Department of Health
and Human Services (HHS)
and Human Services (HHS)
April 28, 2021
NOT-TR-20-019 - Notice of Information: Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects that Involve Human Subjects Research
NOT-TR-23-007 - Notice of Information: NCATS Prior Approval Process for New CTSA Program UM1 and K12 Scholar Projects that Involve Human Subjects Research
National Center for Advancing Translational Sciences (NCATS)
This Notice informs the research community of changes to the NCATS process for Clinical and Translational Science Awards (CTSA) Program 1) Pilot Projects that involve human subjects research and are supported with direct CTSA grant funding and/or voluntary committed cost share; and/or 2) KL2 Projects that involve human subjects research and are supported with direct CTSA grant funding. The described changes will significantly reduce award recipient burden in the administration of clinical and translational science pilot and/or KL2 projects while accelerating the clinical and translational research project process.
Scope
This guidance applies to CTSA UL1 Pilot Program Projects and CTSA KL2 Program Projects.
Guidance
Consistent with NOT-OD-15-129, new UL1 CTSA Program Pilot and/or KL2 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 of NCATS prior approval before the project can begin.
The entry of these studies into the eRA 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 or KL2 project study will result in non-compliance enforcement actions.
Implementation
Additional guidance and instructions are posted on the CTSA Program Governance, Guidelines & Policies website.
The publication of this Notice will rescind NOT-TR-20-019 Notice of Information: Change in NCATS Prior Approval Process for New CTSA Program Pilot Projects that Involve Human Subjects Research.