DoD Traumatic Brain Injury and Psychological Health, Focused Program Award

The intent of the FY22 TBIPHRP FPA is to optimize research and accelerate solutions to a

critical question related to at least one sub-area within one of the three FY22 TBIPHRP FPA Focus

Areas. The award mechanism supports development 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 healthcare products, technologies, and/or practice

guidelines. Proposals/applications may propose applied/preclinical/clinical research and clinical

trials. Clinical trials may be designed to evaluate promising new products, new indications,

pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches

and technologies. Hypothesis-driven health services research, implementation science, and

follow-up care research are also within scope for this mechanism.

Proposed clinical trials should demonstrate feasibility or inform the design of more advanced

trials that determine efficacy in relevant patient populations.

Key aspects of this award include:

Overarching Challenge: FPA proposals/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 FY22 TBIPHRP FPA Focus Areas.

Research Projects: Proposals/applications shall include multiple, distinct research projects led

by individual project leaders that address complementary aspects of the overarching challenge.

Applicants are strongly encouraged to submit a minimum of four research projects; additional

studies are allowed. 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

should not include basic research.3 Preliminary data should 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 proposal/application by ensuring no contact with, recruiting of, or naming of

specific EAB members in the proposal/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 proposal/application’s supporting documentation.

Research Team: The overall effort will be led by a Principal Investigator (PI) with demonstrated

success in leading large, focused 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 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

proposal/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 to be held in the National Capital Area after the

conclusion of year 2 of the period of performance. The PI may bring up to three additional members

of the research team to the meeting. The Milestone Meeting will be attended by members of the

TBIPHRP Programmatic Panel, CDMRP staff, the USAMRAA Grants/Contracts Officer, and other DOD

stakeholders.

Relevance to Military Health: Relevance to the healthcare needs of Service Members, DOD

beneficiaries, 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, DOD beneficiaries,

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

• Collaboration with DOD or Department of Veterans Affairs (VA) investigators or consultants

Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA

research laboratories and programs. Collaborations between researchers at military or Veterans

institutions and non-military institutions are strongly encouraged. These relationships can

leverage knowledge, infrastructure, and access to unique data and research resources that the

partners bring to the research effort, ultimately advancing TBI and psychological health research

of significance to Service Members, DOD beneficiaries, and Veterans. A list of websites that may

be useful in identifying additional information about ongoing DOD and VA areas of research interest or

potential opportunities for collaboration can be found in Appendix II.