DoD Prostate Cancer Idea Development Award

Description

The PCRP Idea Development Award mechanism was first offered in FY97. Since then, 9,389 Idea Development Award applications have been received, and 1,199 have been recommended for funding. The anticipated direct costs budgeted for the entire period of performance for an FY17 PCRP Ideal Development Award will not exceed $375,000 for an award under the New Investigator category, $600,000 for an award under the Established Investigator category, or $1M for an award under the Established Investigator – Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The Idea Development Award supports new ideas that represent innovative approaches to prostate cancer research and have the potential to make an important contribution to the PCRP mission. Although groundbreaking research often involves a degree of risk, applications should be based on a sound scientific rationale that is established through logical reasoning and/or critical review and analysis of the literature. Due to this award’s emphasis on innovation, the presentation of preliminary data relevant to prostate cancer and the proposed project is encouraged, but not required. Any unpublished, preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team. Research deemed innovative may represent a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative. The PCRP seeks applications from investigators from a spectrum of disciplines including, but not limited to, basic science, engineering, bioinformatics, population science, psycho-oncology, translational research, and clinical research. In addition, applicants are expected to address at least one of the PCRP Focus Areas and are highly encouraged to address one of the PCRP Overarching Challenges. If the proposed project does not address any of the Overarching Challenges, the application should describe how the project will nevertheless address a critical need in the field of prostate cancer research and/or patient care. The Idea Development Award also emphasizes the potential impact, both short-term and long-term, of the research project on prostate cancer research and/or patient care. To maximize the potential for impact, investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of preclinical animal experiments; incorporation of experiments to assess clinical relevance and translatability of findings. As such, the PCRP-funded Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org) and/or the North Carolina – Louisiana Prostate Cancer Project (PCaP) (http://www.ncla-pcap.org) are important resources to consider if retrospectively collected human anatomical substances or correlated data are critical to the proposed studies. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and that apply state-of-the art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. New Investigator Category: The Idea Development Award mechanism encourages applications from investigators in the early stages of their careers. The New Investigator category of this award mechanism is designed to allow applicants early in their faculty appointments, or in the process of developing independent research careers, to compete for funding separately from Established Investigators. PIs using the New Investigator category are required to include a collaborator (or collaborators), appropriate to the application, who has experience in prostate cancer research as demonstrated by a record of funding and publications in prostate cancer research. It is the responsibility of the PI to describe how the collaboration(s) will augment his or her expertise to best address the research question. All New Investigator applicants must meet specific eligibility criteria as described in Section II.C, Eligibility Information. PIs employing the New Investigator category are not eligible to apply for the Partnering PI Option. Established Investigator – Partnering PI Option: The Idea Development Award offers a Partnering PI Option with a higher level of funding to support synergistic partnerships among Established Investigators. The Partnering PI Option is structured to accommodate up to a total of three PIs. One member of the team will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with the application. The other PI(s) will be referred to as the Partnering PI(s). Initiating and Partnering PIs each have different submission requirements as described in Section II.D.2, Content and Form of the Application Submission; however, all PIs should contribute significantly to the development of the proposed research project. If recommended for funding, each PI will receive his or her own award. To justify the higher funding level, the research project must be supported by the unique expertise, experience, and abilities of each PI, and it must clearly define the synergistic components that will facilitate and accelerate progress in a way that could not be accomplished through independent efforts. Multidisciplinary projects are encouraged, particularly those that incorporate population science, and multi-institutional projects are allowed. Each proposed study must include a clearly stated plan for interactions among all PIs and organizations involved. The plan 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. While the Partnering PI Option places primary focus on the synergy between established investigators, it is also important that younger investigators be integrated into the research project to help foster their future in prostate cancer research; therefore, all applications submitted under the Partnering PI Option must include support for at least one postdoctoral fellow, who is expected to be integrally involved in the project. Involvement of the postdoctoral fellow is expected to include (but not be limited to) data acquisition and interpretation, as well as dissemination of the research findings through conference presentations and preparation of manuscripts. Research involving human subjects is permitted under this funding opportunity, but is restricted to studies without clinical trials. Correlative studies associated with an existing clinical trial are particularly encouraged, provided that they are determined to be no greater than minimal risk by the Institutional Review Board (IRB) of record and the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO). A clinical trial is defined as a prospective accrual of patients where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction. PIs seeking funding for a clinical trial are encouraged to consider submitting an application to the FY17 PCRP Impact Award. Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All Department of Defense (DoD)-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRMC ORP, HRPO prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application. Submission to HRPO of protocols covering more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol as DoD-supported research and may include extensive modifications to meet DoD human subjects protection requirements. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page ( https://ebrap.org/eBRAP/public/Program.htm) for additional information. Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRMC ORP 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. Specific documents relating to the use of animals in the

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