GHUCCTS Programs & Resources

Pilot Translational and Clinical Studies (PTCS) Funding Priorities:
The following topics reflect the priorities of the National CTSA program and of our hub (GHUCCTS):

• Investigations of environmental determinants of health, particularly those involving clinical and/or public health databases and geospatial mapping, that have the potential to point toward solutions through surveillance or policy.
• Research that expands a translational research focus across the lifespan, including to pediatric and/or geriatric populations;
• Research to address health disparities and the significant burden of conditions that disproportionately affect rural, minority, and other understudied and/or underserved populations. This includes research to better understand and address:
  • the impact of structural racism and discrimination on minority health, e.g., the impact of policies and/or distribution of resources on health outcomes;
  • and/or the impact of discrimination on health and health-related biomarkers.
• Research to provide generalizable clinical and translational science innovations or insights that can be applied to other translational research projects and thereby increase the overall efficiency or effectiveness of translation. Examples include: innovative clinical research designs, such as adaptive designs, serial “n of 1” design, or other approaches to small populations for evaluating interventions; Innovative methodologies that address translational research roadblocks specific to pediatric, geriatric, or other populations throughout the lifespan including new ways to engage under-represented populations; to measure outcomes or validate biomarkers; Innovative approaches to the implementation of precision medicine. 

Pre-pilot award for team building – Up to $10,000 to support the development of new inter or trans-disciplinary research teams that will address problems using scientific approaches beyond the capacity of the individual investigators. Funds may be used for administrative support, communication technology, transportation, and initial data collection, and must be justified in the budget. While these applications will use the same general format as our established pilot award application, the content should emphasize the expertise and activities of the applicants and where these domains could integrate and synergize, proposed process for team building, and anticipated milestones. These awards, if productive, may lead to further pilot funding and/or submission of NIH or other grant applications.

• • Please note that this is considered a separate funding opportunity. One investigator may submit to both opportunities, but it is expected that there will be separate applications submitted for each. (One application for general pilot & one application for pre-award team building)

Funding Opportunity Description 

• Award Amount: up to $40,000 and/or $10,000 for team building pilot (includes Institutional cost share 50/50).
• Duration: Funds must be spent by March 31st, 2024, due to the restrictions on CTSA funding, no- cost extensions cannot be approved
• A 50% cost-share with the applicant institution is required. (For HU and GU this has already been negotiated with your institution, for MHRI, DCVA and ORNL please make sure to speak with your Scientific Center Administrator.)

GHUCCTS Resources for Project/Proposal Development 

The GHUCCTS is offering free consultation services, which may be helpful to you in your proposal development. Topic areas for advice include, but are not limited to: protocol development, regulatory support, study design, biostatistics, feasibility assessment, use of geospatial technology for the District of Columbia, recruitment plan, community engaged research best practices, integration of culturally and linguistically competent approaches, inclusion of diverse populations, etc. Utilization of GHUCCTS consultation services will be viewed favorably by the review committee. Please utilize the links below for more information: 

• GHUCCTS Programs & Resources 
• Bio-statistical Support Services 
  
• Biomedical Informatics 
  
• Clinical Research Units: HU & GU 
• Community Engagement Services Contact: Florencia.Gonzalez@Howard.edu
• Recruitment Services

Requirements for Applications: Applications that do not comply with these guidelines will not be considered for review.

Abstract (250-word limit) To enable community representative review, we require that abstracts be written so as to be understood by a lay audience; do not include, or clearly define, technical terms; and to address relevance to public/community health.

Narrative
• A limit of four (4) pages, consecutively numbered at the bottom of each page
• Contact PI’s name at the top of each page
• Single spaced,
• 11-point font, minimum
• 0.5-inch margins

Description of Aims, Background and Clinical and Translational Impact, Supporting Preliminary Studies, Design and Methods. If the study involves human subjects the description of human subject considerations is not subject to this page limit. References do not count towards 4-page limit.

Biosketches Current NIH biographic sketch for each investigator and/or mentor.

Budget Guidelines (Apply to both the General Pilot Award and the Pre-Pilot Award)

Budget: Funding will be provided for items essential to the conduct of the project. The budget should identify budget details and total by using NIH budget page (PHS 398 FormPage 4). A separate budget and subcontract are needed for each participating institution.

Budget Justification: Budget justifications should include the roles and responsibilities of all personnel (paid and unpaid) and details on the purpose of all requested non-personnel costs. Please utilize the template located in the application.

• Allowable Costs: Laboratory supplies, participant costs, consultants, research support personnel (salary/wages & fringe benefits), use of institutional/core and GHUCCTS services, travel necessary to perform research.
• Unallowable Costs: PI salary support or faculty collaborators, durable equipment >$5,000/unit, office supplies, meals or travel for conferences, publication or presentation costs, professional education or training, indirect costs.

Budgets should not include indirect/F&A costs. 

Departmental and GHUCCTS Executive Approval

Before submitting a PTCS grant application, the PI and any Co-PI that will be requiring institutional cost share is required to obtain approval for submission from his/her departmental chair or division chief and the GHUCCTS executive at their institution, with assurance that appropriate time and resources will be made available to successful applicants. A form is provided in the application packet. GHUCCTS executive contacts are as follows: 

Howard Executive: Dr. Thomas Mellman (tmellman@howard.edu) / Dr. Marjorie C. Gondre-Lewis (mgondre-lewis@howard.edu)
Georgetown Executive: Dr. Joseph Verbalis (verbalis@georgetown.edu)
DCVA Executive: Dr. Marc Blackman (Marc.Blackman@va.gov)
MedStar Executive: Dr. Neil Weissman (Neil.J.Weissman@Medstar.net)
ORNL: Dr. Anuj Kapadia (KapadiaAJ@ORNL.gov)

IRB/IACUC & Human Subject

• Relevance to the priority themes/categories listed at the beginning of the application.
• Use of an interdisciplinary approach. (Consider going outside of your institution if required expertise is more readily available at other GHUCCTS institutions (Georgetown University, Howard University, MedStar, DC Veterans Administration Medical Center, and Oak Ridge National Laboratory) or other CTSA hubs.
• Promising direction for future extramural funding Clearly describes how proposed aims will provide opportunities for future externally funded applications, including but not limited to NCATS initiatives.
• Collaborations between junior and senior investigators. For experienced investigators, participation of junior investigator/trainees; for junior investigators, adequate/appropriate mentoring and consultation.
• Approach Will the proposed methods achieve the aims?
• Significance If successful will the project move the field forward? Does the proposed project answer an important translational research question?
• Innovation Could apply to the approach, technology or its application to a novel focus.