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Reassessing Human Subjects Protections

The clinical research landscape is changing rapidly, and the system for overseeing research has failed to keep pace. The mechanisms for protecting human subjects may be too stringent in some places, too weak in others, and overtaxed and unreliable overall. These essays survey the trouble spots and point the way to effective reform. To order the essays, please contact John Wiley & Sons customer support at 800-835-6770 or


Table of Contents

Trials and Tribulations

Susan Gilbert

Human Research Protections: Time for Regulatory Reform?

Karen J. Maschke

Eight Years after Jesse’s Death, Are Human Research Subjects Any Safer?

Paul Gelsinger and Adil E. Shamoo

Research in the Physician’s Office: Navigating the Ethical Minefield

Lois Snyder and Paul S. Mueller

Tipping Point, Over the Top, or Just Noncompliance as Usual?

Greg Koski