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All NIH grant applications that will involve human subjects are required to complete the Human Subjects System (HSS) in the Application Submission System & Interface Tracking (ASSIST) program. iTHRIV is providing some guidance documents as well as templates to assist in completing this section of a grant application. Please note: every study is unique and may require some or all of the sections to be completed. This website offers the most detailed instructions for completing the HSS section. iTHRIV will offer guidance to teams or individuals preparing the human subject section documents. To request support, please click on "Request a Consult" in the upper right hand corner of the portal.

The "PHS Guide for Required Fields" document provides information about which parts of the HSS section will need to be completed. Please see the table on page 2 for guidance. The "PHS Study Record V2.0" document can be used as a guide. This form will help identify which parts of the HSS section will need to be completed and what documents will need to be included. All information in this document will need to be transferred to the HSS section of the ASSIST program for each study involving human subjects for a grant application. The "HSS_User_Guide" provides detailed information about accessing and using the HSS in the ASSIST program. The documents labeled with numbers correspond to sections of the HSS program which may need to be completed depending on the study type. These templates are to assist in preparing each individual document which must be uploaded separately. Please refer to the table in the "PHS Guide for Required Fields" for the exact sections that will need to be completed for a specific grant application. As a reminder: always refer back to the Funding Opportunity Announcement for detailed instructions concerning submission.

PHS Study Record V3.0 (to download this document, please right click and select 'save link as')

2.3a_Inclusion of Individuals Across the Lifespan
2.4_Inclusion of Women and Minorities
2.5_Recruitment and Retention Plan
2.7_Study Timeline
3.1_Protection of Human Subjects Guide for Non-Exempt Human Subject Research
3.2_Single IRB Plan
3.3_Data and Safety Monitoring Plan
3.5_Overall Structure of the Study Team
4.3_Statistical Design and Power
4.5a_Investigational Product Availability and IND_IDE Status
4.7_Dissemination Plan
5.1_Other Clinical Trial-related Attachments

last updated: 07/23/2025