Human Subjects System (HSS) and Reporting

Steps for accessing and reporting in the Human Subjects System (HSS) for grants, along with related resources can be found on this page. 

 

The HSS system enables grant recipients to electronically report and update their data on human subjects and clinical trials to NIH, and for NIH agency staff to monitor and manage the data.

For grants, the HSS is automatically populated by human subjects and clinical trial data entered by the principal investigator (PI) on the Human Subjects and Clinical Trial Information form in applications submitted to NIH. This data is then made available to PIs and signing officials(SOs) for adding or editing studies through a Human Subjects link on the eRA Commons Status screen.

To submit inclusion enrollment data in a Research Performance Progress Report (RPPR), grant recipients may also access HSS via the Human Subjects link in Section G.4.b Inclusion Enrollment Data of the RPPR, rather than through Status.

As a reminder, information in HSS covers the current project period.

Accessing HSS via eRA Commons

  • SO: Status tab > General Search screen > Specific Award >Action column > Human Subjects Link
  • PI: Status tab > Status — PI Search screen > Status Result — List of Applications/Awards screen > Specific Award >Action column > Human Subjects Link
  • Both: RPPR tab > Manage RPPR > Specific Grant > RPPR Menu screen > Edit button > Inclusion Section (G.4.b) > Human Subjects Link

Accessing Status*

Once logged in to eRA Commons, click on Status on the landing page, or click on the apps icon on the upper left corner of the screen and select Status from the drop-down menu. See Figures 1 and 2.

 Figure 1: The Status button on the eRA Commons landing page

Figure 1: The Status button on the eRA Commons landing page

Figure 2: Accessing Status from the apps icon drop-down menu

Figure 2: Accessing Status from the apps icon drop-down menu

Basic Tasks (step-by-step instructions from the online help)*

* You must be logged into eRA Commons with appropriate role(s) to complete these activities. 

Main Screenshot

Click on thumbnail image to expand to full view.

 

Section G.4.b of the RPPR showing the Human Subjects link

Figure 3: Section G.4.b of the RPPR showing the Human Subjects link

Additional Resources

For R&D Contract Vendors

Policy Links