GOVERNANCE & GUIDELINES

New Projects with Human Subjects Research

Date: February 5, 2019
Last Revision: May 10, 2021

 

The NCATS process for Clinical and Translational Science Awards (CTSA) Program human subject research (HSR) had changed effective 04.28.2021 (see Notice here). This change applies to 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 KL2 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 and KL2 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: new UL1 CTSA Program Pilot and KL2 scholar 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.

NCATS-New-Projects-with-Human-Subjects-Research-Addendum-and-Instructions-for-PIs-and-SOs-v2.1- Updated 05.07.2021

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

REQUIREMENT REMINDERS

  • New Projects with Human Subjects Research Addendum and Instructions v2 04.28.2021 (posted here) must be used to facilitate timely reviews of submissions. The form has not been updated with temporary changes; follow the instructions that match the HSR study categories and process types.
  • 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 or notification request has been submitted to the NIH eRA HSS. Do not re-send the documents via email.  (Updated 04.28.2021)

 

PROCESS OVERVIEW

CTSA Program Prior Approval for new COVID-19-related domestic studies that involve human subjects research (HSR) (effective May 11, 2020)

NCATS will expedite their internal review processes for new COVID-19-related domestic studies that involve human subjects research (HSR) (effective May 11, 2020).

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

Purpose:  The QA/QC Group meets 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 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 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.

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.ico.