Themed Pilots

New Pilot Funding Opportunity for innovation in Integrative Medicine Approaches

The Clinical and Translational Science Collaborative (CTSC) of Northern Ohio at Case Western
Reserve University (CWRU) requests applications for pilot research funding to enhance and grow CTSC activities in the area of integrative medicine.

The CTSC seeks applications from faculty at Case Western Reserve University, Cleveland Clinic, MetroHealth Medical Center, University Hospitals Cleveland Medical Center, the VA Northeast Ohio Healthcare System, Northeast Ohio Medical University, and the University of Toledo.

We intend to award up to four pilot grants, with award amounts at $25,000 to $50,000 each. As with all CTSC activities, and to enhance collaborations among partners, proposed studies must include at least two different CTSC institutions. Community engagement is encouraged, and community collaborators should be listed as co-I on the study and help co-design the proposed study.

Integrative Health—or “whole person health” refers to activities, therapies, devices, and practices that improve and restore health in multiple domains--biological, behavioral, social, environmental, spiritual. Research and implementation of integrative health encompasses connections between mind, body, and spirit, and people in their lived environment and communities. Integrative health also seeks access and improved health through well-coordinated care among different providers and institutions. To achieve this systems approach to disease, integrative medicine aims to empower patients and providers with ready access to conventional, complementary, and novel approaches to care.

In this year’s themed pilot, the CTSC supports the National Center for Complementary and Integrative Health’s (NCCIH) strategic plan “to better define and map a path to whole person health by expanding and building on current activities while advancing new research strategies and ideas.” Integrative Health aims to complement conventional health care, not serve as an alternative. Scientific investigations in Integrative Health may include the effects of diet, nutritional supplements, physical activity, sleep, stress, and the environment on health outcomes. For example, effects of complementary therapies on symptoms such as pain, anxiety, and fatigue are critical areas of study. Delivery of those therapies in geographically diverse and community-focused locations are also key to Integrative medicine innovation.

This project complements the CTSC’s initiatives across Northern Ohio. Integrative health was targeted in this current CTSC cycle as a researcher area that the CTSC would like to encourage within our partners. This year’s pilot seeks not only to support complementary approaches to therapies, but would encourage innovative applications that detail how therapies or interventions can be delivered broadly across the patient populations.

There are three areas of interest in this Pilot Funding Opportunity:

1. Models that address predictive biomarkers for disease risk in multiple organ domains.
2. How the translational science model catalyzes solutions across institutional and community barriers.
3. How integrative approaches reduce burdens on health care systems and improve outcome over the lifespan.

Priority will be given to projects that address novel interventions in addressing the “whole person.”

Case Western Reserve University will serve as the fiscal entity through which each award will be distributed and administered. Awardees will receive additional information regarding disbursement workflow.

Important Considerations and Requirements:

1. Teams must propose a plan for disseminating and implementing their improved health outcomes through integrative medicine solutions in the future.
2. Applicants must have an Integrative Health consultation with Santosh Rao/Sue Marasco as they prepare their applications. Visit https://sparc.case.edu/ > Grant Development > Grant
   Writing Consultation

SECTION I: GENERAL REQUIREMENTS (applies to all applications)

Applicants must read and follow all application instructions in this section as well as funding-specific
instructions noted in Section II.

• Principal Investigators (PIs) must have a PhD, MD, JD, PharmD, PsyD, DNP or equivalent doctoral-level degree and have a faculty appointment at CWRU or one of the CTSC partner institutions, including: University Hospitals, Cleveland Clinic, VA Northeast Ohio Health System, MetroHealth, Northeast Ohio Medical University or the University of Toledo.
• Co-PIs are permitted, but each applicant must submit only one application as PI or co-PI.
• Interested prospective applicants who do not have doctoral-level degrees (e.g., non-clinical staff with master’s degrees, undergraduate degrees, high school diplomas or the equivalent) are highly encouraged to apply by collaborating with a PI.
• The institution of record will be the PI’s primary institution. If the application has two co-PIs, one should be designated as the contact PI and their institution will act as the primary institution of record.
• Research projects must show significant progress (i.e., meeting milestones per proposal timeline) at the three-month mark through a progress report and deliverables statement. Awards may be withdrawn at any time if challenges are not presented timely, an attempt to access additional resources and support to address those challenges is not sought, and significant progress is not demonstrated.
• If human subjects are involved, approved IRB (or official IRB Exemption) or copy of IRB application must be included with the application. Studies involving human subjects must include IRB approval before funds will be released and will not change the expectation for significant progress to be made within three-to-six months. The likelihood of gaining IRB approval in a timely manner will be considered as part of the feasibility criteria.
• PI, co-PI(s), and/or study team staff salaries are not permitted. Exceptions include paying community consultants for the execution of the project.
• Indirect costs are not permitted.
• PI, co-PI(s), and study team must complete a Grant Development/Grant Writing Consultation requested via SPARCRequest, with the CTSC, while preparing their response to take place via Zoom no later than Friday, November 22, 2024.
• PI, co-PI(s), and study team members are encouraged to attend or review recordings or content of supplementary enrichment opportunities (e.g., pilot award information session, webinars with experts, journal articles) that will take place or be made available during the application period.
• PI, co-PI(s), and study team members should involve interdisciplinary institutional departments, as appropriate, in the development of their pilot proposal.
• PI, co-PI(s), and study team members are encouraged to leverage feedback from community organizations and individual members when developing their response (as appropriate).
• Proposed project cannot have current funding, or only modest related intramural or extramural funding that will be enhanced by the pilot activities, representing a distinct sub-aim.
• All award funding must be spent by June 30, 2026. No-cost extensions (i.e., the project end date will not be extended, nor will additional funds be added by the funder to cover the extension) will not be granted.
• All awardees must provide a mandatory six-month progress report and 12-month final report (no later than July 31, 2026). Progress reports will be submitted through InfoReady, that will be forwarded by the CTSC.
• Allowable Costs: recruitment materials; rental of UH Mobile Research Unit; study supplies; community member consultant fees; consumable technology with justification for use in the project; space rental fee; food for events specifically outlined in the application.

APPLICATION PROCESS

• Application must be submitted electronically no later than Monday, December 2, 2024 at 11:59PM via InfoReady.
• Schedule and complete your Grant Development/Grant Writing consultation via SPARCRequest before Friday, November 22, 2024. SPARCRequest is the CTSC's service request system.
• The Project ID number issued to your project, after scheduling your Grant Development/Grant Writing Consultation, will also be the ID number used to apply for the Integrative Medicine pilot.
• To apply for a CTSC Pilot, you need an ID number from SPARCRequest (called a "Project ID"). Obtaining a Project ID from SPARCRequest will help you access Pilot RFAs and applications in InfoReady and link you to other services provided by the CTSC.
• Successful applicants will be notified in early 2025, and if all requirements are met, funding could begin as early as April 1, 2025.
• Applications must meet all general requirements unless an exception is noted. Applications not meeting the requirements may be returned and not reviewed.
• Applicant’s project must address the topic areas and other requirements of the funder to be considered for a pilot grant award.
• Awards will be based on a combination of meritorious proposals and priorities of the funder. Should there be no applications that meet the criteria set, the funder has no obligation to fund an application.

PREPARING YOUR SUBMISSION

The InfoReady System will require the following information or documents to be provided or uploaded.

Formatting

• Please review the online submission form before preparing your final documents.
• All uploaded documents must be PDFs.
• Please use size 11 pt. Arial font with 0.5” margins.
• Maintain margins and adequate spacing between paragraphs and note maximum length for each document.

Information and Documents

• A short summary of the work directed to the general public (i.e., plain language summary) (500 characters, including spaces)
• Specific aims (maximum one page, uploaded as a PDF)
• Significance and urgency, specifically addressing how this project will advance health outcomes through integrative medicine approaches (maximum one-half page, uploaded as PDF)
• Research Strategy (maximum two pages, uploaded as PDF) that includes:
  • Study design, hypothesis, expected results.
  • Study population
  • Approach (methods, data collection, measures, analyses)
  • Investigative team
  • Feasibility
  • Dissemination and implementation plan and next steps (i.e., extramural funding)
• References or URLs (maximum 10 references uploaded as part of the Research Strategy PDF)
• Study timeline and deliverables (applicants must show significant progress within three-to-four months), including plan and timeline for dissemination of research findings and for seeking extramural funding (maximum one-half page, uploaded as PDF)
• Figures may be included as appendices (maximum two pages total for appendices)
• If human/animal subjects are involved, approved Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) or copy of IRB/IACUC application must be included with the application as an uploaded PDF.
• Detailed budget (please download and complete the NIH budget form found on the InfoReady Integrative Medicine Pilot Funding Opportunity)
  • Note: The fringe rate for staff salaries (if applicable) is the current non-federal rate of 34%.
  • Note: There are no Indirect Costs associated with this award.
• Budget justification (provide description and rationale for each expense listed in budget)
• NIH-format biosketches for personnel (maximum five pages per biosketch uploaded as a single PDF)
• Letter(s) of support/commitment (as applicable) (maximum five pages, maximum one page per letter uploaded as a single PDF)

REVIEW PROCESS

• Proposals will be reviewed by a scientific review committee (committee) comprised of reviewers from each institutional partner hospital, may include representatives from: information technology, innovation, community health or community outreach and engagement, and the community at-large. CTSC staff will provide administrative oversight throughout the review process to ensure a standardized review process.
• Reviews will be conducted using NIH-style scoring methods: (1) significance, (2) investigators, (3) approach, (4) feasibility, and (5) overall impact.
• The committee will take the following into consideration:
  • Clear articulation of the problem being addressed in the proposed project,
  • Demonstration of how the proposed work may directly contribute to developing new knowledge toward improved health outcomes through integrative medicine approaches for diverse, historically excluded, and under-resourced populations,
  • Significance, innovation, and timeliness,
  • Expertise of the investigative team and evidence of commitment of investigators and stakeholders to collaborate,
  • Feasibility,
  • Evidence of tangible deliverables, a timeline, dissemination, and implementation plans, and plans for future funding,
  • Likelihood of future success,
  • Budget and budget justification,
  • Dissemination of research findings at a CTSC Forum.
• REMINDER: If no applications meet the criteria set by the funder, the funder has no obligation to fund an application.

REPORTING GUIDELINES

• All awardees must provide a mandatory six-month progress report and a 12-month final report no later than July 31, 2026.
• REMINDER: If challenges are not presented timely, an attempt to access additional resources and support to address those challenges is not sought, and significant progress is not shown by three months, funding may be withdrawn at that time.

QUESTIONS

Pilot questions should be directed to either Sue Marasco or Dr. Santosh Rao.

Submit to InfoReady