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Congressionally Directed Medical Research Programs -- Reconstructive Transplant Research Program -- Investigator-Initiated Research Award
The FY21 RTRP Investigator-Initiated Research Award is intended to support studies that have the potential to make an important contribution to reconstructive transplant research, patient care, and/or quality of life. Though the RTRP Investigator-Initiated Research Award mechanism supports groundbreaking research, all projects must demonstrate solid scientific rationale with military-relevant utility.
Investigator-Initiated Research Award applications may focus on any phase of research from basic through translational, including preclinical studies in animal models, human subjects, human anatomical substances, as well as correlative studies associated with an existing clinical trial. Clinical trials are not allowed under this funding opportunity. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Two new options are available in FY21 under the Investigator-Initiated Research Award, and each are subject to unique funding limits and periods of performance.
Retrospective Focus Area Single PI Option: The Retrospective Focus Area Single PI Option supports retrospective studies related to VCA that are conducted under one PI.
Retrospective Focus Area Multiple PI Option: The Retrospective Focus Area Multiple PI Option supports multi-institutional collaborations for retrospective studies related to VCA that are conducted under two to four PIs, each of which must be associated with a separate institution. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI(s) will be identified as Partnering PI(s). Initiating and Partnering PIs will each have different submission requirements, as described in Section II.D.2, Content and Form of the Application Submission; however, all PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, SOW, and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization.
• Required Pre-Application Deadline: Sep 15, 2021
• Invitation to Submit an Application: Oct. 2021
• Application Submission Deadline: Dec. 8, 2021
Areas of Interest
To meet the intent of the FY21 RTRP Investigator-Initiated Research Award mechanism, applicants must address at least one of the FY21 RTRP Investigator-Initiated Research Award Focus Areas listed below (select both a bolded Focus Area and the appropriate subtopic):
Reduce the risks of VCA-associated immunosuppression
• Define the unique manifestations and/or mechanisms of VCA immunogenicity
• Develop novel approaches for achieving VCA immune tolerance
• Develop less-toxic regimens for maintenance immunosuppression
• Identify unique immunosuppression requirements for VCA compared to other solid organ transplants.
Develop reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-ofcare testing or home monitoring
• Develop reliable non-invasive biomarkers for monitoring chronic VCA graft rejection in a large animal model or banked specimens and medical records
• Identify and/or validate new peripheral biomarkers for acute and chronic rejection
• Develop assays or devices for clinical graft monitoring utilizing validated biomarkers
Retrospective studies for VCA
• Comparison of solid organ immunosuppression protocols and outcomes vs. VCA immunosuppression protocols and outcomes
• Comprehensive assessment of VCAs performed to date, to include but not limited to: ○ Patient selection ○ Immunosuppression protocols employed ○ Long-term recipient outcomes Graft performance (e.g., reinnervation and utility) Chronic rejection Graft status ○ Quality of life (e.g., physical/mental function, daily activities, social participation)
• Assessment of frequency, duration, and severity of rejection episodes, treatment interventions to mitigate rejection episodes, and immunosuppression-related complications (e.g., infection, end organ dysfunction)
• Assessment of VCA outcomes compared to age- and level of injury-matched prosthesis users
Independent investigators at all academic levels (or equivalent) are eligible to be named as a PI (or Initiating or Partnering PI for the Multiple PI Option). There are no limitations on the number of applications for which an investigator may be named as a PI (or Initiating or Partnering PI for the Multiple PI Option); however, the RTRP strongly encourages PIs to focus on the quality of their applications rather than quantity.
The anticipated total costs budgeted for the entire period of performance for an FY21 RTRP Investigator-Initiated Research Award will not exceed $1M for Single PI applications, $1.5M for applications submitted under the Multiple PI Option, $250,000 for applications submitted under the Retrospective Focus Area Single PI Option, and $375,000 for applications submitted under the Retrospective Focus Area Multiple PI Option.