NCATS Human Subjects Research Prior Approval (HSRP) Requests

Date: February 5, 2019
Last Revision: September 9, 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 HSS.

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.)

Additional guidance has been posted here.

Comments and questions about this process? Email:

The CTSA Program National Center for Data to Health (CD2H) is supported by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (Grant U24TR002306).

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National Center for Advancing Translational Sciences (NCATS), 6701 Democracy Boulevard, Bethesda MD 20892-4874 • 301-594-8966