DoD Prostate Cancer, Health Disparity Research Award

The summary for the DoD Prostate Cancer, Health Disparity Research Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.

DoD Prostate Cancer, Health Disparity Research Award: The Health Disparity Research Award supports promising research ideas that have high potential to make a significant impact in eliminating disparities in prostate cancer incidence, morbidity, mortality, and survivorship. Definitions of Health Disparity: The PCRP is interested in research that addresses all different aspects that contribute to health disparity in prostate cancer, including, but not limited to: • Access to health care, which may stem from geographic location, socioeconomic status, or other factors. • Social and cultural factors that may influence patient decisions related to screening and treatment. This could include the role of social/support networks, community influence, cultural or religious practices, psychological health, etc. • Environmental factors that may cause endogenous changes, such as environmental exposures, dietary factors, and other external factors that may contribute to prostate cancer disparities in specific populations. • Biological contributors, such as genetic differences, that can be associated with disparate outcomes in patient populations. It is the responsibility of the applicant to clearly and explicitly describe the area of health disparity that the research proposal aims to address. Community Engagement: Investigators are highly encouraged to engage members of the targeted population or community in the development and implementation of their research project, where appropriate. A comprehensive, but by no means exhaustive, list of health disparity research resources and community or advocacy organizations is provided at the end of the HDRA Award Information section. Applications that involve and utilize population- or community-based organizations to support their research project should demonstrate the level of involvement in letters of support for the application. Impact: Research supported by the Health Disparity Research Award is expected to have the potential to make a significant impact in addressing prostate cancer health disparities. Research with a high degree of innovation is anticipated to have a higher potential for significant impact. Applications must also include a detailed transition plan that articulates the pathway to moving the project's findings to the next phase of development after successful completion of the award, and continue advancing the research toward making a clinical impact, even if clinical impact is not an immediate outcome. Research Scope: Proposed projects may include basic, translational, or clinical research, including clinical trials. Investigators from a spectrum of disciplines, including but not limited to basic science, engineering, bioinformatics, population science, psycho-oncology, translational research, health care services, and clinical research, are encouraged to submit applications, provided they are appropriately focused on an issue of prostate cancer health disparity. Only small-scale, early (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. The inclusion of preliminary data is encouraged but not required. Any preliminary, unpublished data provided should be from the Principal Investigator (PI) or a member(s) of the research team. 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. 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) (https://pcap.bioinf.unc.edu) 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 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: This award encourages research ideas from investigators in the early stages of their careers. The New Investigator category is designed to allow applications naming PIs who are early in their faculty appointments or in the process of developing independent research careers to compete for funding separately from Established Investigators. Applications naming PIs using the New Investigator category are expected to include a collaborator (or collaborators) appropriate to the application who has experience in prostate cancer health disparity research, as demonstrated by a record of funding and publications. The application must describe the potential of the collaboration(s) to be successful and how the collaboration(s) will augment the PI's expertise to better address the research question. All applicants for the New Investigator category must meet specific eligibility criteria, as described in Section II.C, Eligibility Information. 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 PCRP priorities. 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 FY19 PCRP Health Disparity Research Award will not exceed $600,000 for an award under the New Investigator category or $750,000 for an award under the Established Investigator category. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $9.84M to fund approximately four New Investigator category and five Established Investigator category Health Disparity Research 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 “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. 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 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. 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) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. The applicant conducting the trial must post an informed consent form used to enroll subjects on a publicly available Federal website in accordance with Federal requirements (Code of Federal Regulations, Title 49, Part 219 [49 CFR 219]). Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active duty military patient populations and/or DoD resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Access to target active duty military patient population(s) and/or DoD resource(s) or database(s) should be confirmed by including a letter of support, signed by the lowest-ranking person with approval authority. If the proposed research involves access to VA patient populations, VA study resources and databases, and/or VA research space and equipment, VA PIs/co-PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA patients, resources, and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for administering the funds, the application should include a letter from the VA ACOS/R&D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research. Access to certain DoD or VA patient populations, resources, or databases may only be obtained by collaboration with a DoD or VA investigator who has a substantial role in the research and may not be available to a non-DoD or non-VA investigator if the resource is restricted to DoD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DoD or non-VA investigator collaborating with the DoD and/or VA. If access cannot be confirmed at the time of application submission, the Government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s). Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information.