The emergency research regulations, under 21 CFR 50.24, first became effective in November 1996, however this is the FDA's first guidance on the matter, issued after an identified need to assist sponsors, institutional review boards (IRBs) and clinical investigators in interpreting and complying with these regulations, said the agency.

The >new guidance lists four situations where emergency research is considered applicable: when an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) is required; if patients have a life-threatening medical condition and available treatments are unproven or unsatisfactory; when patients cannot give informed consent because of their condition (e.g., unconsciousness); or where in order for it to be effective, the intervention must be administered before obtaining informed consent from the patients legally authorised representative is feasible.

"Studies involving an exception from the informed consent requirements may proceed only after a sponsor has received prior written authorisation from the FDA, and the IRB has found and documented that specific conditions have been met," said the draft document.

In addition, the regulations for emergency research contain specific human subject protection requirements including the need for consultation with representatives of the communities being used in the research; public disclosure of information before the start of the study and following its completion, a commitment by the investigator to make efforts to contact a family member to determine whether the family member objects to the subject's participation, and establishment of an independent data monitoring committee (DMC).

"These additional requirements are necessary because the emergency research permitted under 21 CFR 50.24 involves a particularly vulnerable population," said the FDA.

Those in the industry now have 60 days from the time of publishing to provide comments and suggestions regarding this draft document.