DoD Prostate Cancer, Health Disparity Research Award

The FY23 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 FY23 PCRP Health Disparity Research Award Focus Areas and must explicitly state how the proposed research is related to the selected Focus Areas(s). If the proposed project does not address one of the FY23 PCRP Health Disparity Research Award Focus Areas, the application must provide a description to justify how the project will nevertheless address another critical area believed to contribute to prostate cancer health disparities within the context of the FY23 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, implementation science, and 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 FY23 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 FY23 PCRP Overarching Challenges. Research with a high degree of innovation is anticipated to have a higher potential for significant impact. The impact of the proposed research may include an improved understanding of factors contributing to health disparities or provide advancements that will reduce disparities in prostate cancer incidence, morbidity, mortality, and/or survivorship. Applications must also include a detailed research 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 transition plans are encouraged to consider not just the pathway to developing tangible products (e.g., drugs or diagnostic assays) into clinical testing, but also the implementation of research findings and other evidence-based practices into clinical practice and patient communities.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 a placebo or another 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. The PCRP strongly encourages applications proposing implementation science research that will improve the understanding and translation of research findings and other evidence-based practices into clinical practice and patient communities with respect to addressing prostate cancer health disparities.Projects proposing to investigate 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’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.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 FY23 PCRP priorities.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 types of awards made under the program announcement will be assistance agreements. An assistance 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. 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 “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, 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.The anticipated direct costs budgeted for the entire period of performance for an FY23 PCRP Health Disparity Research Award should not exceed $900,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $11.52M to fund approximately eight FY23 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 FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.Research Involving Human Data, Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data, human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), 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 application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web page https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo for additional information.As of January 20, 2020, U.S. institutions engaged in non-exempt cooperative research must rely on a single IRB to review and approve the portion of the research conducted at domestic sites in accordance with Code of Federal Regulations, Title 45, Part 46.114(b) (45 CFR 46.114[b]). If the proposed, non-exempt research involves more than one U.S.-based 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 encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies. (2) Epidemiologic and behavioral studies that do not seek to study the safety, effectiveness, and/or efficacy outcomes of an intervention. (3) Outcomes research and health services research that do not fit under the definition of clinical trial. Excluded from the definition of clinical research are in vitro studies that utilize human tissues that cannot be linked to a living individual.Note: Studies that meet the requirements for exemption under §46.104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required.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 a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military and/or VA 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.
Categories: Science and Technology and other Research and Development.