Funding Wizard

The USAMRDC’s mission is to provide solutions to medical problems of importance to the American Service Member at home and abroad, as well as to the general public at large. The scope of this effort and the priorities attached to specific projects are influenced by changes in military and civilian medical science and technology (S&T), operational requirements, military threat assessments, and national defense strategies. Extramural research and development programs play a vital role in the fulfillment of the objectives established by the USAMRDC. General information on the USAMRDC can be obtained at https://mrdc.health.mil/.This BAA is intended to solicit extramural research and development ideas using the authority provided by 10 USC 4001. The BAA is issued under the provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in FAR 6.102(d)(2) and 35.016 and in Department of Defense Grant and Agreement Regulations (DoDGARs) 22.315. In accordance with FAR 35.016, projects funded under this BAA must be for basic and applied research to support scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on development of a specific system or hardware solution. Research and development funded through this BAA are intended and expected to benefit and inform both military and civilian medical practice and knowledge. This BAA utilizes competitive procedures in accordance with 10 USC 2302(2)(B) for the selection for award of S&T proposals/applications. For the purposes of this BAA, S&T includes activities involving basic research, applied research, advanced technology development, and, under certain conditions, may include activities involving advanced component development and prototypes.The selection process is highly competitive, and the quantity of meaningful submissions (both pre-proposals/pre-applications and full proposals/applications) received typically exceeds the number of awards that available funding can support.This BAA provides a general description of USAMRDC’s research and development programs, including Research Areas of Interest, evaluation and selection criteria, pre-proposal/ pre-application and full proposal/application preparation instructions, and general administrative information. Specific submission information and additional administrative requirements can be found in the document titled, “General Submission Instructions,” which is available on Grants.gov along with this BAA.The FY23-FY27 USAMRDC BAA is continuously open for a 5-year period, from October 1, 2022 through September 30, 2027, at 11:59 p.m. Eastern Time. Submission of a pre-proposal/pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org/). Pre-proposals/pre-applications may be submitted at any time throughout the 5-year period. If the USAMRDC is interested in receiving a full proposal/application, the Principal Investigator will be sent an invitation to submit via eBRAP. A full proposal/application must be submitted through Grants.gov (http://www.grants.gov/). Invited full proposals/applications can be submitted under this FY23-FY27 BAA through September 30, 2027.

The SCIRP CTRA is intended to support high-impact and/or new/emerging clinical research that may not be ready for a larger-scale clinical trial and for which feasibility/pilot studies are necessary. Projects should demonstrate potential to impact the standard of care, both immediate and long term, or contribute to evidence-based guidelines for the evaluation and care of military Service Members, Veterans, and other individuals living with SCI.• One goal of the FY23 SCIRP CTRA is to translate current and emerging techniques and interventions into the clinical space to de-risk and inform the design of more advanced trials.• Another goal is to identify the most effective diagnosis, treatment, and rehabilitation options available to support critical decision-making for patients, clinicians, care partners, and policymakers.The application should clearly articulate the scientific and strategic steps and/or preparations the research team will take during AND after the project’s period of performance to advance the research to the next stage of clinical development/implementation.The proposed studies may be interventional or observational and may involve some retrospective data analysis. Note that purely retrospective or database-related research will not be supported under this funding opportunity, some element of prospective human enrollment should be included in the project. Small/pilot clinical trials with human subjects are allowable. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a clinical trial is proposed, utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged.The FY23 SCIRP CTRA differs from the FY23 SCIRP Clinical Trial Award (Funding Opportunity Number HT9425-23-SCIRP-CTA) in that the CTRA allows for the execution of both clinical research projects and clinical trials, whereas the Clinical Trial Award is restricted to the execution of clinical trials only.The FY23 CTRA differs from the FY23 SCIRP Translational Research Award (Funding Opportunity Number HT9425-23-SCIRP-TRA) in that the study proposed within an application to the FY23 SCIRP CTRA may consist entirely of a clinical trial. In contrast, if a clinical trial is proposed within a Translational Research Award application, it must make up only a portion of the project’s Statement of Work.Applications to the FY23 SCIRP CTRA mechanism must support prospective clinical research or clinical trials and may not be used for animal research. Investigators seeking support to conduct studies involving animal research should consider applying to the FY23 SCIRP Translational Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-TRA) or FY23 SCIRP Investigator-Initiated Research Award mechanism (Funding Opportunity Number HT9425-23-SCIRP-IIRA).

The SCIRP TRA is intended to support translational research that will accelerate the movement of promising ideas in SCI research into clinical applications. Although not all-inclusive, some examples include demonstration studies of pharmaceuticals and medical devices in preclinical systems and/or clinical research on therapeutics, devices, or practice using human tissues or resources.The ultimate goal of translational research is to move an observation forward into clinical application and accelerate the clinical introduction of health care products, technologies, or practice guidelines. Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinician’s first-hand knowledge of patients and anecdotal data. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan is encouraged to involve a reciprocal flow of ideas and information between basic and clinical science.Applicants need to clearly articulate three points along the translational research spectrum:• Where the field is now;• Where the field will be after the successful completion of the proposed research project; and• What the next step will be after completion of the proposed project.Applications must include preliminary and/or published data that are relevant to SCI and supports the proposed research project.Applications to the FY23 SCIRP TRA may include preclinical animal studies (except where otherwise specified) and/or clinical research involving human subjects and human anatomical substances. Proposal of animal studies is not a required element of this mechanism though applications including animal studies must include a clear justification for the animal model chosen including relevance to human SCI. The FY23 SCIRP TRA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials.The FY23 SCIRP TRA also allows funding for a pilot clinical trial as PART of the funded research project where limited clinical testing of a novel intervention or device is necessary to inform the next step in the continuum of translational research. Such pilot clinical trial studies should be small, make up only a portion of the proposed Statement of Work (SOW), and be utilized to establish feasibility of a potential approach or to aid in device or intervention refinement. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. If a pilot clinical trial is proposed, utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged. Applications that include a pilot clinical trial as part of the proposed research will have additional submission requirements and review criteria. Applications that consist entirely of a clinical trial or multiple pilot clinical trials may be administratively withdrawn.

The SCIRP IIRA is intended to support studies that have the potential to make an important contribution to SCI research, patient care, and/or quality of life.Important aspects of this award mechanism include:• Impact: Applications should articulate the short- and long-term impact of the proposed research on both the SCI research field as well as the SCI community. Projects must address one or more of the FY23 SCIRP Focus Areas.• Relevance to Military Health: Projects should be relevant to spinal cord-injured military Service Members, Veterans, and/or their family members and care partners. Collaboration with military and VA researchers and clinicians is encouraged.• 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. Applications must include preliminary and/or published data that are relevant to the mission of the SCIRP and support the proposed research project.IIRA applications may focus on any phase of research from basic through translational, though studies focused exclusively on target identification are discouraged. Permitted research includes preclinical studies in animal models (except where otherwise specified), research with human subjects or human anatomical substances, as well as ancillary studies associated with an existing clinical trial.Clinical trials are not allowed under this funding opportunity. Applications including animal studies must have a clear justification for the animal model chosen, including relevance to human SCI.

The SCIRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of SCI. Applications should articulate both the short- and long-term impact of the proposed research on individuals with SCI and/or their care partners. The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by SCI within the context of one or more of the FY23 SCIRP Focus Areas.Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant populations. Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. Utilization of decentralized clinical trial strategies that leverage virtual elements/tools for participant enrollment, communication, and data collection is especially encouraged.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. To help elucidate the realities of treating and managing SCIs while deployed, a resource document is now available on the CDMRP website that outlines Spinal Cord Injury Management Within the Military Health System (MHS). Applicants are encouraged to read and consider this document before preparing their applications. The resource can be accessed at https://cdmrp.health.mil/scirp/pdfs/ Beginner's%20Guide%20to%20Military%20Health%20System.pdf.Employing community collaborations to optimize research impact is required. Research funded by the FY23 SCIRP CTA should be responsive to the needs of people with SCI, their families, and/or their care partners. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research. Applications to the FY23 SCIRP CTA are expected to name at least two community partners (e.g., SCI Lived Experience Consultants, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project (see Attachment 4, Collaborative Research Plan).Collaborative research approaches, such as community-based participatory research, participatory action research, and integrated knowledge transition, create partnerships between scientific researchers and community members to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and community members collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of community members within the research team. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy. These methods are critically important for community-level interventions and can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with SCI, their families, and/or their care partners.Collaborative relationships with the lived experience community are often established through integrating community members into research teams as co-researchers, advisors, and/or consultants. Some examples for implementing collaborative research approaches include:• Lived Experience Consultation: The research team includes at least one project advisor with lived SCI experience who will provide advice and consultation throughout the planning and implementation of the research project. Lived Experience Consultants may include individuals with SCI, their family members, and/or their care partners.• Partnership with a Community-Based Organization: The research team establishes partnerships with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project. Community-based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders.• Community Advisory Board Utilization: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of Lived Experience Consultants to a coalition of community-based organizations or any combination thereof. As with Lived Experience Consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

The FY23 LCRP Translational Research Award mechanism supports advanced translational research that will foster transformation of promising ideas in lung cancer into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. Observations that drive a research idea may originate from a laboratory discovery, population-based studies, or a clinician’s firsthand knowledge of patient care. The ultimate goal of translational research is to move a concept or observation forward into clinical application. However, Principal Investigators (PIs) should not view translational research as a one-way continuum from bench to bedside, but can include a reciprocal flow of ideas and information between basic science and clinical science (bench to bedside and/or bedside to bench). Research applications only in the area of mesothelioma will not be accepted. This mechanism is intended to fund a broad range of translational studies with two different funding levels. The following are general examples, although not all-inclusive, of the type of research projects that would be appropriate to propose under the current program announcement:Funding Level 1:Advanced preclinical studies aimed at translating results from animal studies to applications with human samples/cohorts (The Translational Research Award is not intended to support initial mechanistic studies of a new target.)Late-stage preclinical work leading to/preparing for a clinical trial, e.g., Investigational New Drug (IND) application submissionCorrelative studies that are associated with an open/ongoing or completed clinical trial, e.g., projects that utilize biospecimens from clinical trials to improve clinical management of lung cancer and/or define new areas of researchProjects that develop endpoints for clinical trialsFunding Level 2:Pilot clinical trials where limited clinical testing (e.g., small sample size) of a novel intervention is necessary to inform the next step in the continuum of translational researchPreliminary lung cancer relevant data to support the feasibility of the research hypotheses and research approaches are required.

The FY23 LCRP Idea Development Award mechanism promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. This award supports conceptually innovative, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress toward eradicating deaths and suffering from lung cancer. Research applications only in the area of mesothelioma will not be accepted. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale.New Investigators: The FY23 LCRP Idea Development Award mechanism encourages applications from independent investigators in the early stages of their careers (i.e., within 10 years of their first faculty appointment or equivalent). The New Investigator category is designed to allow applicants early in their faculty appointments to compete for funding separately from established investigators. Applications from New Investigators and Established Investigators will be peer and programmatically reviewed separately. Principal Investigators (PIs) using the New Investigator category are strongly encouraged to strengthen their applications by collaborating with investigators experienced in lung cancer research and/or possessing other relevant expertise. It is the responsibility of the applicant to describe how the included collaboration will augment the PI’s expertise to best address the research question. All applicants for the New Investigator category must meet specific eligibility criteria as described in Section II.C, Eligibility Information.Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer.Key elements of this award are as follows:Innovation: Research deemed innovative may introduce a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other uniquely creative qualities.Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward eradicating deaths and suffering from lung cancer.It is the responsibility of the PI to clearly and explicitly articulate the project’s innovation and its potential impact on lung cancer and its relevance to Military Health System (MHS) beneficiaries. The project’s impact to both lung cancer research and to patients with lung cancer should be articulated, even if clinical impact is not an immediate outcome. Applications that demonstrate exceptional scientific merit but lack innovation and high potential impact do not meet the intent of the Idea Development Award.

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

The OCRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ovarian cancer. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

The OCRP Pilot Award supports the exploration of innovative concepts or theories in ovarian cancer that could ultimately lead to critical discoveries or major advancements that will drive the field forward. The proposed research must demonstrate a clear focus on ovarian cancer (e.g., using tissues, cell lines, datasets, or appropriate animal models), and serve as a catalyst to expand or modify current thinking about and/or approaches in ovarian cancer.