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: Teresa M Parker-Reeser Grants Officer

Description:

The intent of the FY24 TBIPHRP FPA is to accelerate the development of solutions to critical question(s) related to at least one sub-area within one of the three FY24 TBIPHRP FPA Focus Areas. The award mechanism supports execution of a synergistic, multidisciplinary research program with the potential to have a significant impact on psychological health conditions and/or TBI through clinical applications, including health care products, technologies, and/or practice guidelines. Applications may propose applied/preclinical/clinical research (including clinical trials). Hypothesis-driven health services research, implementation science, and follow-up care research are also within scope for this mechanism.

Key aspects of the FY24 TBIPHRP FPA include:

• Overarching Challenge: FPA applications must describe a unifying, overarching challenge that will be addressed by the set of research projects proposed. The overarching challenge must be relevant to a critical problem or question in the field of research and/or patient care in at least one sub-area within one of the three FY24 TBIPHRP FPA Focus Areas.

• Research Projects: Applications shall include multiple, distinct research projects led by individual project leaders that address complementary aspects of the overarching challenge. Applicants are required to submit three to five research projects, of which, a clinical research/trial project is strongly encouraged. While individual projects must be capable of standing on their own high scientific merits, they must also be interrelated, synergistic, and align with the overarching challenge to advance a solution beyond what would be possible through individual efforts. The exploration of multiple hypotheses or viewpoints of the same line of questioning is encouraged. This award mechanism is not intended to support a series of research projects that are dependent on the success of one of the other projects. Each project should propose a unique approach to addressing the overarching challenge and be capable of producing research findings with potential to impact the field and/or patient care. Individual research projects may include applied research, preclinical research, clinical research, and clinical trials. Proposed research projects must not include basic research.5 Preliminary data must be included to support each project’s hypothesis/objective(s). There should be a clear intent to progress toward translational/clinical work over the course of the effort.

• Implementation: The research strategy to address the overarching challenge must be supported by a detailed implementation plan that identifies critical milestones and outlines the knowledge, resources, and technical innovations that will be utilized to achieve the milestones. A robust statistical plan and statistical expertise should be included where applicable. A plan for assessing individual project performance and progress toward addressing the overarching challenge must be included in the implementation plan. Plans to include an External Advisory Board (EAB) are encouraged; however, applicants must be careful to avoid potential conflicts of interest (COIs) during review of the application by ensuring no contact with, recruiting of, or naming of specific EAB members in the application. For multi-institutional collaborations, plans for communication and data transfer among the collaborating institutions, as well as how data, specimens, and/or products obtained during the study will be handled, must be included. An appropriate intellectual and material property plan agreed to by participating organizations is required in the application’s supporting documentation.

• Research Team: The overall effort will be led by a Principal Investigator (PI) with demonstrated success in leading large, focused collaborative projects. The PI is required to devote a minimum of 20% effort to this award. The PI should create an environment that fosters and supports collaboration and innovation in a way that engages all members of the team in all aspects of the research plan. The research team assembled by the PI should be highly qualified and multidisciplinary, with identified project leaders for each of the complementary and synergistic research projects. The resources and expertise brought to the team by each project leader should combine to create a robust, synergistic collaboration. The TBIPHRP Science Officer assigned to a resulting award should be invited to participate in research team meetings (e.g., annual meetings of the entire research team). The plan for such meetings should be noted in the application.

• Milestone Meeting: The PI will be required to present an update on progress toward accomplishing the goals of the award at a Milestone Meeting after the conclusion of year 2 of the period of performance. This virtual meeting will be attended by members of the TBIPHRP Programmatic Panel, CDMRP staff, the USAMRAA Grants/Contracts Officer, and other DOD stakeholders.

Clinical trials may be designed to evaluate promising new products, 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. Proposed clinical trials should demonstrate feasibility or inform the design of more advanced trials that determine efficacy in relevant patient populations. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/ Human%20Subjects%20Resource%20Document_DEC2022.pdf.

Research Scope: Applications to the FY24 TBIPHRP FPA may include preclinical applied research (including animal research), clinical research, and clinical trials/testing (or equivalent). The FY24 TBIPHRP ERA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials. This award may not be used to support studies requiring an exception from informed consent (EFIC).

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 more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf.

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.

Clinical trials may be designed to evaluate promising new products, 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. Proposed clinical trials should demonstrate feasibility or inform the design of more advanced trials that determine efficacy in relevant patient populations. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/ Human%20Subjects%20Resource%20Document_DEC2022.pdf.

Research Scope: Applications to the FY24 TBIPHRP FPA may include preclinical applied research (including animal research), clinical research, and clinical trials/testing (or equivalent). The FY24 TBIPHRP ERA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials. This award may not be used to support studies requiring an exception from informed consent (EFIC).

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 more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf.

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.

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 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 $46.5M to fund approximately six FPA 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