Peer Reviewed Orthopaedic Applied Research Award

Description

The FY17 PRORP Applied Research Award (ARA) seeks 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. 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 a primary FY17 PRORP Focus Area listed in Section II.A.1, above. 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. The FY17 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. The anticipated total costs budgeted for the entire period of performance for an FY17 PRORP ARA award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. Research Scope: Research proposed under the FY17 PRORP ARA may include small- to large- scale projects. These awards are expected to yield potential health products, approaches, or technologies positioned for human testing. Upon successful completion, the proposed research is expected to yield knowledge products, approaches, or technologies that have the potential to advance toward clinical translation. Applicants to the FY17 PRORP ARA are asked to consider, where appropriate, the inclusion of large animal studies in their research plan. Inclusion of preliminary and/or published data relevant to the proposed research is required. In addition, investigators must demonstrate logical reasoning. 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 FY17 PRORP ARA may include, but are not limited to: • Refinement of concepts and ideas into potential solutions 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. Awards may not be used to support clinical trials. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For more information on how to distinguish clinical research from clinical trials, see the Human Subject Resource Document at https://ebrap.org/eBRAP/public/Program.htm. Investigators seeking support to conduct a clinical trial should apply to one of the other FY17 PRORP award mechanisms, which can be accessed at http://cdmrp.army.mil/funding/default.shtml. 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 USAMRMC 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. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource 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. 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, S.C., et al. A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (http://www.nature.com/nature/journal/v490/n7419/nature11556/). 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 (Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines can be found at http://www.elsevier.com/ data/promis_misc/622936arrive_guidelines.pdf. Research Involving Animals: All Department of Defense (DoD)-funded research involving new and ongoing research with animals must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (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. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. Principal Investigators (PIs) must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled “Research Involving Animals.” Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies. Refer to General Application Instructions, Appendix 1, for additional information. 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 Landis, S.C., et al. A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (http://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. Use of Military and VA Populations or Resources: If the proposed research plan involves access to active duty military and/or VA patient populations or resources, the PI is responsible for establishing such access. If possible, access to target active duty military and/or VA patient populations/resources should be confirmed at the time of application submission by inclusion of a letter of support, signed by the lowest ranking person with approval authority, for studies involving active duty military Service members, Veterans, military- and/or VA-controlled study materials, and military and/or VA databases. If access cannot be confirmed at the time of application submission, the Government reserves the right to withhold or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resources. Note that access to a Veteran population for clinical studies may only be obtained by either collaboration with a VA investigator, where the VA investigator has a substantial role in the research, or by advertising to the general public. Use Attachment 2 to provide this documentation (see Section II.D.2.b.ii, Full Application Submission Components, Attachment 2: Supporting Documentation ). Encouraged DoD and/or VA Collaboration and Alignment: Military relevance is a key feature of this award. Therefore, PIs are strongly encouraged to collaborate, integrate, and/or align their projects with military and/or VA research laboratories and programs. Although not a comprehensive list, the following websites may be useful in identifying information about ongoing DoD and VA areas of research interest, ongoing research, or potential opportunities for collaboration: Air Force Office of Scientific Research http://www.wpafb.af.mil/afrl/afosr/ Air Force Research Laboratory http://www.wpafb.af.mil/afrl Armed Forces Radiobiology Research Institute http://www.usuhs.edu/afrri/ Clinical and Rehabilitative Medicine Research Program https://crmrp.amedd.army.mil Military Operational Medicine Research Program https://momrp.amedd.army.mil Naval Health Research Center http://www.med.navy.mil/sites/nhrc Navy and Marine Corps Public Health Center http://www.nmcphc.med

Agency Contact

More from Defense Health Agency Contracting Activity - DHACA