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

Sugarman, Jeremy; Sitlani, Colleen; Andrusiek, Dug; Aufderheide, Tom; Bulger, Eileen M.; Davis, Daniel P.; Hoyt, David B.; Idris, Ahamed; Kerby, Jeffrey D.; Powell, Judy; Schmidt, Terri; Slutsky, Arthur S.; Sopko, George; Stephens, Shannon; Williams, Carolyn; Nichol, Graham; the Resuscitation Outcomes Consortium Investigators,

doi:10.1016/j.resuscitation.2009.03.015

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Volume 80, Issue 6 , Pages 644-649, June 2009

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

Jeremy Sugarman
- Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA
- Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
- Corresponding author at: Berman Institute of Bioethics and Department of Medicine, Johns Hopkins University, Hampton House 351, 624 N. Broadway, Baltimore, MD 21205, USA. Tel.: +1 410 955 3119; fax: +1 410 614 9567.
Colleen Sitlani
- Resuscitation Outcomes Consortium Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA, USA
Dug Andrusiek
- Medical Programs, Emergency and Health Services Commission, and School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada
Tom Aufderheide
- Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, USA
Eileen M. Bulger
- Department of Surgery, University of Washington, Seattle, WA, USA
Daniel P. Davis
- Department of Emergency Medicine, University of California San Diego, La Jolla, CA, USA
David B. Hoyt
- Department of Surgery, University of California, Irvine, Irvine, CA, USA
Ahamed Idris
- Department of Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA
Jeffrey D. Kerby
- Section of Trauma, Burns and Surgical Critical Care, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA
Judy Powell
- Resuscitation Outcomes Consortium Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA, USA
Terri Schmidt
- Department of Emergency Medicine and Center for Ethics in Health Care, School of Medicine, Oregon Health & Science University, Portland, OR, USA
Arthur S. Slutsky
- Keenan Research Center of the Li Ka Shing Knowledge Institute at St. Michael's Hospital, and University of Toronto, Toronto, CA, USA
George Sopko
- Division of Cardiovascular Diseases, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA
Shannon Stephens
- Department of Emergency Medicine, Alabama Resuscitation Center, University of Alabama at Birmingham, Birmingham, AL, USA
Carolyn Williams
- Department of Emergency Medicine, Alabama Resuscitation Center, University of Alabama at Birmingham, Birmingham, AL, USA
Graham Nichol
- Resuscitation Outcomes Consortium Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA, USA
- University of Washington – Harborview Center for Prehospital Emergency Care, Department of Medicine, Seattle, WA, USA
the Resuscitation Outcomes Consortium Investigators

Received 10 November 2008; received in revised form 30 January 2009; accepted 4 March 2009. published online 23 April 2009.

Abstract

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) ≤70mmHg or SBP 71–90mmHg and heart rate ≥108beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score ≤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.

Keywords: Research in the emergency setting, Exemption from consent, Research ethics, Subject selection, Clinical trials, Trauma, Race and ethnicity

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☆ A Spanish translated version of the summary of this article appears as Appendix in the final online version at doi:10.1016/j.resuscitation.2009.03.015.

PII: S0300-9572(09)00121-X

doi:10.1016/j.resuscitation.2009.03.015

« Previous Next »Resuscitation
Volume 80, Issue 6 , Pages 644-649, June 2009

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