FDA emergency research policy should not require disclosure of study data, attorney asserts.
Executive Summary
EMERGENCY RESEARCH PUBLIC DISCLOSURE PROPOSAL OPPOSED by Jeffrey Gibbs of the D.C. office of Hyman, Phelps & McNamara in Nov. 6 comments on FDA's proposed policy on waiver of informed consent in emergency research. Calling for FDA to "delete" the proposed requirement for public disclosure of emergency research involving the waivers, Gibbs says that "clinical studies have historically been confidential" with "no regulatory requirement that communities be notified."