New eRA system capabilities now provide the ability for R&D contract vendors to directly submit inclusion data on their awarded contracts through the Human Subjects System (HSS), accessible through the eRA Commons, when requested by NIH staff. This process, for submitting and updating data on participant inclusion in clinical research associated with NIH policies, is now available for all new and existing contracts (see NIH guide notice NOT-OD-24-128).
The existing process for inclusion reporting by contract vendors is email based, with NIH staff requesting contract vendors for the inclusion data. Contract vendors respond via email with a PDF form with the inclusion data, which is then entered into HSS by NIH staff.
Direct submission of this data into HSS will streamline the process; ensure secure data transfer in HSS; avoid the back and forth of emails; and bring the inclusion reporting process for contracts in line with grants.
Affected contract vendors will be notified of any changes to contract requirements by their NIH Contracting Officer.
For access to HSS, the vendor organization must be registered in eRA Commons. The signing official creates their account at the time of registration and can create Commons accounts for any principal investigators associated with the vendor organization who will be entering information in HSS.
Resources
- NIH Guide Notice NOT-OD-24-128
- Quick Start Guide for Contract Vendors: Updating Inclusion Data for Awarded R&D Contracts
- Updating Inclusion Data for Awarded R&D Contracts (video tutorial)
- Human Subjects System and Reporting (webpage)
- Inclusion of Women and Minorities as Participants in Research Involving Human Subjects (webpage)
- Registration in eRA Commons (webpage)
- eRA Commons login
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