Food and Drug Administration Public Hearing on the Conduct of Emergency Clinical Research: Testimony of Dr. Schmidt

The rules surrounding exception from informed consent in emergency research need to strike a balance between protecting human subjects and allowing important research to move forward. The rules have been in place since 1996, and there is now a body of experience with using the rules but limited empirical research on attitudes and experience with the rules. This experience shows that community consultation may be a valuable method of protecting subjects, but its implementation has been difficult. IRBs continue to have questions about interpreting the rules, the public has not shown an interest in attending public meetings, and researchers express frustration about how to conduct the process in a timely and cost-effective manner while protecting subjects.