Gaither JB, Chikani V, Stolz U, Viscusi C, Denninghoff K, Barnhart B, Mullins T, Rice AD, Mhayamaguru M, Smith JJ, Keim SM, Bobrow BJ, Spaite DW: Body Temperature after EMS Transport: Association with Traumatic Brain Injury Outcomes. Prehosp Emerg Care. 2017 Sep-Oct;21(5):575-582. doi: 10.1080/10903127.2017.1308609. Epub 2017 May 8. PubMed PMID: 28481163; NIH Manuscript System ID: NIHMS910946; PubMed Central PMCID: PMC5638643.
Spaite DW, Hu C, Bobrow BJ, Chikani V, Gaither JB, Barnhart B, Adelson PD, Denninghoff KR, Rice AD, Mullins T, Sherrill D, Keim SM: Evaluation of the Combined Prehospital Hypoxia-Hypotension “Depth-Duration Dose” and Mortality in Major Traumatic Brain Injury. Circulation 2017
In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decision-maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.
