Minority Health Archive

Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?☆

Sugarman, Jeremy and Sitlani, Colleen and Andrusiek, Dug and Aufderheide, Tom and Bulger, Eileen M. and Davis, Daniel P. and Hoyt, David B. and Idris, Ahamed and Kerby, Jeffrey D. and Powell, Judy (2009) Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?☆. Resuscitation, 80 (6). pp. 644-649. ISSN 03009572

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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.

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Item Type: Article
Uncontrolled Keywords: Research in the emergency setting; Exemption from consent; Research ethics; Subject selection; Clinical trials; Trauma; Race and ethnicity
Subjects: Health > Health Equity
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Depositing User: Users 141 not found.
Date Deposited: 26 May 2011 10:05
Last Modified: 26 May 2011 10:05
Link to this item (URI): http://health-equity.lib.umd.edu/id/eprint/2515

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