The NCATS process for Clinical and Translational Science Awards (CTSA) Program UL1 Pilot Projects that involve human subjects research (HSR) and are supported with direct CTSA grant funding and/or voluntary committed cost share has changed, effective 04.09.2020 (see Notice here). This change applies to CTSA UL1 Pilot Program Projects, including UL1 Pilot Projects for which the designated study Principal Investigator is a KL2 Scholar. This change does not apply to KL2 Scholar Projects supported by the KL2 grant, all of which continue to require NCATS Prior Approval.
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. In summary, 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 and will require the submission of fewer documents. The entry of these studies into the eRA Human Subjects System (HSS) along with NCATS-specified documentation and email notification of NCATS are required before the project can begin.
The following 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: a.) 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, and b.) all KL2 Scholar Projects that involve human subjects research.
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: Documents should be uploaded to the NIH eRA HSS. Signing Official should notify NCATS Program Official and Grants Management Specialist via email that the prior approval request has been submitted to the NIH eRA HSS. Do not re-send the documents via email. (Updated 04.09.2020)
Resources and Additional Information
NCATS CTSA Program Quality Assurance/Quality Control (QA/QC) Group
Purpose: The QA/QC Group meets on a monthly basis to discuss processes, challenges and best practices related to ensuring the submission of successful CTSA-related information packages to NCATS (with a specific focus on submissions of pilots and KL2 projects conducting research with human subjects). NCATS provides the following administrative supplement to UL1 grants to support a dedicated quality assurance/quality control position: NOT-TR-20-014. Funding by this supplement is not required to participate in the group. If interested in joining the QA/QC Group please reach out to Monica L. Carter-Donerson (monica.carter@nih.gov) to receive registration information for the meetings, be added to the QA/QC Listserv, and have access to the QA/QC Group Discussion Forum.
Notification of Additional Temporary Change to CTSA Program New Domestic KL2 Scholar projects that involve Human Subjects Research (HSR) Studies (Updated July 8, 2020):
In addition to the two temporary HSR process changes detailed on May 11, 2020, the following temporary change harmonizes the submission requirements for UL1 Pilots and KL2 Projects is effective immediately:
The current HSR study categories and process types are summarized here:
REQUIREMENT REMINDERS
Notification of Temporary Process Change: CTSA Program Prior Approval for new COVID-related domestic studies that involve human subjects research (HSR) (Updated May 11, 2020)
The following temporary changes to the processes for new COVID-related domestic studies that involve human subjects research (HSR) are effective immediately:
