What categories should I use in my application 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 allowing respondents to select multiple race categories, once data collection commences.
What if my new application involves analyzing secondary data in which the race and ethnicity categories do not comply with the new OMB guidelines?
If an investigator is using secondary data sets that do not conform to the new OMB guidelines and does not plan to collect any new/additional data from the subjects, this should be noted in the New Application. In this circumstance, the investigator should complete the “Targeted/Planned Enrollment Table” for a New Application and the “Inclusion Enrollment Report” for Continuation Applications, Competing Supplement Applications, and Annual Grant Progress Reports if the data allow. However, if the existing data do not allow accurate correspondence with the new categories, the investigator should report the information using the prior categories and use the 4/98 Version of the Inclusion Table.
The numbers in several parts of the two tables must be the same. In both the “Targeted/Planned Enrollment Table” for a New Application and the “Inclusion Enrollment Report ” for Continuation Applications, Competing Supplement Applications, and Annual Progress Reports, the sum in “Ethnic Category: Total of All Subjects” must equal the sum in “Racial Categories: Total of All Subjects.” In addition, the “Racial Categories: Total Hispanics or Latinos” in Part B of the “Inclusion Enrollment Report Table” must equal the Total Hispanic or Latino number reported in Part A of the “Inclusion Enrollment Report.” Footnotes in the tables clearly identify which numbers must be the same.
Can I use the Targeted/Planned Enrollment Table or the Enrollment Inclusion Report to collect data from individuals?
Neither the Targeted/Planned Enrollment Table nor the Enrollment Inclusion Report should be used for collecting data from individuals. These tables are only to be used for reporting aggregate data. To collect data from an individual respondent, investigators should use respondent self-report or self-identification and use two separate questions. The first question should be about ethnicity, followed by a question that provides the option of selecting one or more racial designations.
Can I ask more detailed questions about ethnicity and race than these guidelines indicate?
The revised OMB guidelines provide minimal standards for data collection. Indeed, researchers are encouraged to explore collecting additional types of information on race and ethnicity that will provide additional insights into the relationships between race and ethnicity and health. Questions identifying membership in subpopulations within the ethnic and racial categories provided by OMB may also be considered, provided they can be aggregated to the standard categories. The scientific question being addressed in the study should guide investigators’ decisions regarding collection of any additional information on ethnicity or race.
I have already begun data collection and my categories do not comply with the new OMB standards. Do I need to change my questions on race and ethnicity in the middle of the study?
If data collection has already begun, we do not expect investigators to change their questions on race and ethnicity prior to the completion of the study. For Annual Progress Reports, in this circumstance, investigators should note that the research project was initiated prior to the implementation of the new reporting guidelines. If the data do not accurately correspond with the new categories, the investigator may continue to use the format in the 4/98 Version of the Inclusion Table.
I began data collection prior to the new standards, but my race and ethnicity questions comply with the new standards. I submitted my original estimates of the study composition using the old standards. How should I present the data in the progress report?
If you began your data collection prior to the implementation of the new standards but your questions on race and ethnicity comply with the new standards, the choice is left up to the investigator as to how to present the data for Annual Progress Reports. We suggest completion of the new Inclusion Enrollment Report.
How should I report race and ethnicity data when my research involves a foreign population?
Investigators are encouraged to design their data collection instruments in ways that allow respondent self-identification of their racial and ethnic affiliation. However, these items should be designed in a way that they can be aggregated into the required categories. Also, the investigator can report on any racial/ethnic subpopulations by listing this information in an attachment to the required table. This may be particularly useful when distinctive subpopulations are relevant to the scientific hypotheses being studied.
When completing the tables, investigators should asterisk and footnote the table indicating that data includes foreign participants. If the aggregated data only includes foreign participants, the investigator should provide information in one table with an asterisk and footnote. However, if the study includes both domestic and foreign participants, we suggest the investigator complete two separate tables – one for domestic data and one for foreign data, with an asterisk and footnote accompanying the table with foreign data.
How do the 1997 OMB revised standards differ from the previous standards?
OMB issued the previous standards for maintaining, collecting, and presenting data on race and ethnicity in 1977. The minimum acceptable categories were: American Indian or Alaska Native; Asian or Pacific Islander; Black, not of Hispanic origin; Hispanic; White, not of Hispanic origin.
The 1997 OMB revised standards now include two ethnic categories (Hispanic or Latino or Not Hispanic or Latino) and five racial categories (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White). When using self-reporting or self-identification to collect data on ethnicity and race, investigators should use two separate questions with ethnicity information collected first followed by the option to select more than one racial designation.