Working with Human Subjects? New Human Subjects System Replaces NIH’s Inclusion Management System


On June 9, 2018, a new Human Subjects System will replace the Inclusion Management System (IMS) currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The new system consolidates human subject information submitted in applications and progress reports and will be used for all human subject-related post-submission updates as of its release on June 9.

Recipients will be able to access the system through the Human Subject link that will be on both the eRA Commons Status page and in the RPPR. Investigators and signing officials will be able to make study updates or corrections (including just-in-time or off-cycle updates) through the new system.

Be prepared! Complete any in-progress enrollment records to ensure their migration to the new system. Note that if you are working on your RPPR on or before June 8, you will be unable to submit any in-progress inclusion data until the entire RPPR is submitted.  In this situation, you should plan to submit your entire RPPR by June 8 or wait until June 9 to enter your inclusion data in the new system. Records that have not been submitted by June 8, 2018 will not be available in the Human Subjects System and will need to be re-entered.

The new system also supports submission of participant-level sex/gender, race, ethnicity and age data using a CSV file to populate the Inclusion Enrollment Report.

Learn more about the transition to the Human Subjects System by reading the guide notice, checking out the website, or by watching a video or viewing other resources on our system training page.