The Department of Defense is offering the Traumatic Brain Injury and Psychological Health Focused Program Award to accelerate solutions and optimize research for TBI and psychological health.

The intent of the FY21 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 FY21 TBIPHRP FPA Focus Areas. The award mechanism supports development of a synergistic, multidisciplinary research program with the potential to have a significant impact on TBI and/or psychological health 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: Focused Program Award 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 FY21 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 research2. 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 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 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.

Refer to Section II.D.6, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.

The USAMRDC executes its extramural research program primarily through the awarding of contracts and assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. An assistance agreement (grant or cooperative agreement) is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).

Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award.

A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. government.

The award type, along with the start date, will be determined during the negotiation process.

Please see Appendix 2, Section E, of the General Submission Instructions for more information.

Relevance to Military Health: Relevance to the healthcare needs of Service Members, Veterans, military beneficiaries, and the American public 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 TBI and/or psychological health that has direct relevance to the health and/or readiness of Service Members, Veterans, military beneficiaries, and the American public

 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, Veterans, military beneficiaries, and the American public. 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.

The CDMRP expects to allot approximately $40.0M to fund approximately five FY21 TBIPHRP FPA proposals/applications. Funding of proposals/applications received is contingent upon the availability of federal funds for this program as well as the number of proposals/applications received, the quality and merit of the proposals/applications as evaluated by scientific 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.

This BAA may support applied research, preclinical research, clinical research, and clinical trials/testing (or equivalent). Focused Program Award proposals/applications that include a clinical trial have additional proposal/application and review requirements. This BAA may not be used to support studies requiring an exception from informed consent (EFIC).

For more information, see Section II.D.2, Content and Form of the Proposal/Application Submission and Section II.E.1, Criteria.

A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219).

Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB review Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.

Research Involving an FDA-Regulated Drug, Biologic, or Device: If a proposed clinical trial involves the use of a drug or biologic that has not been approved by the FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND is not required. If an IND is required, an IND without a partial or complete clinical hold status must be obtained by the FY21 TBIPHRP FPA proposal/application submission deadline. The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.

If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required or if the device qualifies for an abbreviated IDE. If an IDE is required, an active IDE without a partial or complete clinical hold status must be obtained by the FY21 TBIPHRP FPA proposal/application submission deadline. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial. For more information on IDE applications, the FDA has provided guidance at https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide.

Innovative Clinical Trial Design: When appropriate, the TBIPHRP encourages the use of innovative clinical trial design approaches (e.g., Bayesian, adaptive, clinical bio-equivalence, seamless, exploratory/phase 0, basket, stepped wedge) that improve efficiency and ability to determine clinical benefit while maintaining validity, integrity and ethical considerations. Implementation Research: Research from this announcement may support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures to understand, prevent, and treat TBI and psychological health are encouraged.

 For the purposes of this announcement, implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.