What ethnic and racial categories should be used to estimate race and ethnicity, given the new OMB standards?
Investigators should use the categories described in the PHS 398 instructions and listed in the table “Targeted/Planned Enrollment Table” for New Applications. First, the investigator should report the anticipated total number of males and females to be enrolled by Ethnicity (Hispanic or Latino, Not Hispanic or Latino). Then, the investigator should report the anticipated total number of males and females by Racial Categories (American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, White). The total number of subjects in the Ethnic Category section of the table should equal the total number of subjects in the Racial Categories section. Investigators do not need to estimate the anticipated number of individuals reporting multiple racial categories (either total number reporting multiple categories or number reporting specific combinations) for New Applications. However, the investigator must follow the OMB guidelines, which include
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