OpportunityTitle: DoD Prostate Cancer, Health Disparity Research Award
Description: The FY21 PCRP 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. Applications for this award are encouraged to be relevant to one or more of the FY21 PCRP Health Disparity Research Award Focus Areas and must explicitly state how the proposed research is related to the selected focus area(s). If the proposed project does not address one of the FY21 PCRP Health Disparity Research Award Focus Areas, the application must provide a description to justify how the project will nevertheless address a critical disparity-related need within the context of the FY21 PCRP Overarching Challenges. Applications are encouraged from a spectrum of disciplines, including but not limited to basic science, engineering, bioinformatics, population science, psycho-oncology, translational research, health care services.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 Health Disparity Research 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 FY21 PCRP Health Disparity Research Award is expected to have the potential to make a significant impact in addressing prostate cancer health disparities within the context of the FY21 PCRP Overarching Challenges. 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&#8217;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. 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. Only small-scale, early (i.e., up to and including phase 2 or equivalent) clinical trials are allowed. Investigators proposing a clinical trial are highly encouraged to consider leveraging the PCRP Prostate Cancer Clinical Trials Consortium (http://pcctc.org/) to facilitate the rapid initiation and completion of the trial. 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.Projects that are investigating the biological basis of health disparity within one or more populations are encouraged to carefully consider the proposed research methods. The application should especially consider the impact of stratifying populations by either (1) genetic and/or genomic classification of the population(s) or (2) self-reported race, and ensure that the application justifies the selected approach. Applications must include a robust statistical plan with complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study.Investigators are strongly encouraged to incorporate the following components into their study design, where appropriate, in order to maximize the potential impact of the proposed research project: authentication of proposed cell lines; statistical rigor of preclinical animal experiments; and incorporation of experiments to assess clinical relevance and translatability of findings. Investigators are highly encouraged to provide a letter of support indicating access to and the availability of any resources required to support the study.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 applicant organizations to name PIs who are early in their faculty appointments or in the process of developing independent research careers. Applications submitted to the New Investigator category will be assessed using different review criteria for personnel (refer to Section II.E.1.a., Peer Review), and are required to include a collaborator (or collaborators) who has (have) 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&#8217;s expertise to better address the research question. In addition, applicants are strongly encouraged to provide a letter of collaboration from the collaborator(s) describing the collaborator(s) involvement in the proposed work. All applicants for the New Investigator category must meet specific eligibility criteria described in Section II.C, Eligibility Information.The types of awards made under the program announcement will be assistance agreements. An assistance 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. 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. 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, but is not limited to, 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.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, the 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 FY20 PCRP prioritiesThe proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military families, and the American public.The anticipated direct costs budgeted for the entire period of performance for an FY20 PCRP Health Disparity Research Award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $10.8M to fund approximately nine FY21 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.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 Development Command (USAMRDC) Office of ResearchProtections (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. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview 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.If the proposed research is cooperative (i.e., involving more than one institution), a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Clinical research is defined as: (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.A clinical trial is defined as 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. Funded trials are required to post a copy of the IRB-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in Code of Federal Regulations, Title 32, Part 219 (32 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 or VA 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. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.Research Involving Animals: All DOD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC 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. Allow at least 3 to 4 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 SC, et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature, 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.Health Disparity Research Resources: Potential applicants for this award are encouraged to seek collaborations and access to appropriate study populations through the following (or similar) resources:&#8226; CDMRP: Search the CDMRP awards database at https://cdmrp.army.mil.&#8226; The North Carolina &#8211; Louisiana Prostate Cancer Project (PCaP): The PCaP was supported by the PCRP to conduct prostate cancer health disparity studies and developed a large biorepository of health disparity-related epidemiological data and biospecimens that may be requested for use by the research community. Information on PCaP investigators, data, and specimens is available at https://pcap.bioinf.unc.edu.&#8226; National Cancer Institute Center to Reduce Cancer Health Disparities: Search for health disparity research and researchers at https://crchd.cancer.gov/index.html.&#8226; National Institute on Minority Health and Health Disparities (NIMHD) Community-Based Participatory Research (CBPR) Initiative: Contact the NIMHD at https://www.nimhd.nih.gov/programs/extramural/community-based-participatory.html for information on current CBPR programs and scientists and communities engaged in health disparity research.&#8226; Uniformed Services University of the Health Sciences Center for Health Disparities: Search for programs and communities engaged in health disparity research at https://www.usuhs.edu/chd.&#8226; Cancer Prevention and Control Research Network (CPCRN): Contact the CPCRN at http://cpcrn.org/ for information on community participatory research to reduce cancer in disproportionately affected populations.&#8226; Health Resources and Services Administration, Office of Minority Health: Search for health disparity programs and funded investigators at https://www.hrsa.gov/index.html.&#8226; National Institutes of Health (NIH) Research Portfolio Online Reporting Tool (NIH RePORTER): Search for NIH awards at https://projectreporter.nih.gov/reporter.cfm.&#8226; Defense Technical Information Center (DTIC): Search for DOD and other government-funded investigators through DTIC Technical Reports at https://discover.dtic.mil/.&#8226; National Library of Medicine, NIH, PubMed: Search for investigators publishing studies on prostate cancer health disparities at https://www.ncbi.nlm.nih.gov/pubmed.&#8226; U.S. Department of Education: Search for institutions that may have increased access to disproportionately affected populations at https://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst.html.&#8226; International Cancer Research Partnership: Search for investigators and studies relevant to health disparity that are supported by cancer research funders from several countries including the United States, European Union, United Kingdom, and Canada at https://www.icrpartnership.org.&#8226; National Coalition for LGBT Health: For more information on programs focused on Lesbian, Gay, Bisexual, and Transgender (LGBT) research, policy, education, and training, search http://www.healthlgbt.org.&#8226; National LGBT Cancer Network: To obtain more information, search https://www.cancer-network.org.In addition, applicants are encouraged to interact with community or advocacy organizations, as applicable to their proposed studies, such as the American Indian Health Care Association, National African American Outreach Program of the Patient Advocate Foundation, National Alliance for Hispanic Health, National Medical Association, National Rural Health Association, and Prostate Health Education Network, as well as international organizations such as the African-Caribbean Cancer Consortium, African Organization for Research and Training in Cancer, Europa Uomo, European Cancer Patient Coalition, Global Prostate Cancer Alliance, Malecare, Men of African Descent and Carcinoma of the Prostate Consortium, Prostate Cancer Transatlantic Consortium, The Prostate Net, and the Urban League.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone: 301-682-5507 &lt;br/&gt;Email: Help@eBRAP.org