chapter 10: Trusting vs. Policing Researchers
Chapter 11: Bad Behavior: Research Integrity
Chapter 12: Researchers Abroad: Studies in the Developing World

Part VI: The Future
Chapter 13: Changing National Policies
Chapter 14: Conclusions: Other Changes


Appendices
Appendix A: Additional Methodological Information
Appendix B: Semi-Structured Interview
Appendix C: List of Acronyms

Acknowledgements

Editorial Reviews

11/16/2015
Klitzman (Am I My Genes?), director of the Masters of Bioethics program at Columbia University, painstakingly leads readers through the morass of challenges faced by institutional review boards (IRBs). Stunningly, this is the first book to rigorously review these key bodies, which police U.S. clinical trials. IRBs, comprising a hodgepodge of local clinicians, researchers, and citizens, have sanctioned and shaped U.S. clinical trials since 1974. Their problems include lack of uniformity, too-long and too-secretive review processes, and a lack of oversight of—and appeals boards for—IRBs themselves. A full 36% of IRB members have industry ties "despite potential threats to integrity." Klitzman writes that "improvements are clearly possible" and presents some prospects. He also quotes IRB members who feel a decentralized IRB system is necessary to protect intensely individual local community values, but he concludes this is almost always incorrect. Still, change may not come soon. He notes that IRBs have, ironically, "seriously stymied" any attempts to police themselves. Indeed, in Klitzman's two decades of research, his own IRB was the one that was most nervous about this book. This is a detailed first look at a critical aspect of U.S. medicine that may not mesmerize causal readers, but should prove indispensable for reform. (Apr.)

Publishers Weekly

Reviewer: Ruaim A Muaygil, MD (Saint Louis University)
Description: In this book, Robert Klitzman examines hospital Institutional Review Boards (IRBs) through the personal accounts of several IRB members.
Purpose: The author sets out to explore the secret world of IRBs in an effort to better understand how IRBs function, and how members make decisions. Because so little is known about IRBs, they are often viewed negatively and with skepticism. Through this book, the author hopes to improve the public image of IRBs, and puts forth proposals to reform IRB structures and functionality.
Audience: This book reaches a wide audience consisting not just of those working in medical research, but also anyone concerned with the ethics and morality of human research.
Features: The author begins his book with a thorough introduction in which he sets the stage for current perceptions of IRBs. He then delves into an exploration of what it is like to serve on an IRB, including the intra-IRB dynamics of members. The third section focuses on the process of making decisions within an IRB, including resolving disputes, defining research, weighing risks and benefits, and approving consent forms. The author then examines the IRB's relationships with their home institutions, federal agencies, and, finally, the researchers. The final chapter offers some suggestions about how IRB structure and procedure can be improved.
Assessment: This is a highly illuminating book that brings to light an important institution. It is well written and well organized. The author uses several figures and tables to support his arguments, making them more accessible. His proposals for IRB reform are both timely and welcome. Overall, this is an excellent addition to the existing literature on IRBs.

Doody's Review Service

"In this intelligent, rigorous book, Robert Klitzman looks at the morality of morality-at how the bodies set up to protect research subjects can end up injuring us all. This examination of our confused notions of safety, honesty, and transparency demonstrates that none of these is simple, and that in striving toward any one, we easily betray the others. It is a book about how seeking to do the right thing can lead to justice, and about how equally often it fails to do so." — Andrew Solomon, author of The Noonday Demon and Far From The Tree

"Few institutions in America are as powerful and yet as invisible to the public as scientific Institutional Review Boards (IRBs). In this important, pioneering book, Robert Klitzman details the challenges facing IRBs today and offers concrete proposals about how they might function better tomorrow. " —Howard Gardner, Hobbs Professor of Cognition and Education, Harvard Graduate School of Education

"In this thoughtful and probing study, Robert Klitzman concludes both that the IRB system is flawed but that the boards do not by and large operate as an abusive police and are most assuredly needed. The first scholar to examine the memberships of the boards and the contents of their deliberations, Klitzman, himself a physician and scientist, finds that his colleagues might get along better with their IRBs if they appreciated the difficulties of the tasks they face. He also proposes significant reforms in the structure, approach, and procedures of the IRB system that make this book a must read for anyone concerned with balancing the protection of human subjects and safeguarding the practice and progress of science." —Daniel J. Kevles, Stanley Woodward Professor of History, Yale University

"Protection of participants is an important—and inescapable—part of the contemporary world of research. In this sensitive exploration of the groups charged with that task, Robert Klitzman elucidates the complexities of human subjects protection and the reasons why it so often seems less-than-optimal. If we are ever to do better, we must begin with precisely this sort of in-depth appreciation of the challenge of balancing the advance of knowledge with the protection of our fellow human beings." —Paul S. Appelbaum, MD, Elizabeth K. Dollard, Professor of Psychiatry, Medicine & Law, Columbia University

"Robert Klitzman has opened wide the door on the arcane world of institutional review boards (IRBs) and interviewed their members, chairpersons and administrators. He reports on what they think about their own power and performance and their influence on the conduct of research. Based on these perspectives, Klitzman makes the case that IRBs should be shifted to a more humanistic model that recognizes the complex psychological, social and cultural forces that influence their decisions. This is an important insight into this little understood but essential institution." —Robert J. Levine, MD, Yale University

"Institutional Review Boards (IRBs) are both vilified and venerated. With the stakeholders in biomedical and behavioral research holding such starkly different views, one has to wonder, what is the IRB trying to achieve? Robert Klitzman takes a novel approach to this puzzle: he asks IRB chairs, members, and administrators how they make their decisions and why. The result is a fresh and revelatory picture of the limitations as well as the strengths of the 'Ethics Police' that will interest IRB members and administrators as well as investigators who want to move beyond bemoaning the burdens of ethical review. Dr. Klitzman's findings are indispensable for anyone trying to improve the current system, whether at an institutional level or through revision of the Common Rule." —Alexander M. Capron, University of Southern California and former Director, Department of Ethics, Trade, Human Rights and Health Law, World Health Organization

"This extremely valuable volume has done more than just reveal what should be retained, discarded and added to the role and tools of the IRB. It is an indispensable resource for clinicians, researchers, medical libraries, schools of law and for medical ethicists. 'IRBs must allow more research on themselves' Klitzman declares. His own work is a brilliant inaugural step." — Harriet A. Washington, author of Medical Apartheid: The Dark History of Experimentation on Black Americans from Colonial Times to the Present

Featured in Science Magazine

"The Ethics Police? The Struggle to Make Human Research Safe is an essential resource for any human subjects protection program interested in improving its processes and results." —Norman M. Goldfarb, Journal of Clinical Research Best Practices

"Klitzman's interviews and surveys have produced useful information...offering the subjective worldview of IRB members...nOne of Klitzman's most surprising findings is how little IRB members understand how much power they wield... [A]ny critic of the current system will find it in plenty of evidence that drastic reform is needed." — Society

Featured in Society

"This is a detailed first look at a critical aspect of U.S. medicine that may not mesmerize causal readers, but should prove indispensable for reform." — Publishers Weekly

"The book succeeds in providing readers with an insight into a system that operates 'at complex intersections of science, politics, sociology, psychology, money, and ethics'." —BioNews

Library Journal Medicine Best Seller, February 2016.

Featured in- Health Affairs

Featured in- Journal Inquirer

"This is an important book. It should serve as the beginning of continuing study of the ethics of research on human subjects. Every member of an IRB, every investigator who uses human subjects, and all the rest of us who are concerned with the continued progress of essential medical research should obtain and read it." -The FASEB Journal

Featured in - IRB: Ethics & Human Research

"The book is full of examples of research and researchers from different fields, fromcancer to genetic and psychiatric conditions, and public health." -J Relig Health

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