The intent of the FY24 RTRP Qualitative Research Validation and Implementation Award mechanism is to support the continued investigation and further expansion of highly impactful resources for the VCA community that were developed through RTRP-funded qualitative research studies.

These resources

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may benefit individuals throughout the VCA community, including those who are considering or who have already received reconstructive transplant surgery, as well as caregivers, potential donors and their families, and clinicians.

The RTRP recognizes that these resources are not yet deployable products and require further research to ready them for clinical and community use.

Proposed studies should expand previously funded qualitative research for the purposes of validating a VCA resource and/or investigating the most appropriate and effective methods and best practices for disseminating and/or implementing the resource.

Important Note:
This award mechanism is intended to support validation and implementation research, but not the costs of implementation itself.Qualitative research is a form of social inquiry that focuses on understanding how people interpret and make sense of their experiences and the world in which they live.

Observations that drive a research idea may be derived from basic discovery, population-based studies, a clinician’s first-hand knowledge of patients, or anecdotal data.

Qualitative research is intended to be exploratory, open-ended, and unbiased.

The information gathered should be meaningful and culturally appropriate to the participant, unanticipated (not hypothesis-based) by the research team, and rich and explanatory in nature.Implementation science is defined as the scientific study of methods and strategies to adopt and integrate evidence-based health interventions, resources, etc., into clinical and community settings in order to improve patient outcomes and benefit population health.

Implementation research may use a variety of qualitative and quantitative research methods to determine the most appropriate and effective way to transition interventions, resources, etc., into clinical practice, health policy, or everyday use.

The research should be specific to the target population and environment and consider real-world factors and complexities, including an evolving landscape.Important aspects of this award mechanism include:• Qualitative Approach:
The research approach should include primarily qualitative methods.

Qualitative findings may lead the research in a more quantifiable direction, in which case a mixed methods approach is acceptable.

The specific theoretical basis (e.g., interactionism, phenomenology, critical theory) for the study should be stated and should drive the framing of the research problem.• Preliminary data (required):
Applications must include an Outcomes Statement (Attachment 9), which is a summary of the research previously funded, and a description of the research accomplishments, outcomes, and resource(s) developed from that award.

Applications should provide an explanation of how these accomplishments, outcomes, and resource(s) provide the basis for the proposed research and how expansion of the original research ideas will address one or both of the FY24 RTRP Qualitative Research Focus Areas.• Study Design:
The proposed study design, sampling technique, data collection, and recording method(s) should be appropriate to yield trustworthy, credible, robust, and confirmable results.

The documentation of procedures, decisions, and rationale for decisions and conclusions should support consistency, dependability, and duplicability of results and prevent biases and preconceptions.

The data analysis plan should be consistent with the research problem and theoretical basis for the study, and ongoing feedback from participants should be incorporated throughout the project, especially regarding interpretation of data and study conclusions.

It should be clear how the proposed study design will position the resource(s) for the next phase of development or implementation as described in the post-award Implementation Plan (Attachment 10).• Impact:
The short- and long-term impact of the proposed research should be clearly articulated.

Projects must address one or both of the FY24 RTRP Qualitative Research 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.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.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, 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.Clinical trials are not allowed under this funding opportunity.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 4 6. 102 (45 CFR 4 6. 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.Clinical research is allowed under this funding opportunity.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research.

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 §4 6. 104(d)(4) of the Common Rule.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 Qualitative Research Validation and Implementation Award should not exceed $500,00 0. 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, 202 5. The CDMRP expects to allot approximately $500,000 to fund approximately one Qualitative Research Validation and Implementation Award application.

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, 203 0.