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Peer Reviewed Orthopaedic

NEWS RELEASE

Released: June 20, 2016

Defense Health Program
Department of Defense Peer Reviewed Orthopaedic Research Program
Funding Opportunities for Fiscal Year 2016 (FY16)

The FY16 Defense Appropriations Act provides $30 million (M) to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support innovative, high-impact orthopaedic research. The goal of the PRORP is to provide all Warriors affected by orthopaedic injuries sustained in the defense of our Constitution the opportunity for optimal recovery and restoration of function.

As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

The PRORP is providing the information in this pre-announcement to allow investigators time to plan and develop applications. FY16 PRORP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in July 2016. Pre-application and application deadlines will be available when the Program Announcements are released. This pre-announcement should not be construed as an obligation by the government.

Focus Areas: The PRORP considers applications that specifically address the critical needs of the orthopaedic research community in one or more of the FY16 PRORP Focus Areas. The PRORP will solicit research applications that address at least one of the following FY16 Focus Areas (Note: Focus Area requirements vary by award mechanism):

Surgical Care Focus Areas:

  • Peripheral Nerve Injuries: Treatment strategies to improve outcomes from segmental peripheral nerve defects of motor and mixed (motor and sensory) peripheral nerve damage from crush or complete injury.
  • Prevention of Heterotopic Ossification: Techniques to retard or prevent the development of human post-traumatic heterotopic ossification in the upper extremity.
  • Volumetric Muscle Loss: Techniques to regenerate functional, innervated muscle units in treatment of volumetric muscle loss.
  • Extremity Fractures: Strategies to optimize patient outcomes after extremity fracture, i.e., time to begin rehabilitation, weight-bearing strategy.
  • Pelvic Ring Injuries: Treatment strategies to improve outcomes of complex pelvic ring injuries.
  • Compartment Syndrome: Strategies to improve current diagnoses for compartment syndrome.
  • Gaps in Clinical Practice Guidelines: Address gaps in current orthopaedic clinical practice guidelines (CPG) and recommendations (http://www.usaisr.amedd.army.mil/cpgs.html). Applications under this focus area must specify which orthopaedically relevant CPG their application is intended to support. Applicants should also highlight the expected impact of their research on orthopaedic clinical practice.
  • Surgical Techniques to Optimize Gait: Identify surgical techniques to optimize gait efficiency and outcomes for patients with amputation or limb salvage.
  • Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments affecting return to duty, work, or reintegration.

Rehabilitation Focus Areas:

  • Post-Operative Pain Management: Develop strategies for post-operative pain management following orthopaedic trauma that minimize or eliminate opioid use. The primary outcome measures should relate to rehabilitation endpoints and not focus solely on pain scores.
  • Prosthetic and/or Orthotic Device Function: Development and optimization of novel and/or innovative technologies to improve prosthetic and/or orthotic device function and durability, including intuitive efferent and afferent user interfaces and considerations to interoperability.
  • Secondary Physical Health Effects: Techniques or technologies that improve prediction, identification, and reduction of secondary physical health effects (e.g., obesity, arthrosis, osteoporosis, cardiovascular disease) following severe/high-energy traumatic neuromusculoskeletal non-spinal cord injury. The focus should be on injuries sustained between the ages of 18-50 and secondary physical health effects that develop within 5 years of injury.
  • Physical or Occupational Therapy: Development and/or validation of optimal physical or occupational therapy treatment strategies and sequence of progression throughout the rehabilitation continuum to maximize functional outcomes following severe neuromusculoskeletal injury, excluding central nervous system. Examples include optimal dose, timing, frequency, duration, and intensity of rehabilitation interventions.
  • Barriers to Successful Therapy Outcomes: Identify, quantify, and stratify confounding treatable factors (e.g., pain, sleep, nutrition, compliance, etc.) that inhibit or delay optimal orthopaedic rehabilitation outcomes.
  • Rehabilitation Outcomes: Development of validated, standardized measures to objectively assess and improve rehabilitation outcomes, including multi-extremity trauma and/or psychosocial resiliency and reintegration, following neuromusculoskeletal injury.

Award Mechanism Eligibility Key Mechanism Elements Funding
Applied Research Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Pre-application is required; Full application submission is by invitation only.
  • Supports applied research applications focused on advancing optimal treatment and restoration of function for military personnel with musculoskeletal injuries sustained during combat or combat-related activities
  • Applications must address one and only one of the FY16 PRORP Focus Areas.
  • Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation.
  • Clinical trials are not allowed under this award mechanism.
  • Maximum funding of $500,000 for total costs (direct costs plus indirect costs)
  • Maximum period of performance is 3 years
  • All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.
  • The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.
Clinical Trial Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Pre-application is required; Full application submission is by invitation only.
  • Supports the rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries, or non-battle injuries that significantly impact unit readiness and return-to-duty/work rates
  • Applications must address one and only one of the FY16 PRORP Focus Areas.
  • Funding must support a clinical trial and may not be used for preclinical research studies.
  • Collaboration with military researchers and clinicians is encouraged.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.
  • Maximum funding of $3 Million for total costs (direct costs plus indirect costs)
  • Maximum period of performance is 4 years
  • All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.
  • The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.
Integrated Clinical Trial Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications
  • Pre-application is required; Full application submission is by invitation only.
  • Supports the rapid implementation of inter-disciplinary clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries, or non-battle injuries that significantly impact unit readiness and return-to-duty/work
  • Applications must address at least two (minimum of one Surgical Care and one Rehabilitation) and a maximum of four of the FY16 PRORP Focus Areas.
  • Required Qualified Collaborator: To encourage meaningful and productive multidisciplinary collaborations, there must be at least one investigator with rehabilitation expertise and at least one clinician who specializes in orthopaedic or trauma care.
  • Collaboration with military researchers and clinicians is encouraged.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.
  • Maximum funding of $4.5 Million for total costs (direct costs plus indirect costs)
  • Maximum period of performance is 4 years
  • All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.
  • The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.
Clinical Translational Research Award
  • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
  • Pre-application is required; Full application submission is by invitation only.
  • Supports research that evaluates the effectiveness of health care practices and/or interventions with potential to impact the standard of care and contribute to evidence-based guidelines for the evaluation and care of Military or Veteran amputee and/or limb salvage patients.
  • Applications must address at least one of the FY16 PRORP Rehabilitation Focus Areas.
  • Funding must support clinical research studies involving humans.
  • Preliminary or published data relevant to the proposed research project are required.
  • Collaboration with military researchers and clinicians is encouraged.
  • Studies that include active duty military or Veteran participants as all or a portion of the study population will be considered.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.
  • Maximum funding of $2 Million for total costs (direct costs plus indirect costs)
  • Maximum period of performance is 4 years
  • All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.
  • The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Applications must be submitted through the federal government's single-entry portal, Grants.gov. Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released go to the CDMRP website (https://CDMRP.HEALTH.MIL) and select Subscribe to Funding Opportunities & Program Communications. For more information about the PRORP or other CDMRP-administered programs, please visit the CDMRP website (https://CDMRP.HEALTH.MIL).



Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil