Introduction

Description

Fall 2019 Program Description and Call for Applications

These awards are intended to support the development and testing of new approaches and/or tools that increase the speed, efficiency, safety and/or quality of clinical, community, health outcomes and/or implementation research. Successful applicants will define challenges or barriers in the conduct of research and propose the development of a solution or process that can be tested within the pilot project and/or with subsequent extramural funding. This mechanism is not intended to fund basic or preclinical research.

These awards are also intended to support:

1. Preliminary research that will lead to larger extramurally-funded human mechanistic studies, clinical trials, community trials, health outcomes research, or implementation research. 

2. Pre-existing research in the above-referenced areas by incorporating a different discipline and investigator who is new to collaboration with the current team.  The award may be used to leverage data and resources from a currently funded project to expand the research in a new direction, ultimately leading to the submission of an additional grant or expansion of the current effort to a larger-scale extramurally-funded project.

Although not required, all applicants are encouraged to request a consultation from the Biostatistics, Epidemiology and Research Design core at the SC CTSI prior to submitting an application.

NEW in the Scientific Review Process

NOTE:  In addition to review by scientific experts, review panels will also include community members who have undergone a comprehensive reviewer training. A goal of SC CTSI is to integrate community perspectives to aid in shaping our research agenda and to be able to communicate to the public about work funded at SC CTSI.   Integration of community members into the review panel is the first step in this process.  In this cycle, community reviewers will read, score and participate in discussion of the applications. The full application now includes preparation of a two-page lay summary of the application’s content with reduced jargon to promote readability at a nonscientific high school reading level, OR applicants may submit a five minute promotional video which explains your project to a general/lay audience.

Award
Up to $40,000 for one year composed of a 4:1 ratio of funds from SC CTSI to funds from the investigators’ home department(s), school(s) or Institute(s). For example, the maximum award would be $32,000 from SC CTSI and $8,000 from the home department(s), school(s) and/or institute(s) of the participating investigator(s). Applications must include a letter of commitment specifying the amount and source(s) of the cost share.  Applications from multiple departments can derive the cost share in any mix from the participating departments; it is up to the investigators to secure the matching funds to be made available in a USC account at the time of funding award.


Priority

Preference and highest priority will be given to projects that demonstrate a clear path to sustaining extramural funding or to direct implementation of improvements in clinical and translational research processes. Commitment of the PI to a career in research will be considered a plus. Proposals will be evaluated using an NIH-style peer review process.


Eligibility

Full-time faculty members at USC and CHLA as of the date of the award are eligible to apply as PI.   PIs should explain in their cover letter the extent of their commitment to a research career and provide any supplementary materials including confirming materials from a department chair.

  • Postdocs, residents, fellows, students, and community members can be included as co-Is.
  • International Faculty who are non-US citizens/permanent residents must have a USC appointment and currently hold a visa to allow them to remain in the US long enough to complete the proposed project.

Multiple Awards

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 grant if he/she is listed as a co-investigator.


Resubmissions

As of Spring 2018, the SC CTSI Pilot Funding Program will allow only 1 resubmission of the same proposal.  Applicants must indicate “Resubmission” on the electronic application form and uploaded proposal.   When resubmitting a proposal, include one additional page to address the issues raised in the review and emphasize any additional changes made in your proposal.


Cycle Break

Awarded PIs must take a Full Funding CYCLE BREAK before applying again. For example, if you were funded as a PI in Spring 2019, you cannot apply as PI again in Fall 2019 or Spring 2020 during your award period; you must wait for Spring 2021 to apply again. And if you were funded as PI in Spring 2019 and requested a no-cost extension so your 2019 funds will be extended to the 2020 funding period, you cannot apply as a PI in Spring 2021, but must wait a full year from the expiration date of the no-cost extension.


Letter of Support

Applications must include a letter or letters of commitment specifying the amount and source(s) of the cost share from the applicant’s home department chair, institute director, or school dean.


Application

Format

  • Arial font, 11pt
  • Margins: minimum 0.5 inch
  • Figure and Table legends may use smaller font, but no font smaller than 9pt is allowed to insure readability. 
  • Please use appropriate headings in preparing your proposal.
  • No appendices
  • Include page numbers and table of contents
  • All application documents must be merged into a single PDF file

Proposal

A complete application will include the following components arranged in the specified order Please number each page sequentially. Applications should be prepared carefully. The applicant is responsible for the readability of the entire application.

The application should include the following:

  1. Cover Letter (See PI qualifications and commitment to a research career)
  2. Table of Contents
  3. Abstract (max 300 words)
  4. Research Proposal (maximum 5 pages, including figures/tables, excluding literature cited)
    1. Overall Impact and Significance
      1. Discuss the significance of this project in terms of innovation and impact on human health.
      2. Explain the potential for high impact, importance of the problem, and critical barriers.
      3. Describe the next steps in the research agenda if the proposed aims are achieved.
      4. Provide justification and/or evidence that the research question(s) and aims are important from the perspectives/priorities of multiple stakeholders.
    2. Innovation
      1. Describe any novel theoretical concepts, approaches, or methodologies, as well as any novel instrumentation or interventions to be developed or applied in a novel way; describe any advantages over existing methods, instrumentation, or interventions.
      2. Explain any novel refinements, improvements, or applications of theoretical concepts, approaches, methods, instrumentation, or interventions.
    3. Specific Aims
      1. State the specific aims to address the research question.
    4. Approach
      1. Describe the overall strategy, methods, and analyses to be used to accomplish the specific aims of the project.  Specifically describe how the data will be collected, analyzed, and interpreted.  Describe resource sharing plans if appropriate.
      2. Discuss potential problems, alternative strategies, and milestones for success in achieving the aims. 
      3. Describe your specific plan for how project findings can be implemented more broadly.
      4. If the project is in early stages of development, describe any strategies to establish feasibility.  Address the management of any high risk aspects of the proposed work. 
      5. Describe how the project will solidify new multi-disciplinary research collaborations.
      6. Describe plans for disseminating and/or commercializing the findings. Awardees will be invited to present their study results at a Keck School of Medicine and SC CTSI co-sponsored event.
    5. Plans for Extramural Funding
      1. Describe your specific plan of obtaining extramural funding.  This should include what this project will provide with regard to the type of grant that will be targeted. Applicants are encouraged to name specific funding mechanisms if they have been identified. 
  5. A Timeline or project plan with defined milestones; propose only what can be accomplished within ONE YEAR (max 1 page)
  6. Resources and Environment (limit 1/2 page) Document access to any resources and environment that will require for successful completion of the project.
  7. Literature Cited (not included in page limit)
  8. Budget ($40,000 maximum) (PI, co-PI and co-investigator salary support is not allowed). Use the Required PHS 398 Budget Form, Page 4 or download the Budget Form HERE. Award expenditures must comply with the NIH Grants Policy Statement and the Uniform Guidance OMB A-81. Indirect costs are not allowed, including sub-contracts funded by SC CTSI pilot awards.  Sub-contracted institutions are required to waive indirect costs.
    1. Fringe benefits are at USC Rates and NOT federal - http://research.usc.edu/dcg/proposal-development/rates-at-a-glance/
    2. Budget Allowable and Not Allowable Items

 

Allowable

    Not Allowable

PI/Co-PI/Co-Investigator Salary

 

X

Post Doc Salary

X

 

Administrative Support

 

X**

Supplies

X

 

Equipment

X**

 

Software

X

 

Personal Computers

 

X**

Mailing

 

X**

Tuition

 

X

Travel

X**

 

Research Staff Support

X

 

Patient Care

X**

 

Indirect costs at other institutions

 

X***

**Note: Administrative support, equipment, personal computer, mailing, travel expenses and patient costs must be required specifically by the research project proposed, and must be clearly justified for consideration.  Not allowable items will be considered if absolutely required.  If awarded modifications to the submitted budget may be requested if expenses are not clearly justified.

***Indirect costs are not allowed on sub-contracts funded by SC CTSI pilot awards.

 9. Budget Justification Justify all costs and provide detailed information for all requested items.   

10. NIH Biographical sketches of the Principal Investigator and/or Co-Investigators (5-page max for each individual) The NIH biographical sketch is required for all investigators.  Specific roles of each co-investigator must be defined.  (please use latest NIH format found at https://grants.nih.gov/grants/forms/biosketch.htm)   
11. Letter(s) of Support  Applications must include a letter of commitment(s) specifying the amount and source(s) of the cost share from the applicant’s home department Chair or Institute Director.  Cost share must be dedicated to allowable budget costs, and not PI, co-PI or co-investigator salaries.  If resources (e.g., patient samples) from another source are proposed, provide a letter from the source documenting that those resources will be available.  Other letters confirming access to crucial resources including necessary space, release time and environment may be included here.     

12. Lay Summary (written or visual) Prepare a two page summary of Sections A-D from the Research Proposal; in this summary minimize jargon and promote readability at a nonscientific lay level.  You could also choose to prepare a 5 minute video which explains your proposed project to a general (lay) audience. The SC CTSI will provide you with further information for the video. Videos are due to the Research Development Core by 5:00 PM on October 14, 2019.  Please contact rd@sc-ctsi.org to arrange file transfer.

Watch the following videos on how to record from your computer:

HP Computers: https://www.youtube.com/watch?v=QzTMA9mPhsQ

for Macbook Pro:  https://www.youtube.com/watch?v=YMP642HmSck

GUIDANCE: Lay Summaries Tips from Elsevier: https://www.elsevier.com/connect/authors-update/in-a-nutshell-how-to-write-a-lay-summary

  • Predict and cover the “so what?” factor – justify your research.
  • Give some background and context to the research. What prompted you to do it?
  • Follow a logical order. This may not always coincide with a temporal order.
  • Explain the impact of the work – what is going to change (especially in relation to wider society)?
  • Use succinct, short sentences – and write and/or speak in plain English. Imagine you’re talking to an undergraduate who’s just stepped into your introductory class. Or, better still, pretend you’re trying to explain your article to a distant family member who works in retail/fashion/hospitality.
  • Avoid jargon unless absolutely necessary and explain it if you do have to keep it in.
  • Use first person and active voice (“we agreed” rather than “it was agreed”).
  • Use positives not negative sentences: “You will have repeat appointments at least once a fortnight”, rather than “The usual practice is not to schedule repeat appointments more frequently than once a fortnight”
  • Images are very important – try to include one if you can.



Timeline

Timeline for Fall 2019 Cycle

  • RFA Released: July 1, 2019
  • Application Portal Opens September 3, 2019
  • Application Deadline: October 7, 11:59 PM (PST)
  • Review Period (October 21 - November 21, 2019)
  • Study Section Meeting (December)
  • Final Selection Made: January 2020
  • Submission of regulatory approvals to institution and NIH: February - June 2020
  • Funding Period: July 1, 2020 to June 30, 2021



Regulatory Approvals

For projects selected for funding, awards are contingent upon documentation of submission of all applications for required regulatory approvals to Institutional IRB and to the National Center for Advancing Translational Science (NCATS). If the projects selected for funding do not have an Institutional IRB associated with the funded projects, request for IRB approval for these projects will be expected to be filed within two weeks of notification of SC CTSI’s intent to fund.  A special NIH requirement for SC CTSI pilot projects involving human subjects is to obtain prior approval of planned research involving human subjects by NCATS. Prior approval requests for those projects selected for funding will need to be submitted to NCATS after IRB approvals are obtained. Funding associated with human subject research cannot be released until the appropriate approvals have been obtained by both NCATS and USC and forwarded to SC CTSI. Human Subjects (IRB) and other regulatory approvals should indicate that your research is/will be supported by SC CTSI Grant UL1TR001855.


Timeline for Fall 2019 Cycle

Application Portal Opens

Application Deadline

Review Period

Study Section Meeting

Final Selection Made

Submission of regulatory approvals to institution and NIH

Funding Period

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.