The role of genetic and sociopolitical definitions of race in clinical trials

Document Type

Journal Article

Publication Date



Journal of the American Academy of Orthopedic Surgeons


Volume 15, Supplement 1

Inclusive Pages



Clinical Trials as Topic--standards; Clinical Trials as Topic--statistics & numerical data; Continental Population Groups; Race and Ethnicity Data


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.

Peer Reviewed