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Clinical Trials: Are They Safe? Look for the Stamp

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"I would think that that individual could safely ... conclude everything that's going to affect the patient is being looked at with a view to the highest standards. ... You want to look that person in the eye and say, 'This whole thing is being tuned up for your benefit,'" says Federman.

Currently, two standards are being developed as accreditation measures. The committee suggests that the standard emerging from the National Committee for Quality Assurance seems most useful. This tool is ready for a field trial in VA hospitals around the country, although there is some concern that it's not quite ready.

Attorney Alan Milstein represented the Gelsinger family in their lawsuit against the University of Pennsylvania. He also is the attorney for patients in the class action suits in the leukemia and cancer vaccine cases. He tells WebMD that he's not impressed by the new IOM report, done at the request of the U.S. Department of Health and Human Services.

"We need a system of patient advocates where part of the money that goes into all these studies should be to allow independent patient advocates to counsel patients, so that patients understand what's in their best interest," Milstein tells WebMD. "No matter what the investigator tells the subject, the subject believes it's therapeutic."

However, the government official directly responsible for maintaining the integrity of the nation's human research trials lauded the IOM effort. He thinks a seal of approval can work.

"By having an accreditation process that is outside of government but can complement our regulatory and oversight activities, we'll actually be able to move toward a system of smaller, more effective government," Greg Koski, MD, PhD, director of the U.S. Office for Human Research Protections, tells WebMD.

Still, Koski said that not all research tragedies can be prevented. "The hope would be that when tragedies occur, they will be tragedies that don't result from people who have either violated the standards or neglected their responsibilities."

An accreditation standard, if adopted, would apply to both government-funded research and experiments in the private sector, which amounts to about two-thirds of all such studies.

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