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. See below for additional guidance on collection and reporting of this information.
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.
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.
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.
If local laws or customs prohibit collection of information regarding sex/gender, race, and/or ethnicity, investigators should explain this in detail to the NIH.
In terms of addressing inclusion plans in a competing application: Investigators should still describe the demographic characteristics of the planned sample and provide a planned enrollment report.
In terms of reporting progress to the NIH: Investigators are encouraged to “translate” the sex/gender, racial, and/or ethnic information of their participants onto the NIH forms particularly since the OMB racial/ethnic categories are based on world-based geographic origin. However, if this is not feasible, investigators may report the participants as “unknown/not reported” for the category(s) (e.g., sex/gender, race, and/or ethnicity) they cannot report on.
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.
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.
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.