FDA Gets Feedback on Informed Consent Waiver

LAST SEPTEMBER, the Food and Drug Administration (FDA) invited comment on a new proposal for exceptions from the requirement for obtaining informed consent of patients when testing new drugs or devices during medical emergencies. Now those responses are in, and while most generally support the proposal, many respondents expressed reservations and suggested changes in its details. The proposal, aimed at facilitating research while at the same time protecting the patients involved, describes how and under what circumstances exceptions from consent for this type of research could be granted when patients are unable to give consent because of their medical condition. The FDA had issued its proposal (JAMA. 1995;274:1184-1185) in light of increasing concerns that strict interpretation of current regulations intended to protect human subjects from research-related risks was jeopardizing certain types of studies—clinical trials of new drugs or devices used in life-threatening situations when the patients are unable to give