title: 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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  EFIC increased the odds of being enrolled regardless of minority status.
authors.affiliation: aDivision of Biostatistics, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.
authors.forename: Jose-Miguel
authors.initials: JM
authors.lastname: Yamal
authors.forename: Claudia S
authors.initials: CS
authors.lastname: Robertson
authors.forename: M Laura
authors.initials: ML
authors.lastname: Rubin
authors.forename: Julia S
authors.initials: JS
authors.lastname: Benoit
authors.forename: H Julia
authors.initials: HJ
authors.lastname: Hannay
authors.forename: Barbara C
authors.initials: BC
authors.lastname: Tilley
mesh_terms: D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data; D000740:Anemia / Q000150:complications / Q000188:drug therapy; D001213:Asian / Q000706:statistics & numerical data; D001930:Brain Injuries / Q000150:complications / Q000188:drug therapy; D002561:Cerebrovascular Disorders / Q000150:complications / Q000188:drug therapy; D002986:Clinical Trials as Topic / Q000379:methods*; D018864:Cultural Diversity; D004921:Erythropoietin / Q000627:therapeutic use; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D007258:Informed Consent; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D008913:Minority Groups / Q000706:statistics & numerical data*; D016017:Odds Ratio; D018579:Patient Selection; D014481:United States; D044465:White People / Q000706:statistics & numerical data
chemical_list: D006397:Hematinics; D004921:Erythropoietin