The FY20 KCRP Idea Development Award is intended to support innovative ideas and high-impact approaches, based on scientifically sound evidence, to move toward the KCRP vision of eliminating kidney cancer.

The research project should include a well-formulated, testable hypothesis based on

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strong scientific rationale and a well-developed and articulated research approach relevant to active duty Service members, Veterans, other military beneficiaries, and the American public.

Personnel on the proposed team should have a strong background in kidney cancer research.This funding opportunity is open to applicants with eligible EIs and ECIs named as the Principal Investigator (PI).

The FY20 KCRP expects to fund one or more scientifically meritorious application(s) with an ECI named as the PI.

ECIs will be assessed using different criteria for personnel during the review process (refer to Section II.E.

1. a, Peer Review).The following are significant features of this award mechanism:Research Approach:
The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of kidney cancer.

Experimental strategies may be novel or may be based on strong rationale derived from previously published data and/or presented preliminary data.

The feasibility of the research design and methods should be well-defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved.

Additionally, resources should be identified and availability supported through documentation.

Identification of potential problems and pitfalls with alternate approaches should be addressed.

A statistical analysis plan for the proposed research should be included, if applicable, as well as a power analysis to support the design and sample size.Preliminary Data:
Preliminary data are required but need not be in kidney cancer.

Preliminary data may include unpublished or published results from the laboratory of the PI or collaborators named on the application and/or data from the published literature relevant to kidney cancer.Innovation:
Innovative research may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other creative qualities.

This may include high-risk, potentially high-gain, approaches to kidney cancer research, provided the application demonstrates the potential for significant impact on the field of research, patient care, and/or quality of life.

Research that is likely to yield only an incremental advance is not considered innovative.Impact:
Proposed research projects should address a central critical issue or question in kidney cancer research or clinical care.

High-impact research will, if successful, significantly advance current methods and concepts in at least one of the FY20 KCRP Areas of Emphasis.Personnel:
Personnel are considered a crucial element of the FY20 KCRP Idea Development Award.

The application should demonstrate the investigators’ experience in kidney cancer through the PI’s background, the research team, or through collaboration.

Collaborations should be documented. An EI is defined as an independent investigator at or above the level of Assistant Professor (or equivalent) and be 10 years or more from completing a terminal degree.

The EI should have kidney cancer-related experience and background as demonstrated by funding and publication records.

The EI should plan research collaborations and dedicate a level of effort appropriate for the successful conduct of the proposed work. An ECI is defined as an independent investigator at the level of Assistant Professor, Instructor, or Assistant Research Professor (or equivalent) and be less than 10 years from completing their terminal degree (excluding time spent in medical residency or during family medical leave) at the time of the application submission deadline.

This should be clearly articulated by the applicant in their biographical sketch.

Time spent as a postdoctoral fellow is not excluded and must be within the 10-year span from the time of terminal degree.

Postdoctoral fellows are not eligible for ECI designation.

The ECI’s training (postdoctoral or clinical) should demonstrate the ECI’s ability to accomplish the proposed work.

Institutional commitment beyond financial backing such as, but not limited to, independent laboratory space, dedicated research time, and potential collaborations should be demonstrated.

The level of effort dedicated to the proposed work by the ECI should be appropriate for the successful conduct of the research project.

A Career Guide is required and a Career Development Plan is required to be submitted (by ECIs only).The ECI must identify an individual whose role in the project is to provide career guidance for the ECI.

This individual will be the designated Career Guide:– The Career Guide must hold a position at or above the level of an Associate Professor (or equivalent).– The Career Guide must have a proven publication, patent, and/or funding record in kidney cancer research.– The Career Guide must provide a letter of support.The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current Program Announcement: All Applications:
Innovative, high-risk/high-reward and/or preclinical research that is supported by preliminary and/or published data. Early Detection Studies Option:
Basic or preclinical research that focuses on biomarkers, improved imaging capabilities, and/or new technologies that may foster new paradigms for the early detection of kidney cancer.

With justification, applications under the Early Detection Studies Option may request a higher level of funding within the defined period of performance.

Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens. Population Science and Prevention Studies Option:
Preclinical population-based, epidemiology, or public health research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the kidney cancer field.

With compelling justification, applications under the Population Science and Prevention Studies Option may request higher levels of funding within the defined period of performance.

Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens.

Use of data and/or biospecimens from active duty Service members and/or Veterans groups is encouraged.Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.A Congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients.

As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY20 KCRP priorities.The types of awards made under the Program Announcement will be assistance agreements.

An assistance agreement is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.

S.

Government.

An assistance agreement can take the form of a grant or cooperative agreement.

The level of involvement on the part of the Department of Defense (DoD) during project performance is the key factor in determining whether to award a grant or cooperative agreement.

If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).

Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement.

Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award.

The award type, along with the start date, will be determined during the negotiation process.The anticipated direct costs budgeted for the entire period of performance for an FY20 KCRP Idea Development Award will not exceed $600,00 0. The anticipated direct costs budgeted for the entire period of performance for an FY20 KCRP Idea Development Award – Early Detection Studies Option will not exceed $650,00 0. The anticipated direct costs budgeted for the entire period of performance for an FY20 KCRP Idea Development Award – Population Science and Prevention Studies Option will not exceed $2M.

Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 202 1.

For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $1 8. 1M to fund approximately 14 Idea Development Award applications.

Funding of applications received is contingent upon the availability of Federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the Government.

Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds.

It is anticipated that awards made from this FY20 funding opportunity will be funded with FY20 funds, which will expire for use on September 30, 202 6.