Grants and Funding

  Public FAQs  Public FAQs
  NIH Staff FAQs  NIH Staff FAQs
Frequently Asked Questions
Reporting Race and Ethnicity Data
Last Revised: July 30, 2013

  A. Overview of Racial and Ethnic Standards

  1. Who sets the race and ethnicity standards for the categories used in reporting participants to NIH?
  2. Where are the race and ethnicity standards and categories described?

  B. Collection of race and ethnicity information from research participants

  1. Who decides what race and ethnicity a research participant is?
  2. How is racial and ethnic information collected from a research participant?
  3. How do individuals who are more than one race identify?
  4. What if my study involves analyzing an existing dataset in which the race and ethnicity categories do not comply with the 1997 OMB standards?
  5. Can the NIH forms be used to collect data from research participants?
  6. Can more detailed questions than indicated by the OMB guidelines be asked about ethnicity and race?
  7. Since I’m working with non-US participants, how do I collect and report information on sex/gender, race, and ethnicity?

  C. How to report race and ethnicity information to the NIH

  1. When is information on race and ethnicity reported to the NIH?
  2. What report format is used to report sex/gender, race, and ethnicity?
  3. What does the report format transition mean and when does it start?
  4. What about reporting sex/gender, race, and ethnicity on non-competing progress reports?
  5. What is changing on the report formats?
  6. Why is the layout for the forms changing?
  7. Where can more information be found on the modified layout of the reporting format and other information about inclusion policies and procedures?
  8. Since I’m working with non-US participants, how do I collect and report information on sex/gender, race, and ethnicity?
Back to Top

  A. Overview of Racial and Ethnic Standards

  1. Who sets the race and ethnicity standards for the categories used in reporting participants to NIH?

    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.

  2. Where are the race and ethnicity standards and categories described?

    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.

Back to Top

  B. Collection of race and ethnicity information from research participants

  1. Who decides what race and ethnicity a research participant is?

    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.”

    There may be situations where self-report of race and ethnicity is not feasible because the participant is incapable of providing the information.  In these situations, investigators should determine what is the most reasonable approach such as obtaining the information from other sources (e.g., medical records, family members, etc.) or whether it is more appropriate to indicate "unknown/not reported."  

  2. How is racial and ethnic information collected from a research participant?

    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.”

  3. How do individuals who are more than one race identify?

    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.

  4. What if my study involves analyzing an existing dataset in which the race and ethnicity categories do not comply with the 1997 OMB standards?
    If an investigator is using previously collected data sets that do not conform to the current (1997) OMB standards and does not plan to collect any new/additional data from the subjects, this should be noted in the inclusion section of the competing or non-competing application and/or in the comments section of the Planned Enrollment Report. When preparing to report on actual cumulative inclusion enrollment to the NIH, investigators should report the information they have and use the unknown/not reported category, when necessary.  Investigators should not assume what racial or ethnic category an individual would have identified with.
  5. Can the NIH forms be used to collect data from research participants?

    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). 

    Investigators should develop an instrument for collecting this information that is culturally appropriate for the research setting and that meets the scientific needs of the study.  Also, investigators should think carefully about the way the information is asked of participants to ensure they obtain the information needed for their study and for reporting on the forms.  For example, at times, an individual's self-identity (e.g., sex/gender, race, and/or ethnicity) may differ from their genetic, chromosomal, ancestral lineage etc.  Investigators may want to frame the demographic questions differently depending on the scientific goals of the study and what information is needed for that purpose.   

  6. Can more detailed questions than indicated by the OMB guidelines be asked about ethnicity and race?

    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.

  7. Since I’m working with non-US participants, how do I collect and report information on sex/gender, race, and ethnicity?

    When feasible, self-report of sex/gender, race, and ethnicity is the preferred method.  However, working with non-US participants can present a unique challenge to the collection and reporting of racial and ethnic information.  The racial and ethnic standards used for reporting to the NIH are set by the Office of Management and Budget (OMB) and are defined for the US population.  It is not expected that investigators would use the OMB categories for race and ethnicity in data collection instruments designed for use in other countries.  Investigators should design culturally appropriate data collection instruments that allow a participant to self-identify with their racial and ethnic affiliation in a way that is meaningful in the cultural and scientific contexts of the study. However, investigators will need to use the OMB-defined categories for reporting sex/gender, race, and ethnicity to the NIH.  Since the OMB categories are based on world-based geographic origin, this should facilitate the “translation” of the information for reporting purposes to NIH.

    For more information on the categories and their definitions, information can be found here. In addition 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.

Back to Top

  C. How to report race and ethnicity information to the NIH

  1. When is information on race and ethnicity reported 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.

  2. What report format is used to report sex/gender, race, and ethnicity?

    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.

  3. What does the report format transition mean and when does it start?

    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.

  4. What about reporting sex/gender, race, and ethnicity on non-competing progress reports?
    Investigators will continue using the Inclusion Enrollment Report format for reporting race and ethnicity until further notice.  This format includes separate sections for ethnicity and race with Parts A and B for reporting all participants’ race (Part A) and Hispanic participants race (Part B).
  5. What is changing on the report formats?

    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.

  6. Why is the layout for the forms changing?

    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.   

  7. Where can more information be found on the modified layout of the reporting format and other information about inclusion policies and procedures?

    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

  8. Since I’m working with non-US participants, how do I collect and report information on sex/gender, race, and ethnicity?

    When feasible, self-report of sex/gender, race, and ethnicity is the preferred method.  However, working with non-US participants can present a unique challenge to the collection and reporting of racial and ethnic information.  The racial and ethnic standards used for reporting to the NIH are set by the Office of Management and Budget (OMB) and are defined for the US population.  It is not expected that investigators would use the OMB categories for race and ethnicity in data collection instruments designed for use in other countries.  Investigators should design culturally appropriate data collection instruments that allow a participant to self-identify with their racial and ethnic affiliation in a way that is meaningful in the cultural and scientific contexts of the study. However, investigators will need to use the OMB-defined categories for reporting sex/gender, race, and ethnicity to the NIH.  Since the OMB categories are based on world-based geographic origin, this should facilitate the “translation” of the information for reporting purposes to NIH.

    For more information on the categories and their definitions, information can be found here. In addition 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.

Return to Inclusion of Women and Minorities Page


This page last updated on July 30, 2013
Content Manager: GrantsInfo@nih.gov 
Technical Issues: E-mail OER Webmaster