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.

Methods: Minority status of screened (n = 289) and enrolled (n = 191) TBI subjects was determined for this study. We tested for the presence of a minority and EFIC availability interaction in a multiple logistic regression model after controlling for EFIC and minority group main effects and other covariates.

Results: An interaction between the availability of EFIC minority and non-minority enrollment was not detected (odds ratio = 1.22; 95% confidence interval (CI) = 0.29-5.16).

Limitations: Our study was conducted at a single site, and the CI for the EFIC and minority interaction term was wide. Therefore, a small interaction effect cannot be ruled out.

Conclusion: EFIC increased the odds of being enrolled regardless of minority status.

Trial registration: ClinicalTrials.gov NCT00313716.

Figures

Figure 1

CONSORT diagram of screened subjects

Figure 2

Cumulative enrollment of screened and enrolled subjects by month and minority status. Shaded and white regions indicate times when EFIC was and was not available, respectively.