Key Dates

Related Announcements

PAR-21-293: Clinical and Translational Science Award (UM1 Clinical Trial Optional)

PAR-21-336: Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional)

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

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

This Notice informs the research community of the NCATS process for Clinical and Translational Science Awards (CTSA) Program 1) UM1 Pilot Projects that involve human subjects research; and/or 2) K12 Scholar Projects that involve human subjects research.  This Notice also reminds the research community that UM1 Pilot Projects and K12 Scholar Projects are supported with direct CTSA grant funding and that voluntary committed cost share cannot be used to support UM1 Pilot Projects or K12 Scholar Projects.    

Scope

This guidance applies to CTSA UM1 Pilot Program Projects and CTSA K12 Scholar Projects.

Guidance

Consistent with NOT-OD-15-129, new UM1 CTSA Program Pilot and/or K12 Scholar Projects that include human subjects research deemed by the Institutional Review Board (IRB) to be Greater Than Minimal Risk or meet the criteria for an NIH-defined Clinical Trial 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 all studies into the eRA Human Subjects System (HSS) along with modified NCATS-specified documentation continues to be required. For studies that are non-NIH defined clinical trial with minimal risk or exempt (45 CFR 46), NCATS prior approval will not be provided, but 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 K12 Scholar project study will result in non-compliance enforcement actions.

All UM1 Element E research projects will be subject to NIH grants policy for human subjects research available at https://grants.nih.gov/policy/humansubjects.htm.

All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information".

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