Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African
American.”
Native Hawaiian or Other Pacific Islander: A person having origins in any of the original
peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White: A person having origins in any of the original peoples of Europe, North Africa, or the
Middle East.
Reporting Data on Race and Ethnicity: NIH is required to use the above standards and definitions for
race and ethnicity to allow comparisons to other federal databases, especially the census and national
health databases. Federal agencies shall not present data on detailed categories if doing so would
compromise data quality or confidentiality standards.
When collecting data on ethnicity and race, as well as sex/gender, use the categories listed to obtain the
data from individuals on the basis of self-identification. Participants should be asked to identify their
ethnicity and their race. The OMB recommends collecting this information using two separate questions,
with ethnicity information collected first followed by race, with the option to select more than one racial
designation (https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf). The NIH
inclusion enrollment format is not designed for use as a data collection instrument. Collect the data
using instruments prepared for the study, and use that information to complete the NIH inclusion
enrollment form(s). Study participants who self-identify with more than one of the racial categories
should be reported in the aggregate in the "More Than One Race" category.
Collecting and Reporting Data on Subpopulations: Each ethnic/racial group contains subpopulations
that are delimited by geographic origins, national origins, and/or cultural differences. It is recognized
that there are different ways of defining and reporting racial and ethnic subpopulation data. The
subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or
cultural heritage. Attention to subpopulations also applies to individuals who self-identify with more
than one ethnicity or race. These ethnic/racial combinations may have biomedical, behavioral, and/or
social-cultural implications related to the scientific question under study. The collection of greater detail
is encouraged, e.g., on ethnic/racial subpopulations; however, any collection that uses more detail needs
to be organized in such a way that the additional categories can be aggregated into the OMB categories
for reporting data on ethnicity, race, and more than one race. Investigators who have data on
subpopulations are encouraged to provide that information in the Comments field of the inclusion
enrollment forms and/or in the text of their progress report.
Collecting and Reporting Data on Non-U.S. Populations: If conducting NIH-defined clinical research
outside of the United States, design culturally appropriate data collection instruments that allow
participants to self-identify their ethnic and/or racial 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 NIH (see definitions for each ethnic and racial category
above), which will allow for completion of the inclusion enrollment form(s). Since OMB categories
reference world-based geographic origin, this should facilitate completion of the form(s). Enrollment of
participants at non-U.S. sites should be reported to NIH on a separate inclusion enrollment form
from that for reporting participants at U.S. sites, even if they are part of the same study. For
additional guidance and FAQs related to this topic, please refer to:
http://grants.nih.gov/grants/funding/women_min/women_min.htm or contact the program officer.
Reporting Data on Age: Recipients who submitted the last competing application January 25, 2019 or
later must include deidentified data on sex/gender, race, ethnicity and age at enrollment for each study
participant. Age may be reported in units ranging from minutes to years. Data must be provided in .csv
format using the template provided. See tip sheet and video for additional details.
Changes to Planned Enrollment: If there are changes from the planned enrollment originally approved