This grant opportunity from USAMRMC aims to establish a Consortium to conduct clinical studies focusing on improving acute care treatment and long-term rehabilitation outcomes of severe musculoskeletal injuries related to military combat. The Consortium will include a Coordinating Center collaborating with military treatment facilities and clinical study sites. Projects must be relevant to the military, have well-defined objectives, control for variables, and produce results likely to impact clinical practice. Studies must be clinical research or trials, with emphasis on human subjects. The Government will be heavily involved through a Steering Committee, ensuring research priorities align with the program’s goals. Award funds will support the Coordinating Center and associated studies at Clinical Study Sites.
Opportunity ID: 278827
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-15-PRORP-OCRCA |
| Funding Opportunity Title: | DoD Orthopaedic Care and Rehabilitation Consortium Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 01, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Dec 08, 2015 |
| Current Closing Date for Applications: | Dec 08, 2015 |
| Archive Date: | Jan 07, 2016 |
| Estimated Total Program Funding: | $18,000,000 |
| Award Ceiling: | $0 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The PRORP OCRCA mechanism is being offered for the first time in FY15. The PRORP OCRCA is intended to support the establishment of a Consortium that consists of multiple organizations and individuals collaboratively working on clinical studies that are focused on improving both acute care treatment outcomes and functional, long-term rehabilitation outcomes of severe musculoskeletal injuries commonly associated with military combat or combat-related activities. The Consortium will consist of a single Coordinating Center in collaboration with multiple military treatment facilities (MTFs) (required) and non-military Clinical Study Sites (encouraged). The Government anticipates that applicants will assemble an expert team from multiple institutions, including, but not limited to, academia, MTFs, other Government agencies, clinical research institutions, industry partners, and not-for-profit enterprises to satisfy the objectives of this Program Announcement/Funding Opportunity. It is expected that relevant clinical outcomes will require longitudinal evaluations to optimize recovery and restoration of function. At the end of the performance period, it is anticipated that the awardee will establish a strong infrastructure for continuing clinical studies on combat-relevant musculoskeletal injuries and produce products (information, practice guidelines, validated techniques, or devices) that result in changes to, or validation of, current clinical practices that lead to better outcomes for injured Service members, U.S. Veterans, and civilians. All projects should develop a procurement cost estimate for successful treatments so that the military and civilian medical community can conduct a cost-benefit analysis with current practice alternatives, as well as distinguish the optimal cost-effective treatments. Projects must be relevant to the military, have well-defined objectives, control for confounding variables, have a patient population that will allow for an appropriately robust sample size at each Site, be of high quality, and be capable of producing results that are likely to change practice. Studies involving non-military patient populations must describe how they simulate the targeted population (i.e., Armed Forces and/or the U.S. Veteran population). While large, randomized, controlled clinical studies are expected to be part of this multi-institutional Consortium effort, small randomized or pilot clinical trials and observational prospective studies to develop metrics or provide proof of principle to inform future clinical studies are also appropriate. All projects shall be limited to clinical research and 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. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. Clinical research encompasses studies in which individuals are observed or those where certain outcomes are measured. 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. Animal studies are excluded from consideration. The Coordinating Center must apply to this Program Announcement/Funding Opportunity through a single application, and may also serve as a Study Site. The PRORP OCRCA resulting from this Program Announcement/Funding Opportunity will be issued as a cooperative agreement between the recipient (Coordinating Center) and the Government. The Government will have substantial involvement in the Consortium through a Government Steering Committee (GSC) and U.S. Army Medical Research and Materiel Command (USAMRMC) staff interactions with the Consortium. The GSC will review research priorities and make recommendations to the Grants Officer’s Representative (GOR) for the GOR’s consideration, with ultimate approval decisions made by the USAMRAA Grants Officer (GO). Award funds will be used to support the Coordinating Center’s efforts as well as Consortium-associated studies at the Clinical Study Sites. The Coordinating Center will provide management and funding for the Clinical Study Sites through the appropriate subaward or other instrument. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 Email:help@eBRAP.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 278827 Full Announcement-1 -> prorp_fy15_ocrca_pa_gg.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk 301-682-5507 Email: help@eBRAP.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00218423 | Sep 01, 2015 | Dec 08, 2015 | View |
Package 1
Mandatory forms
278827 RR_SF424_2_0-2.0.pdf
278827 RR_Budget_1_3-1.3.pdf
278827 RR_KeyPersonExpanded_2_0-2.0.pdf
278827 PerformanceSite_2_0-2.0.pdf
Optional forms
278827 RR_SubawardBudget30_1_3-1.3.pdf
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