The Human Subjects System (HSS)

Purpose

The HSS system is a shared system that enables grant recipients to electronically update study data on human subjects and clinical trials and report that data to NIH. It also enables agency staff to monitor and manage that data. The information in HSS covers the current project period or competitive segment.

The HSS is automatically populated by human subjects and clinical trial data entered by the principal investigator on the Human Subjects and Clinical Trial Information form in applications submitted for due dates of January 25, 2018 and beyond. This data is then made available to PIs and signing officials through a Human Subjects link that is available on the eRA Commons Status screen and the Research Performance Progress Report (RPPR).

Key Changes

  1. NIH migrated enrollment records in IMS to HSS. Updates to enrollment records must have been submitted to NIH no later than June 8, 2018 or entered in HSS. Updates not submitted by June 8, 2018 are not available in HSS and must be re-entered.
  2. Grant recipients completing an RPPR (Research Progress Performance Report) are prompted to access HSS to update inclusion enrollment reports. Recipients can access the system through the Human Subjects link in the RPPR or the eRA Commons Status page.
  3. Section 6: Clinical Trial Milestone Plan is intended for use in progress reports for competing applications submitted on or after January 25, 2018 and is required for clinical trials unless otherwise noted in the Funding Opportunity Announcement or terms and conditions of award. Recipients should refer to the RPPR Instruction Guide for guidance.
  4. The HSS system includes a new interface and workflow. When submitting studies to the funding agency, Signing Officials (or delegated contact PIs) submit all study records associated with an application at one time rather than separately.
  5. Participant-level sex/gender, race, ethnicity and age data may be submitted in a CSV file to populate the Inclusion Enrollment Report. Participant level data is required for applications submitted January 25, 2019 or later. See NOT-OD-116 for additional information.
  6. Investigators and signing officials may make study updates or corrections (including just-in-time or off-cycle updates) by accessing HSS through the Human Subjects link in the eRA Commons Status page. Some changes, including those involving increased risk to human participants, may require prior approval by NIH.

How NIH Grantees Use HSS

Depending on their roles and privileges, grantees can use the Human Subjects system to:

  • Edit existing studies
  • Add studies
  • Convert Delayed Onset studies

Resources

Additional resources such as video tutorials, crosswalk, and infographic on the Human Subjects System (HSS) are available at https://era.nih.gov/help-tutorials/hss/era-training-hss.htm?q=help-tutorials/era-training-hss.htm.

Additional information about the HHS Human Subjects and Clinical Trials Information form is available at https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm.