DoD Ovarian Cancer Pilot Award

Description

The OCRP Pilot Award supports the exploration of innovative concepts or theories in ovarian cancer that could ultimately lead to critical discoveries or major advancements that will drive the field forward. The proposed research must demonstrate a clear focus on ovarian cancer (e.g., using tissues, cell lines, datasets, or appropriate animal models). The proposed research should include a testable hypothesis based on strong scientific rationale and serve as a catalyst to expand or modify current thinking about and/or approaches in ovarian cancer. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The anticipated direct costs budgeted for the entire period of performance for an FY18 OCRP Pilot Award will not exceed $250,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. Inclusion of preliminary data is not required, but allowed. The strength of the application should be based on sound scientific rationale and logical reasoning. The outcome of research supported by this award should be the generation of robust preliminary data that can be used as a foundation for future research projects. Clinical trials will not be supported by this award mechanism. 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. Innovation is the most important review criterion. Innovative ideas or approaches, if proven correct, will provide new paradigms or insights or technologies or applications that have the potential to meet the OCRP mission of supporting patient-centered research to prevent, detect, treat, and cure ovarian cancer. The following list, although not all-inclusive, provides examples of research that is not innovative: • Exploring a previously tested hypothesis in a different cell line or in a new population • Using a published series of in vitro assays to further characterize a model system • Incorporating known biomarkers into in vivo or clinical models of ovarian cancer • Investigating the next logical step or continuation of a previous research project • Proposing work that is an incremental advancement of published data Research involving cell lines, animal models, human subjects, and human anatomical substances is permitted; however, this award may not be used to conduct clinical trials. Information on clinical trials and phases/classes of study is provided in the “Human Subject Resource Document” available for download from the electronic Biomedical Research Application Portal (eBRAP) at https://ebrap.org/eBRAP/public/Program.htm. 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 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 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 “Research Involving Animals.” 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. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. 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. 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. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K. Awards will be made no later than September 30, 2019. For additional information refer to Section II.F.1, Federal Award Notices.

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