Emergency research rules should not require disclosure of study data, attorney says.
This article was originally published in The Gray Sheet
Executive Summary
PUBLIC DISCLOSURE OF EMERGENCY RESEARCH SHOULD BE ELIMINATED as a requirement in FDA's proposed policy on waiver of informed consent in emergency research, Jeffrey Gibbs, of the Washington, D.C. law firm Hyman, Phelps and McNamara, argues in Nov. 6 written comments to the agency. 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."