If you want to view this help topic offline, it can also be found in the at http://era.nih.gov/files/HSS_user_guide.pdf. Refer to the User Guide's Table of Contents for your specific topic.

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 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

SOs will now 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 may 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 hitlist, click the Select button. The application summary page will be displayed. (click to view Select buttons)

SO hitlist of applications with HS actions

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)

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 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)

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 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)

HSS tab in Application Information

Are you having trouble with Human Subjects System (HSS)? The eRA Service Desk is there to help. Please visit their web page to submit a support ticket.

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