Reporting Inclusion Enrollment Data
NIH Human Subjects System
The Human Subjects System (HSS) serves as a one-stop shop that consolidates study-level human subjects and clinical trial information from researchers, including inclusion plans and enrollment information. HSS allows for researchers to submit deidentified participant-level enrollment data in CSV format and reduces the need for duplicate data entry in other systems, such as Clinicaltrials.gov. NIH staff use HSS to manage all human subject information associated with a grant, cooperative agreement, or contract. HSS serves as an online platform to submit, archive, approve, monitor, and report the planned and actual enrollment of research participants based on sex, race and/or ethnicity. HSS promotes increased transparency by displaying the same information to grant recipients and NIH staff.
The HSS User Guide includes information on key changes, resources, and instructions including reporting inclusion data. HSS tutorial videos describing how to access and utilize HSS are also available. More information is also available on the HSS home page including an overview of HSS, features and updates, training resources, and frequently asked questions.
Inclusion Data by Research, Conditions and Disease Categories
The public reporting of inclusion of participants by sex, race and/or ethnicity is reported for each NIH Research, Condition, and Disease Classification (RCDC) category on the NIH RCDC Inclusion Statistics Report webpage. Enrollment data are reported by demographic categories in accordance with the NIH inclusion policies in effect at the time of submission. Effective August 16, 2025, NIH changed the terminology regarding the inclusion of women to refer to sex only (see NOT-OD-25-131). Data submitted prior to that date reflect the requirements in the previous version of the policy in effect during that period (see NOT-OD-18-014).