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2024-2025 Pilot Grant Application Instructions (Pilot Round 13)

TIMELINE
PRE-APPLICATION GUIDELINES
FORMAT OF FULL APPLICATION
ALLOCATIONS AND EXPENDITURES OF FUNDS
CONSULTATIONS WITH CORES & RESOURCES


PURPOSE:

The Louisiana Clinical and Translational Science (LA CaTS) Center is focused on the theme of “prevention, care and research of chronic diseases in the underserved populations of Louisiana”. The LA CaTS Center is seeking research applications to support highly innovative projects aimed at preparing major publications and grant applications to compete for extramural funding (e.g., NIH, DOD, or Foundations). The 2024-2025 round will favor applications from junior investigators, and applications must include a mentoring component. Collaborative projects that include investigators from more than one LA CaTS institution are highly encouraged. The projects should be focused on understanding the epidemiology, etiology and pathophysiology of chronic diseases that are relevant to the Louisiana population and should help develop new approaches to disease prevention and/or treatment. The program will support research activities and will also provide eligible pilot projects with access to scientific, statistical, and regulatory cores to facilitate their development.

Each award may be up to $50,000/year in total costs for one year. A second year of support may be offered but is not guaranteed and will depend on the availability of funds and the scientific productivity of the pilot project team. Note: Funding is dependent on receipt of the NIH Notice of Award for the LA CaTS Center IDeA-CTR in the grant year the pilot project is funded.  

Areas of research may be related but not limited to:

  1. Early phase clinical trials, including early phase I studies to test or evaluate tolerability in humans, stemming from investigator-initiated research that are ready to start (trials supported by pharmaceutical companies are excluded from these grants).
  2. Animal studies required to support the development of early-stage clinical trials and the testing of novel compounds in the
  3. Research using patient materials (biological samples, questionnaires, surveys, etc.) that are important for the development of new diagnostic tools, prognostic or pathophysiological
  4. Population research projects that aim to develop interventions that improve health outcomes of the residents of Louisiana by using Community Based Participatory Research (CBPR) methods, health literacy methodologies (i.e. use of health literacy as a variable, impact of health literacy on outcomes, use of questionnaires and education that is usable and actionable) and behavior modification studies related to managing risk factors.
  5. Cost-effectiveness of prevention or treatment modalities

As outlined, priority will be given to projects that are very close to initiation, so projects for which the relevant human subjects’ and/or animal care and use reviews are in process or approved will be given priority.

Eligibility Criteria
Applicants will be researchers from the participating institutions that are part of the LA CaTS Center. Applicants must hold a Ph.D., M.D., or equivalent degree. All junior faculty (i.e., assistant professors), will require a letter of support that must indicate a commitment to recruitment or retention of the faculty at a participating institution and a letter of support from the primary mentor. Non-faculty (i.e., post-doctoral fellows, residents, and fellows) are ineligible to receive funding from the NIH LA CaTS award; however, their proposals may be funded by in-kind support from their institution. The Project lead for Pilot projects may not concurrently have research funding from other IDeA Program award mechanisms (e.g. INBRE, COBRE). Pilot projects may not overlap with ongoing funded projects.

A pre-application is required prior to full applications to ensure eligibility and appropriateness of the research topic. Only investigators who submitted and received approval of the pre-application will be eligible to submit a full application.

There is no citizenship requirement for pilot funding recipients but visiting scientists with whom the LA CaTS Center’s institutions do not have a long-term collaborative relationship will not be considered for support.

Prior and current pilot grant awardees and scholars are eligible to submit a pre-application for this round. Applications seeking to extend a pilot project must demonstrate suitable progress on the current award to be considered for additional funding.

Mentoring Component
Applicants must identify two senior mentors (Primary and Secondary Mentors) in their application. A short description of the mentoring plan must be provided in the full application, including the role of the mentors on the project and the nature and frequency of communication between the Principal Investigator and the mentors.

Criteria for Selection and Scoring Method
All applications will be sent to a minimum of three reviewers who are assigned by the Pilot Grants Program Review Committee. Reviewers will score proposals based on the five NIH criteria:1) significance, 2) investigator(s), 3) innovation, 4) approach and 5) environment; with special consideration of the following questions:

  1. Does the project meet the published objectives of the LA CaTS Center to enhance clinical and translational research?
  2. Will the proposed project obtain sufficient data to compete for extramural funding during the period of funding? If successful, will the project likely lead to new research or therapeutic avenues?
  3. Does the project involve novel methodologies to enhance translational research and/or does it meet a need identified in represented populations?
  4. Is the project at an advanced stage, i.e., ready to initiate protocol and/or has regulatory (i.e., IRB) ?
  5. Is the project a collaboration between investigators at one or more of LA CaTS Center institutions (e.g., LSU Health-New Orleans, LSU Health-Shreveport, Tulane, Pennington Biomedical, Xavier, LSU, Children’s Hospital, Ochsner Health System, Southeast Louisiana Veterans Healthcare System, LSU Health School of Dentistry)?
  6. Is the project a collaborative project between investigators (e.g., junior/senior, mentee/mentor, MD/PhD, spans across disciplines)?
  7. If the project involves community-based research, does it follow the Community Based Participatory Research model and consider effective health communication strategies to recognize and address differences in culture, language and health literacy between investigators and community members?

The review criteria will carry equal weight, and the overall scores will be based on the current NIH scale of scoring ranging from 1.0 (outstanding, few weaknesses) to 9.0 (major weaknesses). Reviewers will be asked to provide scores and an overall impact paragraph to include comments on the significance and potential impact of the proposed work, relevance to the LA CaTS Center mission and overall project strengths and weaknesses.

TIMELINE:

Announcement Released:  Monday, November 11, 2024

Pre-application Deadline: Monday, December 9, 2024 by 5:00pm CST; Pre-applications must be sent by email to info@LACaTS.org. Applicants will be notified directly if, based on their pre-application, they are  selected to submit a full application  for the competition. See Pre-application Guidelines below for requirements.

Announcement for Full Application Submission by Friday, December 20; Applicants will be notified directly if, based on their pre-application, they are selected to submit a full application for the competition. Notice of applicants selected to submit full applications will also be sent to the Grants/Sponsored Projects Office or designee at each applicant’s respective institution.

Full Application Deadline: Monday, February 17, 2025 by 5:00pm CST; Applications must be submitted online on the LA CaTS Center SPARC Request System (https://sparc.lacats.org). Applicants will need to create a profile and answer basic information about the proposal before uploading the application. More detailed instructions will be sent to the selected applicants.

  • Please submit in PDF format in color on the LA CaTS website.

Earliest Anticipated Start Date: July 1, 2025; Projects selected for funding may begin after the project proposal and written assurances (e.g., IRB/IACUC) are reviewed and approved by the LA CaTS Center Executive Council, External Advisory Committee and/or NIH.

PRE-APPLICATION GUIDELINES:

The Pre-Application MUST include the following information:

  • Project title, Principal Investigator, names of primary and secondary mentors, and any inter-institutional or multi-disciplinary collaborations
  • Abstract of intended work including a clinical research component or potential for a clinical component utilizing human
  • The Specific Aims of the project (limited to 1 page)
  • Biosketch of the Principal Investigator and Primary Mentor
  • Statement that the applicant’s Sponsored Projects/Grants Office was notified of the Pre-Application
  • If applicable, list any current or pending funding from another NIH IDeA (Institutional Development Award) program (i.e., COBRE, INBRE, etc.) for the Principal Investigator. Include the funding period start and end dates.

FORMAT OF FULL APPLICATION:

The full application packet must include the following (applicants are required to use the NIH PHS 398 forms):

  • Submission Checklist (found on the website, at the bottom of RFA instructions)
  • NIH Form Page 1: Face Page (signed by authorized institutional representative)
  • NIH Form Page 2: Project Summary
  • NIH Form Page 4: Detailed Budget for Initial Budget Period
  • NIH Form Page 5: Budget for Entire Proposed Project Period and Detailed Budget Justification
  • NIH Biosketch of PI and Primary and Secondary Mentors
  • LA CaTS Project Data Form (found on the website, at the bottom of RFA instructions)
  • LA CaTS Core Service Planned Usage Form (found on the website, at the bottom of RFA instructions)
  • Research plan (Plans should range from 5 to 10 pages (maximum) excluding references, abstract, human subjects protection, and vertebrate animals section(s); Arial 11, single-spaced).
    1. Abstract of proposed work (150 words or less), not included in 10-page max, for dissemination purposes if awarded (i.e., LA CaTS Center website, LA CaTS Center governing & advisory boards, LA CaTS Center meetings, ).
    2. Specific Aims
    3. Research Strategy
      1. Significance (address translational relevance and transition to external funding), including how the project relates to obesity, diabetes, or health disparities in the population of Louisiana and how it has the potential to be applied to clinical
      2. Innovation (describe any novel theoretical concepts, approaches or methodologies, instrumentation, or intervention[s] to be developed or used, and any advantage over existing methodologies, instrumentation, or intervention[s]).
      3. Research Approach (describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project; please include anticipated use of LA CaTS Center resources as well as the investigator’s institutional environment).
      4. Statistical Analysis: Applicants are required to consult with the LA CaTS Biostatistics & Epidemiology Core regarding their statistical plan and provide a plan for approval to the Core OR work with the Core to develop a statistical plan. If the applicant has a statistician, the proposed statistical plan must be sent to the LA CaTS Biostatistics & Epidemiology Core (Biostatistics@LACaTS.org) for review before submitting the full application. [This is a requirement for submission.] Requests for a biostatistical consultation are made online on the LA CaTS Center SPARC Request website (https://sparc.lacats.org).Search the SPARC service catalog for the necessary services. Please provide acknowledgement of this requirement in the
    4. Future funding plans: Explain how the completion of the study and data obtained will be used for future funding
    5. Timeline for project completion: Outline major milestones for project completion over the one-year timeframe and include regulatory
    6. Description of mentoring plan: Briefly describe the mentoring plan, including the role of the mentors on the project and the nature and frequency of communication between the Principal Investigator and the nature and frequency of communication between the Principal Investigator and the mentors.
  • Community impact statement: Brief description of how the proposed work will advance health and health equity in Louisiana, suitable for lay audience; highlight expected timeframe of community impact (e.g., may be long term for basic science research).
  • For previously awarded LA CaTS Pilot Investigators applying for a second year of funding for the same project, also include a progress report (not part of the 10-page Research Plan max):
    1. Specific progress made on the project in the first year (1 page maximum), including data collection, specific findings to date, presentations, and publications resulting from the LA CaTS work, and outline clearly how this award differs from the prior
    2. For NIH-defined clinical research, include a completed NIH Inclusion Enrollment Report (NIH PHS 398 form).
  • When human subjects are involved, please include a Human Subjects Protection Plan in accordance with NIH (Link: https://grants.nih.gov/grants/how-to-apply- application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-htm#3.1). The NIH PHS Human Subjects and Clinical Trials Information Form (SF424 R&R-Version E) is not required in the application review stage. However, this form will be required prior to funding if awarded. Applicants should include a description of each section below following the NIH guidelines.
    1. Protection of Human Subjects plan
    2. Inclusion of Women and Minorities
    3. Inclusion of Children
    4. NIH Inclusion Enrollment Report – https://grants.nih.gov/grants/forms/inclusion- enrollment-report.pdf
    1. Description of Procedures: Detailed description of proposed use of animals. Identify species, strains, ages, sex and numbers of animals to be
    2. Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
    3. Minimization of Pain and Distress: Describe procedures for ensuring discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research (describe analgesic, anesthetic, and tranquilizing drugs, and/or comfortable restraining devices).
      Method of Euthanasia: State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

If necessary, additional materials, such as reprints relevant to the project from the PI (2 maximum) or letters can be submitted as an appendix.

  • Copy of IRB or IACUC submission or approval letter (if approval is pending, provide submission date and #) if the project involves human or animal
  • Letter(s) of Support: If a junior faculty serves as PI, a letter of support from the applicant’s mentor must accompany the application. The letter must confirm that the mentor and the institution support an overall plan to establish an independent research career for the
  • If a project requires a sponsor, consultant, or collaborator, this individual must write a letter of support for the application and clarify any potential overlap between their support and the subject of the proposal. This letter should accompany the application.

Allocation and Expenditure of Funds

For assistance in creating the budget, please contact info@lacats.org

Expenditures Allowed:

  • Technical and clinical staff salary support
  • Subject stipends
  • Special fees (pathology, photography, )
  • Research supplies and animal maintenance costs directly related to the project
  • Consulting costs directly related to the project
  • Publication costs, including reprintsSubawards (follow NIH policy)

Expenditures NOT Allowed:

  • Principal Investigator salary support
  • Secretarial/administrative personnel salary support
  • Office equipment and office supplies
  • Computers
  • Tuition
  • Domestic or Foreign Travel
  • Dues and membership fees in scientific societies
  • Honoraria and travel expenses for visiting lecturers
  • Equipment costing more than $5,000
  • Alterations and Renovations

The LA CaTS Center Cores and Resources offer many no-cost or discounted services for pilot grants. Applicants are strongly encouraged not to budget for services (i.e., biostatistics, community engagement, clinical sites, etc.), which the LA CaTS Center Cores and Resources can provide.

Although facilities and administrative costs are allowed under the terms of the prime award, it is our belief that these funds should be used in the spirit intended (i.e., direct costs) in support of this project. It is suggested for an award of this type, institutions forego the facilities and administrative costs and consider these costs as matching funds for the project.

Consultations with LA CaTS Center Cores

In addition to the required consultation with the LA CaTS Biostatistics & Epidemiology Core for the proposal, applicants are encouraged to consult with other LA CaTS Cores during proposal development and the pilot grants application process. To request a consultation or to review all available services, please go to LA CaTS Center SPARC Request (https://sparc.lacats.org) and search the service catalog for the necessary services.

Additional Information: Please check the LA CaTS website or email questions to info@LACATS.org.

Related files:

2024 LA CaTS Pilot Grants Program RFA

LA CaTS Project Data Form

LA CaTS Core Planned Usage Form

LA CaTS Pilot Grants Program Submission Checklist