DoD Prostate Cancer Research Department Grant: Idea Development Award

• Innovation: Research deemed innovative may represent a new paradigm, challenge current paradigms, look at existing problems from new perspectives, leverage unique study populations, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative. Multidisciplinary projects are especially encouraged.

• Impact: Applications are required to address and provide a solution to one or more of the PCRP Overarching Challenges. The potential impact of the research, both short-term and long-term, in addressing the PCRP Overarching Challenge(s) should be clearly described. High-impact research will, if successful, significantly advance prostate cancer research and/or patient care.

• Preliminary Data: 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 Any unpublished, preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team. Regardless of whether preliminary data is included or not, applications should be based on a sound scientific rationale that is established through logical reasoning and/or critical review and analysis of the literature.

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 and epidemiological studies; incorporation of experiments to assess clinical relevance and translatability of findings; and validation in patient cohorts. As such, the PCRP-funded Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org) and/or the North Carolina – Louisiana Prostate Cancer Project (PCaP) (https://pcap.bioinf.unc.edu) are important resources to consider if retrospectively collected human anatomical substances or correlated clinical 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 research ideas from investigators in the early stages of their careers. The New Investigator category of this award mechanism is designed to allow applications naming PIs early in their faculty appointments, or in the process of developing independent research careers, to compete for funding separately from Established Investigators. All New Investigator applicants must meet specific eligibility criteria as described in Section II.C, Eligibility Information. 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.

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 FY18 PCRP Impact Award (Funding Opportunity Number: W81XWH-18-PCRP-IA).

The anticipated direct costs budgeted for the entire period of performance for an FY18 Idea Development Award will not exceed $600,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Extramural Organizations: An assistance agreement (grant or cooperative 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. 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 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.