DoD Kidney Cancer, Postdoctoral and Clinical Fellowship Award
Department of Defense Dept. of the Army -- USAMRAA
The FY23 KCRP Postdoctoral and Clinical Fellowship Award supports recent doctoral or medical school graduates in pursuit of innovative, high-impact kidney cancer research during their postdoctoral and/or clinical fellowship and allows them to obtain the necessary experience for an independent career as a leader in kidney cancer research. Applicants must demonstrate that the proposed research has high potential to lead to, or make, significant advancements in kidney cancer research and/or patient care. Applicants for this award must also exhibit a strong desire to pursue a career in kidney cancer research, with clear evidence for a researcher development plan that will lead to a successful independent career in kidney cancer.The critical components of this award mechanism are:Impact: Research supported by the FY23 KCRP Postdoctoral and Clinical Fellowship Award will have the potential for a major impact and accelerate progress toward ending kidney cancer. The impact may be short term or long term, but must move beyond an incremental advance. Applications are expected to identify the kidney cancer patients or at-risk individuals who would ultimately benefit from the proposed research.Research Strategy: The research proposed as part of the Postdoctoral and Clinical Fellowship Award must have high potential to lead to or make breakthroughs in kidney cancer. The scope of the research may include innovative, high-risk/high-reward research in the early stages of idea development or research already supported by preliminary data with the potential to make significant advancements toward clinical translation. The research strategy should demonstrate sound rationale, logical reasoning, and, if available, preliminary data. The proposed research should show evidence of rigorous experimental design, sufficient experimental details, appropriate controls, a statistical plan, and consideration of pitfalls and alternatives.Principal Investigator (PI): Under this award mechanism, the postdoctoral or clinical fellow is considered the PI and, as such, is expected to write the project narrative, researcher development plan, and other application components, with appropriate guidance from the mentor. While the PI is not required to have previous experience in kidney cancer research, the proposed project and researcher development plan must focus on kidney cancer. Applications must emphasize the PI’s potential for success in becoming an independent kidney cancer researcher based on their qualifications, achievements/honors (including first-author publications and funding), and letters of recommendation.Mentor: The mentor (or co-mentor, if applicable) must possess the appropriate experience in kidney cancer research and/or patient care, to include recent publications and a record of active funding, and clearly demonstrate a commitment to guiding the PI’s research and development as a researcher. If the mentor is not an experienced kidney cancer researcher, then formal co-mentorship by an established kidney cancer researcher is required. The application must include information about the mentor’s experience in conducting innovative research and how they intend to support the PI’s endeavors in kidney cancer. Mentorship by an investigator without an established record of mentoring pre- and/or postdoctoral trainees may be offset by the overall strength of the researcher development plan.Researcher Development Plan: Applications must provide details on the suitability of the PI’s overall researcher development plan for attaining the goals of this award mechanism. Applications must elaborate on the qualities of the research environment in which the candidate will work, provide details on the individualized kidney cancer-focused researcher development plan, and describe how it will facilitate the PI’s career development as an independent, innovative kidney cancer researcher. A multidisciplinary research approach to kidney cancer is highly encouraged, but not required; however, if there are multidisciplinary aspects, they should be clearly outlined in the application.Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this program announcement.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 Postdoctoral and Clinical Fellowship Award should not exceed $195,000. 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 $1.25M to fund approximately four Postdoctoral and Clinical Fellowship 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 Postdoctoral and Clinical Fellowship 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 approval processes for animal studies. Refer to the General Application 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.
Categories: Science and Technology and other Research and Development.