DoD Prostate Cancer, Early Investigator Research Award

Description

FY23 PCRP Early Investigator Research Award supports prostate cancer-focused research opportunities for individuals in the early stages of their careers under the guidance of one or more designated mentors. This opportunity allows early-career investigators to develop a research project, investigate a problem or question in prostate cancer research, and further their intellectual development as prostate cancer researchers of the future. All application components for the FY23 PCRP Early Investigator Research Award are to be written by the Principal Investigator (PI), with appropriate direction from the mentor(s).Key elements of this award mechanism are as follows:• Principal Investigator: The postdoctoral investigator is considered the PI of the application and must exhibit strong potential for and commitment to pursuing a career as an investigator at the forefront of prostate cancer research; however, the PI is not required to have previous prostate cancer research experience. The PI must have 3 years or less of postdoctoral research experience (excluding clinical residency or clinical fellowship training) as of March 31, 2024. The PCRP strongly encourages applications from PIs who demonstrate a commitment to pursuing a career focused on prostate cancer health disparity research.• Mentor(s): Applications must include at least one mentor appropriate to the proposed research project who has experience in prostate cancer research and mentoring as demonstrated by a record of active funding, recent publications, and successful mentorship. The primary mentor can be a junior faculty member, in which case the PI is encouraged to include a secondary mentor with a more robust track record in prostate cancer research and mentorship. Applications that focus on prostate cancer health disparity should include at least one mentor with experience in prostate cancer health disparity research. The selected mentor(s) should also demonstrate a clear commitment to the development of the PI toward independence as a prostate cancer researcher.• Research Approach: Proposed research ideas are required to address one or more of the FY23 PCRP Overarching Challenges. Projects that specifically address the FY23 PCRP Overarching Challenge to advance health equity and reduce disparities in prostate cancer are strongly encouraged. The scientific rationale and experimental methodology should demonstrate in-depth analysis of the research problem presented. 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. Inclusion of preliminary data relevant to prostate cancer and the proposed project is encouraged but not required. Any preliminary data provided should be from the PI, mentor(s), or member(s) of the collaborating team. Additionally, required resources should be identified and supported through documentation. Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.• Researcher Development Plan: The PI must outline an individualized, prostate cancer-focused researcher development plan, which should include a clearly articulated strategy for acquiring the necessary skills, competence, and expertise that will enable the PI to successfully complete the proposed research project and foster the PI’s development as an independent prostate cancer researcher. An environment appropriate to the proposed mentoring and research project must be clearly described, although any deficiencies of resources and/or mentorship at the PI’s institution can be mitigated through collaboration(s) with other institutions. If the PI will be utilizing resources at another institution to successfully complete the proposed project, then the PI is strongly encouraged to designate a co-mentor at the collaborating institution.Investigators are strongly encouraged to incorporate the following components into their study design, where appropriate, in order to maximize the potential impact of the proposed research project: authentication of proposed cell lines; statistical rigor of preclinical animal experiments; and incorporation of experiments to assess clinical relevance and translatability of findings. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and apply state-of-the-art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. Investigators are highly encouraged to provide a letter of support indicating access to and the availability of any resources required to support the study.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 PCRP 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 PCRP Early Investigator Research Award should not exceed $300,000. 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 $7.2M to fund approximately 15 FY23 PCRP Early Investigator Research 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 research encompasses research with patient sam

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