Abstract:Study Objective: Clinical trials conducted under the Exception from Informed Consent (EFIC) Guidelines (21 CFR 50.24) require investigators to attempt prospective consent if possible before enrolling patient under EFIC. Investigators subsequently obtain consent for continued participation for patients enrolled under EFIC when a legally authorized representative (LAR) becomes available. The objective of this study is to describe the timing of patient enrollment into a traumatic brain injury study conducted unde… Show more
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