Post-Award Grant Actions: Prior Approval and Reporting of Research with Human Subjects and/or Vertebrate Animals

The following instructions are provided to assist CTSA Program hubs in determining when prior approval for research with human subjects and/or vertebrate animals is required and how the CTSA Pilot Awards and KL2 scholar research projects should be reported.

KEY DEFINITIONS

Direct Funding: Full and/or partial funding allocated directly to the pilot project from the federal funds awarded to a CTSA Program hub UL1 award.

Voluntary Committed Cost Share: In accordance with Uniform Guidance 2 CFR 200.306, Voluntary Committed Cost Share is cost sharing pledged by the grantee institution on a voluntary basis that is quantified in either the proposal budget and/or narrative and becomes a binding requirement of the award.

Voluntary Uncommitted Cost Share: Any effort or resource contributed to a sponsored award that was not included in either the proposal budget and/or narrative or committed to the sponsor prior to award.

PRIOR APPROVAL

Consistent with the U.S. Department of Human and Health Services regulations (45 CFR 46.120) and NIH policies on human subjects protections and vertebrate animals, NCATS awardees must seek approval from NCATS to conduct research involving human subjects and vertebrate animals that was not described in the original, peer-reviewed grant application. This includes all pilot and KL2 scholar projects that receive any direct funding and/or voluntary committed cost share. While prior approval is required for all CTSA Program hub UL1-funded pilot projects and KL2 scholar projects with human subjects and/or vertebrate animals, generally TL1-supported trainees will work on projects supported by other research grants rather than being funded through the TL1 award. If a trainee supported on the TL1 embarks on an independent research project funded through the CTSA Program hub that includes human subjects and/or vertebrate animals and is independent of the mentor’s research projects, prior approval may be required. In this instance, it is the grantee institution’s responsibility to confirm with the assigned Program Official and Grants Management Specialist whether prior approval is required.

Per NIH Grants Policy, prior approval requests must be submitted no later than 30 days before the proposed activity occurs. Failure to comply with the NIH terms and conditions of award may cause NIH to take one or more actions, including but not limited to disallowance of all or part of the costs of the activity or action not in compliance. Generally, NCATS will respond within 30 days of receiving a complete request. Please note that if a request is returned for any reason, the 30-day turnaround time resets. When NCATS requests clarification on a human subjects research prior approval request, the institution should submit only the questioned/corrected documents via the electronic Research Administration (eRA) Human Subjects System (HSS) module. Similarly, when NCATS requests clarification on a vertebrate animals prior approval request, the institution should submit only the questioned/corrected documents to the Program Official and Grants Management Specialist via email.

Institutional Review Board and/or Institutional Animal Care and Use Committee approval of the research project is always required prior to the submission of a human subjects or vertebrate animal Prior Approval request to NCATS. It is NCATS’ goal to complete the prior approval review process efficiently, so it is important for all necessary documents to be submitted and to promptly respond to inquiries. NCATS Office of Grants Management staff will email the Institutional Signing Official with a copy to the CTSA Program PI to notify the grantee institution of prior approval request decisions.

For human subjects research studies that meet the criteria for Exemption 4 under 45 CFR part 46.101(b), the request must be submitted via the eRA HSS with the Exemption 4 determination. The completed NCATS Human Subjects Research Prior Approval Addendum, as an attachment in HSS Section 5.1, is required. (See: NCATS Human Subjects Research Prior Approval Requests).

Research with human cell lines or tissue repositories that meet the definition of human subjects research requires prior approval.

Prior Approval Submission Instructions for Research Involving:

Pilot Projects

It is strongly recommended that grantee institutions not mix and match sources of funding that have different prior approval requirements. For example, grantee institutions should not partially fund a pilot project with direct funding and voluntary uncommitted cost share.

Source of Pilot Funds Prior Approval Required Prior Approval Required
Direct Funding Yes
Voluntary Committed Cost Share Yes
Voluntary Uncommitted Cost Share No

KL2 Projects

KL2 scholars (and other NIH career development [K] awardees) are eligible to receive pilot project awards. Per NIH Grants Policy (here and in the NIH Notice NOT-OD-17-094) for effort directly committed to the career development award, salary supplementation is allowable but must be from non-Federal sources (including institutional sources). In no case may Public Health Service funds be used for such salary supplementation. Non-Federal or institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the goals of the career development award. For effort not directly committed to the career development award, career development awardee recipients may devote effort, with compensation, on Federal or non-Federal grants as the Program Director/Principal Investigator (PD/PI) or in another role (e.g., co-Investigator), as long as the specific aims of the other supporting grant(s) differ from those of the career development awardee. Therefore, KL2 scholar salaries should not be included in the budget of a pilot project prior approval request. KL2 appointments may be made prior to the submission of prior approval for human subjects and/or vertebrate animal research projects. The KL2 appointment is a separate process through xTrain: https://era.nih.gov/help-tutorials/xtrain.

REPORTING

Grantee institutions are required to include information on NCATS CTSA Program–funded pilot studies in the annual Research Performance Project Report (RPPR) submission.

Pilot Projects

It is strongly recommended that grantee institutions not mix and match sources of funding that have different reporting requirements. For example, grantee institutions should not partially fund a pilot project with direct funding and voluntary uncommitted cost share.

Source of Pilot Funds Source of Pilot Funds RPPR Reporting Required*
Direct Funding Yes
Voluntary Committed Cost Share Yes
Voluntary Uncommitted Cost Share No (Please refer to the instructions below**)

*Refer to the CTSA Program RPPR Specific Reporting instructions for detailed reporting requirements for pilot projects that receive any direct funding and/or voluntary committed cost share. (See: https://ctsa.ncats.nih.gov/governance-guidelines/guidelines/rppr-instructions/)

**For publications resulting from pilot projects funded via voluntary uncommitted cost share, grantee institutions may choose to follow the NIH guidance provided in NOT-OD-16-079—Reporting Instructions for Publications Supported by Shared Resources in Research Performance Progress Reports (RPPR) and Renewal Applications. Per this Guide Notice, if an NIH award’s only contribution to a publication is a shared resource, awardees can opt to list and/or summarize these publications in Section B.2 of the RPPR with the subtitle “Shared Resources.” Publications listed or summarized in this section will not count against the section’s two-page limit and are not required to be tracked and monitored for the purposes of public access compliance. Pilot projects without publications but supported via voluntary uncommitted cost share may also be reported in this same manner in order to document the value of their shared resources developed through the CTSA Program hub award. Note: Grantee institutions are responsible for public access compliance of all publications listed in Section C.1 of an RPPR.

KL2

KL2 scholar research projects that are funded through the UL1 pilot program (as described above) must be reported in the UL1 RPPR. KL2 scholar research projects funded through the KL2 must be reported in the KL2 RPPR.

PROJECT DURATION AND CARRYOVER

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.

ADDITIONAL RESOURCES

NOT-OD-15-129: Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards): Updated Notice.

Examples of Enhancing Quality and Efficiency in the Prior Approval Process: presented during the CTSA Program Webinar—3/28/2018 https://clic-ctsa.org/node/2606

  1. NCATS Prior Approval Process @NCTraCS, Marie Rape, Associate Director NC TraCS Regulatory, The University of North Carolina at Chapel Hill
  2. Prior Approval, Erin Breed, Program Manager, University of California, San Francisco Clinical & Translational Science Institute (CTSI)

QUESTIONS?

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