Race and Ethnicity
A1. 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.
A2. 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.
A3. There are many ways of tabulating the multiple race and
ethnicity responses, particularly since the race and ethnicity categories
are not mutually exclusive. Do the numbers I report have to “add up”?
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.
A4. Can I use the Targeted/Planned Enrollment Table or the Enrollment Inclusion Report to collect data from individuals?
Neither the Targeted/Planned Enrollment Tablet 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. An example of a format for collecting information from
an individual can be found in the “Ethnic Origin and Race” section of
the Personal Data Form Page in the PHS 398 (rev. 5/01)
http://grants.nih.gov/grants/funding/phs398/personal.pdf
A5. 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. For example, after asking the ethnicity and then the race
questions, researchers may opt to ask study participants who choose
multiple categories to identify the group that they identify with
primarily. Further questions identifying membership in subpopulations
within the ethnic and racial categories provided by OMB may also be
considered. The scientific question being addressed in the study should
guide investigators’ decisions regarding collection of any additional
information on ethnicity or race. Information on subpopulations may be
reported by listing the information in an attachment to the required
table.
A6. 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.
A7. 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.
A8. 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.
A9. 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.
