Reporting Inclusion Enrollment Data
NIH Human Subjects System
A new inclusion monitoring system, Human Subject System (HSS), launched on June 8, 2018, to replace the Inclusion Management System (IMS). See the official notice on transition here. This new system serves as a one-stop shop that consolidates study-level human subjects and clinical trial information from researchers. 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 now use HSS to manage all human subject information associated with a grant, cooperative agreement, or contract. This includes plans for inclusion and inclusion enrollment data. HSS serves as an online platform to submit, archive, approve, monitor, and report the planned and actual enrollment of research participants based on sex and 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. An HSS tutorial video for accessing the HSS for program officers and investigators is 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 and 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 NIH Research, Condition, and Disease Classification (RCDC) category by inclusion of women and men data is currently available on the new NIH RCDC Inclusion Statistics Report webpage for FY 2018.