Opportunity Information: Apply for W81XWH 16 GWIRP IIRFA
Apply for W81XWH 16 GWIRP IIRFA
- The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Gulf War Illness Investigator-Initiated Focused Research 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 May 13, 2016 and posted on May 13, 2016.
- Applicants must submit their applications by Oct 20, 2016. (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 11 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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Opportunity Summary:
The DoD Gulf War Illness (GWI) Investigator-Initiated Focused Research Award (IIRFA) is a FY16 funding opportunity from the Department of Defense (DOD-AMRAA) under the Gulf War Illness Research Program. Although it was introduced as a new mechanism in FY16, it is essentially a continuation and refinement of the FY06-FY15 Investigator-Initiated Research Award, with a clearer emphasis on focused, impact-oriented projects. The central purpose is to support research that advances diagnosis or therapeutics for Gulf War Illness, while requiring applicants to spell out a credible pathway to eventual clinical impact for affected Veterans, even if the proposed work itself does not immediately produce a clinical outcome.
A key requirement is that proposed studies must be explicitly focused on Veterans of the 1990-1991 Persian Gulf War who are affected by GWI. Applicants are expected to make a direct, well-supported case for how the work will matter to Gulf War Veterans with GWI, rather than presenting general fatigue, pain, or multisystem illness research that is only loosely connected. The Principal Investigator is responsible for clearly articulating the project s potential impact on GWI, including why the work is important now and how it fits into a translational line of sight toward improved diagnostics or treatments.
The award is structured around three tiers, and applicants must choose the tier that matches the scope and maturity of their project (the guidance stresses that this choice should be driven by the stage and objectives of the science, not by the requested budget). Tier 1, the Discovery tier, is meant for innovative, high-risk/high-reward concepts at an early stage. Preliminary data are not required for Tier 1, but the application still needs strong rationale, clear objectives, and a solid study design. Appropriate projects include foundational work such as defining GWI pathobiology, identifying symptom clusters, or pursuing molecular characterization that could open new diagnostic or therapeutic directions, including ideas borrowed from other diseases that have not yet been examined in Gulf War Veterans with GWI.
Tier 2, Applied Research, is designed for more mature, evidence-supported ideas that are intended to accelerate progress toward a GWI diagnosis or treatment. Unlike Tier 1, Tier 2 requires preliminary data in the GWI field and should be built around a well-formed, testable hypothesis with translational potential. Examples include developing or refining diagnostic approaches, screening active compounds, and building methods to assess target engagement or to flag off-target risks. The expectation is that Tier 2 work is closer to practical application and should clearly move the field toward actionable diagnostics or therapeutic strategies.
Tier 3, Preclinical Validation, supports product-driven research aimed at validating and optimizing promising treatment candidates for GWI, including repurposing existing FDA-approved drugs or therapies for a GWI-related indication. Tier 3 applications must include preliminary data and supporting information appropriate to the proposed development stage, though that evidence does not necessarily need to originate from prior GWI-specific studies. This tier expects an identified bioactive lead (or a limited class of leads) and supporting details such as a plausible mechanism of action, proof of compound identity and purity, access to relevant bioactivity assays, and availability of preclinical GWI models to evaluate in vivo efficacy or mechanism-based activity. Supported activities may include secondary validation of leads, optimization of pharmacologic properties, formulation and stability work, development of GMP production methods, and assembling data typically needed for an Investigational New Drug (IND) submission.
For proposals involving biomarkers, the announcement adds an extra bar: applicants must justify why the biomarker(s) would be specific to Gulf War-related exposures rather than reflecting unrelated factors or post-deployment events. In addition, the program will not support projects that attempt to derive GWI diagnostic biomarkers solely from animal models, signaling that biomarker relevance to Gulf War Veterans and Gulf War-specific exposure context is a major review consideration.
Human subjects research is allowed, but the mechanism explicitly restricts studies to those without clinical trials. In this announcement, a clinical trial is defined as prospective enrollment of human subjects where an intervention is tested for measurable safety or efficacy outcomes (including drugs, devices, biologics, procedures, rehabilitation, behavioral interventions, and similar approaches). Acceptable human-subject work under this award includes retrospective analyses and other non-interventional clinical studies, but applicants who want to run an interventional clinical trial are directed to a different FY16 mechanism, the GWIRP Treatment Evaluation Award.
Administratively, the opportunity is listed as a discretionary program with funding instruments that may include grants and cooperative agreements, under CFDA 12.420. Eligibility is described as unrestricted, meaning a wide range of applicant organizations can apply, subject to any additional eligibility language in the full announcement. The posting and creation dates are May 13, 2016, with an application closing date of Oct 20, 2016, and the program anticipated making around 11 awards. The listing shows an award ceiling of 0, which typically indicates that the ceiling is either not specified in that summary field or is defined elsewhere in the full program announcement rather than as a single fixed cap in the synopsis.
FAQs: DoD Gulf War Illness (GWI) Investigator-Initiated Focused Research Award (IIRFA) (FY16)
What is the DoD Gulf War Illness (GWI) Investigator-Initiated Focused Research Award (IIRFA)?
The IIRFA is a FY16 Department of Defense (DOD-AMRAA) funding opportunity under the Gulf War Illness Research Program. It supports investigator-initiated, focused, impact-oriented research intended to advance diagnosis or therapeutics for Gulf War Illness (GWI), with an expectation that applicants describe a credible pathway toward eventual clinical impact for affected Veterans.
How is this FY16 IIRFA different from earlier investigator-initiated mechanisms?
Although introduced as a new mechanism in FY16, it is described as a continuation and refinement of the FY06-FY15 Investigator-Initiated Research Award. The FY16 version places clearer emphasis on focused projects and requires applicants to spell out how the work could translate toward improvements in diagnostics or treatments for Gulf War Veterans with GWI.
What is the main purpose of the IIRFA?
The central purpose is to support research that advances GWI diagnosis or therapeutics while requiring a clear, credible line of sight toward clinical impact for Veterans affected by GWI, even if the proposed research itself does not immediately produce a clinical outcome.
Who must the research be focused on?
Proposed studies must be explicitly focused on Veterans of the 1990-1991 Persian Gulf War who are affected by Gulf War Illness. Applicants are expected to make a direct, well-supported case that the project will matter to Gulf War Veterans with GWI.
Can I submit a project about general fatigue, pain, or multisystem illness?
The opportunity stresses that proposals should not be loosely connected to GWI. The application should clearly explain how the work is specifically relevant to Gulf War Veterans with GWI rather than presenting broad symptom research with only an indirect connection.
What is the Principal Investigator expected to explain in the application?
The Principal Investigator is responsible for clearly articulating the project’s potential impact on GWI, including why the work is important now and how it fits into a translational pathway toward improved diagnostics or treatments.
How is the award structured?
The IIRFA is organized into three tiers. Applicants must choose the tier that matches the scope and maturity of the project. The guidance emphasizes that tier selection should be driven by the stage and objectives of the science, not by the requested budget.
What is Tier 1 (Discovery) intended to support?
Tier 1 supports innovative, high-risk/high-reward concepts at an early stage. Preliminary data are not required, but the application must still provide strong rationale, clear objectives, and a solid study design.
What are examples of appropriate Tier 1 projects?
Examples include foundational work such as defining GWI pathobiology, identifying symptom clusters, and molecular characterization that could open new diagnostic or therapeutic directions. Tier 1 may also include ideas borrowed from other diseases that have not yet been examined in Gulf War Veterans with GWI.
What is Tier 2 (Applied Research) designed for?
Tier 2 is for more mature, evidence-supported ideas intended to accelerate progress toward a GWI diagnosis or treatment. It is expected to be closer to practical application and to move the field toward actionable diagnostics or therapeutic strategies.
Does Tier 2 require preliminary data?
Yes. Tier 2 requires preliminary data in the GWI field and should be organized around a well-formed, testable hypothesis with translational potential.
What are examples of Tier 2 activities?
Examples include developing or refining diagnostic approaches, screening active compounds, and developing methods to assess target engagement or flag off-target risks.
What is Tier 3 (Preclinical Validation) intended to support?
Tier 3 supports product-driven research aimed at validating and optimizing promising treatment candidates for GWI, including repurposing existing FDA-approved drugs or therapies for a GWI-related indication.
Does Tier 3 require preliminary data?
Yes. Tier 3 applications must include preliminary data and supporting information appropriate to the proposed development stage. The supporting evidence does not necessarily need to come from prior GWI-specific studies.
What does Tier 3 expect applicants to have identified already?
Tier 3 expects an identified bioactive lead (or limited class of leads) and supporting details such as a plausible mechanism of action, proof of compound identity and purity, access to relevant bioactivity assays, and availability of preclinical GWI models to evaluate in vivo efficacy or mechanism-based activity.
What kinds of activities can be supported in Tier 3?
Supported activities may include secondary validation of leads, optimization of pharmacologic properties, formulation and stability work, development of GMP production methods, and assembling data typically needed for an Investigational New Drug (IND) submission.
What additional requirements apply to biomarker proposals?
Biomarker-focused proposals must justify why the biomarker(s) would be specific to Gulf War-related exposures rather than reflecting unrelated factors or post-deployment events.
Can a project develop GWI diagnostic biomarkers solely from animal models?
No. The program will not support projects that attempt to derive GWI diagnostic biomarkers solely from animal models. Biomarker relevance to Gulf War Veterans and the Gulf War-specific exposure context is emphasized as a key review consideration.
Is human subjects research allowed under this award?
Yes. Human subjects research is allowed, but only for studies that do not meet the mechanism’s definition of a clinical trial.
Are clinical trials allowed under the IIRFA?
No. The mechanism explicitly restricts studies to those without clinical trials.
How does the announcement define a clinical trial?
A clinical trial is defined as prospective enrollment of human subjects where an intervention is tested for measurable safety or efficacy outcomes. Interventions include drugs, devices, biologics, procedures, rehabilitation, behavioral interventions, and similar approaches.
What types of human-subject studies are acceptable under this award?
Acceptable human-subject work includes retrospective analyses and other non-interventional clinical studies, as long as they do not involve prospective testing of an intervention for safety or efficacy outcomes.
If I want to run an interventional clinical trial for GWI, where should I apply?
Applicants who want to conduct an interventional clinical trial are directed to a different FY16 mechanism: the GWIRP Treatment Evaluation Award.
What type of program is this and what funding instruments may be used?
The opportunity is listed as a discretionary program. Funding instruments may include grants and cooperative agreements.
What is the CFDA number for this opportunity?
The opportunity is listed under CFDA 12.420.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning a wide range of applicant organizations can apply, subject to any additional eligibility language in the full announcement.
What are the key dates for this FY16 funding opportunity?
The posting and creation dates are May 13, 2016. The application closing date is October 20, 2016.
How many awards were anticipated?
The program anticipated making around 11 awards.
Is there an award ceiling (maximum award amount)?
The listing shows an award ceiling of 0. This typically indicates the ceiling is not specified in that summary field or that the ceiling is defined elsewhere in the full program announcement rather than as a single fixed cap in the synopsis.
Does the award require immediate clinical outcomes?
No. The research does not have to immediately produce a clinical outcome, but applicants must provide a credible pathway toward eventual clinical impact for affected Veterans.
Should tier selection be based on the budget I want to request?
No. The guidance stresses that the tier choice should be driven by the stage and objectives of the science, not by the requested budget.
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