GOVERNANCE & GUIDELINES

NCATS Human Subjects Research Prior Approval (HSRP) Requests

Date: February 5, 2019
Last Revision: January 23, 2020

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 version 4 – New 12.09.2019

(Beginning March 9, 2020, only version 4 of the combined Addendum and Instructions will be accepted.)

Additional guidance has been posted here.

Common Issues with Human Subjects Research (HSR) Prior Approval (PA) Submissions – 12.1.2019

Comments and questions about this process? Email: NCATSDOPAinquiry@mail.nih.gov

Clarification: Do NOT send your prior approval requests for human subjects research to the NCATS prior approval request central mailbox.  Prior approval requests for human subjects research can ONLY be submitted through the NIH eRA HSS.  1.17.2019