NIH POLICY ON REPORTING RACE AND ETHNICITY DATA:  SUBJECTS IN CLINICAL RESEARCH

Release Date:  August 8, 2001

(11/06/06 - See updated list of NIH contacts (MS Word) for this policy)

NOTICE:  NOT-OD-01-053
 
National Institutes of Health
 
POLICY: The NIH has adopted the 1997 Office of Management and Budget 
(OMB) revised minimum standards for maintaining, collecting, and 
presenting data on race and ethnicity for all grant applications, 
contract and intramural proposals and for all active research grants, 
cooperative agreements, contract and intramural projects. The minimum 
standards are described in the 1997 OMB Directive 15, 
http://www.whitehouse.gov/omb/fedreg/directive_15.html. 
 
SUMMARY:  This document provides additional guidance and instruction 
for using the revised minimum standards for maintaining, collecting, 
and presenting data on race and ethnicity found in the PHS 398 (rev. 
5/01) and PHS 2590 (rev.5/01) instructions and forms 
http://grants.nih.gov/grants/forms.htm.  Comparable information will be 
provided in research and development contract solicitations and awards 
for intramural projects. 
This document should be used in conjunction with the instructions in 
the PHS 398 and PHS 2590 instructions and forms.

The 1997 OMB revised minimum standards include two ethnic categories 
(Hispanic or Latino, and 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). The 
categories in this classification are social-political constructs and 
should not be interpreted as being anthropological in nature. Using 
self-reporting or self-identification to collect an individual’s 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. 

Collection of this information and use of these categories is required 
for research that meets the NIH definition of clinical research.  
 
EFFECTIVE DATE:  This policy applies to all new applications and 
proposals, annual progress reports, competing continuation 
applications, competing supplement applications for research grants, 
contracts, and intramural projects as of January 10, 2002. 

I. Revised Minimum Standards for Maintaining, Collecting, and 
Presenting Federal Data on Race and Ethnicity
 
The following are the ethnic and racial definitions for the minimum 
standard categories (1997 OMB Directive 15).
 
Ethnic Categories:
 
Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, 
South or Central American, or other Spanish culture or origin, 
regardless of race.  The term “Spanish origin” can also be used 
in addition to “Hispanic or Latino.”
 
Not Hispanic or Latino
 
Racial Categories:
 
American Indian or Alaska Native: A person having origins in any 
of the original peoples of North, Central, or South America, and 
who maintains tribal affiliations or community attachment.
 
Asian: A person having origins in any of the original peoples of 
the Far East, Southeast Asia, or the Indian subcontinent 
including, for example, Cambodia, China, India, Japan, Korea, 
Malaysia, Pakistan, the Philippine Islands, Thailand, and 
Vietnam. (Note: Individuals from the Philippine Islands have been 
recorded as Pacific Islanders in previous data collection 
strategies.)
 
Black or African American: A person having origins in any of the 
black racial groups of 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, the Middle East, or North Africa.
 
Using respondent self-report or self-identification to collect an 
individual’s 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. 
 
When reporting these data in the aggregate, investigators should 
report: (a) the number of respondents in each ethnic category; (b) the 
number of respondents who selected only one category for each of the 
five racial categories;  (c) the total number of respondents who 
selected multiple racial categories reported as the “number selecting 
more than one race”; and, (d) the number of respondents in each racial 
category who are Hispanic or Latino.  Investigators may provide the 
detailed distributions, including all possible combinations, of 
multiple responses to the racial designations as additional 
information.  However, more detailed items should be designed in a way 
that they can be aggregated into the required categories for reporting 
purposes. NIH is required to use these definitions to allow comparisons 
to other federal databases, especially the census and national health 
databases. Federal agencies will not present data on detailed 
categories if doing so would compromise data quality or confidentiality 
standards.

II. Guidance on Reporting Ethnicity/Race and Sex/Gender in Clinical 
Research
 
NIH requires all grants, contracts, and intramural projects conducting 
clinical research to address the Inclusion of Women and Minorities (see 
http://grants.nih.gov/grants/funding/women_min/women_min.htm).  NIH 
defines clinical research as: (1) Patient-oriented research. Research 
conducted with human subjects (or on material of human origin such as 
tissues, specimens and cognitive phenomena) for which an investigator 
(or colleague) directly interacts with human subjects. Excluded from 
this definition are in vitro studies that utilize human tissues that 
cannot be linked to a living individual. Patient-oriented research 
includes: (a) mechanisms of human disease, (b) therapeutic 
interventions, (c) clinical trials, or (d) development of new 
technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes 
research and health services research. 
 
New Applications (type 1), Competing Continuations (type 2), Requests 
for Proposals, and Intramural Projects
 
Submitting Applications or Proposals Involving the Collection of 
New/Additional Data in Clinical Research:  

Investigators are instructed to provide plans for the total 
number of subjects proposed for the study and to provide the 
distribution by ethnic/racial categories and sex/gender. This 
information must be reported using the newly revised categories 
and according to the new format provided in the Targeted/Planned 
Enrollment table 
http://grants.nih.gov/grants/funding/phs398/enrollment.pdf

Submitting Applications or Proposals Using Existing Data in Clinical 
Research with No Plans for Collecting New/Additional Data:  

Investigators are instructed to provide plans for the total 
number of subjects proposed for the study and to provide the 
distribution by ethnic/racial categories and sex/gender.  Under 
these circumstances, investigators are not required to re-contact 
subjects solely to comply with the newly revised categories. If 
the existing data on ethnicity and race allows accurate 
correspondence with the new categories, the investigator can use 
the format in the Targeted/Planned Enrollment table. However, if 
the existing data do not allow accurate correspondence with the 
new categories, information may be reported using the former 
categories and according to the format in the 4/98 Version of the 
Inclusion Table 
http://grants.nih.gov/grants/funding/women_min/InclusionOld_Form.pdf

Annual Progress Reports (type 5) and Competing Supplement Applications
 
In Annual Progress Reports and Competing Supplement Applications, 
investigators conducting clinical research are required to provide the 
cumulative total enrollment of subjects to-date (as well as any 
proposed additions to the Targeted/Planned enrollment in the case of 
Competing Supplement Applications) and to present the distribution by 
ethnic/racial categories and sex/gender.
 
If Data Collection is Ongoing, Such that New Subjects Will be Enrolled 
and/or Additional Data Will be Collected from Human Subjects:  

Investigators may choose to report ethnicity/race and sex/gender 
sample composition using EITHER the format in the former 4/98 
Version of the Inclusion Table OR the new Inclusion Enrollment 
Report http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf  
[Note: If investigators with on-going data collection choose to 
report information using the new Inclusion Enrollment Report, 
they must continue to use this format for the remaining years of 
the project.]
 
If Data Collection is Complete, Such that No New/Additional Subject 
Contact is Planned:

Investigators may EITHER continue to report using the former 
categories and according to the 4/98 Version of the Inclusion 
Table, OR, if data allow accurate correspondence with the new 
categories, use the format in the new Inclusion Enrollment 
Report. 
 
III. Frequently Asked Questions

1. 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.
  
2.  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. 
 
3. 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.
 
4. 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
 
5. 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. 

6.  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. 
 
7.  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.

8. 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.
 
9.  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. 
 
Additional Information and NIH Contacts
 
Additional information on NIH policy regarding the Inclusion of Women 
and Minorities in Clinical Research can be found at the website 
http://grants.nih.gov/grants/funding/women_min/women_min.htm

 The following extramural staff from the NIH Institutes and Centers may 
be contacted for further information about the policy and relevant 
Institute/Center programs:

 Dr. Miriam Kelty
 National Institute on Aging
 Gateway Building 
 7201 Wisconsin Avenue, Room 2C218
 Bethesda, MD  20892
 Telephone:  (301) 496-9322
 Email:  keltyM@nia.nih.gov
  
 Dr. Eleanor Hanna
 National Institute on Alcohol Abuse and Alcoholism
 Willco Building
 6000 Executive Boulevard, Suite 514
 Rockville, MD  20892
 Telephone:  (301) 594-6231
 Email:  ehanna1@mail.nih.gov
  
 Dr. John McGowan 
 National Institute of Allergy and Infectious Diseases
 6700 B Rockledge 
 6700 Rockledge Drive
 Bethesda, MD  20817
 Telephone:  (301) 496-7291
 Email:  jm80c@nih.gov
  
 Dr. Julia Freeman
 National Institute of Arthritis and Musculoskeletal and Skin Diseases
 Natcher Building 
 Building 45, Room 5AS19F
 Bethesda, MD  20892
 Telephone:  (301) 594-4543
 Email:  freemanj@ep.niams.nih.gov

 Dr. Joan T. Harmon
 National Institute of Biomedical Imaging and Bioengineering
 Room 697
 6707 Democracy Boulevard
 Bethesda, MD  20892
 Telephone:  (301) 594-8813
 Email:  joan_harmon@nih.gov
  
 Dr. Marvin Kalt
 National Cancer Institute
 Executive Plaza North
 6116 Executive Boulevard, Suite 8001
 Bethesda, MD  20892
 Telephone:  (301) 496-5147
 Email:  kaltm@dea.nci.nih.gov

 Dr. Susan Streufert 
 National Institute of Child Health and Human Development
 6100 Executive Boulevard
 Building 61EB, Room 4A05
 Bethesda, MD  20892
 Telephone:  (301) 435-6856
 Email:  streufes@mail.nih.gov
  
 Dr. Julie Gulya
 National Institute on Deafness and Other Communication Disorders
 Executive Plaza South 
 6120 Executive Boulevard, Room 400D-7
 Rockville, MD  20892
 Telephone:  (301) 435-4085
 Email:  gulyaj@ms.nidcd.nih.gov

 Dr. Norman S. Braveman 
 National Institute on Dental and Craniofacial Research
 Natcher Building
 Building 45, Rm 4AN24C
 Bethesda, MD  20892
 Telephone:  (301) 594-2089
 Email:  BravemanN@de45.nidr.nih.gov
  
 Dr. Robert Hammond
 National Institute of Diabetes and Digestive and Kidney Diseases
 2 Democracy Boulevard, Room 715
 Bethesda, MD  20892
 Telephone:  (301) 594-8834
 Email:  hammondr@extra.niddk.nih.gov 

 Dr. Teresa Levitin
 National Institute on Drug Abuse
 Neuroscience Building
 6001 Executive Boulevard, Room 3158
 Bethesda, MD  20852
 Telephone:  (301) 443-2755
 Email:  tlevitin@nida.nih.gov 

 Dr. Anne P. Sassaman
 National Institute of Environmental Health Sciences
 P.O. Box 12233, MD EC-30
 Research Triangle Park, NC  27709
 Telephone:  (919) 541-7723
 Email:  sassaman@niehs.nih.gov 

 Dr. Lore Anne McNicol
 National Eye Institute 
 Executive Plaza South 
 6120 Executive Boulevard, Room 350
 Rockville, MD  20892
 Telephone:  (301) 496-5301
 Email:  loreanne.mcnicol@nei.nih.gov
  
 Dr. Alison Cole
 National Institute of General Medical Sciences
 Natcher Building
 Building 45, Room 2AS49K
 Bethesda, MD  20892
 Telephone:  (301) 594-1826
 Email  colea@nigms.nih.gov
  
 Ms. Sharry Palagi
 National Heart, Lung and Blood Institute
 Building 31 
 31 Center Drive, Room 5A-07
 Bethesda, MD 20892
 Telephone:  (301) 402-3424
 Email:  palagis@nih.gov

 Dr. Mark Guyer
 National Human Genome Research Institute
 Building 31
 31 Center Drive, Room B2B07
 Bethesda, MD  20892
 Telephone:  (301) 496-7531
 Email:  guyerm@exchange.nih.gov

 Dr. Richard Nakamura
 National Institute of Mental Health
 Neuroscience Building 
 6001 Executive Boulevard, Room 8235
 Bethesda, MD  20852 
 Telephone:  (301) 443-3675 
 Email:  rnakamur@mail.nih.gov
  
 Dr. Meredith Temple
 National Institute of Neurological Disorders and Stroke
 Neuroscience Building 
 6001 Executive Boulevard, Room 2227
 Bethesda, MD  20892- 9525
 Telephone:  (301) 496-1447 
 Email:  templem@ninds.nih.gov  
  
 Dr. Carole Hudgings
 National Institute of Nursing Research
 Natcher Building
 45 Center Drive, Rm 3AN-12
 Bethesda, MD  20892
 Telephone:  (301) 594-5976 
 Email:  carole_hudgings@nih.gov
  
 Dr. Christine Goertz
 National Center for Complementary and Alternative Medicine
 Building 31
 31 Center Drive, Room 5B-58
 Telephone:  (301) 402-1030 
 Email:  GoertzC@od.nih.gov

 Dr. Eric Bailey
 National Center on Minority Health and Health Disparities
 2 Democracy Boulevard, Suite 800
 Bethesda, MD  20817
 Telephone:  (301) 402-1366
 Email:  baileye@od.nih.gov
  
 Dr. Geoffrey Cheung
 National Center for Research Resources
 Rockledge Centre I
 6705 Rockledge Dr, Rm 6118
 Bethesda, MD  20817
 Telephone:  (301) 435-0768
 Email:  cheungg@ncrr.ncrr.nih.gov
  
 Dr. Kenneth Bridbord
 Fogarty International Center
 Building 31
 31 Center Drive, Room B2C39
 Bethesda, MD  20892
 Telephone:  (301) 496-2516
 Email:  bridbordk@ficod.fic.nih.gov

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