Assistant Director, Strategic DEI & Health Disparities
Research Equity, Accessibility, Diversity, & Inclusion (READI) Clinical Trials Barrier Elimination Pilot Funding Opportunity
|Available Funds:||Up to ten $20K awards|
|Funding Period:||Project timelines can be 6-12 months; earliest start date is approx. March 1, 2024|
|Application Deadline:||Wednesday, January 31, 2024 at 11:59PM|
|Funding Source:||Clinical and Translational Science Collaborative of Northern Ohio at Case Western Reserve University|
The Clinical and Translational Science Collaborative (CTSC) of Northern Ohio at Case Western Reserve University (CWRU) requests applications for pilot research funding to increase diversity in clinical trials and enhance community engagement by addressing barriers to clinical trial participation. We intend to award up to ten pilot grants, with award amounts up to $20K.
The CTSC seeks applications from faculty at Case Western Reserve University, Cleveland Clinic, MetroHealth Medical Center, University Hospitals Cleveland Medical Center, the Louis Stokes Cleveland Veterans Administration Medical Center, Northeast Ohio Medical University, and the University of Toledo. Proposed studies must include at least two different CTSC institutions.
Community engagement seed funds are also embedded in this pilot to encourage meaningful collaborations with the community. These seed funds will be given to projects that are co-led by academia and community (i.e., with one Co-PI being from one of the CTSC partners and the other Co-PI from the community).
Applications must be submitted electronically no later than Wednesday, January 31, 2024, 2023 at 11:59PM via InfoReady.
According to the National Institutes of Health, one way to address the lack of diversity in clinical trials is by addressing barriers to participation. Lack of diversity in clinical trials results in a shorter lifespan, for historically excluded communities, due to lack of data on new discoveries that could prevent disease and compound health disparities, increased economic burden on individuals (e.g., less disability-free life) and institutions (e.g., fewer years with a viable workforce), and more. Challenges with recruitment and retention, include: study burden (e.g., number of visits, transportation, travel, invasiveness of procedures), distrust (e.g., of medical institutions, researchers), lack of knowledge and understanding about the clinical research process (e.g., informed consent process), and fear of risk and randomization. In response to these challenges, the CTSC has created a Research Equity, Accessibility, Diversity, and Inclusion (READI) Clinical Trial Barrier Elimination Pilot Funding Opportunity to support new research initiatives that will make immediate progress toward increasing diversity in clinical trials.
Our goal is to provide research teams with resources to test a new, and ideally novel, method of eliminating one or more barriers to clinical trial participation amongst historically excluded, underserved communities and special populations with intersectional emphasis on: race/ethnicity (i.e., African American/Black, Hispanic, Latino/a), sex/gender (e.g., LGBTQ+, women), rural communities, older adults, and people with disabilities.
Priority will be given to projects that have a high impact on expanding knowledge or developing new knowledge on existing challenges with eliminating barriers to clinical trial participation amongst historically excluded, underserved communities and special populations with intersectional emphasis on: race/ethnicity (i.e., African American/Black, Hispanic, Latino/a), sex/gender (e.g., LGBTQ+, women), rural communities, older adults, and people with disabilities. Teams must propose a plan for implementing their barrier elimination solution in the future.
Projects that do not directly address or relate to clinical trial participation barriers and community engagement will not be considered.
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.
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, Louis Stokes Veterans Administration Medical Center, MetroHealth, Northeast Ohio Medical University or the University of Toledo.
- 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. For Community Engagement Seed Grants, the academic PI’s institution will be considered the primary institution of record.
- Research projects must show significant progress (i.e., meeting milestones per proposal timeline) by July 31, 2024, as documented through a three-month progress report and deliverables. 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 Research Equity, Accessibility, Diversity, and Inclusion (READI) Consultation requested via SPARCRequest, with the CTSC, while preparing their response to take place via Zoom no later than Wednesday, January 24, 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 February 28, 2025. 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 three-month progress report (no later than July 31, 2024) and final report (no later than March 31, 2025 for 12-month projects). Progress reports will be submitted through InfoReady, that will be forwarded to 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 must be submitted electronically no later than Wednesday, January 31, 2024 at 11:59PM via InfoReady at https://cwru.infoready4.com.
- Schedule and complete your READI Consultation via SPARCRequest before Wednesday, January 24, 2024. SPARCRequest is the CTSC's service request system.
- The Project ID number issued to your project, after scheduling your REDI Consultation, will also be the ID number used to apply for the REDI 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 by mid- to late-February, and if all requirements are met, funding could begin as early as March 1, 2024.
- 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.
- 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 diversity in clinical trials via elimination of participation barriers and community engagement (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 (recruitment/data collection, measures, analyses)
- Investigative team
- Dissemination 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 IRB/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)
- 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)
- Proposals will be reviewed by a scientific review committee (committee) comprised of reviewers from each institutional partner hospital, may include representatives from: offices of diversity, equity, and inclusion, 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 will directly contribute to developing new knowledge eliminating barriers to research participation 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
- Evidence of tangible deliverables, a timeline, 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.
- All awardees must provide a mandatory three-month progress report no later than July 31, 2024 and final report (no later than March 31, 2025 for 12-month projects).
- 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 four months, funding may be withdrawn at that time.
Pilot questions should be directed to Gelise Thomas, Assistant Director, Strategic DEI & Health Disparities and Wesley Chen, Pilot Coordinator, at READIPilot@case.edu.