GOVERNANCE & GUIDELINES

NCATS Human Subjects Research Prior Approval (HSRP) Requests

Date: February 5, 2019
Last Revision: February 5, 2019

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.

NCATS Human Subjects Prior Approval Addendum and Instructions for PIs and SOs – New 02.05.2019

(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