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The PRCRP is seeking to advance cancer research through development of early-career investigators. This funding opportunity requests application for the Career Development Award – Scholar Option (also known as the Virtual Cancer Center Scholar Option. The Career Development Award – Fellow Option is not being offered at this time). Under this award mechanism, the early-career investigator is considered the Principal Investigator (PI), and the application should focus on the PI’s research and career development. Preliminary data are not required. However, logical reasoning and a sound scientific rationale for the proposed research must be demonstrated. This award supports impactful research projects with an emphasis on discovery. Scholar Option: Supports an independent, highly accomplished early-career investigator (referred to as a Scholar) to conduct impactful research under the guidance of an experienced cancer researcher (i.e., Career Guide). Scholars will commit to participate in the FY20 PRCRP Virtual Cancer Center (VCC) (CSVCC – Convergent Science Virtual Cancer Center). The unique, interactive VCC focuses on fostering the next generation of cancer researchers. This award provides intensive mentoring, national networking, and a peer group for junior faculty. Scholars are required to interact with the VCC Director, Deputy Director, and other Scholars in addition to their Career Guide. The intention of the Scholar Option is to support the highly accomplished investigator toward the goal of leadership in cancer. The critical components of the Career Development Award – Scholar Option: · Principal Investigator: The PI must be an early-career researcher or physician-scientist within 7 years after completion of their terminal degree by the time of the application deadline (excluding time spent in residency, clinical training, or on family medical leave). Time spent as a postdoctoral fellow is not excluded. Postdoctoral fellows are not eligible for this award mechanism. The PI’s record of accomplishments and the proposed research will be evaluated regarding their potential for contributing to at least one of the FY22 PRCRP Topic Areas in Section II.A.1. The Scholar must be in a tenure-track position or equivalent position. The Scholar must demonstrate significant accomplishments, including first-author publications, extramural funding, and show excellence in cancer research as supported by letters of recommendation. The Scholar must have independent laboratory space separate from the Career Guide’s laboratory or other mentor’s laboratory. The Scholar and Career Guide are required to attend a biennial multi-day VCC workshop and, in alternate years, a 1 day VCC workshop. For more information on the eligibility criteria for the Virtual Cancer Center Scholar Option, refer to Section II.C.1. · Career Guide: The Scholar must designate a Career Guide. The Career Guide must be an experienced cancer researcher, as demonstrated by a strong record of funding and publications. In addition, the Career Guide must demonstrate a commitment to advancing the PI’s career in cancer research. The Career Guide for applications submitted to the Career Development Award – Scholar Option (CDA-SO) must also be committed to fully participating in the VCC and potentially serving on the VCC’s Advisory Board as requested by VCC Leadership. · Career Development Plan: A career development plan is required and should be prepared with appropriate guidance from the Career Guide. The career development plan should include a clearly articulated strategy for acquiring the necessary skills, competence, further independence, and expertise to advance their career at the forefront of cancer research in at least one of the FY22 PRCRP Topic Areas. The Scholar must show career milestones and pathways toward achieving the milestones. The Scholar should demonstrate clear commitment to at least one of the FY22 PRCRP Topic Areas through a career development plan designed to enhance further networking and collaboration. The Scholar must also articulate interaction with the VCC. · Impact: The applicant must articulate the potential impact the proposed work will have on cancer research and/or patient care. Impactful research will accelerate the movement of promising ideas in cancer research into clinical applications. · Preliminary data are not required. Any preliminary data included in the application is subject to evaluation and review. Research proposed should be based on strong scientific reasoning and relevant literature.

The intent of the FY23 ERP RPA is to create an avenue to support new or existing collaborative research partnerships between/among investigators to address a research problem or question in a manner that would be unachievable through separate efforts. It is expected that investigators will utilize their distinct but complementary perspectives to synergistically address a central problem or question critical to PTE research and those living with PTE, their families, and/or their care partners.

Initially created in FY09, the OCRP Ovarian Cancer Academy Award mechanism is a unique, interactive virtual academy providing intensive mentoring, national networking, collaborations, and a peer group for junior faculty. The overarching goal of the Ovarian Cancer Academy (OCA) is to develop successful, highly productive ovarian cancer researchers in a collaborative research and career development environment.The OCA is a virtual career development and research training platform that consists of Early-Career Investigators (ECIs), their Designated Mentors from different institutions, and an Academy Dean and Assistant Dean. The OCRP Ovarian Cancer Academy – Early-Career Investigator Award is not a traditional career development award; the ECI is expected to participate in monthly webinars and annual workshops and to communicate and collaborate with other members of the Academy (other ECIs, Mentors, Dean, Assistant Dean) as well as with the advocacy community. Since its inception, the Academy’s ECIs have presented at and chaired sessions for ovarian cancer-specific symposia and served on symposia review committees. They have also served as peer reviewers for the Department of Defense (DOD) OCRP and other funding agencies.

The TDA is intended to improve diagnosis now. Proposed projects must build knowledge, capacity, and research to reduce important barriers to obtaining a diagnosis, meaningful disease monitoring, and accurate prognosis. Barriers could include but are not limited to cost, patient access and education, clinical implementation, relationship to clinical outcome measures, biomarker validation, diagnosis technologies, lack of longitudinal data to inform prediction/prognosis, health equity barriers including structural and social determinants of health, and more. The investigator must clearly attune their project to provide true benefit to the intended end user – the person with dementia and their families.Key elements of this mechanism are:• Near term applicability: To meet the intent of this mechanism, applications should be focused on addressing diagnosis now. Near term, for the FY23 PRARP TDA, means acceleration within three to five years, focusing on implementation to the community as soon as possible.• Person-focused research: For diagnostic/prognostic outcomes proposed by the research to be successful, those impacted by AD/ADRD need to buy into the approach. This means researchers should design their projects to focus on the people who need the outcomes most, and the best way to do this is to partner with those stakeholders. Therefore, the FY23 PRARP TDA requires all projects to include collaborative community partner approaches.For this mechanism, there is an expectation that the investigator will host a community meeting with a facilitated discussion, to occur within the first three quarters of the period of performance that will help inform the execution of the research. This meeting should involve the intended research population and their community. The intent of this meeting is to gather feedback and input that will inform the execution of the research, optimize and refine research questions and execution therefore as well as help inform the dissemination strategy of the research outcomes.• Prospective recruitment of study participants: To meet the intent of the mechanism, the TDA requires an element of prospective human subjects’ data collection. The proposed project should leverage existing resources where possible; however, the study must ensure the advances proposed by the project aims are representative and applicable to a diverse population. Consideration of equitable, diverse inclusion of the study populations and team is essential to ensuring AD/ADRD diagnostic or prognostic solutions are of benefit to all and is a high priority for the program.

The Early Investigator Research Award supports MS-focused research opportunities for individuals in the early stages of their careers, under the guidance of one or more designated Mentors. This opportunity allows for early-stage investigators to develop a research project, investigate a problem or question in MS research, and further their intellectual development as an MS researcher of the future. All application components for the Early Investigator Research Award are expected to be written by the Principal Investigator (PI), with appropriate direction from the Mentor(s).

The MBRP Technology/Therapeutic Development Award is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical application that address one or more of the critical gaps included in the FY22 MBRP TTDA Focus Areas. Products under development must be relevant to military application and address the needs of military Service Members, Veterans, and/or beneficiaries.The product(s) to be developed may be a tangible item such as a pharmacologic agent (including, but not limited to, drugs or biologics); or device-focused. Knowledge products may be considered, provided that the knowledge is applicable to a technology or therapeutic under development. (A “knowledge product” is a non-materiel product that addresses an identified need in one or more of the FY22 MBRP TTDA Focus Areas, is based on current evidence and research, aims to transition into medical practice, training, tools, or to support materiel solutions [systems to develop, acquire, provide, and sustain medical solutions and capabilities], and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.) The Principal Investigator (PI) must provide a transition plan (including potential funding and resources; see Attachment 7: Transition Plan and Regulatory Strategy) showing how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the completion of the MBRP award. At the time of pre-application submission the proposed product must be at a minimum technology readiness level (TRL) or knowledge readiness level (KRL) of 3 (Appendix 2).Proof-of-concept and prototype/preliminary version of the proposed product demonstrating the potential utility of the proposed product must be established at the time of pre-application submission. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.This award mechanism is intended to facilitate progression of research that is supported by significant preliminary data but has not yet advanced to the level of clinical use. Examples of the types of research that may be supported include, but are not limited to:• Testing new therapeutic or technologic modalities (ex: agents, delivery systems, chemical modification of lead compounds, device testing and/or validation) using established or validated preclinical systems• Designing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or technologies for use in advanced preclinical studies• Developing pharmacologic agents through absorption, distribution, metabolism, excretion, and toxicity studies• Investigational New Drug (IND) or Investigational Device Exemption (IDE) enabling studiesThe 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 total costs budgeted for the entire period of performance for an FY22 MBRP TTDA Award will not exceed $2.21M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $4.42M to fund approximately two Technology/ Therapeutic Development 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 FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.Impact: The overall impact of the proposed product is a key component of this award mechanism. The applicability to one of the FY22 MBRP Focus Areas should be clearly described. Investigators must describe the potential impact of the research, both short-term and long-term, on the lives of burn-injured individuals. High-impact research will, if successful, lead to the development and translation of therapeutic or technologic advances for clinical application in the care of burn-injured casualties, such as prevention, detection, diagnosis, treatment, or standards of care, and promoting positive long-term outcomes for military health and medicine, as well as the general public.Relevance to Military Health: Relevance to the healthcare needs of military Service Members, Veterans, military beneficiaries, and/or the American public is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:• Explanation of how the project addresses an aspect of burn injuries relevant to the military• Description of how the therapy, technology, or knowledge gained from the proposed research could be implemented to address a military needUse of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military 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. Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaboration with DOD or VA investigators is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 3.Clinical trials and clinical research studies are not permitted under this award mechanism. Projects involving the use of human anatomical specimens are permitted, provided that the use of such specimens is necessary for device validation, or in vitro or ex vivo studies. Applicants proposing clinical research should consider submitting to the FY22 MBRP Clinical Translational Research Award mechanism.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.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. (3) Outcomes research and health services research. Note: Studies that meet the requirements for Institutional Review Board (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.Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core 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 (https://www.nature.com/articles/nature11556). While these standards were written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in research and should be applied consistently across translational studies. Projects that include research on animal models are required to submit Attachment 8, Animal Research Plan, as part of the proposal/ application package to describe how these standards will be addressed. Applicants should consult the Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines 2.0 to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.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 USAMRDC 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. Allow up to 3 months to complete the HRPO regulatory review and approval process following submission of all required and complete documents to the HRPO. 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) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.If the proposed research involves 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.Research Involving Animals: All research funded by the FY22 MBRP TTDA 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.

The Era of Hope Scholar Award supports individuals early in their careers who have demonstrated significant potential to effect meaningful change in breast cancer. These individuals should be exceptionally talented scientists who have shown that they are the “best and brightest” in their field(s) through extraordinary creativity, vision, innovation, and productivity. They should have demonstrated experience in forming effective partnerships and collaborations and must exhibit strong potential for future leadership in breast cancer research.As the intent of the Era of Hope Scholar Award is to recognize creative and innovative individuals rather than projects, the central features of the award are the demonstrated ability of the individual named as the Principal Investigator (PI) in the application to go beyond conventional thinking in their field and the innovative contribution that the PI can make toward ending breast cancer. The application should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention. Experience in breast cancer research is not required; however, the application must focus on breast cancer, and the PI must maintain a 50% dedication of their full-time effort during the award period to breast cancer research. This effort in breast cancer research can be through a combination of this award and other current support. Individuals from other disciplines who apply novel concepts to breast cancer are encouraged to submit. The PI is encouraged to assemble a research team that will provide the necessary expertise and collaborative efforts toward accomplishing the research goals. The PI’s research team must include two or more breast cancer consumer advocates. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they may not be employees of any organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.

The Behavioral Health Science Award supports innovative research and high-reward studies that span the spectrum of behavioral health science, including quality of life, symptom management, resilience, neurocognitive deficits, and psychosocial issues related to cancer diagnosis, treatment, and survivorship. Studies must address one or more of these critical issues in at least one of the FY22 PRCRP Topic Areas. The overall intention of the Behavioral Health Science Award is to advance behavioral health cancer science and fill gaps in the understanding of survivorship, including investigations into the psychological health and well-being of those affected by cancer (e.g., patients, family members). This may include investigations into studies that improve mental health and/or cancer-related outcomes in defined populations. Studies also may assess the relationship(s) between behavioral and social functioning in relation to cancer initiation, progression, detection, treatment, and rehabilitation. Applications may propose behavioral science that examines quality-of-life studies, decision-making and/or cognitive function research, development and testing of educational interventions, and symptom management (e.g., toxicity of treatment, palliative care, psychological distress and anxiety). Applications may target development of evidence-based practices, behavioral health science interventions and surveillance, and identification of psychosocial patient outcomes. Studies involving animal use are not appropriate for the Behavioral Health Science Award. If animal studies are proposed, the application may be withdrawn. The critical components of this award mechanism are: · Impact: The Behavioral Health Science Award is intended to support research that demonstrates the potential to have a major impact on patient outcomes, especially during the three stages of survivorship (acute, extended, and/or permanent). The proposed study must demonstrate how the research will transform behavioral health outcomes related to at least one of the FY22 PRCRP Topic Areas. Research should challenge paradigms with respect to impact on patient care and outcomes. Proposed projects may include translational or clinical research, including pilot clinical trials. Impactful research will accelerate the movement of promising ideas into clinical applications and advance the behavioral health science in the area of survivorship. · Study Design: Applications should clearly articulate the chosen design of the study. Studies entailing retrospective or prospective recruitment should define the type of architecture of the study (e.g., descriptive, correlational, field experimental, meta-analyses). Study populations should be clearly defined. The rationale should support the chosen study design with statistical evaluation to back the design. Questionnaires should be described in sufficient detail to justify interpretation of potential results. Research involving animal studies is not considered appropriate for the Behavioral Health Science Award. While not prohibited, strong justification must be included in the project narrative for any animal studies proposed. · Preliminary Data: The Behavioral Health Science Award will require preliminary data for all studies that propose the active (prospective) recruitment of human subjects for pilot clinical trials. Studies not proposing active recruitment of human subjects are not required to present preliminary data, but should be supported by sound reasoning and relevant literature. · Patient Advocate Participation: Applications to the Behavioral Health Science Award funding opportunity are required to include patient advocates. The research team must include at least one cancer patient advocate who will be integral throughout the planning and implementation of the research project. The patient advocate will be a person living with cancer; a person previously diagnosed with/treated for cancer but who now has no evidence of disease; or a family member or caretaker of someone with cancer. As a lay representative, the patient advocate should be active in a cancer advocacy organization. The patient advocate should be involved in the development of the research question, project design, oversight, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. The role of the patient advocate should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, cancer. At least one patient advocate should have a high level of knowledge of current cancer issues in the selected FY22 PRCRP Topic Area(s).

The intent of the FY23 ERP IDA is to solicit novel, innovative research that has the potential to increase our understanding of PTE to improve quality of life, especially in Service Members, Veterans, and/or their care partners. The work should innovatively challenge existing research paradigms or exhibit high levels of creativity.

The OCRP Investigator-Initiated Research Award is intended to support high-impact research that addresses a critical need and has the potential to make an important contribution to ovarian cancer or patient/survivor care. Research projects may focus on any phase of research, from basic laboratory research through translational research, excluding clinical trials. The application must demonstrate logical reasoning and a sound scientific rationale established through a critical review and analysis of the literature for the application to be competitive. Applications must include preliminary data that are relevant to ovarian cancer and support the proposed research project. These data may be unpublished or from the published literature.