FDA ISSUES DRAFT GUIDANCE ON EXCEPTION FROM INFORMED CONSENT RULES FOR EMERGENCY RESEARCH

The FDA Aug. 29 published draft guidance on exceptions to informed consent requirements for emergency clinical research.

Firms may not be required to obtain informed consent from subjects being enrolled in clinical investigations, or from their legally authorized representatives, in cases of emergency research for which:

An investigational new drug application or investigational device exemption is required; The human subjects have life-threatening conditions for which available treatments are "unproven or unsatisfactory;" Subjects cannot give informed consent because of their conditions (such as being unconscious); or To be effective, the intervention must be administered before informed consent is given.

The draft guidance can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0331-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0331-gdl0001.pdf).