Food and Drug Law Journal, Vol. 66, p. 243, May 2011
22 Pages Posted: 29 Apr 2011 Last revised: 24 May 2014
Date Written: February 17, 2011
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.
Keywords: Personalized medicine, Institutional Review Boards, BiDil, race-based medicine, drug development
Suggested Citation: 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: https://ssrn.com/abstract=1763184