DoD Kidney Cancer, Idea Development Award

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Funding Opportunity ID: 316618
Opportunity Number: W81XWH-19-KCRP-IDA
Opportunity Title: DoD Kidney Cancer, Idea Development Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
CFDA Number(s): 12.420
Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:
Agency Code: DOD-AMRAA
Agency Name: Department of Defense
Dept. of the Army — USAMRAA
Posted Date: May 31, 2019
Close Date: Oct 01, 2019
Last Updated Date: May 31, 2019
Award Ceiling: $0
Award Floor: $0
Estimated Total Program Funding: $5,760,000
Expected Number of Awards: 9
Description: The FY19 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 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. The anticipated direct costs budgeted for the entire period of performance for an FY19 KCRP Idea Development Award will not exceed $400,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. This funding opportunity is open to applications with eligible EIs and ECIs named as the Principal Investigator (PI). The FY19 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 KCRP defines the ECI as being less than 10 years from completing a terminal degree (doctorate or any medical degree), excluding time spent in medical residency or family medical leave. 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. A Career Guide is required, and a Career Development Plan is required to be submitted (by ECIs only). 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 FY19 KCRP Areas of Emphasis. • Personnel: Personnel are considered a crucial element of the FY19 KCRP Idea Development Award. The application should demonstrate the investigators’ expertise in kidney cancer through the PI’s background, the research team, or through collaboration. Collaborations should be documented. o An EI should be 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 expertise 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. o An ECI should be an independent investigator at the level of Assistant Professor, Instructor, or Assistant Research Professor (or equivalent) and be less than 10 years from completing his/her 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 his/her biographical sketch. 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. 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 FY19 KCRP priorities. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The CDMRP expects to allot approximately $5.76M to fund approximately nine 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 FY19 funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025. Awards will be made no later than September 30, 2020. For additional information, refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. An assistance agreement (grant or cooperative 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. 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 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. Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Applications that involve recruitment of human subjects must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subjects recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. Clinical trials are not allowed. New FY19 definition: A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active duty military patient populations and/or DoD resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Access to target active duty military patient population(s) and/or DoD resource(s) or database(s) should be confirmed by including a letter of support, signed by the lowest-ranking person with approval authority. If the proposed research involves access to VA patient populations, VA study resources and databases, and/or VA research space and equipment, VA PIs/co-PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA patients, resources, and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for administering the funds, the application should include a letter from the VA ACOS/R&D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research. Access to certain DoD or VA patient populations, resources, or databases may only be obtained by collaboration with a DoD or VA investigator who has a substantial role in the research and may not be available to a non-DoD or non-VA investigator if the resource is restricted to DoD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DoD or non-VA investigator collaborating with the DoD and/or VA. If access cannot be confirmed at the time of application submission, the Government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s). Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRMC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled “Research Involving Animals.” Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information. The CDMRP intends that information, data, and research resources generated under awards funded by this Program Announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K.
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