The CTSI offers several funding opportunities that each releases its own FOA. Information about these opportunities can be found on this page.
The CTSI is funded by the National Center for Advancing Translational Sciences (NCATS), an NIH Center. Pilot and K12 projects funded through the CTSI must meet all NIH requirements.
Most CTSI proposals receive three formal reviews: two that are internal to the University and one external by NCATS. CTSI highest scoring proposals that include human or animal research receive a Just-in-Time (JIT) letter. The JIT letter explains the information and documents required for the NCATS review. This review by NCATS is called the Prior Approval (PA) process.
This page contains several frequently asked questions about the CTSI internal funding process. In addition, there are CTSI staff available to assist you through this process—their contact information is provided below.
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- Breanne Johnson, Pilot Program Manager
- Lyalya Sultanova, K12 and Partner Scholar Program Manager
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- Some Departments have Regulatory specialists as an administrative resource
- The IRB website has great resources for submitting an application
- Help with federal regulatory requirements:
- IACUC provides consultations and training
- The CTSI QA/QC NCATS Prior Approval Navigator can also help you find the best person to contact: UtahCTSI_Pilots@hsc.utah.edu
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Online and UofU Help for Grant Writing
NIH Webpages and YouTube Videos
UofU Grant Writing Courses
CTSI Grant and Protocol Writing Tips
UofU Grant Resources
- Tip: Staff who coordinate and/or perform tasks related to the experimental/intervention portion of the project, such as study coordinators, research nurses, research assistants, lab technicians, etc, are valuable reviewers of the Research Design and Methods section for feasibility and clarity. The following are some elements that improve clarity:
- Study Calendar or Schedule of Activities
- Study schema and flow diagram
- Detailed inclusion and exclusion eligibility criteria
- Detailed descriptions of tests/interventions (a separate study protocol may be necessary to adequately cover these details)
- Tip: Staff who coordinate and/or perform tasks related to the experimental/intervention portion of the project, such as study coordinators, research nurses, research assistants, lab technicians, etc, are valuable reviewers of the Research Design and Methods section for feasibility and clarity. The following are some elements that improve clarity:
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- YES! The worksheet contains directions and you can also reference this online guide.
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*The NIH definition of a clinical trial can include minimal risk studies, therefore, even if your IRB determination letter states “minimal risk” it can meet the NIH definition of a clinical trial.
If you answer ‘Yes’ to all of the following questions, your study meets the NIH definition of a clinical trial and, therefore, must meet NIH requirements for clinical trials. See this NIH webpage for assistance
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
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- Yes, if it meets the NIH definition of a clinical trial, you must register your project and submit results. (NIH Policy)
- Your department likely has a CT.gov PRS administrator (expert) who can assist you with registering and reporting results in CT.gov. Please see this website for more information and a contact list of Department PRS administrators
- NIH policy requires that the informed consent contain specific wording notifying participants that the study is registered in ClinicalTrials.gov.
- This can be found on the IRB’s website - scroll down to the section “Is there a statement describing the confidentiality of records?” and open “Sample Language”
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- Even though the acronyms are similar, PMID and PMCID numbers are different and come from different systems. An article may be in PubMed and have a PubMed number; however it also needs to be submitted to PubMed Central to be compliant with the NIH Public Access policy.
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- Publications resulting as a direct result of support from the CTSI are required to be submitted to PubMed Central to comply with the NIH Public Access Policy
- Please note, publishing an article as “open access” does not meet the NIH Public Access Policy
- See the cite and submit page for more information on the NIH Public Access Policy
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- NCATS Guidance for Human Subject Prior Approval
- NCATS Guidance for Live Vertebrate Animal Prior Approval
- University of Utah Clinical Research Standard Operating Procedures
- University of Utah Clinical Research Template Tool Kit
- Guidelines on Determining Authorship in Scholarly or Scientific Publications, including Resolution of Disputes Regarding Authorship
- Office of Sponsored Projects Researcher's Handbook: Information and Worksheet for Determining Authorship