Enrollment of racially/ethnically diverse participants in traumatic brain injury trials: effect of availability of exception from informed consent.

ABSTRACT:

Background

The Final Rule regulations were developed to allow exception from informed consent (EFIC) to enable clinical trial research in emergency settings where major barriers exist for informed consent. There is little known evidence of the effect of the Final Rule in minority enrollment in clinical trials, particularly in traumatic brain injury (TBI) trials. A clinical trial funded by the National Institute of Neurological Disorders and Stroke was conducted to study the effects of erythropoietin on cerebral vascular dysfunction and anemia in subjects with TBI. There were periods of time when EFIC was and was not available for enrollment into the study.

Purpose

To explore the effect of EFIC availability on TBI trial enrollment of minority versus non-minority subjects.

SUBMITTER: Yamal JM 

PROVIDER: S-EPMC3974159 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature