Concerns rise over waived-consents

June 14, 2006

Concern is growing in the Untied States over waived consents that could lead a person to unknowingly become a test subject in a medical trial.

Critics want to know whether people understand how consents work and whether they are given adequate protection when they become test subjects, reports USA Today.

The report said Wednesday's edition of the Journal of American Medical Association talks of a trial that was halted because a device used to revive cardiac-arrest victims failed to save more lives than when rescuers performed cardio-pulmonary resuscitation.

The JAMA study says as many as 10 people in one city may not have been revived because of their participation.

The newspaper said patients in such studies, which are often financed by manufacturers of the tested product, are treated under a broad federal rule. That rule 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.

Supporters say there is no substitute for such testing in emergency cases of life-and-death situations.

Copyright 2006 by United Press International

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