DoD Traumatic Brain Injury and Psychological Health, Health Services Research Award

Maturing research ideas into clinical practice and patient benefit is at the heart of all CDMRP research programs. Despite significant investment, the gap between what is possible and what is achieved remains. Even after information, tools, and interventions have been successfully evaluated in their intended populations, the development of knowledge to support their broader dissemination and implementation has often remained outside the scope. The FY24 TBIPHRP HSRA intends to bridge the gap between research, practice, and policy by building real-world evidence on how interventions, clinical practices/guidelines, and policies can be deployed to targeted populations at the appropriate time.Research Scope: The FY24 HSRA will fund clinical research (including clinical trials). Preclinical and animal research are prohibited. Prospective or retrospective clinical research or clinical trials involving human subjects, human subject data/records, and human anatomical substances are allowed. Proposed clinical trials should include interventions, clinical practices/guidelines, and policies that are well-supported within the literature and in relevant patient population(s). This award may not be used to support studies requiring an exception from informed consent (EFIC).Key aspects of the FY24 TBIPHRP HSRA: Precision Medicine Approaches: When appropriate, the TBIPHRP encourages the use of precision medicine approaches. These tailored treatments deliver the right treatment at the right time while considering an individuals unique characteristics. Community-Based Participatory Research: The application must include Community-Based Participatory Research (CBPR) approaches in the development and execution of the clinical research/trial. CBPR approaches should be documented in Attachment 8. Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical research/trial is required. Untested novel interventions are discouraged: Novel interventions that have not been evaluated in the intended population(s) are discouraged. Applicants seeking funding for novel interventions should consider one of the other FY24 TBIPHRP announcements. Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Inquiry Review Board [IRB] review) are exempt from this requirement. Clinical Trial Start Date: If applicable, the proposed clinical trial is expected to begin no later than 6 months after the award date. Intervention Availability: If applicable, the application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.The FY24 HSRA applications may include (not all inclusive): Research that accelerates the uptake and implementation of evidence-based research into clinical practice. Comparative effectiveness research comparing the benefits and harms of emerging or established interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings. Development and evaluation of strategies to overcome barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines. Analysis of existing data or resources to inform clinical practice. Modification of established clinical tools for their intended population or environment. Analysis of existing clinical tools to maximize patient-relevant outcomes. Identification and analysis of the circumstances that create a need to stop or reduce (de-implement) the use of interventions, tools, policies, and guidelines that are ineffective, unproven, low-value, or harmful are within scope. Analysis of TBI and/or psychological health outcomes associated with the implementation of clinical practice guidelines, evidence-based practices, and process improvements.Early-Career Investigator Partnering Option: The FY24 TBIPHRP HSRA includes an Early-Career Investigator Partnering Option that is structured to accommodate two Principal Investigators (PIs), one of whom is an Early-Career Investigator. The combined direct costs budgeted for the entire period of performance in the applications of the Initiating PI and Partnering PI should not exceed $2.5M. The PIs may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. One PI will be identified as the Initiating PI and will be responsible for most of the administrative tasks associated with application submission. The other investigator will be the Partnering PI. At least one of the Initiating or Partnering PIs must be an Early-Career Investigator. The intent is not to create mentor-mentee arrangement. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The application is expected to describe how the PIs unique experience/expertise combined as a partnership will better address the research question, how the unique experience/expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. If recommended for funding, each PI will be named to an individual award within the recipient organization(s). For individual FY24 TBIPHRP HSRA submission requirements for the Initiating and Partnering PI, refer to S Section II.D.2, Content and Form of the Application Submission.A clinical trial is defined in 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 more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf.Clinical trials may be designed to evaluate pharmacologic agents (drugs or biologics), diagnostics, devices, therapies, clinical guidance, behavioral interventions, emerging approaches and technologies, and/or new indications for products currently U.S. Food and Drug Administration (FDA)-approved or -cleared. Interventions that are not FDA-regulated (or international equivalent) are within scope but the regulatory status must be documented in Attachment 12, Regulatory Strategy.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 46.104(d)(4) of the Common Rule.Multi-Institutional Clinical Research/Trials: As of January 20, 2020, U.S. institutions engaged in non-exempt cooperative research must rely on a single IRB to review and approve the portion of the research conducted at domestic sites (45 CFR 46.114(b)). If the proposed, non-exempt research involves more than one U.S.-based institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Communication and data transfer between or among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed on by all participating institutions is also required for multi-institutional clinical research/trials.Relevance to Military Health: Relevance to the health care needs of Service Members, their Families, and Veterans is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health: Explanation of how the project addresses an aspect of psychological health conditions and/or TBI that has direct relevance to the health and/or readiness of Service Members, their Families, and Veterans. Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need. Use of military or Veteran populations, samples, or datasets in the proposed research, if appropriate.Awards supported with FY24 funds will be made no later than September 30, 2025.The CDMRP expects to allot approximately $15.5M to fund approximately four HSRA 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.