The questions compiled below represent questions from the CTSA recipient institution community discussed in the CTSA Quality Assurance/Quality Control Group meeting and questions posted in the QA/QC Group Discussion Forum. Responses provided in this document are in accordance with NIH Grants Policy and do not supersede recipient institutional policies.
CTSA Quality Assurance/Quality Control Group Frequently Asked Question – Last Updated November 16, 2022
Q: Should you include the KL2 scholar’s stipend in the NCATS prior approval request for a KL2 HSS or VAS project?
A: The KL2 scholar stipend cannot be included with the KL2 project budget. Please refer to section 2, question 2 of the Human Subjects Research Addendum.
Q: Should a KL2 Scholar be appointed in eRA xTrain before completing the submission of a prior approval request?
A: Yes. Per the terms of award on all KL2/K12 grants, all statements of appointment must be submitted in xTrain before or at the start of each scholar appointment. If a HSS or VAS prior approval is submitted to NCATS before a statement of appointment is submitted in xTrain, NCATS approval will be delayed until the statement of appointment is submitted and accepted. No stipend or other allowance may be paid until the appointment form has been submitted and all grant provided research funds must go to grant supported scholars. It is also helpful if the AOR/SO notifies the NCATS GMS and PO once an appointment is submitted so they may begin the eligibility review.
Q: What happens if a KL2 scholar receives a Research Project Grant (RPG) while appointed on a KL2 grant?
A: The allowability of concurrent support is dependent upon program needs and the eligibility and allowability outlined in NOT-OD-08-065 and The NIH Grants Policy Statement Section 22.214.171.124. Concurrent support must be requested through the recipient institution AOR/SO to the assigned NCATS GMS and PO via a prior approval request. It is important to note that per NOT-OD-08-065 concurrent support can only be considered for an independent research project grant if that application was submitted AFTER the scholar is active on the KL2 or K12 grant.
Q: Can TL1 trainees be pilot project PIs?
A: The TL1 grant is a training mechanism for pre- and postdoctoral fellows preparing for a career in research and is not geared towards individuals engaging in independent research. However, in rare occasions, TL1 trainees (particularly postdoctoral trainees) may conduct independent research supported through the UL1/UM1 Pilot Program Core. The CTSA Program hub must request prior approval for all research conducted by trainees through the Pilot Program that will be independent of the mentor’s research project and ensure proper oversight of the trainee-investigator.
Q: What are the Inclusion Enrollment Report (IER) Requirements for KL2 projects?
A: For the KL2 program, IER is not required if the scholar is conducting research under a mentor’s project. If the KL2 scholar is conducting an independent clinical study that is not covered under the mentor’s IRB approval and is using KL2 research funds to support the clinical study (including clinical trials), they should alert their Program Officer ahead of time and must follow NCATS guidelines for Human Subject Research prior approvals and Inclusion Enrollment Reports must be updated at the time of the RPPR.
Q: If a study has several aims with different enrollment criteria per aim, should the PI provide several cumulative enrollment tables?
A: In general, for every planned enrollment report there should only be one cumulative enrollment table.
Q: Is reporting pursuant to the Inclusion Across the Lifespan (age at enrollment) policy required for pilots and KL2 projects?
A: The Inclusion Across the Lifespan policy applies to all grant applications submitted for due dates on or after January 25, 2019. Research that was submitted before January 25, 2019, continues to be subject to the Inclusion of Children in Clinical Research Policy.
Q: If there is a discrepancy between planned and actual enrollment (e.g., enrollment delay) should that be explained in the inclusion enrollment section 2.9 comments section?
A: Yes, the comments clarify the reason behind the discrepancies in the enrollment numbers.
Q: Is the Human Subject System (HSS) Section 3.1 an important part of the prior approval document and studies involving human subject research (HSR)?
A: It is an important part of the prior approval document. Please ensure that you follow the template provided in February 2022 QA/QC Meeting Presentation about HSS Section 3.1 and complete the section accordingly. This section should be completed to avoid delay in prior approval process. Even if prior approval is not required, the recipient should ensure that HSS Section 3.1 is addressed, with all necessary sections explained in the February 2022 QA/QC Meeting. This document ensures that the study team is taking necessary steps to ensure participants’ safety and reduce risk.
Q: What is the reporting process for a pilot that needs to be extended to the next budget period?
A: All active HSS and VAS projects supported by NIH research funds and or voluntary committed cost share must be reported in the RPPR. Please reference the NCATS CTSA RPPR Supplemental Instructions for additional clarification. The pilot project activity may cross over budget periods. However, per NIH Grants Policy and the Notice of Award, the institution CANNOT carry over funds from one budget period to another without NIH prior approval. Repeated prior approval requests to transfer funds from one budget period to another for the same/similar program costs will be denied. Please work with your Office of Sponsored Programs to establish your pilot program in a manner that complies with NIH Grants Policy and avoids setting up a need for continual carryover requests for pilot program funds.
Q: Why should recipients wait for two weeks after notification for category 2 pilots and KL2 projects before starting the project?
A: NCATS POs will confirm that the HSS packet is complete, and the Category 2 designation is appropriate. A Category 2 pilot may start when all materials are submitted via HSS and the documents are being reviewed by NCATS staff BUT if materials are not complete, are not clear, and/or the safety of the Human Subjects appears to be compromised in the study, the study may have to be paused while NCATS is acquiring additional materials. NCATS will communicate this to you through your AOR. Hence, NCATS recommends that the awardee wait two weeks before starting the study to allow NCATS internal review process to complete.
Q: When a recipient submits a new pilot project for prior approval does NIH consider them covered by a Certificate of Confidentiality (CoC)?
A: Yes. See the NIH OER page on CoCs here for more information.
Q: Is a Study Timeline required for a study under Exemption 4?
A: The study timeline is optional if:
Q: If a recipient does not currently have an approved foreign component on the parent grant, what steps are needed to approve a foreign component in a pilot project?
A: A change in foreign involvement on a grant requires prior approval as outlined on the NCATS CTSA website. You must first work with your AOR/SO to submit a prior approval request to NIH to have foreign components approved under the parent award. This is a lengthy process that also requires significant justification. Please ensure you have considered this in the pilot project timeline. If the foreign component is approved under the parent award, please follow the guidance included in the HSS submission forms for foreign components.
Q: Is prior approval required for using existing data previously collected outside of the US not using NCATS funding?
A: It’s dependent on where the dataset is located. If the dataset is de-identified and the property of the award recipient and currently is domestically located with the award recipient, it is not a foreign component. All the information should be provided to NCATS and it is recommended to discuss with the PO.
Q: Is prior approval required to purchase special purpose equipment needed for research from a foreign vendor under a UL1 pilot project?
A: You must first work with your AOR/SO to determine if the equipment is defined as special purpose and the prior approvals required to move forward (equipment purchase, foreign component). The HSS prior approval submission should include the procurement with a strong justification which will be reviewed within the context of the study protocol. Please see here.
Q: If a recipient has a vertebrate animal study (VAS), where the animal breeding occurred in another institution, while the research is taking place at the recipient institution, does the NIH prior approval package need to contain IACUC approval from both institutions or just the recipient institution who is euthanizing the animal and doing the in-vitro study?
A: If the breeding is described in VAS section of the application and/or is part of the budget, then IACUC approval from the breeding institution is required. If the breeding is not described in the pilot application, IACUC approval for the breeding protocol does not need to be submitted.
Q: If a study record on the ClinicalTrials.gov site is updated, will the section 6 of HSS be automatically updated? Additionally, will updates in HSS be automatically populated in ClinicalTrials.gov?
A: The system does not automatically do that, but the system does allow it. The award recipient needs to manually click the populate button to refresh data from clinicaltrials.gov. However, there are things that are checked against the clinicaltrials.gov live. Hence if the HSS information is no longer current, it will lead to warnings and/or errors. Additionally, awardees can export from HSS to clinicaltrials.gov. The export feature will send updates from HSS to clinicaltrials.gov. Again, it is a manual process and is not automatically initiated.
Q: Does a minimal risk study that meets the NIH definition of clinical trial need to be entered into clinicaltrials.gov?
A: Yes, all clinical trials need to be entered into clinicaltrials.gov. A minimal risk study that meets the NIH definition of clinical trial is expected to be registered and entered into the clinicaltrials.gov website.
Q: If the institutional IRB determines an NIH-Defined Clinical Trial to be a minimal risk study, is it submitted for prior approval under category 1 or 2?
A: The recipient should submit the study for NCATS prior approval under category 1. Please refer to the CTSA website.