Access Human Subjects System (HSS)

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 might 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 results in access, via HSCT Post Submission, to information in regular study records, such as inclusion enrollment reports. Delayed onset study records are also accessible.

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

SOs see a link on the Status page for Pending Human Subjects Action. (click to view).

Pending Human Subjects Action link on Status page for SOs

Select the Pending Human Subjects Action link to be taken to the Search for Applications screen. On this screen, you can search via a submission status or use additional details to narrow the search results. (click to view screen)

Search for Applications landing page when the Pending Human Subjects Action link is clicked

On the resulting search results, click the Select button. The application summary page is displayed. (click to view Select buttons)

SO hitlist of applications with HS actions

Additionally, the SO can use the General Search on the Status screen to find a list of applications and then select the Human Subjects link in the Action column. (click to view Human Subjects links)

Status result for SO highlighting Human Subjects as an Action

PIs

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)

List of Applications for PIs

The resulting search results have a Human Subjects button in the Available Actions column on those applications with exempt or non-exempt human subjects research.
Selecting the Human Subjects button opens the Summary page for that application with the HSCT Post Submission tab available to access the human subjects data and make necessary updates, such as updates to Inclusion Enrollment Reports (IERs). IERs replace the Inclusion Data Records (IDRs) used in the prior inclusion management system. (click to view PI hitlist)

Status result for PI highlighting Human Subjects as an Available Action

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)

Showing top of Manage RPPR screen highlighting the Special Reporting tab

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)

Showing the Human Subjects link in section G.4.b

The above methods 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 takes you to a Study Record(s) screen where all study records and delayed onset studies associated with your grant are displayed. (click to view)

HSCT tab in Application Information

NOTE: Click the Update Submission Status button if you want to change the Status to “Work in Progress” in order to edit the application.