New Projects with Human Subjects Research

NCATS PROCESS FOR CTSA PROGRAM 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 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 the involved 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-21-293; thus 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 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 eRA Human Subjects System (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-ver4.2

Comments and questions about this process?
Email: NCATSDOPAinquiry@mail.nih.gov

REQUIREMENT REMINDERS:

• Documents must be uploaded to the NIH eRA Human Subjects System (HSS).
• Signing Official must notify the NCATS Program Official and Grants Management Specialist via email that the prior approval or notification request has been submitted to the NIH eRA HSS. Do not resend the documents via email. Email notification of NCATS for prior approvals and notifications: NCATSPriorApprovalRequest@mail.nih.gov
• Instructions (above) must be used to facilitate timely reviews of submissions. Follow the instructions that match the HSR study categories and the process types.
• NCATS will expedite their internal review processes for new COVID-19-related domestics studies that involve human subjects research (HSR) (effective May 11, 2020).
• 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. More information about the process here.

NCATS CTSA Program Quality Assurance/Quality Control (QA/QC) Group:

Purpose: The QA/QC Group meets bi-monthly 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 K projects conducting research with human subjects). NCATS provided the following administrative supplement to UL1 grants to support a dedicated quality assurance/quality control position: NOT-TR-20-014 (expired September 10, 2022) and continues this type of support in the new CTSA funding opportunity (PAR-21-293). Funding by this supplement is not required to participate in the group. If interested in joining the QA/QC Group please reach out to Lauren Fitzharris (lauren.fitzharris@icf.com) to receive registration information for the meetings, be added to the QA/QC Listserv, and have access to the QA/QC Group Discussion Forum. Click here to get started with the NCATS CTSA Program Quality Assurance/Quality Control (QA/QC) Discussion Forum.

Information related to this group (meetings, FAQs, etc.) can be found on the QA/QC Group Shared Drive (Log in is required). If you have issues with accessing the shared drive, please contact support@ctsa.io

CTSA Quality Assurance/Quality Control Group Frequently Asked Questions (FAQs)