Review of the 1995 Food and Drug Administration/National Institutes of Health Public Forum on informed consent in clinical research conducted in emergency circumstances.
We describe some of the deliberations and questions raised by the recent Food and Drug Administration/National Institutes of Health Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. Consent will have to be waived in emergency medical research if such research is to be conducted, because it is virtually impossible to obtain meaningful informed consent in emergency circumstances. There is clearly a conflict between research subject autonomy and society's perceived need for answers about emergency medical care. Who will resolve this dilemma and how it will be resolved are important questions for modern medicine.
Lamiell
J M
JM
Clinical Investigation Regulatory Office, U.S. Army Medical Department Center and School, Fort Sam Houston, TX 78234, USA.
Grabenstein
J D
JD
Vander Hamm
D G
DG
D004630:Emergencies; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D009316:National Institutes of Health (U.S.); D014481:United States; D014486:United States Food and Drug Administration