Opportunity Information: Apply for W81XWH 21 S TBIPH2
The FY21 DoD Traumatic Brain Injury and Psychological Health (TBIPHRP) Focused Program Award (FPA) is designed to push the field toward practical, clinically meaningful solutions for traumatic brain injury and/or psychological health. Instead of funding a single standalone study, this mechanism is built to support a coordinated, multidisciplinary research program that can answer a critical, high-priority question and translate findings into real-world impact. The expectation is that funded work will move toward clinical application, such as new or improved healthcare products, technologies, clinical decision tools, and practice guidelines, with a clear line of sight to improving care for patients affected by TBI and related psychological health conditions.
A central requirement is that applicants define one unifying, overarching challenge: a single big problem or question that matters to patient care or the research field and that fits within at least one sub-area of one of the program's three designated FY21 focus areas. The proposed program then has to tackle that challenge through multiple distinct research projects that are intentionally designed to complement one another. The program strongly encourages at least four separate projects (more are allowed), each led by its own project leader, with projects that are individually strong but also clearly interrelated and synergistic. The emphasis is on a coordinated set of approaches or hypotheses that, when combined, can advance a solution faster or more convincingly than separate, unrelated studies could. At the same time, the award is not meant for a chain of projects where later work only happens if an earlier project succeeds; each project should stand on its own and produce useful outcomes even if another project runs into setbacks.
In terms of scientific scope, the FPA supports applied research, preclinical research, clinical research, and clinical trials, including trials that test promising products or strategies. This can include evaluating new products, new indications for existing treatments, drugs or biologics, devices, clinical guidance, or emerging technologies and approaches. The announcement also explicitly welcomes hypothesis-driven health services research, follow-up care research, and implementation science, including studies that examine how to overcome real-world barriers to adoption, scale-up, sustainability, or even de-implementation of ineffective or harmful practices. One key limitation is that basic research is not the target for this mechanism. Applicants are also expected to provide preliminary data for each project to justify the hypothesis or objectives and to show that the work is positioned to progress toward translational and clinical impact during the award period.
The application must include a detailed implementation plan that lays out critical milestones and shows how the team will get from current evidence to deliverables that matter. Reviewers will be looking for a credible operational strategy: what resources will be used, what technical innovations make success plausible, and how progress will be tracked across projects and toward the overarching challenge. Where appropriate, applications need robust statistical planning and statistical expertise, along with clear methods for monitoring performance at both the project level and the overall program level. For collaborations that span multiple institutions, the proposal should spell out how the partners will communicate, share and transfer data, and manage specimens and study products. The program also requires an intellectual property and material property plan agreed to by the participating organizations, reflecting the practical, translational focus and the expectation that outputs may move toward real-world deployment.
The award is meant to be led by a Principal Investigator with a track record of running large, focused efforts, and the PI must commit at least 20 percent effort to the project. The research team must be multidisciplinary, with clearly identified project leaders whose combined expertise creates a strong, integrated program rather than a collection of loosely connected studies. The program also anticipates active engagement with the TBIPHRP Science Officer assigned to the award; applicants should plan for team meetings (for example, annual full-team meetings) that include inviting the Science Officer to participate. In addition, a formal Milestone Meeting is required after the end of year 2 in the National Capital Area, where the PI will present progress to a group that may include the programmatic panel, CDMRP staff, the grants/contracts officer, and other DoD stakeholders; the PI may bring up to three additional team members.
Military health relevance is a defining feature. Applicants are expected to show how their program addresses needs tied to the health, readiness, and care of Service Members, Veterans, and military beneficiaries, while also ideally producing benefits that translate to civilian care (a dual-use value proposition). Proposals can strengthen this relevance by using military or Veteran populations, samples, or datasets when appropriate, and by collaborating with DoD or VA investigators. The announcement encourages alignment with existing DoD and VA research labs and programs, and it explicitly supports partnerships between military/Veterans institutions and non-military organizations to leverage unique infrastructure and data resources.
Administratively, the opportunity (W81XWH-21-S-TBIPH2) is offered by the Department of Defense through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under CDMRP. Awards may be issued as either grants or cooperative agreements, with the choice depending on whether substantial government involvement is expected during performance. The DoD anticipated allocating about $40 million total to fund roughly five awards. The original application closing date was December 16, 2021, and awards were to be made no later than September 30, 2022, with FY21 funds anticipated to expire for use on September 30, 2027.
For clinical trials, the program includes additional expectations and compliance requirements. The announcement uses a standard definition of a clinical trial (prospective assignment of human subjects to an intervention to evaluate effects on health-related outcomes) and notes that funded trials must post the IRB-approved informed consent form on a publicly available federal website in line with federal human subjects protections requirements (32 CFR 219). It also clarifies regulatory expectations for FDA-regulated products: if a trial involves an unapproved investigational use of a drug/biologic, an IND may be required, and if it involves a device, an IDE may be required. If required, an active IND/IDE without a clinical hold must be in place by the proposal submission deadline, and the authorization must match the product/device and indication being tested. The program also encourages innovative, efficient trial designs (such as Bayesian or adaptive approaches, basket trials, or stepped wedge designs) when they fit the scientific and ethical context, reflecting an interest in accelerating learning while maintaining rigor.
Overall, this grant mechanism is aimed at teams that can organize a large, coherent program around one pressing TBI and/or psychological health challenge, execute multiple coordinated projects with strong preliminary support, and deliver translational outcomes that can realistically change clinical practice or healthcare delivery for military and civilian populations.Apply for W81XWH 21 S TBIPH2
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Traumatic Brain Injury and Psychological Health, Focused Program Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Aug 06, 2021.
- Applicants must submit their applications by Dec 16, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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FAQs: FY21 DoD Traumatic Brain Injury and Psychological Health (TBIPHRP) Focused Program Award (FPA)
What is the TBIPHRP Focused Program Award (FPA) intended to fund?
The FY21 DoD TBIPHRP Focused Program Award is intended to fund a coordinated, multidisciplinary research program (not a single standalone study) that pushes toward practical, clinically meaningful solutions for traumatic brain injury (TBI) and/or psychological health. The emphasis is on translating findings into real-world impact, such as healthcare products, technologies, clinical decision tools, and practice guidelines that can improve care.
Is this award meant for one research project or multiple projects?
It is meant for multiple distinct research projects that are intentionally designed to complement one another under one unified program. The announcement strongly encourages at least four separate projects (more are allowed), each led by its own project leader, and designed to be synergistic.
What is the "one unifying, overarching challenge" requirement?
Applicants must define a single, overarching challenge: one big problem or critical question that matters to patient care or the research field and that fits within at least one sub-area of one of the program's three designated FY21 focus areas. The entire research program must be organized around solving or answering that one challenge.
How should the individual projects relate to each other?
Each project should be individually strong and able to produce useful outcomes on its own, while also clearly interrelated with the other projects. The program is looking for synergy where the combined projects advance a solution faster or more convincingly than unrelated studies could.
Are "dependent" or sequential projects allowed (where later work only happens if earlier work succeeds)?
The award is not meant for a chain of projects where later work can only proceed if an earlier project succeeds. Each project should stand on its own and still generate valuable outcomes even if another project experiences setbacks.
What types of research does the FPA support?
The FPA supports applied research, preclinical research, clinical research, and clinical trials. It can include testing promising products or strategies, evaluating new products, new indications for existing treatments, drugs or biologics, devices, clinical guidance, and emerging technologies and approaches.
Does the opportunity support health services research or implementation science?
Yes. The announcement explicitly welcomes hypothesis-driven health services research, follow-up care research, and implementation science. This includes studies on overcoming real-world barriers to adoption, scale-up, sustainability, and even de-implementation of ineffective or harmful practices.
Is basic research a good fit for this mechanism?
No. Basic research is not the target for this mechanism. The award is oriented toward translational and clinical impact, with a clear path to deliverables that matter in practice.
Is preliminary data required?
Yes. Applicants are expected to provide preliminary data for each project to justify the hypothesis or objectives and to demonstrate the program is positioned to progress toward translational and clinical impact during the award period.
What is required in the implementation plan?
The application must include a detailed implementation plan with critical milestones and a credible operational strategy. Reviewers will be looking for how resources will be used, what technical innovations support feasibility, and how progress will be tracked across individual projects and toward the overarching challenge.
Are statistical plans and expertise expected?
Yes. Where appropriate, applications need robust statistical planning and statistical expertise, along with clear methods for monitoring performance at both the project level and the overall program level.
What collaboration details are expected for multi-institution programs?
If the program spans multiple institutions, the proposal should explain how partners will communicate, share and transfer data, and manage specimens and study products.
Is an intellectual property (IP) and material property plan required?
Yes. The program requires an intellectual property and material property plan agreed to by the participating organizations. This reflects the translational focus and the expectation that outputs may move toward real-world deployment.
Who should lead the program, and what is the PI effort requirement?
The award is intended to be led by a Principal Investigator with a track record of running large, focused efforts. The PI must commit at least 20 percent effort to the project.
How is the research team expected to be structured?
The team must be multidisciplinary and include clearly identified project leaders. The combined expertise should form a strong, integrated program rather than a collection of loosely connected studies.
What level of DoD involvement should applicants expect during the award?
The opportunity anticipates active engagement with the TBIPHRP Science Officer assigned to the award. Applicants should plan for team meetings (for example, annual full-team meetings) and should include inviting the Science Officer to participate.
Is there a required in-person meeting?
Yes. A formal Milestone Meeting is required after the end of year 2 in the National Capital Area. The PI will present progress to a group that may include the programmatic panel, CDMRP staff, the grants/contracts officer, and other DoD stakeholders. The PI may bring up to three additional team members.
What does "military health relevance" mean for this opportunity?
Applicants must show how the program addresses needs tied to the health, readiness, and care of Service Members, Veterans, and military beneficiaries. Proposals are also expected to ideally produce benefits that translate to civilian care (a dual-use value proposition).
How can applicants strengthen the military health relevance of their proposal?
The announcement notes that relevance can be strengthened by using military or Veteran populations, samples, or datasets when appropriate, and by collaborating with DoD or VA investigators. It also encourages alignment with existing DoD and VA research labs and programs, including partnerships between military/Veteran institutions and non-military organizations.
Who is offering this funding opportunity?
The opportunity (W81XWH-21-S-TBIPH2) is offered by the Department of Defense through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP).
Will awards be issued as grants or cooperative agreements?
Awards may be issued as either grants or cooperative agreements. The choice depends on whether substantial government involvement is expected during performance.
How many awards and how much total funding were anticipated?
The DoD anticipated allocating about $40 million total to fund roughly five awards.
What were the key dates mentioned for this opportunity?
The original application closing date was December 16, 2021. Awards were to be made no later than September 30, 2022. FY21 funds were anticipated to expire for use on September 30, 2027.
Are clinical trials allowed under this mechanism?
Yes. The FPA supports clinical trials, including trials designed to test promising products or strategies, as part of a broader focused program.
How does the announcement define a clinical trial?
It uses a standard definition: prospective assignment of human subjects to an intervention to evaluate effects on health-related outcomes.
What informed consent posting requirement applies to funded clinical trials?
Funded trials must post the IRB-approved informed consent form on a publicly available federal website, consistent with federal human subjects protections requirements (32 CFR 219).
What are the FDA regulatory expectations for trials involving drugs/biologics or devices?
If a trial involves an unapproved investigational use of a drug or biologic, an IND may be required. If it involves a device, an IDE may be required.
If an IND or IDE is required, when must it be in place?
If required, an active IND/IDE without a clinical hold must be in place by the proposal submission deadline, and the authorization must match the product/device and indication being tested.
Does the program encourage innovative clinical trial designs?
Yes. The announcement encourages innovative and efficient trial designs when appropriate, including Bayesian or adaptive approaches, basket trials, or stepped wedge designs, to accelerate learning while maintaining rigor.
What kinds of outcomes is the program ultimately trying to produce?
The program is intended to deliver translational outcomes with a clear line of sight to improving care, such as new or improved healthcare products, technologies, clinical decision tools, and practice guidelines that can change clinical practice or healthcare delivery for military and civilian populations.
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| DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award Apply for W81XWH 21 S TBIPH1 Funding Number: W81XWH 21 S TBIPH1 Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Traumatic Brain Injury and Psychological Health, Translational Research Award Apply for W81XWH 21 TBIPHRP TRA Funding Number: W81XWH 21 TBIPHRP TRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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