The activation of the new NIH eRA Human Subjects System (HSS) presents an opportunity to consolidate and simplify the submission, review, and approval of Prior Approval requests that involve human subjects research conducted through NCATS UL1 pilot projects and KL2 scholar projects. All Prior Approval requests for human subjects research must be submitted to NCATS no later than 30 days before the proposed implementation of research involving human subjects, via the new NIH eRA HHS.
(Beginning March 6, 2019, only version 3 of the combined Addendum and Instructions will be accepted.)
FAQs have been posted here: CTSA Program Prior Approval Frequently Asked Questions
Comments and questions about this process? Email: NCATSDOPAinquiry@mail.nih.gov