Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

The FY24 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 FY24 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 comentorship 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. 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, addresses the FY24 KCRP strategic priorities and/or 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: 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, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/CongressionalTestimonies/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/or their Families. 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 program announcement. 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. 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 Postdoctoral and Clinical Fellowship Award should not exceed $195,000. 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 $2.18M to fund approximately seven Postdoctoral and Clinical Fellowship 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.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org