Human Subjects System

Learn about the Human Subjects System, an electronic eRA system for grant recipients to electronically report and update their data on human subjects and clinical trials to NIH; and for NIH staff to monitor and manage this data.

Purpose

​NIH developed the Human Subjects System (HSS), which consolidates human subjects and clinical trial information in one place, as part of its larger effort to comply with 21^st Century Cures requirements to enhance accountability and transparency in NIH clinical research.
 
HSS is a shared system, used both by principal investigators and signing officials on one hand and by NIH staff on the other.
 
The system was launched in June 2018 and replaced the Inclusion Management System (IMS), used for reporting participant sex/gender, race, and ethnicity information. See Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018 (NOT-OD-18-179).

 

Accessing HSS

HSS is accessed via the Human Subjects link in eRA Commons (via the RPPR tab or the Status tab). It is used by grant recipients primarily when submitting their Research Performance Progress Report (RPPR) to add/update human subjects study information; create new inclusion enrollment reports; or view/edit/update existing enrollment data. It is also used to make off-cycle corrections or updates after application or RPPR submission (see infographic (right) for a representation of these processes).  

Important Note: The Human Subjects and Clinical Trials Information form appears for all recipients with human subjects studies. However, those who submitted competing applications prior to January 25, 2018 only need to update inclusion data via the Human Subjects link in the RPPR.  The remaining fields (e.g. milestones) are not required to be filled out. 
Those who submitted applications on or after January 25, 2018, may need to fill out more fields than the inclusion data for their RPPR.