Opportunity Information: Apply for W81XWH 15 GWIRP IIRA

  • The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Gulf War Illness Investigator Initiated 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 Military Medical Research and Development.
  • This funding opportunity was created on Jul 8, 2015 and posted on May 14, 2015.
  • Applicants must submit their applications by Oct 29, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $3,600,000.00 to eligible and selected applicants.
  • 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.
Apply for W81XWH 15 GWIRP IIRA

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Opportunity Summary:

The DoD Gulf War Illness Investigator Initiated Research Award (IIRA) is a Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA) funding mechanism under the Gulf War Illness Research Program (GWIRP) meant to push forward new, investigator-driven ideas that can establish proof of principle and set up larger follow-on studies. First offered in FY2006, the program had received 208 applications with 57 recommended for funding up to the time of this FY2015 announcement, signaling that it is competitive but also established. The central requirement is that proposals stay tightly focused on Gulf War Veterans affected by Gulf War Illness (GWI), and that the Principal Investigator clearly explains how the work will meaningfully impact GWI understanding, diagnosis, or future treatment development.

A key feature of this award is its emphasis on the complex, chronic, multisymptom nature of GWI. Funded projects can span basic through clinical research, but the overall aim is practical: improve how GWI is defined and diagnosed, better characterize symptom patterns, and deepen understanding of the underlying biology (pathobiology). A major priority is identification of objective measures, especially biomarkers, that can distinguish healthy Veterans from those with GWI or clarify biological mechanisms driving symptoms. The announcement also highlights interest in studying chronic effects of neurotoxic exposures at doses comparable to what troops may have encountered during deployment, reflecting the view that long-term and latent consequences of exposures are central to the illness as experienced today.

The IIRA is structured to lower barriers for innovative early-stage concepts. Preliminary data are not required, which allows researchers to propose well-justified ideas that may be new to the GWI field. At the same time, applications without preliminary data still need a strong scientific rationale and can be grounded in clinical observations or in discoveries from related chronic multisymptom illnesses, as long as the proposed work is clearly translated back to GWI and Gulf War Veterans. This makes the mechanism suitable for exploratory but disciplined studies that test whether a promising concept is plausible in the GWI context.

For animal research, the opportunity is fairly prescriptive. Animal studies are expected to model long-term and latent effects of toxic exposures to mirror the current status of GWI patients decades after the war, not just short-term toxicity. The program discourages creating brand-new animal models; investigators are expected to use established models unless there is a compelling scientific reason to do otherwise. This reflects a preference for approaches that are more immediately interpretable and comparable across studies, rather than spending limited resources on model development.

Beyond biomarker discovery and mechanistic studies, the award also supports early translational development work tied to GWI-targeted interventions. This includes pharmacologic agent testing through absorption, distribution, metabolism, and excretion (ADME) studies, as well as toxicology work that can support Investigational New Drug (IND)-enabling pharmacology and toxicology packages. Preclinical development of non-pharmacological interventions is also allowable, which broadens the scope to include potential device-based, behavioral, or other non-drug approaches, provided they are clearly justified as relevant to GWI.

A notable FY2015 update is explicit guidance for applications proposing biomarker research, reflecting the challenges of finding reliable markers in a condition tied to exposures that occurred more than two decades earlier. Applicants are strongly encouraged to design biomarker studies in ways that address confounding factors common in legacy cohorts and archived materials. Recommended approaches include using pre-existing, well-characterized GWI patient samples with matched controls where storage and handling artifacts are understood and controlled; focusing on biomarker candidates already supported by peer-reviewed literature with plausible diagnostic utility (for example, markers related to neural inflammation, mitochondrial dysfunction, or hormonal imbalance); validating markers linked to Gulf War-specific exposures in a way that separates them from post-deployment life events; and identifying markers within clinically meaningful subgroups (either by shared symptom patterns or by known exposure histories). The guidance also stresses conceptual clarity: investigators should distinguish between biomarkers of exposure itself, biomarkers of biological effects caused by exposure, and biomarkers of GWI as a clinical syndrome. For exposure-related markers, applicants are expected to do a broad survey of available Gulf War exposure data. Importantly, deriving biomarker candidates primarily from animal models is stated to not meet the intent of the biomarker focus under this award, signaling a preference for human-relevant samples and data when the goal is diagnostic biomarker advancement.

Administratively, this FY2015 opportunity (Funding Opportunity Number W81XWH-15-GWIRP-IIRA) was offered as a grant or cooperative agreement within the science and technology / research and development category, with no cost sharing requirement and eligibility listed as unrestricted (open to any entity type, subject to any additional eligibility text in the full announcement). The program anticipated about 5 awards with an estimated total funding level of $3.6 million. The posting date was May 14, 2015, with an original and final closing date of October 29, 2015, and the opportunity archived on November 28, 2015. For access issues, the announcement directs applicants to the CDMRP Help Desk (301-682-5507).

FAQs: DoD Gulf War Illness Investigator Initiated Research Award (IIRA) (FY2015)

What is the Gulf War Illness Investigator Initiated Research Award (IIRA)?

The IIRA is a Department of Defense funding mechanism under the Gulf War Illness Research Program (GWIRP), managed by the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to move forward new, investigator-driven ideas that can establish proof of principle and position the work for larger follow-on studies.

What is the main purpose of this award?

The award aims to support practical research that improves understanding, definition, and diagnosis of Gulf War Illness (GWI), and that lays groundwork for future treatment development. The opportunity emphasizes proof-of-principle work that can justify larger studies later.

Who or what must the research focus on to be responsive?

Proposals must stay tightly focused on Gulf War Veterans affected by Gulf War Illness (GWI). The Principal Investigator is expected to clearly explain how the proposed work will meaningfully impact GWI understanding, diagnosis, or future treatment development.

What types of research are supported (basic, clinical, translational)?

Projects may span basic through clinical research. The overall intent is to improve how GWI is defined and diagnosed, better characterize symptom patterns, and deepen understanding of underlying biology (pathobiology), including work that supports early translational development of GWI-targeted interventions.

Does this award emphasize the chronic, multisymptom nature of GWI?

Yes. A key feature of the opportunity is its emphasis on the complex, chronic, multisymptom nature of GWI, and on research approaches that reflect how the illness presents decades after the war.

Are biomarkers a priority under this award?

Yes. A major priority is identifying objective measures, especially biomarkers, that can distinguish healthy Veterans from those with GWI or clarify biological mechanisms driving symptoms.

What does the FY2015 announcement say about designing biomarker studies?

The FY2015 update provides explicit guidance to address confounding factors common in legacy cohorts and archived materials. Recommended approaches include using pre-existing, well-characterized GWI patient samples with matched controls where storage and handling artifacts are understood and controlled; focusing on biomarker candidates supported by peer-reviewed literature with plausible diagnostic utility; validating markers linked to Gulf War-specific exposures while separating them from post-deployment life events; and identifying markers within clinically meaningful subgroups based on symptom patterns or known exposure histories.

How should applicants think about different kinds of biomarkers?

The announcement stresses conceptual clarity by distinguishing between biomarkers of exposure, biomarkers of biological effects caused by exposure, and biomarkers of GWI as a clinical syndrome.

Can biomarker candidates be derived primarily from animal models?

No. The announcement states that deriving biomarker candidates primarily from animal models does not meet the intent of the biomarker focus under this award, indicating a preference for human-relevant samples and data when the goal is diagnostic biomarker advancement.

What kinds of biomarker candidates are highlighted as examples?

Examples of plausible diagnostic candidates mentioned include markers related to neural inflammation, mitochondrial dysfunction, or hormonal imbalance, particularly when supported by peer-reviewed literature.

Is research on neurotoxic exposures relevant to this opportunity?

Yes. The opportunity highlights interest in studying chronic effects of neurotoxic exposures at doses comparable to what troops may have encountered during deployment, reflecting the view that long-term and latent consequences of exposures are central to the illness.

Are preliminary data required to apply?

No. Preliminary data are not required, which is intended to lower barriers for innovative early-stage concepts. However, applications still need a strong scientific rationale and justification.

If preliminary data are not required, what can the rationale be based on?

Applications may be grounded in clinical observations or discoveries from related chronic multisymptom illnesses, as long as the proposed work is clearly translated back to Gulf War Illness and Gulf War Veterans.

What expectations are described for animal studies?

Animal research is expected to model long-term and latent effects of toxic exposures to mirror the current status of GWI patients decades after the war, rather than focusing only on short-term toxicity.

Does the program encourage developing new animal models?

No. The program discourages creating brand-new animal models. Investigators are expected to use established models unless there is a compelling scientific reason to develop a new one.

Does this award support intervention development work?

Yes. The award supports early translational development tied to GWI-targeted interventions, including pharmacologic agent testing and certain preclinical development activities for non-pharmacological interventions.

What pharmacologic development activities are specifically mentioned?

Examples include absorption, distribution, metabolism, and excretion (ADME) studies and toxicology work that can support Investigational New Drug (IND)-enabling pharmacology and toxicology packages.

Are non-pharmacological interventions allowed?

Yes. Preclinical development of non-pharmacological interventions is allowable, including approaches that may be device-based, behavioral, or otherwise non-drug, provided they are clearly justified as relevant to GWI.

How competitive or established is this award mechanism?

The award was first offered in FY2006. Up to the time of the FY2015 announcement, the program had received 208 applications with 57 recommended for funding, suggesting it is competitive and established.

What is the Funding Opportunity Number for this FY2015 IIRA announcement?

The Funding Opportunity Number is W81XWH-15-GWIRP-IIRA.

What type of award instrument is used?

The opportunity was offered as a grant or cooperative agreement within the science and technology / research and development category.

Is cost sharing required?

No. The announcement specifies no cost sharing requirement.

Who is eligible to apply?

Eligibility is listed as unrestricted (open to any entity type), subject to any additional eligibility language in the full announcement.

How many awards and how much total funding were anticipated?

The program anticipated about 5 awards, with an estimated total funding level of $3.6 million.

When was this opportunity posted and when did it close?

The posting date was May 14, 2015. The original and final closing date was October 29, 2015.

Is this opportunity still open?

No. The opportunity was archived on November 28, 2015.

Who should applicants contact for access issues?

For access issues, the announcement directs applicants to the CDMRP Help Desk at 301-682-5507.

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