By 2060, the US Census Bureau projections indicate that the United States will no longer have a single majority population; rather, the nation will be composed of a “plurality” of races and ethnic groups.1 In the early 1990s, congressional legislation set forth guidelines to include women and encourage the inclusion of members of racial and ethnic minority groups in federally sponsored human participant research.2,3 While substantial gains have been made regarding the participation of women in clinical research, the number of minorities appears to be lagging. Compliance with congressional mandates as well as valid analysis of differences between sexes or races/ethnicities requires an accurate system of inclusion data tracking.
Investigators trying to comply with these requirements have found that collecting data on racial/ethnic characteristics was confounded by variations in language, definitions of race/ethnicity, and ever-changing reporting requirements. The result has been multiple variations in acceptable standards for collection of race/ethnicity data since implementation of the requirements, which initially divided the population into only 4 categories: American Indian or Alaskan Native, Asian or Pacific Islander, black, and white.4 The current revision by the US Department of Health and Human Services, Agency for Healthcare Research & Quality is based on a 2-question survey that begins by asking about Hispanic/Latino ethnicity and then about race, which is now divided into 6 categories (Table).5 Clearly, race/ethnicity standards are continuously evolving as deficiencies in our data collection methods are documented and new groups are recognized, for example those who identify as multiracial…