With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection. [A] trial, which is reported in today's Journal of the American Medical Association (JAMA), was halted because a device called the AutoPulse, which was used to revive cardiac-arrest victims, failed to save more lives than when rescuers performed cardiopulmonary resuscitation. Patients in these types of studies...are treated under a broad federal rule that allows researchers to test emergency treatments on patients with specific, life-threatening medical conditions without their explicit consent as long as they remain under close watch of independent reviewers. Studies have included large, multi-city, randomized trials, which scientists consider the gold standard for medical research. The [PolyHeme] trial has raised concern among some ethicists and alarm in Congress, where Sen. Charles Grassley, R-Iowa, chairman of the Finance Committee, is conducting an investigation. Grassley is concerned that people who live in the 19 states where PolyHeme is being tested have had inadequate notice about the trial. The FDA requires that community input be sought in the regions around test sites. It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential 'guinea pig,' without providing a practical, informative warning to the public," Grassley wrote in a letter to the FDA in February.

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