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Emergency Use of a Test Article in a Life-Threatening Situation

Schulman IRB - Information for InvestigatorsIf there is an emergency use of a test article in a life-threatening situation (as defined in
21CFR 312.81(a)1-2, 21CFR 812.36(a) or Medical Devices Regulations SOR/98-282), Schulman requires descriptive and detailed documentation concerning the use.

Schulman does not review prospective emergency research where an exception from informed consent requirements for emergency research is being requested as outlined in 21 CFR 50.24.

Submit the Emergency Use of a Test Article in a Life-Threatening Situation Report.