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The Ethics Police? : The Struggle to Make Human Research Safe
by M.D. Robert L. 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.  Read more...

 
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More About The Ethics Police? by M.D. Robert L. 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

 
Details
  • ISBN-13: 9780199364602
  • ISBN-10: 0199364605
  • Publisher: Oxford Univ Pr
  • Publish Date: April 2015
  • Page Count: 422
  • Dimensions: 1 x 6 x 9 inches
  • Shipping Weight: 1 pounds


Related Categories

Books > Medical > Ethics

 
Publishers Weekly Reviews

Publishers Weekly® Reviews

  • Reviewed in: Publishers Weekly, page .
  • Review Date: 2015-11-16
  • Reviewer: Staff

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 ofand appeals boards forIRBs 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.)

 
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