The Ethics Police?

“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 itfails 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 theyface. 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 humansubjects 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 theprotection 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 thatinfluence 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 foranyone 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 ofExperimentation on Black Americans from Colonial Times to the PresentFeatured 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.” – SocietyFeatured 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’.” –BioNewsLibrary Journal Medicine Best Seller, February 2016.Featured in- Health AffairsFeatured 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 JournalFeatured 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

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 ofGenetic 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 CommonwealthFund. 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.