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 or gender, race, and 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
NIH has refined methods for reporting data on inclusion of participants by sex or gender, race and ethnicity by research condition and disease category as part of implementing the 21st Century Cures Act and responding to recommendations from the Government Accountability Office (GAO). The public reporting of inclusion data by sex or gender for each NIH Research, Condition, and Disease Classification (RCDC) category is currently available on the NIH RCDC Inclusion Statistics Report webpage, starting with FY 2018.