Public FAQs  Public FAQs
  NIH Staff FAQs  NIH Staff FAQs
Frequently Asked Questions
Inclusion on the Basis of Sex/Gender and Race/Ethnicity
Last Revised: May 23, 2018




    I. General NIH Inclusion Policy Questions
    1. What is the purpose of the NIH policy on the inclusion of women and racial/ethnic groups as participants in research?
      The overarching goal of this policy is to ensure the appropriate inclusion of women and minorities in all clinical research supported by the NIH.  NIH supported clinical research should address/include the population(s) at risk for the disease or condition under study and ensure that the distribution of study participants by sex/gender, race and ethnicity reflects the population needed to accomplish the scientific goals of the study.

      Full details on the policy are available here.  There are additional requirements for studies meeting the NIH definition for a Phase III clinical trial.  These are addressed under FAQ Section II.  
    2. What is subject to the policy?
      All research projects supported by the NIH that meet the NIH definition for clinical research are subject to the NIH inclusion policy.  This includes studies supported by grants, cooperative agreements, R&D contracts, and NIH intramural programs.  Here is a link to a decision tree to help in determining whether a given study is subject to the policy.  A text version of this decision tree can be found here.

      Because of how human subjects' research is defined, there may be studies using information from humans that is not considered human subjects research.  Although these studies are not subject to the NIH Inclusion Policy, this does not mean that an understanding of the demographics (e.g., sex/gender, race, ethnicity, age, etc.) is not important.  The NIH encourages applicants to address this information, as appropriate, for the scientific question(s) under study.
    3. What is the definition of NIH clinical research?
      Clinical research is defined 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 colleaguedirectly 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, and (d) development of new technologies;
      (2) Epidemiologic and behavioral studies; and
      (3) Outcomes research and health services research.  
      Note:  Studies that meet the requirements for Institutional Review Board (IRB) review Exemption 4 are not considered NIH-defined clinical research.  More information on Exemption 4 can be found here

      For the purposes of inclusion policy only:  Additional clarification of part (1) of the NIH definition of clinical research:
      What does the term “patient-oriented” encompass?  Patient-oriented research includes inpatient and outpatient settings as well as healthy volunteers.
      Who is considered a “colleague?”  A colleague is considered to be anyone involved in conducting the research; doing any activity related to  the research other than just providing specimens/data (also referred to as a provider).
      What is considered a “direct interaction?”  In addition to having a direct interaction by an investigator (or colleague) with the participant, another form of direct interaction is defined as any colleague/investigator with access to PII (personally identifiable information).
    4. How is research that is Exempt from IRB (Institutional Review Board) review considered under the NIH inclusion policy?
      Human subjects research that meets the criteria for IRB Exemption 4 is not considered “clinical research” as defined by NIH; therefore, the NIH policy for addressing inclusion of women and minorities do not apply to research that is determined to meet the criteria for Exemption 4.  However, research meeting other IRB exemptions may or may not meet the NIH definition for clinical research and should be considered on a case by case basis to determine whether the NIH inclusion policy applies. 
    5. Is cost an acceptable justification for not including certain groups in clinical research studies or trials?
      No.  The cost associated with ensuring that the clinical research study population composition is appropriate in regards to sex/gender, racial, and/or ethnic distribution is not an acceptable justification for excluding a particular group(s).
    6. What is the “target population” for a given study?
      The number of subjects in the trial or study that are expected to be enrolled during the entire period of the study and are needed to evaluate the research question, and the expected distribution by sex/gender, race, and ethnicity based on the prevalence of the disease or outcome of interest in the population and study characteristics.
    7. When is someone considered a “participant” whose enrollment should be reported to the NIH?

      Any individual who is considered to be a human subject for a study as defined by 45 CFR 46 is considered a participant whose enrollment should be reported to NIH.  An individual is considered to be a human subject once the individual is enrolled or entered into the study, including situations where data is collected about an individual through a proxy, such as the collection of data about infants from mothers.  This definition includes all subjects who are eligible to contribute data to the scientific aims of the study, including individuals who subsequently dropout.  Subjects who are screened for participation but are not eligible would not be considered as participants.  This definition is limited to studies that fall under definition of clinical research at NIH.

    8. Are clinical research subjects required to provide information about their sex/gender, race, and ethnicity?
      Whenever possible, collection of information on sex/gender, race, and ethnicity should involve self-report by the individual research participant.  The data collection instrument should include the option to not identify sex/gender, race, and/or ethnicity.  In which case, these participants would be reported to the NIH as “unknown/not reported.”
    9. Can I design a clinical research study that limits inclusion to a specific sex/gender, racial, and/or ethnic group?

      Yes.  When proposing any study meeting the NIH definition of clinical research you should address plans for inclusion in the context of the study population, considering such factors as who is at risk for the disease or condition under study.  If you propose to further limit your sample within a given study population, additional justification should be provided in the context of the scientific goals of the study and why this is an appropriate sample.

    10. What do I do if my study sample is from a geographic area with a limited population?
      When proposing any study meeting the NIH definition of clinical research you should address plans for inclusion in the context of the study population, considering such factors as who is at risk for the disease or condition under study.  If you are in a geographic area with a limited population, additional justification should be provided in the context of the scientific goals of the study and why this is still an appropriate sample.  Cost to recruit certain groups is not an acceptable justification for limiting the inclusion of those groups.  If you are aware of similar research completed or underway employing populations complementary to those available proposed in your study, you can present this as a rationale for limited representation.  Alternatively, if the appropriate sample cannot be achieved in your geographic area, you should also address the feasibility of making collaborative or other arrangements to include the appropriate populations in your sample, e.g., seeking collaborators in other geographic areas where there is access to the other populations.
    Back to Top


    II. Questions Regarding NIH-defined Phase III Clinical Trials
    1. Are there additional inclusion policy requirements for NIH-defined Phase III clinical trials?
      In addition to addressing inclusion as for any NIH-defined clinical research study, investigators conducting NIH-defined Phase III clinical trials must also address requirements for valid analysis in their competing application and address progress in their non-competing (progress report) application.
    2. How should valid analysis be conducted?
      To conduct a valid analysis, many investigators present primary outcomes stratified by sex/gender and race/ethnicity.  NIH recognizes that many studies will not have sufficient statistical power to definitely answer whether there are clinically significant differences in how well the intervention works among sex/gender and racial/ethnic groups.  However, even when these analyses are not powered, they may still have value in informing future studies.  For example, the data may be used in meta-analysis of related clinical trials that further explore potential differences in effect by sex/gender and race/ethnicity.  NIH expects that investigators consider how data from valid analyses may inform future studies when designing their study, including their use in subsequent meta-analysis.
    3. What are the requirements for applicable NIH-defined Phase III clinical trials?
      Applicable NIH-defined Phase III clinical trials have additional reporting requirements for the valid analyses required in the competing and non-competing applications.  If a NIH-defined Phase III clinical trial is also an applicable clinical trial, the results of subgroup analyses must be reported in Clinicaltrials.gov.  To determine if your study is an applicable clinical trial, see this link.  Instructions regarding Clinicaltrials.gov registration and reporting can be found here.
    4. At what stage of study development should investigators consider sex/gender, race, and ethnicity for an NIH-defined Phase III clinical trial and develop plans for valid analyses?
      Applicants and offerors are expected to consider the potential for clinically important differences in sex/gender, race, and ethnicity when planning, conducting, analyzing, and reporting an NIH-defined Phase III clinical trial and address plans for conducting valid analyses in the application.  Applicants/offerors are expected to review existing evidence of significant difference in intervention effect by sex/gender and race/ethnicity. Based on prior studies, one of the three situations below will apply:
       
      1. Prior Studies Support the Existence of Significant Differences
       
      If the data from prior studies strongly support the existence of significant differences of clinical or public health importance in intervention effect based on sex/gender, racial/ethnic, and relevant subpopulation comparisons, the primary question(s) to be addressed by the proposed NIH-defined Phase III clinical trial and the design of that trial must specifically accommodate these expected differences.
       
      Example:  If males and females are thought to respond differently to intervention X, then the NIH-defined Phase III clinical trial must be designed to answer two separate primary questions, one for the effect of intervention X on males and the other for the effect of intervention X on females, with adequate sample size for each question.
       
      2. Prior Studies Support No Significant Differences
       
      If the data from prior studies strongly support no significant differences of clinical or public health importance in intervention effect based on sex/gender, race, ethnicity, and/or relevant subpopulation comparisons, then analyses by sex/gender, race, and/or ethnicity are not required.  However, the inclusion and analysis of sex/gender and/or racial/ethnic subgroups is still strongly encouraged.
       
      Example:  If evidence from prior studies demonstrates, to the satisfaction of the scientific community, that there are no differences in the effect of intervention Y among racial and ethnic groups, then analysis of the trial’s primary question by race and ethnicity is encouraged, but not required.
       
      3. Prior Studies Neither Support nor Negate Significant Differences
       
      If the data from prior studies neither strongly support nor strongly negate the existence of significant differences of clinical or public health importance in intervention effect based on sex/gender, racial/ethnic, and relevant subpopulation comparisons, then the NIH-defined Phase III clinical trial will be required to include sufficient and appropriate entry of participants by sex/gender, race, and/or ethnicity, so that valid analysis of the intervention effects can be performed.  However, the trial will not be required to provide high statistical power for these comparisons.
       
      Example:  If insufficient evidence exists to determine if males and females respond differently to intervention Z, then the study must be designed in a way to provide the results of the effect of intervention Z separately for males and females.  The study is encouraged, but not required, to ensure an adequate sample size to provide high statistical power.
    5. What constitutes “prior evidence” of differences in outcome by sex/gender or race/ethnicity?

      Prior evidence may come from a variety of sources, including data from basic research and earlier phase studies, as well as clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies.

    Back to Top


    III. Questions on Inclusion Information When Submitting NIH Applications/Proposals
    1. What inclusion-related information do I need to submit in my competing application/proposal if conducting NIH-defined clinical research?
      When submitting a new application/proposal to the NIH that includes NIH-defined clinical research studies, investigators should address plans for inclusion on the basis of sex/gender, race, and ethnicity as well as complete the Planned Enrollment Report. At a minimum, the inclusion plan should describe the proposed sample distributions by sex/gender, race, and ethnicity. You should justify the proposed sample in the context of the scientific goals of the proposed study.
       
      When submitting a competing renewal application, provide a narrative description regarding the cumulative enrollment from previous funding period as part of the progress report. Inclusion enrollment reports should not be used for this purpose.
      More detailed instructions are available in the application instruction guides available here.
    2. How do I address inclusion if I do not have definite plans to conduct human subjects research, such as in the case of delayed onset studies?
      The federal Protection of Human Subjects regulations, 45 CFR 46, recognize that certain research applications may be submitted to a sponsoring agency with the knowledge that human subjects will be involved during the period of support, but definite plans for this involvement cannot be described in the application (45 CRF 46.118).  As noted in the NIH Grants Policy Statement (GPS) 4.1.15, after award and prior to the involvement of human subjects, the grantee must submit a detailed human subjects section that follows the NIH competing application instructions to the NIH awarding Institute/Center (IC) for approval.  Additional guidance on the submission of this information is described here.
    3. What form(s) do I use to submit inclusion enrollment information in my competing application/proposal?
      When submitting a new application to the NIH that includes NIH-defined clinical research studies, you should address plans for inclusion on the basis of sex/gender, race, and ethnicity as well as complete the Planned Enrollment Report.

      When submitting a competing renewal application, provide a narrative description regarding the cumulative enrollment from previous funding period as part of the progress report. Inclusion enrollment reports should not be used for this purpose.

      If you are conducting a new research study using an existing dataset, use the Cumulative Inclusion Enrollment Report rather than the Planned Enrollment Report.

      More detailed instructions are available in the application instruction guides available here.
    Back to Top


    IV. Working with Existing Datasets and/or Resources
    1. Does the NIH inclusion policy apply to research using existing datasets or other types of existing resources involving human subjects?
      If the study is considered human subjects’ research and meets the NIH definition of clinical research, then it is subject to the NIH inclusion policy.
    2. For the purposes of inclusion policy, what is an existing dataset/resource?
      An existing dataset may be constructed of different types of data including but not limited to survey data, demographic information, health information, genomic information, etc.  Also included would be data to be derived from existing samples of cells, tissues, or other types of materials that may have been previously collected for a different purpose or research question but will now be used to answer a new research question.  In general, these will be studies meeting the NIH definition for clinical research with a prospective plan to analyze existing data and/or derive data from an existing resource and where no ongoing or future contact with participants is anticipated.
    3. Is it acceptable to use existing datasets or resources that are limited to specific sex/gender, racial, and/or ethnic groups?
      Yes.  You can propose a study or analyses of an existing dataset where the cohort is limited in sex/gender, racial, and/or ethnic participation.  However, you should justify why this dataset is useful in the proposed scientific context, particularly if the dataset does not reflect the population of the disease or condition under study.  Some factors that can be considered as part of the justification include the nature of the scientific question, a requirement for data provided by the cohort, or addressing a gap in knowledge.
    4. If I am using an existing dataset or resource, what form(s) do I use when submitting my application/proposal?
      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.  As noted above, if you are conducting research with an existing cohort or dataset, you would use the Cumulative Inclusion Enrollment Report rather than the Planned Enrollment Report.
    5. If I am working with an existing dataset or resource, how do I complete the table? Do I provide the sex/gender, race, and ethnicity information for the entire dataset?
      You should provide the sex/gender, race, and ethnicity information only for the data points you will use from the existing dataset or resource.  You would provide information for the entire dataset or resource if you were analyzing data from all individuals in that dataset or resource.  If your project is limited to analyzing data from only a subset of subjects in the existing dataset or resource, then you would complete the inclusion table using data only from the subset of subjects included in your analysis.  For example, if you want to analyze data from 2000 individuals in a large population based survey that includes 10 million individuals, you would provide the sex/gender, race, and ethnicity information for the 2000 individuals you plan to analyze.  If you were analyzing information about all 10 million participants, you would provide the sex/gender, race, and ethnicity information for all 10 million.
    6. What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?
      If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited.  The existing dataset sample can be provided on the Cumulative Inclusion Enrollment Report as described above.  The participants to be prospectively recruited should be accounted for on a Planned Enrollment Report with the competing application/proposal and actual recruitment numbers will be reported to the NIH at least annually on the Cumulative Inclusion Enrollment Report.
    7. What do I do if my proposed study involves multiple, different existing datasets or resources? How do I address inclusion and complete the forms?
      If you are proposing a study that will include multiple existing datasets/resources, you may submit the datasets/resources on separate Cumulative Inclusion Enrollment Reports or consolidate onto one Cumulative Inclusion Enrollment Report.  The decision to use separate forms or one consolidated form should be considered in the context of the scientific goals of the study and whether there is value in providing separate forms to illustrate the breakdown of sex/gender, race, and ethnicity information for each dataset/resource.  Also, please be sure to check with FOA (Funding Opportunity Announcement) you are applying to in case there is additional guidance on this issue.
    Back to Top


    V. Monitoring Inclusion in Multi-site Studies
    1. In studies or trials involving multiple sites, is each study site required to address inclusion separately?
      No.  When multi-site clinical research studies (or trials) are proposed, the appropriate distribution by sex/gender, race, and ethnicity should consider the recruitment across the different sites.  The funding Institute or Center (IC) at NIH and/or the PI/research team may decide that it is useful to provide inclusion data individually by site or by overall study, but it should not be provided both ways.
    2. In multi-component applications, does each component (or subproject) have to address inclusion separately?
      It depends.  Inclusion plans and the distribution of a planned sample by sex/gender, race, and ethnicity should be considered for each clinical research study or trial.  If a given study spans multiple components, only one Planned Enrollment Report (for that given study) needs to be provided; however, depending on the structure of the multi-component application, the inclusion plans may need to be referenced in more than one component.  See the application guide instructions and the specific Funding Opportunity Announcement (FOA) for additional guidance.
    Back to Top


    VI. Monitoring Inclusion When Working with non-U.S. Participants
    1. Does the NIH inclusion policy apply to studies conducted outside of the US that are supported by the NIH?
      Yes, the NIH inclusion policy applies to NIH-supported studies conducted outside of the United States.  Working with non-US participants can present a unique challenge to reporting racial and ethnic information to the NIH.  However, investigators are expected to report information on the sex/gender, race, and ethnicity of participants.
    2. 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 reference world-based geographic origin, this should facilitate the “translation” of the information for reporting purposes to NIH.

      More information on the OMB categories and their definitions 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.
    3. What if I’m conducting a study with sites within the US and outside the US?
      It is important for reporting purposes to NIH that US and non-US participants be distinguishable.  At a minimum, investigators must provide separate planned and cumulative inclusion enrollment reports for US and non-US participants even if part of the same study.  Further breakout of enrollment reports by site, country, etc. is permissible.  Additional instructions are available in the application packages here.
    Back to Top


    VII. How Inclusion Is Considered in the NIH Peer Review Process and Funding Decisions for Applicants
    1. How is inclusion by sex/gender, race, and ethnicity in clinical research considered in peer review?
      Peer reviewers will be asked to evaluate the plans for the inclusion by sex/gender, race, and ethnicity in the application; specifically, they will evaluate it as acceptable or unacceptable.  Reviewers are instructed that their assessment of the applicant’s plan should be factored into the score for scientific and technical merit.  Specific reviewer guidance can be found here.
    2. Does the peer review consider additional factors about sex/gender, race, and ethnicity when the application includes an NIH-defined Phase III clinical trial(s)?
      Yes.  In addition to reviewing plans for inclusion by sex/gender, race, and ethnicity when an NIH-defined Phase III clinical trial is proposed, the reviewers will evaluate the study design and plans addressing valid analysis.  The peer reviewer guidelines also address this and can be found here.
    3. How is the NIH inclusion policy considered in peer review with studies conducted outside of the US?
      For any study (whether conducted in the US or outside of the US), peer reviewers will assess whether the sex/gender, race, and ethnicity of the proposed sample is appropriate given the scientific goals of the study.  Peer reviewers will be asked to evaluate the plans for the inclusion by sex/gender, race, and ethnicity in the application; specifically they will evaluate the plans as acceptable or unacceptable.  Reviewers are instructed that their assessment of the applicant’s plan should be factored into the score for scientific and technical merit.  Specific reviewer guidance can be found here.
    4. How will the peer review of inclusion affect the scoring of my application?
      Reviewers are instructed that their assessment of the applicant’s plan should be factored into the score for scientific and technical merit.  Specific reviewer guidance can be found here.
    5. What happens if my application gets an unacceptable rating for inclusion at peer review?
      The Scientific Review Groups (SRGs) will evaluate the plans for inclusion in a manner consistent with the evaluation of all other factors that contribute to the overall impact score.  Acceptable or unacceptable codes are assigned to each application for sex/gender and race/ethnicity.  Any application given an unacceptable code “U,” results in a bar-to-­funding and must be resolved before the application/proposal is funded.
    6. If I’m a peer reviewer, where can I find additional guidance on the peer review of inclusion?
      Additional peer review guidance for inclusion can be found here.
    Back to Top


    VIII. How to Collect and Report Sex/Gender, Race, and Ethnicity in Awarded NIH Projects

      A. Overview of Racial and Ethnic Standards

    1. Who determined 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.  

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

      The current (1997) OMB categories are:

      • American Indian or Alaska Native. A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation 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.
      • 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.
      • Hispanic or Latino. A person of Cuban, Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin, regardless of race. The term, "Spanish origin," can be used in addition to "Hispanic or Latino."

      B. Collection of Race and Ethnicity Information from Research Participants

    1. Who decides a participant’s race and ethnicity?
      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.

      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 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. When submitting a competing renewal application, provide a narrative description regarding the cumulative enrollment from previous funding period as part of the progress report. Inclusion enrollment reports should not be used for this purpose. More detailed instructions are available in the application instruction guides 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.  Information about the forms can be found in application guide instructions.
    3. How should race and ethnicity data be reported for research participants who identify with more than one race?
      In structuring an appropriate demographic data collection, participants should be offered the choice to select all racial categories that they deem appropriate.  When the investigator reports to the NIH, individuals who selected multiple racial categories should be aggregated under the “more than one race” category.
    4. What do I do if there are subjects that did not identify their sex/gender, race, and/or ethnicity?
      Participants always have the right to not identify with any category, in which case they will be reported to the NIH as “unknown/not reported.”

      D. How to Collect and Report Sex/Gender Information to the NIH

    1. I’m planning to recruit or am recruiting individuals whose sex at birth does not align with their gender identity, and/or individuals who do not identify as female or male. How do I address this in regard to inclusion data collection and reporting?

      When collecting and reporting information about sex/gender, it’s important to consider what is most relevant to the scientific question under study (e.g., sex at birth, current gender identity, etc.).  The NIH encourages investigators to design their data collection instruments in a way that allows the participants to self-identify their sex or gender in a way that is meaningful within the study’s context.  Participants always have the option not to identify with either sex/gender category.

      While the sex/gender categories on NIH inclusion enrollment forms represent the minimum standard for federal data collection, investigators may collect data using other categories (e.g. non-binary) as long as they can aggregate the data into the sex/gender categories listed on the form.  Investigators should keep in mind that information reported on the Cumulative Inclusion Enrollment Report should be based on self-report of participants whenever possible.  Investigators are encouraged to use the comment field to provide additional clarification about the sex or gender of the participants, which can be especially helpful when large numbers of subjects identifying as “unknown/not reported” are expected. 

    Back to Top


    IX. Inclusion - Grants Closeout and Inclusion
    1. How is inclusion handled during the grants closeout process?

      Per the Final Progress Report instructions, investigators should provide:

      1. Updated inclusion enrollment within the final progress report.  This means that investigators should provide updated inclusion enrollment report(s) for any studies conducted within the project period (or the current competitive segment for renewal grants).
      2. If appropriate, indicate whether children were involved in the study or how the study was relevant for conditions affecting children.

      Per the Final Progress Report instructions, investigators should provide:

      1. Updated inclusion enrollment within the final progress report.  This means that investigators should provide updated inclusion enrollment report(s) for any studies conducted within the project period (or the current competitive segment for renewal grants).
      2. If appropriate, indicate whether children were involved in the study or how the study was relevant for conditions affecting children.
    2. Are there any inclusion requirements after grant closeout?
      Possibly.  If the project included an applicable NIH-defined Phase III, results of analyses need to be reported in clinicaltrials.gov within 12 months of the study’s primary completion date.  For information about submitting results to Clinicaltrials.gov, see https://clinicaltrials.gov/ct2/manage-recs/how-report.
    Back to Top


    X. Additional Information
    1. Where do I go to get more information on the NIH inclusion policy for sex/gender, race, and ethnicity?
      Grants and Cooperative Agreements:  Additional information about grants and cooperative agreements may be obtained from NIH staff identified in Request for Applications (RFAs), Program Announcements (PAs), or on awards.  The following staff from the NIH Institutes and Centers may be contacted for further information about the policy and relevant Institute/Center programs.  A list of NIH contacts is available here.

      Contracts:  For information about contract policy, the contracting officer for the specific contract or the Division of Acquisition Policy and Evaluation, Office of Acquisition Management and Policy (301-496-6014), may be contacted.
    2. Where can I find information on the recruitment and retention of women and minorities in clinical research?

      Information regarding the recruitment and retention of women and racial and ethnic minorities is available through the following resources:

      • NIH Outreach Toolkit, provided by the NIH Office of Research on Women’s Health (ORWH): this toolkit provides recruitment case studies and other important information regarding the recruitment and retention of women in research.
      • AccrualNet: this resource provided by the National Cancer Institute (NCI) includes literature, tools, and educational/training materials for recruiting and retaining clinical trial participants, including underserved populations and racial and ethnic minorities.
      • The National Institute on Aging (NIA) Health Professionals Information website: NIA’s website provides materials to assist healthcare professionals in communicating with older adults, including considerations for diverse populations. See also this featured research story on minority recruitment.
      • EMPACT: this consortium funded by the National Institute on Minority Health and Health Disparities (NIMHD) provides online training and other materials to increase the participation of racial and ethnic minorities in clinical trials.
      • Points to Consider about Recruitment: provided by the National Institute of Mental Health (NIMH), this resource outlines important considerations for the recruitment and retention of research participants, including women and racial and ethnic minorities.


Technical Issues: E-mail OER Webmaster