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

Lisa Eckstein, Georgetown University

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 critiquing the requirements that clinical trials must satisfy in order to be approved by Institutional Review Boards (IRBs). The proposed model highlights a number of gaps in the regulatory framework’s response to research that uses racial or ethnic proxies. Compliance with such a model could significantly improve the process for developing any future race-based drugs.