Funding Wizard

The FY22 BCRP Clinical Research Extension Award aims to extend the data collection, follow- up, and analysis of breast cancer clinical research studies. The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research by addressing the knowledge lost due to limited or early termination of patient follow-up and sample collection and analysis. The critical components of this award mechanism are: Impact: Research supported by the FY22 BCRP Clinical Research Extension Award will have the potential for a major impact and accelerate progress toward ending breast cancer. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: Although not all-inclusive, research proposed under the FY22 BCRP Clinical Research Extension Award may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients currently/previously enrolled in an open/ongoing or completed clinical trial. The proposed research may be hypothesis testing/generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. The award may not be used to directly support a clinical trial. Feasibility: Preliminary data to support the scientific rationale and feasibility of the research approaches are required. Applications are strongly encouraged to also describe the clinical relevance of the proposed research. The applicant must demonstrate availability of, and accessibility to, the necessary resources or populations to accomplish the proposed research. Data Evaluation and Sharing: Proposed research should be based on study sample size that will ensure that the results support valid conclusions and further translation towards clinical application. It is the applicant’s responsibility to provide sufficient evidence that the sample size is appropriate to meet the study's objectives. The applicant must outline a plan to share the experimental platforms and molecular data generated from the proposed research with the scientific community. Partnering PI Option: The FY22 BCRP Clinical Research Extension Award encourages applications that include meaningful and productive collaborations between investigators. The Partnering PI Option is structured to accommodate two Principal Investigators (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. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring a distinct contribution to the application; collaborations between basic science and clinical researchers are highly encouraged. 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 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. 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. 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, and it is the applicant’s responsibility to outline the advocates’ role in the design and execution of the study. 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 FY23 BCRP Clinical Research Extension Award aims to extend the data collection, follow- up, and analysis of breast cancer clinical research studies. The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research by addressing the knowledge lost due to limited or early termination of patient follow-up and sample collection and analysis. The critical components of this award mechanism are: Impact: Research supported by the FY23 BCRP Clinical Research Extension Award will have the potential for a major impact and accelerate progress toward ending breast cancer. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: Although not all-inclusive, research proposed under the FY23 BCRP Clinical Research Extension Award may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients currently/previously enrolled in an open/ongoing or completed clinical trial. The proposed research may be hypothesis testing/generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. The award may not be used to directly support a clinical trial. Feasibility: Preliminary data to support the scientific rationale and feasibility of the research approaches are required. The applicant must demonstrate availability of, and accessibility to, the necessary resources or populations to accomplish the proposed research. Data Evaluation and Sharing: Proposed research should be based on study sample size that will ensure that the results support valid conclusions and further translation toward clinical application. It is the applicant’s responsibility to provide sufficient evidence that the sample size is appropriate to meet the study's objectives. The applicant must outline a plan to share the experimental platforms and molecular data generated from the proposed research with the scientific community. Partnering PI Option: The FY23 BCRP Clinical Research Extension Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two Principal Investigators (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. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring a distinct contribution to the application; partnerships between basic science and clinical researchers are highly encouraged. 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 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. 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. Applicants are discouraged from being named as a PI, Initiating PI, or Partnering PI on multiple Clinical Research Extension Award applications unless they are clearly addressing distinct research questions. 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, and it is the applicant’s responsibility to outline the advocates’ role in the design and execution of the study. 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 FY23 ARP Career Development Award supports early-career, independent investigators and/or the transition of established investigators from other research fields to conduct innovative, DOD FY23 Autism Research Program Career Development Award 5 high-impact ideas or early-phase, proof-of-principle clinical trials with the potential to have a major impact on ASD. Applications are strongly encouraged to address one of the FY23 ARP Career Development Award Areas of Interest or provide justification that the proposed research addresses a critical problem, question, or need in ASD.This award enables such investigators to compete for funding separately from investigators with established programs of ASD research. Previous experience in ASD research is allowed, but not required. However, in FY23 Career Development Award applications that name a Principal Investigator (PI) with limited background in ASD research, the ARP strongly encourages the inclusion of collaboration with investigators who are experienced in ASD research and/or possess other relevant expertise in order to strengthen the application.

The FY21 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 FY21 RTRP Advanced Technology Development Award Focus Areas listed in Section II.A.1 above. All products to be developed should 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 animal research and/or human subjects research, as appropriate; however, clinical trials are not allowed under this funding opportunity.

The FY22 VRP CTA supports the rapid implementation of early-phase clinical trials (i.e., phase 0 through phase 2a) of new interventions with the potential to have a significant impact on the treatment or management of service-connected eye injury and visual dysfunction. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. 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. Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219).

The PRP EIRA supports research opportunities for investigators in the early stages of their careers, under the guidance of one or two designated Mentor(s). The Early Investigator is considered the Principal Investigator (PI) of the application and must exhibit strong potential for, and commitment to, pursuing a career as an investigator at the forefront of PD research; however, the PI is not required to have previous PD research experience. Applications must include at least one Mentor, appropriate to the proposed research project, who has experience in PD research and mentoring as demonstrated by a record of active funding, recent publications, and successful mentorship.

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.

The RTRP Clinical Network Award mechanism was first offered in FY20, with awards to be made as grants or cooperative agreements. Three applications were received, but none were funded. This FY22 research announcement is being offered through a different type of award mechanism, a Research Other Transaction Award (rOTA) under the authority of 10 USC 4021.Statement on the Research Other Transaction Agreement: The principal purpose of a rOTA is to carry out non-duplicative basic, applied, and advanced research projects rather than the acquisition of property or services for the direct benefit or use of the government. The anticipated deliverables to the government under a rOTA are reports on research rather than prototypes.The rOTA requires resource sharing, with government funds not to exceed the total amount provided by other parties to the maximum extent practicable. Offerors will be required to demonstrate how resources (e.g., cash and non-cash) will be made available for this project. The rOTA is intended to promote the use of best business practices and to foster relationships among performers from different sectors.In addition, as a matter of DOD policy, rOTAs may only be awarded when one or more for-profit firms are to be involved either in the: (1) performance of the research project(s) or (2) commercial application of the research results. A consortium should either include, collaborate with, or involve one or more for-profit firms (e.g., pharmaceutical company to provide medication, rehabilitation clinic to provide services to recipients, etc.) in addition to state or local government agencies, institutions of higher education, or other nonprofit organizations. For the FY22 Clinical Network Award, the for-profit firm may be involved in either Phase 1, Phase 2, or both phases of the award.The government will enter into negotiations to finalize the terms and conditions of the anticipated Agreement with the presumptive awardee after applications are evaluated in accordance with Section III.B.1 and Section III.B.2 of this Research Announcement. A draft Agreement has been provided for informational purposes. The content of the draft Agreement reflects the government’s baseline terms and conditions for an expenditure-based rOTA and is subject to negotiation upon selection of the most advantageous offeror.General Information: The RTRP intends to allocate up to $13M to support the RTRP Clinical Network over 6 years, subject to availability of funding. This effort will be executed through a two-phase approach in the form of a single award to the Clinical Network Coordinating Center, hereby referred to as the Coordinating Center. The Coordinating Center will serve as the Clinical Network information and planning nexus, providing administrative, operational, and data management support services to implement Clinical Network activities in a timely manner. The period of performance for Phase 1 is 2 years, with maximum funding of $3M in RTRP funding for Coordinating Center costs. RTRP funding for the Phase 2 is contingent on successful completion of Phase 1 objectives and subject to the availability of funding. The period of performance for Phase 2 is 4 years, with maximum funding of $10M in RTRP funding for Coordinating Center costs and Network Site costs. The Coordinating Center will manage funding to the Network Sites through the execution of subaward agreements for Phase 1 and/or Phase 2 reimbursable activities and for other key collaborators. See Section I.E., Funding, for additional information.

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 fundamentally new approach that is significantly more effective 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 (HT9425-23-BCRP-BTA12 for Levels 1 and 2 and HT9425-23-BCRP-BTA4 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.

The ARP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ASD. Applications are strongly encouraged to address one of the FY23 ARP Clinical Trial Award Areas of Interest. If the proposed study does not address an Area of Interest, an explanation of how the study addresses an important problem with respect to individuals with ASD must be provided. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), behavioral interventions, devices, clinical guidance, and/or emerging approaches and technologies. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies.