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The Role of Genetic and Sociopolitical Definitions of Race in Clinical Trials

Dr. Payne is Assistant Research Professor, Department of Health Policy, George Washington University, Washington, DC. Dr. Royal is Associate Professor, National Human Genome Center, Howard University, Washington, DC.

None of the following authors or the departments with which they are affiliated has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article: Dr. Payne and Dr. Royal. Research funded partially by the National Human Genome Research Institute, National Institutes of Health, Grant Number P20HG03373.

Although the concept of race has been disputed for decades, race continues to be used as a variable in biomedical research. Public Law 103-43 calls on the National Institutes of Health to develop guidelines for defining "minority group" and "their subpopulations" for the purposes of ensuring that they are included in clinical trials. Current guidelines use census racial categories, even though these categories are labeled as not scientific by their creator, the Office of Management and Budget. Three policy options exist for improving the National Institutes of Health Policy on Reporting Race and Ethnicity: (1) using genetic ancestry instead of census racial categories; (2) developing a standardized definition of race using current science; and (3) redefining minority group populations and subpopulations using social environment variables rather than census racial categories.