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FDA to seek public comment on interim rule for wartime waivers of informed consent, Pendergast testifies.

Executive Summary

FDA RECEIVING "VERY FEW" REQUESTS FOR EMERGENCY RESEARCH INFORMED CONSENT WAIVERS, FDA Deputy Commissioner Mary Pendergast testified at a May 8 hearing of Rep. Shays' (R-Conn.) Government Reform/Human Resources Subcommittee. "FDA has tracked all INDs and [Investigational Device Exemptions] submitted under this rule...to ensure its adequacy for protecting research subjects and to ensure it is appropriately applied," Pendergast said. "To date, there have been very few submissions under this rule. We have received one IDE application and four IND applications under the emergency research rule."

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