The National Institutes of Health has recently announced that it will replace the current Inclusion Management System (IMS) which is used to report the sex/gender, race, and ethnicity of participants in human subjects research studies. The new system will be the Human Subjects System (HSS). The HSS will consolidate human subjects and clinical trial information in one place. The information captured in the HSS is generally that submitted on the new PHS Human Subjects and Clinical Trials Information form, which is presented in applications for due dates on or after January 25, 2018 as well as information collected from Research Performance Progress Reports (RPPRs).

The HSS is scheduled to go live on June 9, 2018 and the IMS will be taken offline at that time. Therefore, the “Inclusion” link will no longer appear in the eRA Commons system after June 9, 2018. All data submitted to NIH via the IMS prior to June 9, 2018 will be migrated into the new HSS. Therefore, if updates to enrollment records are required they must be submitted to NIH no later than June 8, 2018 or entered in HSS. Updates not submitted to NIH by June 8, 2018 will not be available in HSS and must be re-entered.

NIH investigators completing an RPPR (Research Progress Performance Report) will be prompted to access HSS to update inclusion enrollment reports. Recipients may access the system through the Human Subjects link in the RPPR or the eRA Commons Status page.

For full details on the transition from IMS to HSS, investigators are strongly encouraged to review NIH NOT-OD-18-179 for information on Key Changes related to the transition.

An HSS Overview is also available, along with an HSS Training page.


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