Notice of Information: Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects that Involve Human Subjects Research

Notice Number: NOT-TR-20-019

Key Dates
Release Date: April 9, 2020

Related Announcements
None

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

This Notice informs the research community of changes to the NCATS process for Clinical and Translational Science Awards (CTSA) Program Pilot Projects that involve human subjects research and are supported with direct CTSA grant funding and/or voluntary committed cost share. The described changes will significantly reduce award recipient burden in the administration of clinical and translational science pilot projects and accelerate the clinical and translational research project process.

Scope

This guidance applies to CTSA UL1 Pilot Program Projects and does not apply to projects funded under the CTSA KL2 Program. All KL2 Scholar Projects that involve human subjects research continue to require NCATS Prior Approval.

Guidance

Prior to this Notice, NCATS required the submission and prior approval for all new CTSA Program Pilot Projects that involve human subjects research supported via direct CTSA funding support and/or voluntary committed cost share. As of the stated effective date above, NCATS will no longer require CTSA institutions to wait for NCATS approval for new domestic UL1 CTSA Program Pilot Projects involving human subjects that are deemed by the IRB or recipient institution to be non-NIH-defined Clinical Trial minimal risk or exempt (45 CFR 46) studies. The entry of these studies into the eRA the Human Subjects System (HSS) along with modified NCATS-specified documentation continues to be required. Although NCATS prior approval will no longer be provided, non-NIH defined clinical trial minimal risk or exempt (45 CFR 46) studies may not begin until all required documentation has been submitted into the eRA HHS system. Failure to submit the required documentation prior to initiating the pilot project study will result in non-compliance enforcement actions.

Consistent with NOT-OD-15-129, new UL1 CTSA Program Pilot Projects that include human subjects research deemed by the Institutional Review Board (IRB) to be Greater Than Minimal Risk, meet the criteria for an NIH-defined Clinical Trial, or include a foreign component continue to require entry of the study into the eRA HSS and official notification from NCATS of NCATS’ Prior Approval before the project can begin.

Implementation

Additional guidance and instructions are posted on the CTSA Program Governance, Guidelines & Policies website.

Inquiries

Please direct all inquiries to:

NCATSDOPAinquiry@mail.nih.gov