DoD Kidney Cancer, Idea Development Award

The FY24 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. Personnel on the proposed team should have a strong background in kidney cancer research.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 Preliminary data may include unpublished or published results from the laboratory of the Principal Investigator (PI) or collaborators named on the application and/or data from the published literature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 FY24 KCRP Focus Areas.Personnel: Personnel are considered a crucial element of the FY24 KCRP Idea Development Award. The application should demonstrate the investigators experience in kidney cancer through the PIs background, the research team, and/or through collaboration. Collaborations should be documented.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.Partnering PI Option: The FY24 KCRP supports collaborative research to bring a new perspective to kidney cancer research and/or facilitate progress in the field by combined efforts. Therefore, the KCRP Idea Development Award mechanism includes a Partnering PI Option, which is structured so that two investigators, each of whom will be designated as a PI and receive a separate award, will work synergistically on a single project. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should collaborate to develop a synergistic project addressing one or more of the FY24 KCRP Idea Development Award Focus Areas. Applications submitted by a mentor and trainee as Initiating PI and Partnering PI do not meet the intent of the Partnering PI Option. Multidisciplinary and multi-organizational projects are allowed. Initiating and Partnering PIs each have different submission requirements, as described in Section II.D.2, Content and Form of the Application Submission; however, both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. It should be clear that both investigators have had an equal level of intellectual input and effort in developing the application. If recommended for funding, each PI will be named to an individual award within the recipient organization.Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and the American public. If the proposed research relies on access to unique 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.Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.(3) Outcomes research and health services research that do not fit under the definition of clinical trial.Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under 46.104(d)(4) of the Common Rule.Organizational-Level Emphasis:The following areas of emphasis are broadly applicable to many CDMRP programs, not just the KCRP. Investigators are encouraged to consider addressing these areas in their applications if doing so is appropriate for their line of research and addresses the FY24 KCRP strategic goals and focus areas described in Section II.A.1 and Section II.A.2.Nuclear Medicine: Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.Women's Health: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women’s health.Metastatic Cancer Task Force: 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, the 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 FY24 KCRP priorities.Rigorous Study Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (https://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.Military Service Involvement: Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and the American public. If the proposed research relies on access to unique 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.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated direct costs budgeted for the entire period of performance for an FY24 KCRP IDA should not exceed $800,000. The anticipated combined direct costs budgeted for the entire period of performance for an FY24 KCRP Idea Development Award Partnering PI Option will not exceed $1.2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards supported with FY24 funds will be made no later than September 30, 2025.The CDMRP expects to allot approximately $18.56M to fund approximately 13 Idea Development Award applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer 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 FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.