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|NIH Staff FAQs|
A. Overview of Racial and Ethnic Standards
The racial and ethnic standards are set by the Office of Management and Budget (OMB). The racial and ethnic categories are defined in terms of geographic origins. For more information on the categories and their definitions, information can be found here.
In addition to the link above to the OMB description, information about the race and ethnicity categories and use of the NIH forms is available in the SF242 R&R and other NIH application forms available at http://grants.nih.gov/grants/forms.htm.
B. Collection of race and ethnicity information from research participants
Typically, the research participant should be provided the opportunity to self-select and report the racial and ethnic categories that they identify with. Also, data collection must allow for participants to not provide these data, in which case they will be reported to the NIH as “unknown/not reported.”
Investigators should design culturally appropriate demographic data collection approaches that allow individuals to self-select the racial and ethnic standards they identify with. Generally, investigators should ask race and ethnicity as two separate questions. The first question should ask an individual’s ethnicity, followed by a question that provides the option of selecting one or more racial categories. As discussed above, individuals have the right not to select any category(s), in which case they will be reported to the NIH as “unknown/not reported.”
In structuring an appropriate demographic data collection, participants should be offered the choice to select as many racial categories that they deem appropriate. When the investigator reports to the NIH, these individuals will be aggregated under the “more than one race” category.
The NIH forms should not be used for collecting data from research participants. These forms are only to be used for reporting the enrollment of individuals by sex/gender, race, and ethnicity to the NIH for a given study(s).
The scientific question being addressed in the study should guide investigators’ decisions regarding collection of any additional information on ethnicity or race. Researchers are encouraged to consider collecting additional information on race and ethnicity that will provide insights into the relationships between race and ethnicity and health. The 1997 OMB guidelines provide minimum standards for data collection and should be used when reporting race and ethnicity to the NIH. However, discussion of more detailed information on race and/or ethnicity may be provided in the competing application and/or non-competing progress reports submitted to the NIH.
C. How to report race and ethnicity information to the NIH
In general, when conducting NIH-defined clinical research, investigators are expected to include women and minorities unless inappropriate with respect to the health or the scientific goals of the study. See here for more details on the policy.
Submitting a competing application: When submitting a new or competing renewal application to the NIH, investigators should address plans for inclusion on the basis of sex/gender, race, and ethnicity in their research studies as well as complete the Planned Enrollment Report. In addition to Planned Enrollment Reports, investigators submitting a competing renewal application should also complete a Cumulative Inclusion Enrollment Report(s) to describe progress on inclusion from the previous funding period. Additional instructions are available in the application packages available here.
Submitting a non-competing application (progress report): Investigators should complete an Inclusion Enrollment Report for each study to describe progress in enrolling individuals by sex/gender, race, and ethnicity. Additional instructions are available in the application packages available here.
The NIH provides forms with the different application packages for completing information on sex/gender, race, and ethnicity. We are transitioning to a modified layout of the forms starting with competing applications. For additional details see this Guide Notice.
Starting with September 2013 receipt dates, investigators preparing new or renewal competing applications will use the modified reporting format available in competing application packages. Note: SBIR/STTR applications will begin using the modified layout after the September 7, 2013 receipt date.
The data collection is the same as are the racial and ethnic standards. The changes are to add the “more than one race” category to the Planned Enrollment Report and to simplify the layout of the forms.
The layout of the forms is changing to reduce confusion about how to complete the tables and to ensure that everyone understands that, for each participant, information about race and information about ethnicity are collected, resulting in two separate pieces of data.
For additional information on the modified layout of the reporting formats and which report formats to use for competing and non-competing applications, please refer to the slide deck available at: http://grants.nih.gov/grants/funding/women_min/women_min.htm