The FY21 KCRP Translational Research Partnership Award supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in kidney cancer toward clinical applications. This award supports the development of translational research collaborations between two independent, faculty-level (or equivalent) investigators to address a central problem or question in kidney cancer in a manner that would be less readily achievable through separate efforts. One partner in the collaboration must be a research scientist and the other must be a clinician. It should be clear that both have had equal intellectual input in the design of the research project. Multi-institutional partnerships are encouraged. At least one member of the partnership must have experience either in kidney cancer research or kidney cancer patient care. Inclusion of experts from outside the kidney cancer field is encouraged. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism.
Preliminary data to support the feasibility of the research hypothesis and research approaches are required; however, these data do not necessarily need to be derived from studies of kidney cancer.
Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinician’s firsthand knowledge of patients and anecdotal data. The ultimate goal of translational research is to move a concept or observation forward into clinical application that is relevant to active-duty Service Members, Veterans, other military beneficiaries, and the American public. However, members of the partnership should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between basic and clinical science. There should be an intellectual synergistic partnership between the clinic and the laboratory.
The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.
The Translational Research Partnership Award requires more than one PI. 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 the Partnering PI. 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. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. It is the responsibility of the PIs to describe how their combined expertise will better address the research question and explain why the work should be done together rather than through separate efforts.
The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.
The following are significant features of this award mechanism:
• Partnership: The success of the project should depend on the unique skills and contributions of each partner.
• Translation: The application should provide evidence for the reciprocal transfer of information between basic and clinical science or vice versa in developing and implementing the research plan. Translational research may include correlative studies and/or development of or use of annotated biorepositories. The application should demonstrate how the study will leverage clinical information to address knowledge gaps in resulting outcomes, validate key research findings, expand upon potentially transformative results, and/or investigate novel findings.
• Impact: The proposed research should indicate the potential to have a significant impact on kidney cancer research and/or patient care and have the potential to accelerate the movement of promising ideas (in prevention, diagnosis, detection, prognosis, treatment, and/or survivorship) into clinical applications. Clinical trials are not allowed.
• Feasibility: The application should demonstrate that the investigators have access to the necessary specimens, data, and/or intervention, as applicable.
• Preliminary Data: Unpublished results from the laboratory of the PIs or collaborators named on the application and/or data from the published literature that are relevant to kidney cancer and the proposed research project, are required.
Projects including correlative studies: The FY21 KCRP Translational Research Partnership Award may support correlative studies that are associated with an ongoing or completed clinical trial. The application should demonstrate access to the necessary specimens and/or data of the proposed cohort. Appropriate access must be confirmed at the time of application submission. See Attachment 10, Letter(s) Confirming Access to Specimens and/or Data.
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 FY21 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 anticipated direct costs budgeted for the entire period of performance for an FY21 KCRP Translational Research Partnership Award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.
The CDMRP expects to allot approximately $3.6M to fund approximately three Translational Research Partnership 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.