DoD Reconstructive Transplant Research, Investigator-Initiated Research Award

The FY24 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. Important aspects of this award mechanism include: Study Design and Feasibility: The proposed study design should be clearly described, rigorous, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, as applicable. If a model system is included in the research, it should be appropriate for the study and applicable to VCA. Impact: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY24 RTRP Investigator-Initiated Research Award Focus Areas. Military Relevance: All projects must be responsive to the health care needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their Family members, caregivers, or clinicians, as well as the general public. Collaboration with military researchers and clinicians is encouraged, but not required. Preliminary Data: Observations that drive a research idea may be derived from laboratory discovery, population-based studies, a clinicians first-hand knowledge of patients, or anecdotal data. Preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed research must be included.Important Note: Leveraging novel findings from solid organ transplant research for testing in a VCA setting is acceptable if the rationale and benefits for doing so are appropriately explained and justified. For example, it should be clear why the anticipated result might be different in VCA, or why its important to confirm the result is the same in VCA, or why repeating the study in a VCA setting could lead to new mechanistic insights or a better understanding of unique aspects of VCA.Investigator-Initiated Research Award applications may focus on any phase of research from basic through translational, including preclinical studies in animal models, and clinical research in human subjects or human anatomical substances, as well as correlative studies associated with an existing clinical trial.Advancing Womens Health Research and Innovation: 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 womens health outcomes and/or advancing knowledge for women’s health. The RTRP therefore encourages research that addresses how various aspects of reconstructive transplant affect women uniquely, disproportionately, or differently from men.Multiple Principal Investigator (PI) Option: The Investigator-Initiated Research Award includes an option for up to four PIs. 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). All PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section II.D.2, Content and Form of the Application Submission.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 clinical and 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 (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 Department of Defense (DOD) or VA Resources: Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the VA, and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique 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.For research involving animals, human subjects, human anatomical substances, or human cadavers, please see to the General Application Instructions, Appendix 6, for more information.Clinical trials are not allowed under this funding opportunity. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is allowed under this funding opportunity. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.(3) Outcomes research and health services research that do not fit under the definition of clinical trial.Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under 46.104(d)(4) of the Common Rule.In-Progress Review: The RTRP holds annual In-Progress Review meetings in a virtual setting as a forum for award performers to present progress updates to the Programmatic Panel and RTRP staff. Award recipients may receive an invitation to present their project at one of these meetings during the period of performance of their award.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated total costs budgeted for the entire period of performance for an FY24 RTRP Investigator-Initiated Research Award should not exceed $1.0M for single PI applications and $1.5M for applications submitted under the Multiple PI Option. 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 $4.0M to fund approximately three Investigator-Initiated Research Award 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.