Abstract

http://ssrn.com/abstract=1763184
 


 



Beyond Racial and Ethnic Analyses in Clinical Research: A Proposed Model for Institutional Review Boards


Lisa Eckstein


Georgetown University Law Center

February 17, 2011

Food and Drug Law Journal, Vol. 66, p. 243, May 2011

Abstract:     
In 2005, the Food and Drug Administration’s approval of BiDil for use only in self-identified African Americans brought to the fore the longstanding debate about the use of race and ethnicity in medical research and practice. While this issue has received considerable attention in the science and social science literature, thus far there has been little consideration about the legal and regulatory implications of “race-based medicine.” This paper seeks to fill this gap by advocating the use of Institutional Review Boards (IRBs) in balancing the social and medical implications of race-based research. To assist them in this role, I propose a model to guide IRB approval of clinical trials based on the role of race or ethnicity in the study design. That is, whether a study includes racial and ethnic minorities: (1) with no specific analyses of racial or ethnic variability (race-inclusive research); (2) for the purpose of studying potential differences between racial or ethnic groups (race-targeted research); or (3) for the purpose of studying specific racial or ethnic groups (race-exclusive research). Compliance with such a model could significantly improve the process for developing any future race-based drugs.

Number of Pages in PDF File: 22

Keywords: Personalized medicine, Institutional Review Boards, BiDil, race-based medicine, drug development

Accepted Paper Series





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Date posted: April 29, 2011 ; Last revised: May 24, 2014

Suggested Citation

Eckstein, Lisa, Beyond Racial and Ethnic Analyses in Clinical Research: A Proposed Model for Institutional Review Boards (February 17, 2011). Food and Drug Law Journal, Vol. 66, p. 243, May 2011. Available at SSRN: http://ssrn.com/abstract=1763184

Contact Information

Lisa Eckstein (Contact Author)
Georgetown University Law Center ( email )
600 New Jersey Avenue, NW
Washington, DC 20001
United States
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