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

• Published in: Journal of the American Academy of Orthopaedic Surgeons Vol. 15 Suppl 1; p. S100
• Main Authors: Payne, Jr, Perry W, Royal, Charmaine
• Format: Journal Article
• Language: English
• Published: United States 2007
• Subjects: Clinical Trials as Topic - standards; Clinical Trials as Topic - statistics & numerical data; Continental Population Groups; Guidelines as Topic; Human Genome Project; Humans; Minority Groups; Terminology as Topic; United States; United States
• ISSN: 1067-151X
• DOI: 10.5435/00124635-200700001-00021

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.