Dept. of the Army -- USAMRAA

Title Due Date Maximum Award Amount Description
DoD Kidney Cancer, Nurse-Initiated Research Award Varies

The FY22 KCRP Nurse-Initiated Research Award supports innovative, high-impact kidney cancer research, conducted by nurses working in clinical practice and/or an academic environment (doctor of nursing practice [D.N.P.] or doctor of philosophy [Ph.D.]), to advance ideas or clinical care. Proposed research must demonstrate potential to have a major impact in kidney cancer, ideally in a multi-disciplinary manner led by a nurse. Applications are strongly encouraged to address one of the FY22 KCRP Focus Areas or must provide justification that the proposed research addresses a critical problem, question, or need in kidney cancer.Nurses make up the largest group of health professionals within the health system and nursing is the largest profession in the United States. Nurses engage in more regular interactions with patients and their families, relative to other health professionals. Nurses who have earned advanced degrees (Ph.D. in particular) are being recognized more frequently for their contributions bridging clinical practices and patient care experiences to nurse-initiated research. Their evidenced-based investigations have resulted in advancements to healthcare delivery and the growing field of nurse scientist-led investigations. Please refer to Appendix 2 for further reference. This award enables the nurse-scientist(s) to compete for research funding that will help determine the best practices to both inform and improve kidney cancer patient care. Although the project should address an important question in kidney cancer patient care, studies may also seek to investigate topics associated with access to care, health equity/health disparities, communication/patient education, quality of life, or patient support systems (not all-inclusive).Research Approach: The proposal must pursue a kidney cancer project and should have high potential to lead to, or make breakthroughs in, kidney cancer patient care, survivorship, and outcomes research (not all-inclusive). The feasibility of the research design and methods should be well-defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved. Below are some examples of projects that this award is intended to support (not all-inclusive):• Projects that develop best practice models for support of nurses and patient care• Evaluating the effects (long- and short-term) of interventions on patients and/or patient care• Investigating psychosocial issues relevant to people living with kidney cancer, their families, and/or their care-partners• Conducting nurse practice for kidney cancer patients during a period of medical crisis (e.g., COVID-19, nurse shortages, access to therapies)Preliminary Data: The inclusion of preliminary data relevant to kidney cancer and the proposed project is encouraged but not required. All research projects must include a well-formulated, testable hypothesis based on strong scientific rationale. Any preliminary data provided should be from the Principal Investigator (PI) and/or collaborating investigator(s); additionally, required resources should be identified and supported through documentation. At minimum, the PI or one collaborating investigator must have experience with kidney cancer research.Impact: Research supported by the Nurse-Initiated Research Award will have the potential to improve patient care for those living with kidney cancer. The impact may be short term or long term but must move beyond an incremental advance. Applications are expected to identify the kidney cancer patients or at-risk individuals who would ultimately benefit from the proposed research. At least the PI or one collaborating investigator must have experience with kidney cancer patient care.Qualified Collaboration Option (New for FY22): In FY19, the KCRP awarded a Clinical Consortium Award to create a network of institutions focused on designing and executing phase 1 and 2 clinical trials. The Kidney Cancer Research Consortium (KCRC) has now been established to investigate promising therapeutics for kidney cancer. Applicants to the FY22 Nurse-Initiated Research Award are encouraged to make use of the established infrastructure of the KCRC, such as recruitment networks, existing protocols, Common Data Elements (CDEs), and data management procedures. A letter of collaboration from the KCRC is required, outlining the services that will be shared to bring value to the government.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.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/2018/05/0…) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY22 KCRP 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 anticipated direct costs budgeted for the entire period of performance for an FY22 KCRP Nurse-Initiated Research Award or FY22 KCRP Nurse-Initiated Research Award – Qualified Collaboration Option will not exceed $300,000. 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 $0.96M to fund approximately two Nurse-Initiated 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 FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.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 Institutional Review Board (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.Clinical trials are not allowed. 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.The Nurse-Initiated Research Award will not directly support intervention clinical trial costs; however, correlative studies and other research projects that run in parallel to a clinical trial are permissible. 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 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.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 research funded by the FY22 KCRP Nurse-Initiated Research Award 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.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341146
DoD Kidney Cancer, Clinical Trial Award Varies

The KCRP Clinical Trial Award supports the rapid implementation of early-phase clinical trials (phase 0, phase 1, phase 1/2) with the potential to have a significant impact on the treatment or management of kidney cancer. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, surgical procedures, behavior modifications, clinical guidance, and/or emerging approaches and technologies. Therapeutic approaches testing existing interventions for new indications in kidney cancer are also encouraged. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform kidney cancer patient care.Funding from this award mechanism must support a clinical trial. 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. For more information, a Human Subject Resource Document is provided at https://cdmrp.army.mil/pubs/pdf/ Human%20Subjects%20Resource%20Document.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY22 KCRP program announcements being offered.Cell Therapy Focus Option (New for FY22): The FY22 KCRP Clinical Trial Award may support cell therapy clinical trials. Such studies may require additional resources due to required optimization of cell therapy manufacturing or clinical trial correlative studies. Applicants may request higher levels of funding within the defined period of performance. The application must demonstrate access to the necessary specimens and/or data of the proposed cohort. Appropriate access must be confirmed at the time of application submission.Qualified Collaboration Option (New for FY22): The KCRP will offer a Qualified Collaboration Option to encourage leveraging of existing infrastructure previously funded. Qualifying organizations must be a federally funded partnership/consortium, such as the Kidney Cancer Research Consortium, with established infrastructure to support multi-institutional studies to leverage shared resources and core capabilities such as data management, clinical trial database administration, statistical analysis, tissue repositories, etc., that will improve study efficiency and reduce redundancies and duplication. A letter of collaboration from the collaborating organization demonstrating their commitment is required, outlining the services that will be shared to bring value to the government.Key aspects of the KCRP Clinical Trial Award mechanism:• Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for U.S. Food and Drug Administration (FDA)-regulated studies.• Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical trial is required.• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. • Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study. The quality and stability of the product should be documented and commensurate with current FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practice [GMP] guidelines). Funds from this award may not be used to support costs associated with producing or acquiring the specified intervention (i.e., purchasing from the manufacturer).• Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of FDA processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart D, are fulfilled.• Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study and a data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the trial must use a 21 CFR 11-compliant database and appropriate data standards. For more on data standards, see https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf.If the proposed clinical trial involves the use of a drug that has not been approved by the FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND is not required. If an IND is required, the IND application must be submitted to the FDA by the Clinical Trial Award application submission deadline. The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelop… the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence if an IDE is not required or the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted to the FDA by the Clinical Trial Award application submission deadline. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial. If the clinical trial of an investigational product will be conducted at international sites, evidence that an application to the relevant national regulatory agency of the host country(ies) has been submitted by the Clinical Trial Award application submission deadline is required.Funded trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 219. Funded studies are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section B, for further details.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 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 FY22 KCRP Clinical Trial Award or an FY22 KCRP Clinical Trial Award – Qualified Collaboration Option will not exceed $1.5M. The anticipated direct costs budgeted for the entire period of performance for an FY22 KCRP Clinical Trial Award – Cell Therapy Focus Option will not exceed $2.0M. 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 $8.0M to fund approximately 2 Clinical Trial Award and 1 Clinical Trial Award – Cell Therapy Focus Option 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.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, 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, plans for the multi-institutional structure governing the research protocol(s) should be outlined. In addition, a written plan for single IRB review arrangements must be provided for research conducted in the United States involving more than one institution. 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. Communication and data transfer between or among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed on by all participating institutions is also required for multi-institutional clinical trials.Use of DOD or 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.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341145
DoD Kidney Cancer, Academy of Kidney Cancer Investigators – Early-Career Scholar Award Varies

Academy of Kidney Cancer Investigators (AKCI) is a virtual career development and research mentoring platform that consists of Early-Career Scholar (ECS)/Designated Mentor pairs from different institutions, and an Academy Dean. The KCRP AKCIECSA is not a traditional career development award; the ECS is expected to conduct research, participate in monthly webinars, and annual workshops and to communicate and collaborate with other members of the Academy (other Early-Career Scholars, mentors, Dean) as well as with the kidney cancer advocacy community.The KCRP Academy of Kidney Cancer Investigators – Early-Career Scholar Award supports a unique, interactive virtual academy providing intensive mentoring, national networking, collaborations, and a peer group for junior faculty emerging as potential leaders of kidney cancer research. The overarching goal of the AKCI is to advance kidney cancer research through development of highly productive kidney cancer researchers in a collaborative research and career development environment.The Academy Dean, selected in FY19, serves as a resource for the ECS and mentors, assessing the progress of the ECS, and facilitating communication and collaboration among all of the Early-Career Scholars and mentors, as well as with research and advocacy communities. In addition to fostering ECS scientific development, the AKCI, through its leadership by the Academy Dean, provides professional and leadership development of the ECS to include skills and competencies needed to fund and manage a productive laboratory or research team.This FY22 program announcement is soliciting Early-Career Scholars and Designated Mentors to join the existing Academy of Kidney Cancer Investigators. This award mechanism enables the ECS (the Scholar named as the Principal Investigator [PI] on the application) to pursue a kidney cancer project that may be basic, translational, and/or clinical research. The Designated Mentor is not required to be at the same institution as the ECS.The KCRP encourages applications from Early-Career Scholars whose ability to commit to conducting kidney cancer research is limited by minimal resources or a lack of resources, such as a qualified Designated Mentor at their institution, access to kidney cancer research tools, opportunities for establishing collaborations, or other obstacles, which should be identified in the application.Preliminary data to support the feasibility of the research applications and approaches are required; however, this data does not necessarily need to be derived from the kidney cancer research field.The ECS must be in the early-career stage. This award provides the ECS with funding, networking, and collaborative opportunities, and research experience necessary to develop and sustain a successful, independent career at the forefront of kidney cancer research. This award also provides support and protected time for the ECS for 4 years of intensive research under the guidance of a Designated Mentor experienced in kidney cancer research. Although the AKCI will serve as a conduit to share knowledge and research experience among all Academy members, the ECS and Designated Mentor will be responsible for developing the career development plans of the ECS and for designing and executing the proposed research. The ECS must clearly articulate their commitment to a career as a kidney cancer researcher and to participating in and contributing to the growth of the AKCI.The Designated Mentor must have a strong record of mentoring and training early-career investigators. With the goal to expand and enrich mentorship capacity within the Academy, a Designated Mentor must agree to also serve as a Secondary Mentor to another ECS in the Academy. The Designated Mentor will be limited to one Primary (applicant ECS/mentor pair) and one Secondary Mentorship. Applicants are not permitted to list the Dean of the Academy as a Designated Mentor. The ECS and Designated Mentor are required to attend a biennial multi-day Department of Defense (DOD) KCRP AKCI Workshop and, in alternate years, a 1-day DOD KCRP AKCI Workshop.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or 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 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.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/2018/05/0…) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY22 KCRP 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 anticipated direct costs budgeted for the entire period of performance for an FY22 KCRP AKCIECSA will not exceed $725,000. 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 $3.48M to fund approximately three Academy of Kidney Cancer Investigators – Early-Career Scholar 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.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 Institutional Review Board (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.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. Clinical trials are not allowed. 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.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 research funded by the FY22 KCRP AKCIECSA 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.Guidelines for Animal Research: 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. 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 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.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341143
DoD Reconstructive Transplant, Advanced Technology Development Award Varies

The FY22 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation. Important aspects of this award mechanism include: - Study Design and Feasibility: The proposed study design should be clearly described, rigorous, well-integrated, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, if applicable. It should be clear how the proposed study design of this project will position the product for the next phase of development as described in the post-award Transition Plan (Attachment 9). - Impact/Military Relevance: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY22 RTRP Advanced Technology Development Award Focus Areas listed in Section II.A.1 above. All products to be developed must be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers, or clinicians, as well as the general public. Collaboration with military and VA researchers and clinicians is encouraged but not required. - Transition Plan: The post-award Transition Plan (Attachment 9) should include potential funding and resources and show how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the successful completion of this award. A regulatory strategy as applicable to the proposed research/product should also be included. - Preliminary Data: Proof of concept demonstrating potential utility of the proposed product, or a prototype/preliminary version of the proposed product, must already be established. Preliminary and/or published data that are relevant to reconstructive transplantation, and that support the rationale for the proposed study, must be included (these data may be unpublished if from a member of the research team, or from the published literature). Proposed research and products to be developed may be materiel products such as drugs, biologic agents, or devices, or knowledge-based products such as technical reports and clinical practice guidelines that inform clinical/operational decisions and promote evidence-based changes in clinical practice and standard of care. Proposed research may include preclinical studies in animal models, human subjects, human anatomical substances, as well as correlative studies associated with an existing clinical trial.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341132
DoD Reconstructive Transplant, Investigator- Initiated Research Award Varies

The FY22 RTRP Investigator-Initiated Research Award (IIRA) is intended to support studies that have the potential to make an important contribution to reconstructive transplant research, patient care, and/or quality of life. Though the RTRP IIRA mechanism supports groundbreaking research, all projects must demonstrate solid scientific rationale with military-relevant utility. Important aspects of this award mechanism include: - Study Design and Feasibility: The proposed study design should be clearly described, rigorous, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, as applicable. - Impact: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY22 RTRP Investigator-Initiated Research Award Focus Areas. - Military Relevance: All projects must be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers or clinicians, as well as the general public. Collaboration with military researchers and clinicians is encouraged, but not required. - Preliminary Data: Observations that drive a research idea may be derived from laboratory discovery, population-based studies, a clinician’s first-hand knowledge of patients, or anecdotal data. Preliminary and/or published data that are relevant to reconstructive transplantation and that support the rationale for the proposed research must be included. Investigator-Initiated Research Award applications may focus on any phase of research from basic through translational, including preclinical studies in animal models, human subjects, human anatomical substances, as well as correlative studies associated with an existing clinical trial.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341133
DoD Reconstructive Transplant, Concept Award Varies

The intent of the FY22 RTRP Concept Award is to support the exploration of a highly innovative new concept or untested theory that addresses an important problem relevant to reconstructive transplantation and the FY22 RTRP Concept Award Focus Areas. The Concept Award is not intended to support a logical progression of an already established research project, but instead supports high-risk studies that have the potential to reveal entirely new avenues for investigation. Though the RTRP Concept Award mechanism supports groundbreaking research, all projects must demonstrate solid scientific rationale with military-relevant utility. Important aspects of this award mechanism include: - Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, examine existing problems from new perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative and is not consistent with the intent of this award mechanism. - Relevance: Projects should address at least one of the FY22 RTRP Concept Award Focus Areas. All projects must be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers or clinicians, as well as the general public. - Presentation of preliminary data is not allowed; however, applications should demonstrate the ability to achieve interpretable results. A rationale for the proposed work must be provided. - Reviewers at both tiers of review will be blinded to the identity of the Principal Investigator (PI), collaborators, and their organizations. Applications that identify the PI, collaborators, or their organizations in certain components of the application (i.e., Project Narrative; References; List of Abbreviations, Acronyms, and Symbols, and Statement of Work; see Section II.D, Application and Submission Information, for details) will be rejected for noncompliance. A document describing common blinding mistakes to avoid can be found on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). - Young/early-career investigators are encouraged to apply. Investigators at or above the level of postdoctoral fellow are eligible to apply.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341113
DoD Breast Cancer, Innovator Award Varies

The Innovator Award supports visionary individuals who have demonstrated exceptional creativity, innovative work, and paradigm-shifting leadership in any field including, but not limited to, breast cancer. The Innovator Award will provide these individuals with the funding and freedom to pursue their most novel, visionary, high-risk ideas that could accelerate progress to ending breast cancer. Because the intent of the Innovator Award mechanism is to recognize these remarkably creative and innovative visionary individuals, rather than projects, the central feature of the award is the innovative contribution that the Principal Investigator (PI) can make toward ending breast cancer. The PI should have a record of challenging the status quo, shifting paradigms by changing a field of research or approach to patient care, exhibiting high levels of creativity, and demonstrating promise for continued innovation in future work. These rare individuals will be able to articulate a vision for ending breast cancer that challenges current dogma and demonstrates an ability to look beyond tradition and convention. The PI is also expected to be established in their field and have demonstrated success at forming and leading effective partnerships and collaborations. To further the development of innovative individuals and spark the generation of novel ideas, applications are required to incorporate the mentoring of promising junior investigators. 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. Individual from other disciplines who will apply novel concepts to breast cancer are encouraged to submit. The PI is expected 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 cannot be employees of any of the 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 on the research and its potential impact for individuals with, or at a risk for, breast cancer.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341027
DoD Breast Cancer, Breakthrough Award Levels 1 and 2 Varies

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a new approach that is fundamentally better than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget. The current program announcement discusses the Breakthrough Award Levels 1 and 2. Funding Levels 3 and 4 are available under other program announcements (W81XWH-22-BCRP-BTA3-2 and W81XWH-22-BCRP-BTA4-2, respectively). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcement before submitting the pre-application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level. The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement: · Funding Level 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development or is an untested theory that addresses an important problem. To foster research that yields new avenues of investigation, preliminary data are not required. Proof of concept is the anticipated outcome. · Funding Level 2: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape. · Funding Level 2: Population Science and Prevention Studies: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape. With compelling justification, population science and prevention studies may request higher levels of funding and an additional year in the period of performance. Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Levels 1 and 2 applications unless they are clearly addressing distinct research questions. Applications in which a mentor and their current postdoctoral fellow or junior investigator are named as Initiating and Partnering PIs do not meet the intent of the Partnering PI Option. Applications where one PI is providing samples, animal models, or investigational agents while the other PI is conducting most or all of the experiments and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341028
DoD Breast Cancer, Breakthrough Award Level 3 Varies

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a new approach that is fundamentally better than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget. The current program announcement discusses the Breakthrough Award Level 3. Funding Levels 1, 2, and 4 are available under other program announcements (W81XWH-22-BCRP-BTA12-2 for Levels 1 and 2 and W81XWH-22-BCRP-BTA4-2 for Level 4). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcements before submitting the pre- application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level. The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement: Funding Level 3: Advanced translational studies with a high degree of project readiness. Where relevant, proof of availability of and access to necessary data, human samples, cohort(s) and/or critical reagents must be provided. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) involvement, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s). Applications must state a realistic timeline for near-term clinical investigation. Small-scale clinical trials (e.g., first in human, phase 1/1b) may be appropriate. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Level 3 applications unless they are clearly addressing distinct research questions. Applications where one PI is providing samples, animal models, or investigational agents while the other PI is conducting most or all of the experiments and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project. Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, 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. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, and they should be active in a breast cancer advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, breast cancer. 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.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341029
DoD Breast Cancer, Era of Hope Scholar Award Varies

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.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341010