OpportunityTitle: DoD Kidney Cancer, Concept Award
Description: The FY19 KCRP Concept Award supports highly innovative, untested, potentially groundbreaking novel concepts in kidney cancer. The Concept Award is not intended to support an incremental progression of an already established research project but, instead, it allows Principal Investigators (PIs) the opportunity to pursue serendipitous observations. Preliminary data are not allowed. This award mechanism supports high-risk studies that have the potential to reveal entirely new avenues for investigation. Applications must describe how the new idea will enhance the existing knowledge of kidney cancer or develop an innovative and novel course of investigation. Research completed through a Concept Award may generate sufficient preliminary data to enable the PI to prepare an application for future research. 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 FY19 KCRP priorities. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the general public. Reviewers will be blinded to the identity of the PI, collaborators, and their organization(s). Due to the blinded nature of the review process, identifying or making references to the PI, collaborator(s), or their organization(s) in the Project Narrative, List of Abbreviations, Acronyms, and Symbols, Impact Statement, or Innovation Statement is prohibited and will result in administrative rejection of the application. Refer to Section II.D.2.b.i, Full Application Guidelines, for more information. The FY19 KCRP Concept Award is designed for preliminary investigations. Researches involving human subjects or specimens must be either exempt under Title 32, Code of Federal Regulations (CFR), Part 219, Section 104(d) (32 CFR 219.104[d]) or eligible for expedited review (32 CFR 219.110 or 21 CFR 56.110). Clinical trials are not allowed under this Program Announcement. Studies that do not qualify for exempt status will be administratively withdrawn. For additional information on clinical research, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. The anticipated direct costs budgeted for the entire period of performance for an FY19 KCRP Concept Award will not exceed $75,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $0.96M to fund approximately 8 Concept 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 FY19 funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025. Awards will be made no later than September 30, 2020. For additional information, refer to Section II.F.1, Federal Award Notices. 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. An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a &#8220;thing of value&#8221; to a &#8220;state, local government,&#8221; or &#8220;other recipient&#8221; 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 &#8220;no substantial involvement&#8221; 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. Research involving human subjects or specimens must be either exempt under 32 CFR 219.104[d] or eligible for expedited review (32 CFR 219.110 or 21 CFR 56.110). Exemption or expedited status is first determined by the Institutional Review Board (IRB) of record. Investigators must review their institutional requirements and guidelines for filing with the IRB for exempt or expedited status. Studies that do not qualify for exempt or expedited status will be administratively withdrawn. Clinical trials are not allowed. New FY19 definition: A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All 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 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. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. 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 as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Applications that involve recruitment of human subjects must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subjects recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. 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. 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.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone:  301-682-5507 &lt;br/&gt;Email:  help@eBRAP.org