NEW NIH Human Subjects System (HSS) effective June 9th, 2018

NIH announced last week that they are retiring the Inclusion Management System (IMS) and replacing it with a new Human Subjects System (HSS) as of June 9th, 2018. Per the NIH HSS website, “The HSS system is a shared system that enables grant recipients to electronically report and update their data on human subjects and clinical trials to NIH; and for NIH agency staff to monitor and manage the data.”

The information you provide in the new PHS Human Subjects and Clinical Trials Information form in proposals, and in the Research Performance Progress Reports (RPPRs), automatically populate in this new HSS system. Updates to human subjects and clinical trial-related information have to be done in HSS via the eRA Commons Status page as of June 9th, 2018.  IMS will no longer be available as of this date.  Examples of updates you may need to do in HSS include converting a delayed onset study to a full study record, providing interim data as per direct requests from NIH staff, informing NIH of registration, or reporting participant sex/gender, race, and ethnicity information.

Training Materials:

Please see the official NIH announcement that explains more of the details of this transition:

Stephanie F. Scott, MS, CRA
May 16, 2018