The Human Subjects System can be accessed by Principal Investigators (PIs) or Signing Officials (SOs) through either the RPPR or through the Status screen in eRA Commons
Human subjects information may need to be updated in the following scenarios:
- Post-award for updates to the Research Performance Progress Report (RPPR)
- Pre-award (post review) for just-in-time information or correction of human subjects data
- Off-cycle updates as required in the Funding Opportunity Announcement or terms and conditions of award
- Corrections to human subject data
Here is a quick summary of the ways HSS can be accessed (more detailed instructions follow):
- 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
Each method will result in access, via HSCT Post Submission, to inclusion enrollment reports in regular and delayed onset study records.
To edit an existing study, log into eRA Commons and access the Human Subjects link via the RPPR or Status tabs.
Access via Status
- SOs will now see a link on the Status page for Pending Human Subjects Action.
(click to view)
- Select the Pending Human Subjects Action link to be taken to the Search for Applications screen. On this screen, you may search via a submission status or use additional details to narrow the search results. (click to view screen)
- On the resulting hitlist, click the Select button. The application summary page will be displayed. (click to view Select buttons)
- Additionally, the SO may use the General Search on the Status screen to produce a hitlist of applications and then select the Human Subjects link in the Action column.
(click to view Human Subjects links)
- A PI can click on the Status tab and then on List of Applications/Awards to see a list of their applications.
(click to view)
- The resulting hitlist will have a Human Subjects button in the Available Actions column on those applications with Inclusion Enrollment Reports (IERs). IERs replace the Inclusion Data Records (IDRs) used in the prior inclusion management system.
Selecting the Human Subjects button will open the Summary page for that application with the HSCT Post Submission tab available to access the human subjects data. (click to view PI hitlist)
Access via RPPR
To Access HSS via an RPPR, select the RPPR tab and then, in the Edit view, select the tab labeled, G Special Reporting Req. (click to view)
After selecting the GSpecial Reporting Req tab, scroll down to section G.4.b Inclusion Enrollment Data and then select the link for Human Subjects. (click to view)
The above methods will take the user to the Application Information screen and provide access to the HSCT Post Submission tab.
Click on the HSCT Post Submission tab. This will take you to a Study Record(s) screen where all study records and delayed onset studies associated with your grant are displayed. (click to view)