Center for Biomedical Imaging Pilot Studies Program

Request for Proposals

*Funding of any and all University at Buffalo Clinical and Translational Science Institute (CTSI) pilot study awards will be dependent upon allocation of funds to the pilot study program.

The UB CTSI provides seed grants for pilots encouraging clinical translational research. The CTSI Center for Biomedical Imaging (CBI) is seeking to fund innovative pilot imaging studies. Projects must:

Aim to generate preliminary data for submission of extramural federal and private research grant applications, and
Apply or develop novel imaging methodologies and technologies that will yield generalizable solutions to research problems that can be translated to a clinical setting, and/or
Seek to apply available imaging methods to novel multidisciplinary clinical and translational research at UB and Buffalo Translational Consortium institutions.

Projects will be given preference if they:

Support the design, development, and/or validation of novel imaging biomarkers that will advance clinical and translational research
Use already existing acquisition and analysis methods to broaden the user base
Have strong scientific merit
Address health disparities in underserved or underrepresented minority populations and rare diseases in the Western New York region
Use the CBI structural/functional imaging capabilities to study post-COVID-19 associated sequelae and comorbidities, and/or
Pair “early stage” (by NIH definition) investigators with established investigators (i.e., PIs who have a history of substantive extramural research funding), thus providing a built-in mentoring system for KL2 scholars
Promote multi-disciplinary collaborations will be given priority for consideration of funding.

Research that addresses health disparities can be implemented across all levels of analysis with imaging correlates, including examples such as understanding genetic or epigenetic effects on health disparities in structural or functional imaging outcomes; through biological and neurobiological influences on health disparities, individual differences in response to drugs that may explain differential health benefits to new or commonly used pharmacological interventions; or developing unique programs that address health disparities for underrepresented populations in Western New York, including T3 and T4 translational research projects.

In addition, proposals that will advance the ways in which creativity and innovation can be stimulated, fostered, and augmented in the design and conduct of clinical-translational imaging-related research will be entertained.

No clinical trials beyond phase IIA will be supported by the program.

These pilot imaging studies will be partially supported by the CBI at the Clinical and Translational Science Award (CTSA), by providing imaging hours on 9.4T and PET/CT scanners at “at no cost,” with intended durations of one year, beginning on January 1, 2021.

There is no deadline for pilot studies submission or completion. The CBI will support pilot projects based on available scanning time and human resources at the 9.4T and PET/CT scanners. The CBI anticipates that it will support three pilot projects per calendar year on 9.4 and PET/CT scanners.

Eligibility Criteria

You must 1) be a full-time faculty member at UB or an affiliated Buffalo Translational Consortium institution; 2) agree, if called upon, to serve as a reviewer of other proposals submitted for pilot studies funding either by UB faculty or in exchange of reviews with other CTSA institutions; and 3) must report grant progress, publications and grants resulting from the pilot study on a quarterly basis to the CBI during and for up to three years after conclusion of the project*.

*Any publications resulting from the pilot study, including those that arise beyond three years, must cite the CTSA.

Application Process

Applying for pilot studies funding involves a two-tiered process:

Submission of a Letter of Intent (LOI), and
Submission of a full proposal (if invited, following review of the LOIs).

Letter of Intent Submission

There is a two-page limit for LOIs. First page should provide 1) succinct title for the proposal and 2) list of names/degrees and institutional affiliations of all investigators involved in the project. Second page should provide a succinct abstract of the proposal, summarizing a) what the project entails; b) a clear statement of the translational significance of the project, the expected outcomes, and the potential application of those outcomes; and 3) how the pilot study will lead to substantive extramural funding (e.g., an NIH R01, R21, or comparable grant).

FORMAT: LOIs should be submitted as a single PDF in Arial 11-point font, single-spaced text, 0.5-inch margins. Submissions must be emailed to CTSA-Pilot-Studies@buffalo.edu. All applicants will be notified after 30 days from the receipt of LOI with a decision as to whether or not their proposal has been selected to move forward to the second tier of the application process.

DUE DATE: There is no due date. Please submit your proposal at any time during the calendar year.

Full Proposal Submission (by invitation)

Invited applicants should use the following template.

Page 1:

a. Project title

b. Names/degrees of all project investigators and their institutional affiliations

c. Abstract (300 word max)

d. Five key words relevant to your research topic

e. Two sentences that describe your project for a general scientific audience

f. Indication whether the project involves human and/or animal subject research

Pages 2-5 (four-page limit):

a. Specific aims

b. Background and significance of the project, including the clinical-translational relevance and potential impact on the field

c. Brief overview of approach, avoiding minutiae of methods and jargon

d. Study timeline with specific milestones to be accomplished

e. Role of pilot study in securing extramural funding for a larger, forward-going project

f. Brief explanation why the project meets the goals of the CBI Pilot Study Program

Additional Information

References
Budget and Justification (one-page limit): The maximum allowable imaging budget support for each pilot project is 100 scanning hours, including protocol development and implementation. Please note that faculty salaries/fringe, tuition, and equipment are not allowable expenses on pilot awards.
NIH Biosketches: A current NIH biosketch for each investigator should be provided (five-page limit per biosketch). The personal statements for each investigator should make clear their role as it pertains to the project.
Appendix: If applicable, provide a copy of the critiques from the prior review of your submitted proposal. If a similar proposal has been reviewed and scored but not funded, by an external funding agency, provide a complete summary statement. Appendices, other than funding agency reviews, are not allowed and will not be reviewed if attached.

FORMAT: Full proposals should be submitted as a single PDF in Arial 11-point font, single-spaced text, 0.5-inch margins. Proposals must be emailed to CTSA-Pilot-Studies@buffalo.edu.

DUE DATE and NOTIFICATIONS: There is no due date. Please submit your proposal at any time during the calendar year. All received proposals will be reviewed on an ongoing basis and the applicants will be notified in 90 days with a decision as to whether or not their proposal has been selected for imaging support.

REQUIREMENT: For proposals involving human subjects, the Principal Investigator is to register their study with Central Study Registration (CSR). To begin the CSR process, a proposal document (at minimum) is required. For any questions regarding CSR registration, please contact the CTSI Clinical Research Facilitators (716-829-4357).

The HRP-503-Protocol template can be found in the CLICK portal, within the IRB Library section, under the “Templates” tab.

Please note the following exceptions to CSR Registration and scientific review of HRP-503 protocols:

If you are submitting your protocol to the IRB for determination of “Not Human Subjects Research.”
If you are seeking “Exempt Status” from the IRB for your study.
Due to reporting requirements, chart reviews must be registered within the system. If bypassing CSR, please leave a comment in Click indicating you are seeking one of the above listed determinations. This will allow the IRB Intake Coordinator to know your study should not be returned for registration.

*It is recommended that PIs from Roswell Park Comprehensive Cancer Center follow a similar process while utilizing the RPCCC Click and IRB.

Review Process

Applications will be rated using the following criteria.

Scientific merit and innovation
Clinical significance and translational impact on the field
Potential for securing extramural funding
Realistic milestones and feasibility of completion within one year
Rationale and utilization of the “at no cost” scanning hours

The reviews of the proposals will be conducted by:

The CBI technical and faculty personnel to ensure feasibility of the proposed study
Independent imaging core steering committee
External reviewers