Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Joshua D McKean Grants Officer

Description:

The FY24 RTRP Idea Discovery Award is intended to support innovative, untested, high-risk/ potentially high-reward concepts, theories, paradigms, and/or methods relevant to reconstructive transplant. The outcome of research supported by this award should be the generation of robust data that can be used as a foundation for new avenues of scientific investigation.

Important aspects of this award mechanism include:

• Innovation: The proposed project should be novel and innovative. Innovative research may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other uniquely creative qualities. If the proposed project is building upon established research performed in solid tissue organs, there must be justification for how the proposed theory is novel. Research that is an incremental advance upon published data or a logical progression of an already established research project is not considered innovative and will not be considered for funding under this award mechanism.

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 it’s 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.

• Hypothesis and Rationale: The proposed research project should include a well-formulated testable hypothesis based on strong scientific rationale and study design. If a model system is included in the research, it should be appropriate for the study and applicable to VCA.

• Preliminary Data: Inclusion of preliminary and/or published data that support the scientific rationale or evidence that the proposed work can be completed are required; however, the proposed work should be innovative and untested.

• Impact: Applications must address at least one of the FY24 RTRP IDA Focus Areas. The anticipated outcome(s)/product(s), including material and/or knowledge products, should be clearly articulated, as should the anticipated long-term gains from this research trajectory.

• Military Relevance: All projects should 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.

Advancing Women’s 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 women’s 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.

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.

Because the FY24 RTRP Idea Discovery Award is designed for preliminary investigations, projects involving human subjects or anatomical substances will not be supported unless they are exempt under Title 32, Code of Federal Regulations, Part 219, Section 104(d) (32 CFR 219.104[d]) or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110. Studies that do not qualify for exempt status or expedited review will be administratively withdrawn and will not be funded. Therefore, 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 Idea Discovery Award should not exceed $500,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

DOD FY24 Reconstructive Transplant Idea Discovery Award 7

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $2.5M to fund approximately five Idea Discovery 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.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org