Opportunity Information: Apply for W81XWH 11 GWIRP IIRA
Apply for W81XWH 11 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 Apr 28, 2011 and posted on Apr 27, 2011.
- Applicants must submit their applications by Aug 24, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,920,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 Investigator Initiated Research Award (IIRA) is a research funding opportunity under the Department of the Army's Congressionally Directed Medical Research Programs (CDMRP), within the Gulf War Illness Research Program (GWIRP). It is meant to push the science forward on Gulf War Illness (GWI), a chronic, multi-symptom condition affecting many Gulf War veterans. The award emphasizes investigator-driven ideas, especially early or developmental projects that can establish proof of principle and lay groundwork for larger follow-on studies. Since the mechanism began in FY2006, the program reported receiving 94 applications, with 29 recommended for funding, which signals a competitive but active funding track.
The main goal is to improve how GWI is defined and diagnosed, better characterize the symptom profile, and deepen understanding of the underlying biology (pathobiology). The program is particularly interested in work that can identify objective ways to distinguish ill veterans from healthy veterans, such as validated biomarkers or other measurable indicators, and in studies that clarify biological pathways that could become treatment targets. In addition to human-focused work, the IIRA also welcomes studies on the chronic, long-term effects of neurotoxic exposures at levels comparable to what service members may have encountered during the Gulf War, including latent effects that only become clear over time.
Research topics highlighted as areas of interest span multiple body systems and reflect the multi-system nature of GWI. Priority areas include central nervous system structure and function, with specific attention to the potential role of glial biology (including astrocytes and microglia) in symptom development; central neuroinflammatory processes; autonomic nervous system function; neuroendocrine measures; immune parameters and indicators of chronic infection; gastrointestinal complaints; genetic, genomic, proteomic, and metabolic characteristics; respiratory symptoms; and sexual dysfunction. The common thread across these areas is the search for objective indicators of abnormal biological processes that align with the lived symptom burden in affected veterans.
The mechanism is designed to encourage new ideas, so preliminary data are not required. Investigators can include preliminary results if they have them, and the preliminary work does not need to originate in the GWI field as long as the proposed study is logically justified and clearly centered on Gulf War veterans with illness. If no preliminary data are provided, the proposal is expected to rest on a strong scientific rationale, which could come from clinical observations or from extending relevant discoveries from other chronic multi-symptom illnesses into the GWI context. In all cases, the responsibility is placed on the Principal Investigator to clearly explain how the work could meaningfully impact GWI understanding, diagnosis, or future treatment development.
There are clear rules around study design, particularly for human subjects research. Human subjects research is allowed, but clinical trials are not permitted under this specific award. For this announcement, a clinical trial is defined as a prospective study where human participants are enrolled and an intervention (such as a drug, device, biologic, surgery, rehabilitation approach, behavioral intervention, or similar) is tested for measurable outcomes related to safety, effectiveness, efficacy, or other direct effects on participants. Non-interventional approaches are acceptable, including retrospective analyses and other observational or non-intervention designs. Applicants who want to run an intervention study are directed to use other GWIRP mechanisms, such as the Innovative Treatment Evaluation Award or the Clinical Trial Award.
For applicants proposing clinical research (non-trial) involving GWI populations, the program requires use of a published case definition to define the GWI cohort, and that definition must reflect the multi-symptom nature of the illness. For animal model studies, the expectation is that models should reflect long-term and latent effects of relevant toxic exposures so that the experimental design better mirrors the current, chronic state observed in GWI patients rather than only acute toxicity.
The announcement also states what it will not fund. Projects whose central premise is that psychiatric disease or psychological stress is the primary cause of GWI are explicitly excluded. Likewise, although Gulf War veterans have a higher rate of ALS than non-deployed peers, the GWIRP will not accept proposals focused on ALS as the main research topic. That said, studies centered on GWI symptomatology may include veterans with ALS only if ALS is encompassed within the study's GWI case definition. Separate DoD funding streams exist for ALS through the CDMRP ALS Research Program.
Administratively, the funding opportunity is listed as a discretionary program using grants and cooperative agreements under CFDA 12.420 (Military Medical Research and Development). It is open to a wide range of applicant types (unrestricted eligibility) and does not require cost sharing or matching. For the FY2011 posting, the opportunity anticipated about two awards with an estimated total funding level of $1.92 million. The announcement was posted in late April 2011, with an August 2011 closing date, and it was archived in September 2011. A help desk phone number (301-682-5507) was provided for applicants who had trouble accessing the full announcement.
FAQs: DoD Gulf War Illness Investigator Initiated Research Award (IIRA)
What is the Gulf War Illness Investigator Initiated Research Award (IIRA)?
The IIRA is a Department of Defense research funding opportunity offered through the Department of the Army's Congressionally Directed Medical Research Programs (CDMRP), within the Gulf War Illness Research Program (GWIRP). It supports investigator-driven research intended to move the science forward on Gulf War Illness (GWI), a chronic, multi-symptom condition affecting Gulf War veterans.
What is the main purpose of this award?
The award is designed to advance understanding of Gulf War Illness by improving how GWI is defined and diagnosed, better characterizing symptom profiles, and deepening knowledge of underlying biology (pathobiology). A recurring priority is identifying objective ways to distinguish ill Gulf War veterans from healthy veterans, such as validated biomarkers or other measurable indicators, and clarifying biological pathways that could become targets for future treatments.
Is this mechanism geared toward early-stage or proof-of-concept ideas?
Yes. The IIRA emphasizes investigator-driven concepts, including early or developmental projects that can establish proof of principle and provide a foundation for larger follow-on studies.
How competitive has this award been historically?
Since the mechanism began in FY2006, the program reported receiving 94 applications, with 29 recommended for funding. This suggests the mechanism has been active and competitive.
Are preliminary data required to apply?
No. Preliminary data are not required for this mechanism.
Can I include preliminary data if I already have it?
Yes. Investigators may include preliminary results if available.
Do preliminary findings need to come specifically from prior Gulf War Illness research?
No. Preliminary work does not need to originate within the GWI field, as long as the proposed study is logically justified and clearly centered on Gulf War veterans with illness.
If I do not include preliminary data, what is expected instead?
If no preliminary data are provided, the application is expected to rely on a strong scientific rationale. The rationale can be grounded in clinical observations or in extending relevant discoveries from other chronic multi-symptom illnesses into the Gulf War Illness context. In all cases, the Principal Investigator is expected to clearly explain how the work could meaningfully impact GWI understanding, diagnosis, or future treatment development.
What types of research topics are considered priorities?
Areas of interest reflect the multi-system nature of GWI and include central nervous system structure and function (including the potential role of glial biology such as astrocytes and microglia), central neuroinflammatory processes, autonomic nervous system function, neuroendocrine measures, immune parameters and indicators of chronic infection, gastrointestinal complaints, genetic/genomic/proteomic/metabolic characteristics, respiratory symptoms, and sexual dysfunction. Across topics, the common theme is identifying objective indicators of abnormal biological processes that align with symptom burden in affected veterans.
Does the program support research on neurotoxic exposures related to the Gulf War?
Yes. In addition to human-focused work, the award welcomes studies examining chronic, long-term effects of neurotoxic exposures at levels comparable to those service members may have encountered during the Gulf War, including latent effects that may only become apparent over time.
Is human subjects research allowed under this award?
Yes. Human subjects research is allowed under this mechanism, provided the work does not meet the announcement's definition of a clinical trial.
Are clinical trials allowed under the IIRA?
No. Clinical trials are not permitted under this specific award.
How does the announcement define a clinical trial?
For this opportunity, a clinical trial is defined as a prospective study in which human participants are enrolled and an intervention is tested for measurable outcomes related to safety, effectiveness, efficacy, or other direct effects on participants. The announcement lists examples of interventions such as drugs, devices, biologics, surgery, rehabilitation approaches, behavioral interventions, or similar interventions.
What kinds of study designs are acceptable if clinical trials are not allowed?
Non-interventional approaches are acceptable, including retrospective analyses and other observational or non-intervention study designs.
If my project involves an intervention, where should I apply instead?
Applicants who intend to run an intervention study are directed to other GWIRP mechanisms, such as the Innovative Treatment Evaluation Award or the Clinical Trial Award.
If I propose clinical research (non-trial) involving Gulf War Illness participants, how must I define the GWI cohort?
The program requires use of a published case definition to define the GWI cohort, and the case definition must reflect the multi-symptom nature of Gulf War Illness.
What are the expectations for animal model studies?
Animal models are expected to reflect long-term and latent effects of relevant toxic exposures, so that the experimental design mirrors the chronic state observed in Gulf War Illness patients rather than focusing only on acute toxicity.
Are projects allowed if they argue that psychiatric disease or psychological stress is the primary cause of Gulf War Illness?
No. Projects whose central premise is that psychiatric disease or psychological stress is the primary cause of GWI are explicitly excluded from funding under this announcement.
Will the program fund proposals primarily focused on ALS?
No. While Gulf War veterans have a higher rate of ALS than non-deployed peers, the GWIRP will not accept proposals focused on ALS as the main research topic under this opportunity.
Can a Gulf War Illness study include participants with ALS?
Studies centered on GWI symptomatology may include veterans with ALS only if ALS is encompassed within the study's GWI case definition.
Is there another DoD program that funds ALS-focused research?
Yes. The announcement notes that separate DoD funding streams exist for ALS through the CDMRP ALS Research Program.
What agency and program administer this award?
The award is administered under the Department of the Army's CDMRP as part of the Gulf War Illness Research Program (GWIRP).
What is the CFDA number associated with this funding opportunity?
The opportunity is listed under CFDA 12.420 (Military Medical Research and Development).
Who is eligible to apply?
The opportunity states unrestricted eligibility, meaning a wide range of applicant types may apply.
Is cost sharing or matching required?
No. The announcement states there is no cost sharing or matching requirement.
What funding level and number of awards were anticipated for the FY2011 posting?
For the FY2011 posting, the opportunity anticipated about two awards with an estimated total funding level of $1.92 million.
What were the key dates for the FY2011 posting?
The announcement was posted in late April 2011, had an August 2011 closing date, and was archived in September 2011.
What should applicants do if they had trouble accessing the full announcement?
The posting provided a help desk phone number (301-682-5507) for applicants who experienced difficulty accessing the full announcement.
Is this opportunity a mandatory or discretionary program?
It is listed as a discretionary program using grants and cooperative agreements.
What kinds of outcomes does the program seem most interested in?
Based on the stated goals and priority areas, the program is particularly interested in work that improves objective identification of GWI (for example, validated biomarkers or other measurable indicators), strengthens diagnosis and case definition approaches, clarifies symptom profiles, and advances understanding of biological pathways that could later be leveraged as treatment targets.
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