Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

Orthopaedic injuries have a profound impact on military readiness and return to work/activity/duty. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Department of Defense Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (e.g., during training, leisure activities, resultant from old injuries, etc.) present one of the greatest threats to the readiness of our Service Members and military. Early stabilization, treatment, and rehabilitation of orthopaedic injuries in both civilian and military populations have led to better outcomes, particularly in the prevention of secondary complications and in minimizing morbidity. Availability of orthopaedic care and treatment as early as possible, or as close to the point of injury as possible, also minimizes limb loss and affects military readiness.

Although the PRORP is interested in supporting military-focused research, research supported by the PRORP is expected to also apply to all individuals who have sustained a major orthopaedic injury.

With the initiation of the Arthritis Research Program, the FY24 PRORP may not fund arthritis research; however, research that addresses conditions or health abnormalities related to arthritis is permitted provided the proposed research addresses the selected Focus Area.

The FY24 PRORP ARA seeks applied research applications focused on advancing optimal treatment and restoration of function for individuals with orthopaedic injuries sustained during combat and service-related activities. Applicants are encouraged to address how the proposed research will support patient care and allow patients to more quickly return to duty/work. It is expected that any research findings would also provide benefit to the general population. To meet the intent of the award mechanism, applications must specifically address an FY24 PRORP ARA Focus Area, listed in Section II.A.1, above.

The FY24 PRORP ARA is focused on applied research, defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of promising new knowledge products, pharmacologic agents, behavioral and rehabilitation interventions, diagnostic and therapeutic techniques, clinical guidance, and/or emerging approaches and technologies.

Awards may not be used to support fundamental basic research. Basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications toward process or products in mind.

Research Scope: Research proposed under the FY24 PRORP ARA may include small- to large-scale projects. Upon successful completion, the proposed research is expected to yield knowledge products, approaches, or technologies that have the potential to advance toward clinical translation. Strong transition plans are expected.

Inclusion of preliminary and/or published data relevant to the proposed research is required. Applicants must demonstrate logical reasoning for the proposed work. To be competitive, the application must include a sound scientific rationale and a well-formulated, testable hypothesis established through a critical review and analysis of the literature.

Studies allowed under the FY24 PRORP ARA may include, but are not limited to:

• Refinement of concepts and ideas into potential solutions, or research tools, with a view toward evaluating technical feasibility of emerging approaches, technologies, and promising new knowledge products.

• Evaluation, maturation, and/or down-selection of potential product candidates (drugs, biologic constructs, or devices/systems) in vitro and/or in vivo.

• Preparation activities needed to support a future clinical trial or regulatory submission.

Applications to the FY24 PRORP ARA mechanism must support preclinical applied research and may not be used for clinical research studies. Applicants seeking support for clinical research projects should consider the FY24 PRORP Clinical Translational Research Award (Funding Opportunity Number HT942524PRORPCTRA), Clinical Trial Award (Funding Opportunity Number HT942524PRORPCTA), or Women’s Health Research Award (Funding Opportunity Number HT942524PRORPWHRA) mechanisms.

The funding instrument for awards made under the program announcement will be grants (31 USC 6304).

Rigor of Experimental Design: 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 SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 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. Projects that include research on animal models are required to submit Attachment 8, Animal Research Plan, as part of the application package to describe how these standards will be addressed. Applicants should consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) 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.

Women’s Health Research: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women's health outcomes and/or advancing knowledge for women's health. Applications proposing research that solely address women’s health may also consider the FY24 PRORP WHRA mechanism, Funding Opportunity Number HT942524PRORPWHRA.

Encouraged Department of Defense (DOD) and/or VA Collaboration: Military relevance is a key feature of this award. Principal Investigators (PIs) are encouraged, but not required, to collaborate with DOD or VA researchers and clinicians.

Use of DOD or VA Resources: If the proposed research involves access to 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.

The anticipated total costs budgeted for the entire period of performance for an FY24 PRORP Applied Research Award should not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $3.75M to fund approximately five ARA applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer 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 FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org