Transparent Reporting of Demographic Characteristics of Study Participants

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. 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. 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.

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