DoD Traumatic Brain Injury and Psychological Health, Investigator-Initiated Research Award

The FY23 TBIPHRP IIRA is intended to support studies that will make an important contribution toward understanding, preventing, assessing, and treating psychological health conditions and/or TBI. Research projects may focus on applied research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial.Applications should clearly demonstrate the project’s potential near-term and long-term outcome(s)/product(s) (knowledge and/or materiel) and how they will impact a critical problem or question in the field of research and/or patient care in the FY23 TBIPHRP IIRA Focus Areas(s) addressed. Research involving human subjects and human anatomical substances is permitted; however, this FY23 TBIPHRP IIRA may not be used to conduct clinical trials.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 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.Optimizing Research Impact Through Community Collaboration: Research funded by the FY23 TBIPHRP should be responsive to the psychological health conditions and/or TBI needs of the lived experience, family, and care provider communities. Through the establishment and utilization of effective and equitable collaborations and partnerships, the translational and impact potential of the proposed research can be maximized. For the FY23 TBIPHRP IIRA, inclusion of Community-Based Participatory Research (CBPR) approaches is encouraged, particularly for studies involving human subjects, but not required. The inclusion of CBPR can be documented in Attachment 11, CBPR Letters of Commitment, and Attachment 12, CBPR Statement, if applicable. CBPR supports collaborative research that involves scientific researchers and community members working together to address diseases and conditions, particularly those that disproportionately affect health disparity populations. Recognizing the strength of each partner, scientific researchers and community members collaborate and contribute equitably their expertise on all aspects of the project, which may include a needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. CBPR features shared responsibility for and ownership of the research project, and the research results are jointly interpreted, disseminated, and fed back to affected communities and may be translated into interventions or policy. CBPR methods are critically important for community-level interventions and conditions affecting health disparity populations. CBPR methods, such as Lived Experience Consultation (LEC), can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with psychological health conditions and/or TBI.CBPR collaborative relationships are often established through integrating community members into research teams as co-researchers, advisors, and consultants. CBPR team members cannot be employees of any of the organizations participating in the application. Some examples of CBPR collaborations include:• LEC: The research team includes at least one member with lived psychological health conditions and/or TBI experience who will provide advice and consultation throughout the planning and implementation of the research project. LECs may include individuals with a TBI or psychological health condition, their family members, or care partners. Ideally an LEC should an individual(s) nominated by a foundation or advocacy group in order to represent the diversity of those with TBI or psychological health conditions, vs. individual experiences.• Partnership with a community-based organization: The research team establishes partnerships with at least one community-based organization that provides advice and consultation throughout planning and implementation of the research project. Community- based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders.• Community advisory board (CAB): A CAB is composed of multiple community stakeholders and can take many forms, from a board of LECs to a coalition of community- based organizations or any combination thereof. As with LEC and organizational partners, the CAB provides advice and consultation throughout planning and implementation of the research project.Early-Career Investigator Partnering Option: The FY23 TBIPHRP encourages applications that include meaningful and productive collaborations between investigators. The FY23 TBIPHRP IIRA includes an Early-Career Investigator Partnering Option that is structured to accommodate two PIs, one of whom is an Early-Career Investigator. 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. One of the named PIs on an application submitted under the Early-Career Investigator Partnering Option must be an Early-Career Investigator who may be either the Initiating or Partnering PI. 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 organizations. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.The anticipated direct costs budgeted for the entire period of performance for an FY23 TBIPHRP IIRA should not exceed $500,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.
Categories: Science and Technology and other Research and Development.