Pilots

Purpose: To encourage early exploration of high-risk translational research and translational science ideas focused on emerging areas of basic and applied science with clear relevance to clinical or public health application.

Rationale: The ICTS Pilot Studies Program is funded by the National Center for the Advancement of Translational Sciences (NCATS) at NIH. The ICTS Pilot Awards are designed specifically to support exceptionally innovative and/or unconventional research projects that have the potential to create or overturn fundamental paradigms. As stated by NCATS: “Examples of pilot studies include feasibility studies, secondary analysis of existing data, development of new research methodology and/or new tools, dissemination of effective tools, methods, processes, or early development of new therapy/technology.” Recently, NCATS has emphasized an interest in funding studies that address common roadblocks to translational research. These “translational science” projects address generalizable principles or processes that can accelerate scientific translation.

The UCI ICTS is pleased to announce a new call for the Pilot Studies Program. Up to eight one-year awards in the amount of $25,000 will be conferred in this round. The estimated funding period is July 1, 2023 – June 30, 2024.

Eligibility
Principal Investigators (PIs) must be full time UCI faculty from any school or discipline; junior and mid-career faculty, women, and members of underrepresented groups in biomedical sciences are especially encouraged to apply, but established investigators pursuing novel research lines are also welcome. Faculty from the Children’s Hospital of Orange County (CHOC) and the Long Beach VA* are also encouraged to apply. If CHOC and VA applicants do not have a joint UCI faculty appointment, their proposals must have a UCI co-PI.

To be eligible to apply for Pilot Studies Awards, the Principal Investigator or co-Investigator MUST attend a workshop on general application preparation or one of the special-topic workshops offered by the ICTS. Workshops are currently scheduled for October. Registration is required to attend, so please register for a workshop. Zoom meeting details will follow registration. Additional workshops may be added in response to interest.

Investigators may only submit one application in which they are listed as PI or Co-PI. However, a PI can be on more than one application if he/she is listed as a co-investigator.

Investigators who received a Pilot Studies Award from the ICTS in the prior year must take a full funding cycle break before applying again. For example, if you were funded as a PI for 2022, you cannot apply as a PI again for the 2023 pilot cycle; you must wait for the following 2024 pilot cycle to apply again.

*All awards to CHOC and VA will occur via a subcontract; no overhead costs will be provided.

Eligible Projects
Clinical Translational Science Projects, currently not funded and aimed at obtaining preliminary results for a full application for extramural funds, are considered eligible. Emphasis will be placed on innovation and transformative potential of submitted proposals. The content of proposals, while obviously linked to applicants’ current research, should demonstrate a clear evolution towards novel, relevant, and untested research areas.

A clinical translational science project is defined as any project aimed at accelerating the transition from discoveries arising from laboratory, clinical, or population studies into clinical applications. Note that in addition to traditional research studies, these awards are also open to proposals to pilot innovations in translational science; such projects might include research on translational workforce development and training, new strategies for accelerating the research process, or new approaches to recruiting participants into clinical trials from challenging populations (e.g., patients in a NICU or underrepresented populations).

For additional information: Translation (https://ncats.nih.gov/translation), Translational Science Spectrum (https://ncats.nih.gov/translation/spectrum), and I Am Translational Science | National Center for Advancing Translational Sciences (nih.gov).

Owing to the one-year funding period of the awards, no projects requiring an IND or an IDE will be considered for funding.

Application Process: Two Phase

Phase One: Pre-Application

Application Opens: Monday, October 10, 2022

Deadline: Monday, November 7, 2022

A pre-application is REQUIRED. Not all submitted pre-applications will advance to Phase Two for review.
The pre-application will be submitted via REDCap and must include:

• Project Title
• Amount Requested (maximum allowable is $25,000)
• Names of Principal Investigator(s) and Co-Investigators
• Biosketch for Principal Investigator(s) (New NIH format)
• Abstract (max 250 words)
• Project Plan:
  • Study Hypothesis/Research Question: Briefly explain the project’s significance, aims and objectives (max 200 words)
  • Evidence of feasibility: Present evidence for the expectation that the project will be completed within a one-year timeframe (max 200 words)
  • Translational/clinical significance of the project: Explain how the results of the research could translate to meaningful health impact (max 200 words)
  • Research Methods: Please address the source of the study data (humans, animals, archived samples, etc.) and provide a brief description of the study protocol: what is being done to whom, including where and by whom (max 200 words)
  • Translational Science Focus: Relevance of the proposed project to translational science. NCATS defines Translational Science as research that is “focused on understanding a scientific or operational principle underlying a step of the translational process with the goal of developing generalizable principles to accelerate translational research” (max 200 words)
    For additional information see https://ncats.nih.gov/translation.
• Additional Information:
  • Keywords: Please provide 3-5 keywords to best describe your study and type of expertise needed for providing a quality review. Keywords can describe content and/or methodology

Phase Two: Full Proposal

Application Opens: Based on scoring of pre-applications, selected applicants will be invited to submit a full proposal. Invitations will be issued on or before Tuesday, December 20, 2022.

Deadline: Friday, February 3, 2023

Documents and information submitted in the pre-application phase will transfer to the full application. Please update any changes that have been made since submission. All material must include the investigator’s name at the top right corner, and use a font no smaller than 11 pts, with margins no narrower than 0.5 inches.

In addition to the materials from the pre-application (updated if necessary) the application must include:

• Biosketches for co-Is (New NIH format)
• Suggested Reviewers
• General Summary of the project written to be accessible to a general (i.e., non-academic) audience (500 words max)
• Research Plan (5 pages max, plus references) must include:
  • Specific Aims
  • Significance (be sure to address the translational potential of the project)
  • Innovation
  • Approach
  • Plans for applying for extramural funding
• ICTS Pilot Project Implementaion Plan
• Home department letter of support
• Budget (itemized, 1 page maximum)
• Budget Justification
  • Funds cannot be used to support computer purchases or travel
  • No overhead will be provided for outside collaborators or institutions
  • Other personnel salaries are allowable
• For junior faculty only (assistant professor or lower): Please name senior faculty mentor

For junior faculty (assistant professor or equivalent): before funds are released, a senior faculty mentor from the awardee’s home department must agree to act as a mentor (including general project supervision, participation in an initial milestone-setting meeting, and periodic progress report meetings). Note that naming a junior faculty PI will not disadvantage the proposal. The named PI should be the individual who will be doing majority of the work.

Regulatory Approval: Please note that while having regulatory approval (IRB, IACUC) is not necessary at the time of submission, awarded funds will not be released, by NIH mandate, until such approval has been received. Because NIH does not allow carry-forward on these one-year awards, if all regulatory approvals have not been received 6 months after award date, the ICTS may withdraw the award.

Resubmissions: Applications that were not funded during a prior call for ICTS pilot awards may be resubmitted a second time by checking the appropriate box during the application process. Resubmissions will have the opportunity to address the criticisms raised during the review process; however, no additional space will be allowed for the rebuttal, which will have to be included in the 5-page limit of the research plan. A maximum of ONE resubmission will be allowed for each previously unfunded project.

Post-Award Project Support: Before funds are released, an activation meeting will be held with the awardee, a department financial analyst, and ICTS staff at which the team will review the project implementation plan and explain the Research Acceleration and Facilitation Team support that will be provided to the research team.

Application Review Process: Review criteria will include:

• Significance and impact of the proposed research
• Qualifications of the PI and research team
• Innovation
• Approach; Scientific strength of the research design
• Scientific environment
• Translational/clinical impact
• Project feasibility within the proposed time frame
• Likelihood of generating extramural funding

The UCI ICTS participates in a national CTSA External Reviewer Exchange Consortium (CEREC) to improve fairness in the scientific review process and better match applicants with feedback from experts in their respective fields. In submitting an application, you agree to allow reviewers external to UC Irvine access to your application materials.

For more information, please contact Dr. Margaret Schneider at mls@uci.edu or Amanda Woodworth at woodwora@uci.edu.

To register for an ICTS Workshop, please use this link.

APPLICATION DEADLINES:
Letter of Intent: Monday, November 7, 2022
Full Proposal (invited applicants): Friday, February 3, 2023