OpportunityTitle: DoD Prostate Cancer Impact Award
Description: The PCRP Impact Award mechanism was first offered in FY10. Since then, 213 Impact Award applications have been received, and 30 have been recommended for funding. The anticipated direct costs budgeted for the entire period of performance for an FY17 PCRP IA award will not exceed $750,000 for a Single PI and will not exceed $2M for a Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The Impact Award encourages applications that support the full spectrum of research projects or ideas that specifically focus on scientific and clinical prostate cancer issues, which, if successfully addressed, have the potential to make a major impact in eliminating death from prostate cancer and enhancing the well-being of men experiencing the impact of the disease. The critical components of this award mechanism are: Impact: The Impact Award is intended to support research that demonstrates the potential to have a major impact on an area of paramount importance in prostate cancer. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly describe the potential impact of the proposed study on prostate cancer and to convey its level of significance. Applicants are highly encouraged to address one of the PCRP Overarching Challenges and are expected to address at least one of the PCRP Focus Areas. 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. Proposed projects may include basic, translational, or clinical research, including clinical trials, but must demonstrate clinical relevance. The potential impact of the proposed research is expected to be near-term and it must be significant and go beyond an incremental advance. 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. As such, the PCRP-funded Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org) and/or the North Carolina &#8211; 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. Research Scope: 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, including clinical trials. Only small-scale (i.e., up to and including Phase II or equivalent) clinical trials are allowed. Investigators proposing a clinical trial are highly encouraged to consider leveraging the PCRP Prostate Cancer Clinical Trials Consortium (PCCTC) (http://pcctc.org/) to facilitate the rapid initiation and completion of the trial. Projects that incorporate population science-based approaches are particularly encouraged. Applications must include preliminary data to support feasibility of the study. Any unpublished, preliminary data provided should originate from the laboratory of the PI or a member(s) of the research team. Partnering PI Option: The Impact Award mechanism offers a Partnering PI Option with a higher level of funding to support synergistic partnerships. The Partnering PI Option is structured to accommodate up to three PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI(s) will be identified as a 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. 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 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 U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO) 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 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) &#8220;Funding Opportunities &amp; Forms&#8221; web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. A clinical trial is defined as a prospective accrual of patients (human subjects) in whom an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction. 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 proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled &#8220;Research Involving Animals.&#8221; Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information. 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, S.C., 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 ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines can be found at http://www.elsevier.com/__data/promis_misc/622936arrive_ guidelines.pdf. The CDMRP intends that information, data, and research resources generated under awards funded by this Program Announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. This information should be provided as the Data and Research Resources Sharing Plan as described in Section II.D.2.b, Full Application Submission Content of this Program Announcement. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K. Awards will be made no later than September 30, 2018. For additional information refer to Section II.F.1, Federal Award Notices.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone: 301-682-5507 &lt;br/&gt;Email: help@eBRAP.org