Initial Experience Using the Food and Drug Administration Guidelines for Emergency Research Without Consent, ,

Beginning November 6, 1996, Food and Drug Administration regulation 21 CFR 50.24 has allowed research without consent in limited circumstances while requiring additional patient protection in the form of community consultation and disclosure. We report our experience in complying with these regulations in Multicenter Vest CPR protocol, the first investigational device study done under this new ruling. We found uncertainty in inter-pretation of the requirements for community consultation. The acceptance of research without consent varied among the parties exposed to this protocol, but neither physicians nor the lay public expressed major reservations. The consultation process was time-consuming, demanding, and relatively costly. Further clarification of the community consultation standard and additional dialogue on this important topic will help to foster additional research in cardiopulmonary resuscitation. [Kremers MS, Whisnant DR, Lowder LS, Gregg L: Initial experience using the Food and Drug Administration guidelines for emergency research without consent. Ann Emerg Med February 1999;33:224-229.]