NCATS Process for CTSA Program Prior Approval Requests for Human Subjects Research

Consistent with NOT-OD-15-129, the NCATS process for Clinical and Translational Science Awards (CTSA) Program human subject research (HSR) applies to:

• New UL1/UM1 Projects that involve human subjects research and are supported with direct CTSA grant funding and/or voluntary committed cost share; and/or
• New KL2/K12 Projects that involve human subjects research and are supported with direct CTSA grant funding; and/or
• New UM1 Pilot Projects that involve human subjects research and are supported with direct CTSA grant funding (Reminder: voluntary cost share is not accepted in the CTSA Pilot Module of the UM1 PAR-24-272; therefore these pilots must not be submitted for prior approval); and/or
• Delayed onset UM1 Element E Research projects; and/or
• New UM1 Element E Research Projects that were not submitted with the original application

Relevant Notices:

• NOT-TR-21-026: Notice of Information: Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects and KL2 Projects that Involve Human Subjects Research
• NOT-TR-23-007: Notice of Information: NCATS Prior Approval Process for New CTSA Program UM1 and K12 Projects that Involve Human Subjects Research

Process Overview

Category 1 Studies

Applies to: Projects involving human subjects deemed by the Institutional Review Board (IRB) to be Greater Then Minimal Risk, meet the criteria for an NIH-defined Clinical Trial.

Requires: Entry of the study into the eRA Human Subjects System (HSS) and official notification from NCATS of NCATS’ Prior Approval before the project can begin.

Category 2 Studies

Applies to: Projects involving human subjects that are deemed by the Institutional Review Board (IRB) to be non-NIH-defined Clinical Trial minimal risk or exempt (45 CFR 46) studies.

Requires: Entries of these studies in the HSS along with NCATS-specified documentation and email notification of NCATS are required before the project can begin. Note: NCATS does not require CTSA institutions to wait for NCATS approval to begin the study.

Instructions

NCATS New Projects with Human Subjects Research Addendum and Instructions for PIs and SOs ver4.3 (Word - 203KB) 

Submission of Prior Approval Requests 

Please refer to CTSA Prior Approval FAQs for additional information. 

Comments and questions about this process? Email us.

Requirement Reminders

• Documents must be uploaded to the NIH eRA HSS.
• A Signing Official must concur with the HSS prior approval submission. This can be accomplished either by the AOR submitting the study request in HSS or if the AOR delegates HSS submission roles within the HSS system, then the AOR must submit a notification that the prior approval request has been submitted to the NIH eRA HSS.  This AOR notification must be sent via email.
• Instructions (above) must be used to facilitate timely reviews of submissions. Follow the instructions that match the HSR study categories and the process types.
• Adding, changing or transferring work to a foreign component under a grant to a domestic or foreign award requires NCATS prior approval PRIOR to receiving prior approval with human subjects. Find detailed information on the prior approval process to add a foreign component.