Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?
BACKGROUND
Concerns have been raised about the enrollment of racial and ethnic minorities in research in the emergency setting when it is not possible to obtain informed consent. However, there is a paucity of data related to the validity of such claims.


METHODS
Retrospective comparison of registry enrollment (4/1/2006-3/31/2007) and trial enrollment (4/1/2007-3/31/2008) from three sites in the Resuscitation Outcomes Consortium. Subjects compared met the following criteria: (1) shock, defined by blunt or penetrating force to the body with either systolic blood pressure (SBP) < or =70 mmHg or SBP 71-90 mmHg and heart rate > or =108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score < or =8.


RESULTS
Overall, compared to a registry there were no differences in the percent of racial or ethnic groups enrolled in the clinical trial [odds ratio (OR) for Blacks versus Whites: 0.87, 95% confidence interval (CI) 0.65-1.16, p=.34; OR for Hispanics versus Whites 1.04; 95% CI 0.72-1.49, p=.85]. However, Blacks were less likely than Whites to be enrolled in the TBI cohort [OR 0.58 (0.34-0.97), p=.04].


CONCLUSIONS
Despite some discordance in subgroups, there was no overall difference in the racial and ethnic distribution of subjects enrolled in a multi-center clinical trial of severe trauma compared to a registry accounting for study entry criteria. These findings help address justice concerns about enrollment of racial and ethnic minorities in trauma research performed using an exception from informed consent under emergency circumstances.
Sugarman
Jeremy
J
Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD 21205, USA. jsugarm1@jhmi.edu
Sitlani
Colleen
C
Andrusiek
Dug
D
Aufderheide
Tom
T
Bulger
Eileen M
EM
Davis
Daniel P
DP
Hoyt
David B
DB
Idris
Ahamed
A
Kerby
Jeffrey D
JD
Powell
Judy
J
Schmidt
Terri
T
Slutsky
Arthur S
AS
Sopko
George
G
Stephens
Shannon
S
Williams
Carolyn
C
Nichol
Graham
G
D000293:Adolescent; D000328:Adult; D035843:Biomedical Research / Q000592:standards*; D044383:Black People / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic; D004632:Emergency Medical Services; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D008913:Minority Groups / Q000706:statistics & numerical data; D018579:Patient Selection; D011287:Prejudice; D044469:Racial Groups / Q000706:statistics & numerical data*; D012042:Registries; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology; D044465:White People / Q000706:statistics & numerical data; D014947:Wounds and Injuries / Q000453:epidemiology*; D055815:Young Adult; D001741:Black or African American