Beginning June 9, 2018, the National Institutes of Health will launch a new Human Subjects System. The system will replace the Inclusion Management System currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The HSS consolidates human subjects and clinical trial information in once place. It will be used for all human subject-related post-submission updates as of its release on June 9.
See the May 11, 2018, guide notice of changes for the transition from inclusion management system to new human subjects system. This change is in response to the 21st Century Cures requirements to enhance accountability and transparency in NIH clinical research.
Learn more about the transition to the Human Subjects System at the website or the NIH Extramural Nexus blog post. Key transition information: 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 need to be re-entered.