DoD Kidney Cancer, Idea Development Award

The FY23 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 Preliminary data may include unpublished or published results from the laboratory of the PI or collaborators named on the application and/or data from the published literature relevant to kidney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 FY23 KCRP Focus Areas. Personnel: Personnel are considered a crucial element of the FY23 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.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.• NEW for FY23 – Partnering PI Option: The FY23 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 FY23 KCRP Idea Development Award Focus Areas or another critical problem, question, or need in kidney cancer. 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. Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.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. 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 FY23 KCRP priorities.Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military families, and the American public.The combined anticipated direct costs budgeted for the entire period of performance for an FY23 KCRP Idea Development Award should not exceed $800,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The anticipated direct costs budgeted for the entire period of performance for an FY23 KCRP Idea Development Award – Partnering PI Option will not exceed $1,200,000.Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $17.28M to fund approximately 11 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 FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.Research Involving Human Data, Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data, human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), 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 application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web page https://mrdc.health.mil/index.cfm/ collaborate/research_protections/hrpo for additional information. As of January 20, 2020, U.S. institutions engaged in non-exempt cooperative research must rely on a single IRB to review and approve the portion of the research conducted at domestic sites in accordance with Code of Federal Regulations, Title 45, Part 46.114(b) (45 CFR 46.114[b]). If the proposed, non-exempt research involves more than one U.S.-based institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Clinical trials are not allowed. A clinical trial is defined 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.Clinical research encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research 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 study 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 tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under §46.104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required.Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military and/or VA patient populations and/or DOD or VA 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. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.Research Involving Animals: All research funded by the FY23 KCRP Idea Development Award involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO 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. Allow at least 3 to 4 months for ACURO regulatory review and Appendix 1, for additional information.Guidelines for Animal Research: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in Landis, SC, et al. A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (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. Applicants should consult the Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines 2.0 to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.
Categories: Science and Technology and other Research and Development.