DoD Kidney Cancer, Translational Research Partnership Award

The FY23 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 (bench to bedside and/or bedside to bench). 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 two PIs. 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 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.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 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 FY23 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 11, 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 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 anticipated direct costs budgeted for the entire period of performance for an FY23 KCRP Translational Research Partnership Award should 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, 2024. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $6.0M to fund approximately five 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 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 Translational Research Partnership 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 Instructions, 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.