New Projects with Human Subjects Research

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.

New Projects with Human Subjects Research Addendum and Instructions for PIs and SOs version 1.0 – New  04.9.2020

(Beginning May 1, 2020, only version 1.0 of the new Addendum and Instructions will be accepted.)

Additional guidance has been posted here.

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)

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:

• New domestic KL2 Scholar 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 may begin following the entry of these studies into the eRA Human Subjects System (HSS) along with NCATS-specified documentation and email notification of NCATS at NCATS_CTSA_Pilot_HS@mail.nih.gov. That is, formal Prior Approval requirements are suspended for both COVID-19-related and non-COVID-19 KL2 Scholar HSR Category 2 studies (not a clinical trial and are minimal risk or exempt). All projects that include a foreign component require formal Prior Approval.

The current HSR study categories and process types are summarized here:

REQUIREMENT REMINDERS

• Email notification of NCATS for Process Types
  • Standard and Expedited Prior Approval: NCATSPriorApprovalRequest@mail.nih.gov
  • Notification & HSS Study Entry: NCATS_CTSA_Pilot_HS@mail.nih.gov

• New Projects with Human Subjects Research Addendum and Instructions v1.0 04.01.2020 (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.

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:

1. New COVID-19-related domestic KL2 Scholar 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 may begin following the entry of these studies into the eRA Human Subjects System (HSS) along with NCATS-specified documentation and email notification of NCATS. That is, formal Prior Approval requirements are suspended for these studies.
2. 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 Projects 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. However, COVID-19-related projects will be prioritized and receive an expedited Prior Approval review from NCATS.