Human Subjects System—Refresher and Advice

Refresh your understanding of when and how to use the NIH Human Subjects System (HSS) with our overview and advice.

Use the HSS to electronically report, view, and update human subjects enrollment, inclusion, and clinical trial data for your NIH applications and grants. For example, you can:

• Edit data for existing studies, add a new study, and convert delayed onset studies to a full study record.
• Complete your Research Performance Progress Reports (RPPR) with data the HSS imports from your application.
• Upload Human Subjects Data Directly to ClinicalTrials.gov from the HSS.

Principal investigators (PIs) and signing official (SOs) have different HSS Roles and Privileges. To access HSS, go to the Status or RPPR section of the eRA Commons and use the Human Subjects link. Get a demonstration in the Accessing HSS Video.

eRA and NIAID staff offer these points of advice and troubleshooting tips:

• The access link for HSS will not appear in the eRA Commons until after peer review is complete for your application.
• The PI and SO can update Section 1—Basic Information items 1.1, 1.2, 1.3, and 1.5. Only NIH staff can update item 1.4 (Clinical Trial Questionnaire).
• Your institutional SO can check whether your study records are ready to submit to NIH. The SO should use the Pending Human Subject Action link in the Status section of eRA Commons. 
• Find instructions for each field of the study record at PHS Human Subjects and Clinical Trials Information.

For NIAID-specific HSS guidance, check the following resources. Direct your questions to the relevant staff contacts:

• Human Subjects Research Requirements in Grants SOP and NIAID Contacts
• Send NIAID the Cumulative Inclusion Enrollment Report on Research Using Human Subjects

To get technical assistance with HSS, read the Online Help, check the User Guide (PDF), and contact the eRA Service Desk.