What Are the Requirements for Reporting on Human Study Participant Age, Sex/Gender, and Race/Ethnicity?


NIH awardees must report individual-level study participant data on: 1) Sex/Gender, 2) Race, 3) Ethnicity, and 4) Age at Enrollment in annual progress reports. This individual-level data must be de-identified and submitted using the required .csv template file.

Important: do not modify the format of the template. The categories set in the columns should not be deleted or edited; the data for each participant can be entered on rows.

Need help? Check out our Participant-Level Data Template Tip Sheet, instructional video, and the instructions in the HSS Online Help.

This requirement is effective for competing applications for due dates January 25, 2019 or later (NOT-OD-18-116).


    1. The file is uploaded in the eRA Human Subjects System (HSS). HSS can be accessed from the eRA Commons Status Module.

  1. If Race is captured as “Other Race” must we recode to Unknown in the Participant Level Data (PLD) Template?
    If Gender is captured as “Non-binary” must we recode to Unknown in the PLD-Template?

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