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

Hardcover | April 21, 2015

byRobert Klitzman

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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 establishResearch 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 violationspersist. 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 includenot 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. RobertKlitzman 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 interpretethics 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.

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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 establishResearch Ethics Committees, known as Institut...

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 ove...

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Format:HardcoverDimensions:432 pages, 9.29 × 6.5 × 1.5 inPublished:April 21, 2015Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199364605

ISBN - 13:9780199364602

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Table of Contents

Part I: Introduction1. Protecting the People We Experiment OnPart II: Who IRBs Are2. "Inside the Black Box": Becoming and Being IRB MembersPart III: What IRBs Do: The Contents of IRB Decisions3. Weighing Risks and Benefits and Undue Inducement4. Defining Research and How Good It Needs To Be5. What to Tell Subjects: Battles Over Consent Forms6. From "Nitpicky" to "User-Friendly": Inter-IRB Variations and Their CausesPart IV: IRBs vs. Institutions: The Contexts of Decisions7. Federal Agencies vs. Local IRBs8. The Roles of Industry9. The Local Ecologies of InstitutionsPart V: IRBs vs. Researchers10. Trusting vs. Policing Researchers11. Bad Behavior: Research Integrity12. Researchers Abroad: Studies in the Developing WorldPart VI: The Future13. Changing National Policies14. Conclusions: Other ChangesAppendicesAppendix A: Additional Methodological InformationAppendix B: Semi-Structured InterviewAppendix C: List of AcronymsAcknowledgements

Editorial Reviews

"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 researchon 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