A government study in the Journal of the American Medical Association found that 5% to 16% of almost 24,000 active clinical studies are "gap trials," meaning they are not covered by federal rules protecting the safety and rights of study participants. Researcher Dr. Deborah Zarin of the NIH said many people may think that the same rules cover all human research trials. "I think the fact that it's more of a patchwork system may be news to people," Zarin said, but she noted some trials that fall into the gap category may still be operated under the rules.

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