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W81XWH-17-PCRP-HDRA DoD Prostate Cancer Health Disparity Research Award DOD Dept. of the Army -- USAMRAA

By: Regina Ramazzini

Deadline: Sep 28, 2017

The PCRP Health Disparity Research Award mechanism was first offered in FY01. Since then, 499 Health Disparity Award applications have been received, and 87 have been recommended for funding. The anticipated direct costs budgeted for the entire period of performance for an FY17 PCRP HDRA award will not exceed $450,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The Health Disparity Research Award supports new ideas based on innovative concepts or methodologies for health disparity research with the potential to make an important contribution toward eliminating death from prostate cancer and enhancing the well-being of men impacted by the disease. Studies proposed for this award mechanism are expected to improve the understanding of and/or address factors that contribute to differences in the disease experience across populations, ultimately contributing to eliminating disparities in prostate cancer incidence, morbidity, mortality, and survivorship. Applicants for this award must explicitly state how the proposed research is related to an area of prostate cancer health disparity. The PCRP is interested in research that addresses all different aspects that contribute to health disparity in prostate cancer, including social, cultural, and/or biological contributors. Because of the emphasis on innovation, the inclusion of preliminary data relevant to prostate cancer and the proposed project 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 Any preliminary, unpublished data provided should be from the Principal Investigator (PI) or a member(s) of the research team. 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, provided they are appropriately focused on an issue of prostate cancer health disparity. In addition, all applications are expected to be relevant to one or more of the PCRP Focus Areas and are encouraged to be responsive to one or more of the PCRP Overarching Challenges. If the proposed project does not address one of the Overarching Challenges, the application must describe how the project will nevertheless address a critical disparity-related need in the field of prostate cancer research and/or patient care. The Health Disparity Research Award also emphasizes the potential impact, both short-term and long-term, of the research project in reducing or eliminating prostate cancer health disparities. 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) (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. New Investigators: This award encourages applications from investigators in the early stages of their careers. The New Investigator category is designed to allow PIs, early in their faculty appointments or in the process of developing independent research careers, to compete for funding separately from established investigators. PIs using the New Investigator category are required 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. It is the responsibility of the PI to 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. PIs may choose to incorporate the required collaborator through the Qualified Collaborator Option (described below), provided the collaborator meets the requirements of the Qualified Collaborator Option. All applicants for the New Investigator category must meet specific eligibility criteria, as described in Section II.C, Eligibility Information. The Health Disparity Research Award offers two additional options for consideration for both Established Investigators and New Investigators: 1. Qualified Collaborator Option: The Health Disparity Research Award strongly supports collaborative research involving basic, population science, and clinical researchers; researchers with prostate cancer expertise and those with health disparity expertise; and/or researchers and community organizations that may be critical to the study of populations disproportionately affected by prostate cancer. Although these and other types of collaborations are, in general, strongly encouraged, collaborations that meet specific criteria will qualify for a higher level of funding, as described in Section II.D.5, Funding Restrictions For the application to qualify for a higher level of funding, the PI must submit a Qualified Collaboration Statement that clearly describes the proposed collaborator and collaboration and addresses how each of the criteria below are met. In addition, the collaborator must provide a letter of collaboration describing his/her involvement in the proposed work. It should be clear from both documents that the successful completion of the project depends on the unique skills and contributions of both the PI and the qualified collaborator. The following criteria must be met to use the Qualified Collaborator Option: • The collaborator must significantly contribute to the project such that the proposed work could not be accomplished without his/her involvement. This is expected to include both intellectual input and research resources (e.g., supplies, reagents, equipment, personnel, services, tissue samples, or access to patients or populations). • The collaborator must contribute at least a 10% level of effort to the project. Contribution of the collaborator should be reflected in the application budget. • If the PI does not have experience in prostate cancer research and/or working with disproportionately affected populations, the collaborator must possess such experience. 2. Nested Young Investigator Option: This award also supports the incorporation of young investigators into the research project in order to provide highly motivated predoctoral and postdoctoral scientists experience in prostate cancer health disparity research. The young investigator is not required to have previous health disparity or prostate cancer research experience, but should have a sincere interest in pursuing a career in resolving disparities in prostate cancer incidence, morbidity, mortality, and survivorship. This option primarily provides additional funding to support the salary of the young investigator who will be working on the proposed research project. In addition, an individualized researcher development plan focused in prostate cancer disparities must be described, and the plan should include a clearly articulated strategy for acquiring the necessary skills, competence, and expertise that will enable the young investigator to successfully complete the proposed research project and foster the young investigator’s development as a prostate cancer health disparity researcher. While the application may include multiple predoctoral or postdoctoral researchers to support the project, only one predoctoral or postdoctoral young investigator may be included per application under the Nested Young Investigator Option. Research involving human subjects is permitted under this funding opportunity, but is restricted to studies without clinical trials. Correlative studies associated with an existing clinical trial are particularly encouraged, provided that they are determined to be no greater than minimal risk by the Institutional Review Board (IRB) of record and the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO). 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. PIs seeking funding for a clinical trial are encouraged to consider submitting an application to the FY17 PCRP Impact Award (Funding Opportunity Number: W81XWH-17-PCRP-IA). 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 USAMRMC ORP, 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. 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) “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. 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. Health Disparity Research Resources: Potential applicants for this award are encouraged to seek collaborations and access to appropriate study populations through the following resources: • Congressionally Directed Medical Research Programs: Search the CDMRP awards database at http://cdmrp.army.mil. • The North Carolina – Louisiana Prostate Cancer Project: 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 http://www.ncla-pcap.org/. • The Prostate Cancer Biorepository Network: The PCBN is supported by the PCRP to develop and maintain a multi-institutional prostate cancer biorepository that facilitates the collection, processing, annotation, storage, and distribution of high-quality human prostate cancer biospecimens to be distributed to the prostate cancer research community. The PCBN offers several types of biospecimens that may be useful for health disparity studies. Information on these biospecimens is available at http://www.prostatebiorepository.org. • National Cancer Institute Center to Reduce Cancer Health Disparities (CRCHD): Search for health disparity research and researchers at http://crchd.cancer.gov/index.html. • National Institute on Minority Health and Health Disparities (NIMHD) Community Based Participatory Research (CBPR) Initiative: Contact the NIMHD at http://www.nimhd.nih.gov/programs/extra/cbpr.html for information on current CBPR programs and scientists and communities engaged in health disparity research. • Uniformed Services University of the Health Sciences (USU) Center for Health Disparities: Search for programs and communities engaged in health disparity research at https://www.usuhs.edu/chd. • American Association for Cancer Research, Minorities in Cancer Research (AACR MICR): Search for health disparity research and researchers at http://www.aacr.org/Membership/Pages/Constituency%20Groups/minorities-in-cancer-research___1C81B8.aspx. • 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. • Intercultural Cancer Council (ICC): Search for regional resources and community-based organizations at https://www.interculturalcancercouncil.org/. • Health Resources and Services Administration (HSRA) Office of Minority Health: Search for health disparity programs and funded investigators at https://www.hrsa.gov/index.html. • National Institutes of Health (NIH) Research Portfolio Online Reporting Tool (NIH Reporter): Search for NIH awards at http://projectreporter.nih.gov/reporter.cfm. • Defense Technical Information Center (DTIC): Search for DoD and other Government-funded investigators through DTIC Technical Reports at http://www.dtic.mil/dtic/. • National Library of Medicine, NIH, PubMed: Search for investigators publishing studies on prostate cancer health disparities at http://www.ncbi.nlm.nih.gov/pubmed. • U.S. Department of Education: Search for institutions that may have increased access to disproportionately affected populations at http://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst.html. • 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. • National Coalition for LGBT Health: For more information on programs focused on lesbian, gay, bisexual, and transgendered (LBGT) research, policy, education, and training, search http://www.healthhiv.org/sites-causes/national-coalition-for-lgbt-health/. • National LGBT Cancer Network: To obtain more information, search http://www.cancer-network.org. In addition, PIs are encouraged to interact with 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, Prostate Health Education Network, and international organizations such as the African-Caribbean Cancer Consortium, African Organization for Research and Training in Cancer (AORTIC), Global Prostate Cancer Alliance, Malecare, Men of African Descent and Carcinoma of the Prostate (MADCAP) Consortium, Prostate Cancer Transatlantic Consortium, The Prostate Net, and the Urban League or other organizations that may provide an avenue for collaborations to facilitate applicable studies. 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, 2018.

For additional information refer to Section II.F.1, Federal Award Notices.
CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org


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