The Responsible Use of Racial and Ethnic Categories in Biomedical Research: Where Do We Go from Here?

2 Pages Posted: 26 Jan 2011

See all articles by Susan M. Wolf

Susan M. Wolf

University of Minnesota Law School

Date Written: Fall 2006


Debate over the proper use of racial and ethnic categories in biomedical research has raged in recent years. With the Human Genome Project showing that human beings are overwhelmingly alike genetically, exhibiting more genetic variation within supposed "races" than between them, many have come to doubt the scientific utility of such categories. Yet federal authorities use Directive 15 from the Office of Management and Budget (OMB) to mandate the continued use of such categories in research. Moreover, researchers studying health disparities argue that data collection using racial and ethnic categories is necessary to determine whether conditions and care vary by race and ethnicity. Epidemiologists also defend the use of racial and ethnic categories to understand contributors to disease such as the stress of experiencing racial prejudice and reduced access to care because of bias. A number of conflicting proposals have been offered, some to discipline and improve the use of racial and ethnic categories, and some to eliminate such categories.

To make progress in this debate, the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences and Center for Bioethics convened a conference on "Proposals for the Responsible Use of Racial and Ethnic Categories in Biomedical Research." The conference included the lead investigator and inventor on the patent for BiDil, the first drug approved by the FDA for patients of a particular racial or ethnic group -- in this case, African-American patients with heart failure. Substantial controversy surrounds the drug and the FDA’s action. Conference participants debated the BiDil issues and more broadly considered the range of proposals for the responsible use of racial and ethnic categories in biomedical research, including proposals by researchers, journals, and federal authorities. The participants considered the constitutionality, scientific acceptability, and policy implications of those proposals. This 11-article symposium is the result, including articles by Troy Duster, Dorothy Roberts, Mildred Cho, Raj Bhopal, Gregg Bloche, Jay Cohn, Morris Foster, Rose Brewer, Margaret Winkler, Eric Lillquist, and Charles Sullivan.

Keywords: Race, ethnicity, biomedical research, human subjects research, genetics, bioethics, BiDil, discrimination, health disparities, census categories, social construction, constitutional law, health law

Suggested Citation

Wolf, Susan M., The Responsible Use of Racial and Ethnic Categories in Biomedical Research: Where Do We Go from Here? (Fall 2006). Journal of Law, Medicine and Ethics, Vol. 34, No. 3, pp. 483-559, 2006. Available at SSRN:

Susan M. Wolf (Contact Author)

University of Minnesota Law School ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States
612-625-3406 (Phone)
612-624-9143 (Fax)


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