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: Burzie C Baker III Grantor

Description:

The FY24 VRP FTTSA is intended to support a highly collaborative and translational team initiative that will fundamentally advance the understanding and treatment of eye injury and/or visual dysfunction that result from military exposure (e.g., blast, blunt, thermal, chemical, directed energy trauma).

Key aspects of the FTTSA include:

• Overarching Challenge: Team science is a collaborative effort that leverages the strengths of investigators specializing in different fields to address an overarching scientific challenge or question. To identify an overarching challenge or question that meets the intent of the FTTSA, investigators are strongly encouraged to consider barrier(s) to and/or gap(s) in the understanding, prevention, diagnosis, mitigation, and/or treatment of eye injury or visual dysfunction associated with military exposure and envision what may be achievable in 10 to 15 years. Based on the long-term expectation, investigators will identify what should and can be achieved in the short term and will design projects and research teams around these goals.

• Research Projects

○ Applications shall include at least three but no more than five distinct research projects that together form a concerted and synergistic effort to address the overarching challenge. Each project, as well as the overall effort, must align with one or more of the FY24 VRP Focus Areas. The potential topics of individual projects are wide-ranging. The examples provided below are illustrative and not exhaustive:

− Elucidation of molecular, cellular, and biophysical mechanisms of eye injury or visual dysfunction associated with military exposure

− Identification of significant changes in pathophysiology over time after military exposure to inform targeted treatments

− Identification of biomarkers and potential therapeutic targets

− Development and validation of therapeutic agents and/or devices

DOD FY24 Vision Focused Translational Team Science Award 5

− Development and validation of drug delivery platforms appropriate for eye injury or visual dysfunction associated with military exposure

− Development or improvement of clinically relevant trauma models

− Design of protection to mitigate the impact of military exposure on eye and vision

− Development of lightweight portable assessment or diagnostic capability

○ Individual projects must be capable of standing on their own scientific merits. The FY24 VRP FTTSA is not intended to support a series of research projects dependent on the success of any other project. Each project should propose a unique approach to address the overarching challenge and be capable of producing research findings with potential to impact the visual system trauma research field and/or patient care. Preliminary data to support the feasibility of each proposed research project are required.

○ Individual research projects may focus on any phase of research (e.g., basic, translational, applied, clinical, observational). The FY24 VRP FTTSA allows one of the projects to include a pilot clinical trial (PCT), but not a full-scale clinical trial. In contrast to full-scale clinical trials that are designed to determine safety or efficacy, the purpose of the PCT is to inform the feasibility, rationale, and design of subsequent clinical trials through limited clinical testing of a novel intervention. Applications that do include a PCT as part of the proposed research will have additional submission requirements and review criteria and should demonstrate sufficient understanding of regulatory approval requirements and the regulatory approval process.

• Implementation: The research strategy to address the overarching challenge should include a detailed implementation plan for participating research groups to coordinate efforts, facilitate collaboration, and create synergy through open and frequent communication, interaction, sharing of results/data/resources, and other means as applicable and necessary. The coordination, collaboration, and synergy are intended to advance a solution beyond what would be possible through individual efforts.

• Research Team: (New in FY24) The FY24 FTTSA is structured to have an Overall Lead Principal Investigator (PI) and multiple Project PIs. The Overall Lead PI will lead the overall effort as well as the execution of one project. The Overall Lead PI must have demonstrated success in leading large collaborative research project(s). Leaders of the other projects will be designated as Project PIs. Each PI may lead no more than one project.

o The Overall Lead PI will be responsible for the majority of the administrative tasks associated with application submission. Project PIs will have their own submission requirements. If recommended for funding, all PIs will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Overall Lead PI and Project PIs, refer to Section II.D.2, Content and Form of the Application Submission.

DOD FY24 Vision Focused Translational Team Science Award 6

o All key personnel should be committed to regular and open discussions of research plans, exchange of ideas, sharing of expertise and results, and other collaborative efforts. The CDMRP Science Officer assigned to a resulting award must be invited to participate in periodic research team meetings. The plan for such meetings should be noted in the application.

A clinical trial is defined in 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 retrospectively analyze data generated from previously conducted clinical trial(s) are not considered a clinical trial.

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.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org