Notice Number: NOT-OD-18-179
Key Dates
Release Date: May 11, 2018
Issued by
National Institutes of Health (NIH)
Purpose
As part of NIH efforts to comply with 21st Century Cures requirements to enhance accountability and transparency in NIH clinical research, NIH has developed a new Human Subjects System (HSS), which consolidates human subjects and clinical trial information in once place. Information captured in HSS is generally submitted on the PHS Human Subjects and Clinical Trials Information form in application packages submitted for due dates January 25, 2018 or later and Research Progress Performance Reports (RPPR). Post-submission updates to human subjects and clinical trial-related information (including human subjects protections, participant and enrollment information, and Clinicaltrials.gov registration and reporting information) must be made in HSS via the eRA Commons Status page after June 9, 2018.
HSS will replace the Inclusion Management System (IMS), used for reporting participant sex/gender, race, and ethnicity information. The Inclusion link will no longer appear on the Commons Status page as of June 9, 2018.
Key Changes
(1) NIH will migrate enrollment records currently in IMS to HSS. Updates to enrollment records must be submitted to NIH no later than June 8, 2018 or entered in HSS. Updates not submitted by June 8, 2018 will not be available in HSS and must be re-entered.
Resources
Additional information about the Human Subjects System (HSS) is available at https://era.nih.gov/hss_overview.cfm.
Additional information about the PHS 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.
Inquiries
Please direct all inquiries to:
For questions about this notice, contact OEPMailbox@mail.nih.gov.
For requests for technical assistance, contact the eRA Service Desk.