Budgets ranging from $20,000 – $40,000
Proposals due July 20, 2015 by 5pm

CDTR Pilot Guidelines

The full details are on the web at:  http://cdtr-chaicore.vipapps.unc.edu/cdtr-program-guidelines/

I. Purpose

The goal of the program is to facilitate the success of Early Stage Investigators as they enter the field of diabetes translational research, with a focus on becoming independently funded diabetes researchers. The pilot and feasibility program also seeks to facilitate the success of more senior investigators as they change fields and enter the field of diabetes translational research.

Our definition of translational research is, “research designed to translate the findings from basic research or clinical research quickly and efficiently into medical practice in either clinical or community settings, resulting in meaningful health outcomes.”

Projects focused on type 1, type 2, or gestational diabetes will be considered. Projects should also highlight their innovation as it relates to health disparities and translation.

Projects must be designed to specifically inform grant applications for NIH or other comparable external funding for work to be accomplished at UNC or our partnering institutions (East Carolina University, UNC-Pembroke, Wake Forest University, and Robeson County Health Department).

The UNC Center for Diabetes Translation Research to Reduce Health Disparities (CDTR) includes three Core units. We strongly encourage (but do not require) use of these Core capacities for pilot projects. If you intend to use Cores services in your proposal, we encourage you to consult with CDTR faculty or staff prior to your submission to ensure the best integration of Core services.

CDTR Cores include:

The Health Literacy and Numeracy Core, is a national resource, to improve understanding of diabetes-related information in vulnerable and ethnically diverse populations. Core Director, Stacy Bailey, PhD, may be contacted at scbailey@email.unc.edu

The Health Information Technology Core, provides consultation about technology resources, such as telehealth, mobile phone, clinical measures sensing devices, and web resources that create access and enhance type II translational research in rural, ethnically diverse, and underserved communities. Core Director, Rich Davis, MD, may be contacted at Richard_davis@med.unc.edu.

The Community Connections Core, fosters bi-directional research and training using methods of community-based participatory research (CBPR) in collaboration with a minority serving academic institution, UNC-Pembroke, and the Robeson County Health Department, both serving an ethnically diverse population of approximately a third each: American Indians, African Americans; and Caucasians. Core Director, Alice Ammerman, DrPh, may be contacted at alice_ammerman@unc.edu.

General questions about core resources should be addressed to CDTR Project Manager Kelley Cardone at Kelley_cardone@med.unc.edu

Specific questions about your proposal’s suitability for this funding mechanism should be address to the Pilot and Feasibility Program Director, Tom Keyserling, MD, at Thomas_keyserling@med.unc.edu

II. Available Funding

The CDTR pilot and feasibility program is co-funded by the CDTR and the North Carolina Translational and Clinical Sciences (NC TraCS) Institute, home of the NIH-funded Clinical Translational Sciences Awards (CTSA). Each year, the CDTR will fund up to 3 awards, each for $20,000-40,000, for a period of one year.

III. Dates

July 20, 2015	Proposals Due
August 2015	Review Panel convenes
September 2015	AwardAnnounced

IV. Eligibility

Principal investigators may have their primary appointments from UNC-Chapel Hill or from our partnering institutions: UNC-Pembroke, East Carolina University, Wake Forest University, and Robeson County Health Department. When the PI is from one of these partnering institutions, a co-investigator from UNC-Chapel Hill must be included in the proposal, and this individual must provide a letter of support indicating their specific role on the project.

Early Stage Investigators, or Senior investigators who are changing fields, and who plan to enter the field of diabetes translational research are eligible to apply. For Early Stage Investigators (defined as assistant professors), evidence of mentoring must be provided via a letter that describes the existing mentoring activities between the PI and the mentor, and specific plans for mentoring during the funding period and thereafter, including plans for leadership in the external grant application to follow the pilot work. It is expected that the Early Stage Investigator will be PI for the external grant to follow.

More senior PI’s who are new to UNC or our partnering institutions (defined as having been on faculty for less than 2 years) are eligible to apply if the proposed pilot and feasibility work represents a new direction or a continuation of prior work if research is necessary locally to be competitive for NIH or comparable funding. This must be clearly explained. Otherwise, a statement is required that explains why the proposed work represents a change of direction for the more senior PI.

Post-doctoral fellows and residents are not eligible to apply.

V. Pilot Proposal Format and Length

The format of the NIH proposals (including font and length guidelines except as noted below) is required, as follows:

1. Project Summary/Abstract and Relevance
2. Budget and Justification (see below)
3. Biosketch for Key Personnel (NIH style)
4. Specific Aims (one page)
5. Research Strategy (5 pages as follows)
   • Significance (1/2 – 1 page)
   • Innovation (1/2 – 1 page)
   • Approach (3-4 pages)
6. References (no page limit)
7. Human Subjects (no page limit; this section should not be used to circumvent the page limits of the Research Strategy)
8. Appendices are allowed: up to 5 items, excluding Letters of Support (LOS)

Do not include published papers or documents that are available on the Internet.
Appropriate documents may include intervention materials, protocols, unique data collection forms, etc.

9. Letters of Support (no limit)

It is expected that Letters of Support will be provided from clinical and/or community organizations that will be participating in the project. For Junior Faculty PI’s, a LOS is required from the Mentor (see Eligibility). For PI’s from partnering institutions, a LOS is required from a co-investigator from UNC-Chapel Hill (see Eligibility)

VI. Review Criteria

The primary review criteria is likelihood of the pilot work leading directly to a fundable proposal for diabetes translation research, to be written by the Pilot Study PI and submitted to NIH, CDC or other comparable federal agency within a short time following completion of the Pilot project. Pilot Proposals that are not part of a longer-term vision for a specific research effort will not be funded. The research effort (meaning, the Pilot project and the proposal to follow) must be designed to generate new knowledge relevant to translation of diabetes research to clinical or community settings. Therefore, pilot projects are expected to be designed to generate preliminary data to provide proof of concept and /or address issues of feasibility for a planned federal research proposal. Preliminary data are not required for the Pilot proposal but some specific evidence that the work has merit scientifically and that the proposed effort is feasible within the time and funding level of the Pilot program is required. It is strongly encouraged that the Pilot Proposal includes specific plans regarding the proposal for federal funding following the Pilot work.

The pilot project can target primary, secondary or tertiary prevention or clinical care, and can use whatever study design is appropriate to address the Aims of the project. When addressing primary prevention of type 2 diabetes, the effort should clearly be linked to diabetes prevention beyond general obesity treatment or prevention. For example, this may be done by targeting populations at high risk for diabetes. Projects that target obesity in a general manner without a focus on diabetes will not be funded.

Proposals will be reviewed using the standard NIH criteria:

Score	Descriptor	Additional Guidance on Strengths/Weaknesses
1	Exceptional	Exceptionally strong with essentially no weaknesses
2	Outstanding	Extremely strong with negligible weaknesses
3	Excellent	Very strong with only some minor weaknesses
4	Very Good	Strong but with numerous minor weaknesses
5	Good	Strong but with at least one moderate weakness
6	Satisfactory	Some strengths but also some moderate weaknesses
7	Fair	Some strengths but with at least one major weakness
8	Marginal	A few strengths and a few major weaknesses
9	Poor	Very few strengths and numerous major weaknesses

 

Minor Weakness: An easily addressable weakness that does not substantially lessen impact
Moderate Weakness: A weakness that lessens impact
Major Weakness: A weakness that severely limits impact

VII. Budget Documentation and Allowable Expenses

A detailed budget and justification must be provided using the standard NIH expense categories.

Link to the NIH budget form page is: http://grants.nih.gov/grants/funding/phs398/phs398.html
You should select Form Page 4: Detailed Budget for Initial Budget period.

PI’s may include up to $8000 for salary and fringe benefits. Justify use of pilot funds for PI salary carefully.

Student time (i.e., stipend) is allowed, however tuition is not allowed.

Travel is allowed for conduct of the research, or for travel to scientific meetings.

All elements of the budget will be carefully reviewed; justifications should provide adequate information for this review, particularly for any single item that consumes 10% or more of the total budget.

Applicants may increase the available total funds by bringing matching funds (of any amount) from their home department to add to the funds provided via this pilot program. Such a match is not required, but is desirable as a demonstration of departmental support of the investigator and his/her proposed work.

Indirect costs are not allowable.

VIII. Resubmissions

Consistent with NIH guidelines, one resubmission per proposal is allowed. There are three requirements for a Resubmission application:

• The PI must clearly address the noted weaknesses of the application.
• An Introduction must be included that summarizes the responses to the issues and criticisms raised in the Summary Statement and in reviews. The Introduction may not exceed one page.
• New text in the proposal body must be marked in the text of the application by bracketing, use of parallel lines on the margins or change of typography. Do not underline or shade the changes. Do not send documents in track changes. Do not mark where text was deleted.

Resubmissions will be accepted along with new proposals, using the same due date as for new proposals.

IX. Application Procedure

All materials submitted as one pdf document to cdtr_pilot@unc.edu.

All materials are to be submitted by 5pm on the due date.