The purpose of the Kaganov Research Initiative in Pulmonary Medicine and Engineering, supported by a generous gift from Dr. Alan and Mrs. Carol Kaganov, is to build robust collaborations between engineers and biomedical scientists or clinicians to conduct basic, translational or clinical research that focuses directly on or has relevance to lung function and diseases, especially pulmonary fibrosis. To achieve this purpose, the Initiative will fund multiple research proposals.
I. Overview & Purpose
The Kaganov Research Initiative in Pulmonary Medicine and Engineering focuseson research on lung function or diseases of the lung, especially pulmonary fibrosis, with the following priorities:
- improve our understanding of disease mechanisms,
- enhance diagnosis,
- create more effective treatments
- find pathways to cure idiopathic pulmonary fibrosis and other lung diseases.
Grant proposals should describe multidisciplinary research that meaningfully engages investigators from at least the Schools of Engineering and Medicine. Research on relevant basic biomedical questions, development of enhanced understanding of disease mechanism, the development of therapies, diagnostics or devices, clinical research/trials (excluding Phase 2 or beyond), epidemiological, and/or community-based studies is within scope. The Initiative is especially interested in proposals that build new collaborations and/or teams, and proposals that might lead to extended, productive collaborations and follow-on funding.
Applications for funding of up to $150,000 (direct costs only) will be considered. Some faculty effort may be included (not to exceed 20% of the budget). If you are requesting faculty salary, justify the request in relation to departmental expectations and actual effort on the project. The proposed research should be appropriate to the budget and must be accomplished within one year.
A Kaganov Initiative grant application need not have extensive background material or preliminary data. Accordingly, reviewers will be encouraged to focus their evaluations on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding of or the treatment of lung disease, particularly idiopathic pulmonary fibrosis. Appropriate justification for the proposed work can be provided through literature citations, data from other sources or from investigator-generated data. All applications should discuss a path to subsequent financial support through grant funding, new company formation, licensing, not-for-profit partnering, or other channels.
II. Key Dates
- Application Submission Deadline: October 30, 2019
- Final Selection: approximately third week of November, 2019
- Project Planning/Run-In Period (if needed): November/December, 2019
- Funding Period: January 1, 2020 - December 31, 2020
- Proposals must demonstrate a real collaboration between a faculty member with an appointment in the Pratt School of Engineering and a faculty member with an appointment in the School of Medicine.
- Proposals must be submitted by Duke regular rank faculty and comply with the Duke University Policy on PI Status in the Duke Faculty Handbook.
- The co-PIs cannot haveprimary appointmentsin the same School.Priority may be given to applications that include one or both PIs with a primary appointment in Medicine or Pratt (i.e. rather than the applicants having primary appointments in, for example, Arts & Sciences).
- Applications are encouraged from new teams of investigators and existing collaborators proposing a new research topic.
- Because of the focus of this funding opportunity, the applicants are highly encouraged to have physicians or scientists with lung disease expertise at least in the extended collaborative team.
- More than one proposal may be submitted per faculty member acting as PI, but the faculty member is only eligible to receive one award as PI during a given funding cycle.
- Teams whose proposal to a previous Kaganov Pilot Project RFP was not selected for funding may resubmit the proposal if it meets the requirements for this announcement.
- Teams that have previously received Kaganov grant funding may submit a competitive renewal application. Please indicate in the application whether and how previous milestones were achieved, and how the new application extends or is different from the prior work. The application will be reviewed with the general pool of applications.
Each award will consist of up to $150,000 (direct costs only) with an expected start date of January 1, 2020 and ending on December 31, 2020. No-cost extensions (carryovers) will not be permitted. When preparing your budget, please discuss with your division/departmental G&C representative or financial manager that the grant makes no provision for G&A costs.
V. Proposal Preparation
- Email your intent to apply to Donna Crenshaw. We suggest consulting with MEDx Leadership or with a member of the Kaganov Initiative Steering Committee ahead of preparing the proposal.
- You are welcome to suggest reviewers whom you know are familiar with your field of research or the research methods proposed. There is an opportunity to include names and email addresses for potential reviewers at the grant submission site or you may send reviewer suggestions to Donna Crenshaw.
- MEDx recommends involving a biostatistician/bioinformatician early in the application development process and including biostatistical or bioinformatics support in the budget where necessary to ensure success. For investigators without access to a biostatistician, biostatistical support may be obtained through the Duke CTSI Biostatistics Core. The core provides an initial, brief consultation upon request at no cost. For teams requiring bioinformatics or genomic analysis support, contact the Genomic Analysis and Bioinformatics Core Facility, which also provides an initial consultation service at no cost.
VI. Application Procedures
Proposal sections will be uploaded as two PDF files and include the co-PI last names in the filenames.
The first file is the Scientific Abstract (see 1, below). Name this file: PI lastname_PI lastname_Abstract. The second file contains list items 2-6 (below) assembled as one PDF. Name this file: PI lastname_PI lastname_Proposal.
- Scientific Abstract: The abstract is a summary of the proposal for use by review committee members and Duke MEDx (1-page limit. Please include the title, names of the PIs (including collaborator names is optional here) a brief introduction, the aims, and the expected outcomes).
- Research Proposal (5-page limit, including tables and figures. Use 1-inch margins, single line spacing, and font no smaller than Arial 10. References do not count towards the 5-page limit.) Research proposal should address the following:
- Explanation of unmet need and/or scientific significance, and how the proposed research is responsive to the Overview & Purpose (see Section I) of this Request for Proposals
- Research plan and approach to achieving the Aims
i. Include stage of the project/product
ii. Include preliminary data if helpful (not required)
- Proposed research timeline.
- Plan for follow-on support or translation if that is the logical next step. Indicate if this research is currently funded and how.
- References (References do not count towards the 5-page limit and should be included at the end of the research proposal and assembled as a single PDF.)
- Budget with Budget Justification using PHS 398 Form Pages 4 and 5 (Page 5 is for the Budget Justification section only and you may use more pages as needed. Combine all pages into a single PDF).
- Human and/or Animal Subjects: Institutional Review Board (IRB) or Institutional Animal Care & Use Committee (IACUC) approval is not required prior to submission but will be required prior to transfer of funds. Briefly describe any human and/or animal subject issues. (For example, if human subjects are involved, provide a description of their involvement and characteristics. Describe the sources of materials that will be obtained from human subjects as part of their study participation. Provide assurance that the project will be reviewed and approved by the Duke IRB and comply with HIPAA. If vertebrate animals are to be used, provide a description of the proposed use of the animals in the work. Projects involving animal subjects must be reviewed and approved by the Duke IACUC. There is no page limit to this section, but it should be as brief as possible.)
- Biographical sketches for all key personnel, including current and pending sources of support. Please use the new (2018) “NIH Biosketch Form”.
VII. Budget Guidelines
Please note the following during budget preparation:
- The budget period is January 1, 2020 through December 31, 2020. No General & Administrative (G&A) costs may be included; the awardees are funded for direct costs only.
- Grant funds may be budgeted for
- salary support for the PI or faculty collaborators, students, post-docs and research support personnel (Unlike NIH grants, there are no expected minimum efforts for faculty PIs, unless directed by your primary organizational unit. Salary for faculty, research staff, and students must reflect actual institutional based rates supplied to you by your grants managers or business office.)
- graduate student tuition or tuition remittance
- travel necessary to perform the research
- small equipment, subcontracts, research supplies and core lab costs, or
- other purposes deemed necessary for the successful execution of the proposed project
- Projects that will build prototype devices may include purchases of large components. These are allowable expenses and for budget purposes will be listed as equipment. (Explain in the budget justification that these are prototype expenses and not capital equipment.)
- Grant funds may not be included in the budget
- foreign components, as defined in the NIH Grants Policy Statement
- effort for post-doctoral trainees or fellows that is already on training grant equivalents
- capital equipment
- office supplies or communication costs, including printing
- meals or travel, including to conferences, except as required to collect data
- professional education or training
- computers or audiovisual equipment
- manuscript preparation and submission, or
- indirect costs (The indirect rate is 0% for all direct costs, including subcontracts.)
Awarded funds must be used to conduct the work proposed. Duke MEDx reserves the right to revoke funding in the event it is determined that funds were not spent in accordance with the approved proposal without prior notification and approval.
VIII. Application Review and Post-Award Processes
- Typically, each application is reviewed by three researchers and/or clinical experts from the School of Medicine and the School of Engineering. Reviewers will be asked to consider the following criteria:
- Alignment with the goals of the Kaganov Research Initiative.
- Overall impact – The impact score will reflect the reviewer’s overall evaluation, not an average of individual criterion scores.
- Significance – Does the project address an important clinical or scientific problem or a critical barrier to progress? Is there a strong scientific premise for the project?
- Innovation – Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
- Approach – Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
- Investigators and Collaboration – Does the proposed research require expertise from both the engineering and medicine PIs? Are the PIs, collaborators, and other researchers well suited to the project?
- Potential for future funding. The proposed pilot work should collect preliminary data or develop tools that will lead to a competitive proposal submitted to an external funding agency. It is helpful if the team can elaborate upon opportunities for future funding or tech transfer.
- Project Planning Run-In Period: The projects selected for funding will undergo a run-in period of up to two months (if needed) to ensure that all requisite preliminary work, including IRB, animal use, and any other institutional approvals are obtained before funding is released.
IX. Terms of the Award
- A. Approvals Required Prior to Funding Start Date
Prior to receiving funds, research involving human subjects must have appropriate approvals from the Duke IRB. If the research includes animals, the appropriate IACUC animal research forms must also be approved before the project’s start date. Failure to pursue approval and notify MEDx of the outcome in the requested timeframe may result in cancellation of funding.
- B. Project Start-up and Post-award Reporting
Investigators agree to submit brief written interim and final progress reports. Duke MEDx will contact awardees at the appropriate time to request these reports. MEDx may terminate and reallocate residual funds for any team failing to submit the written reports in a timely manner. Proposed aims of funded projects may be changed, added, or deleted during the funding period, pending Investigator and Duke MEDx review and agreement. Projects should complete in the 12-month period; no-cost extensions will not be permitted.
Investigators will communicate with Duke MEDx during the project run-in period to review project plans and ensure projects are ready to start by January 1, 2020.
For additional information on this funding opportunity, please contact Donna Crenshaw.