Opportunity Information: Apply for W81XWH 12 GWIRP IIRA
Apply for W81XWH 12 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 Jun 26, 2012 and posted on Mar 10, 2012.
- Applicants must submit their applications by Jul 24, 2012. (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 funding opportunity under the Department of the Army's Congressionally Directed Medical Research Programs (CDMRP) Gulf War Illness Research Program (GWIRP). It is meant to move Gulf War Illness (GWI) research forward by supporting investigator-driven projects that tackle the complex, multi-symptom condition affecting Gulf War veterans. The award is positioned as a proof-of-principle mechanism, meaning it is intended to help researchers generate strong early evidence that can justify larger, follow-on studies later.
The core purpose of the award is to improve how GWI is defined and diagnosed, to better characterize its symptoms, and to deepen understanding of the underlying biology (pathobiology). The program encourages research spanning basic to clinical domains, with an emphasis on objective ways to distinguish ill veterans from healthy veterans, such as biomarkers or other measurable indicators. Projects that help identify plausible treatment targets are also encouraged, even though the mechanism itself restricts the kind of human research it will support (it does not allow clinical trials). In addition to studies centered on veterans, the opportunity also explicitly welcomes studies examining the long-term, chronic effects of neurotoxic exposures at levels comparable to those encountered during the Gulf War, reflecting ongoing concerns that exposures may contribute to persistent illness.
The announcement highlights several specific scientific areas of interest, largely centered on measurable biological abnormalities that could explain or track GWI. Priority topics include central nervous system structure and function, with particular attention to glial biology (including astrocytes and microglia) and how these cells may contribute to symptoms; central neuroinflammatory processes; autonomic nervous system dysfunction; neuroendocrine measures; immune parameters and indicators of chronic infection; gastrointestinal complaints; genetic, genomic, proteomic, and metabolic characteristics; respiratory symptoms; and sexual dysfunction. Across these areas, the common thread is a push toward objective indicators of biological processes rather than purely descriptive symptom reporting.
The IIRA is designed to foster new ideas and does not require preliminary data, which lowers the barrier for innovative or cross-cutting concepts. At the same time, applications without preliminary results are expected to rest on a solid scientific rationale, which could come from clinical observations or from translating findings from related chronic multi-symptom illnesses into the GWI context. No matter the approach, proposals must keep the focus clearly on ill Gulf War veterans, and the principal investigator is expected to spell out the project’s likely impact on GWI in a direct, explicit way.
For studies involving human participants, the award permits clinical research but prohibits clinical trials. In this context, a clinical trial is defined as prospective enrollment of human subjects where an intervention (such as a drug, device, biologic, surgery, rehabilitation approach, behavioral intervention, or similar) is tested for outcomes related to safety, effectiveness, or efficacy. Non-interventional designs such as retrospective studies are acceptable. Investigators who want to run an interventional trial are directed instead to other GWIRP mechanisms, including the Innovative Treatment Evaluation Award or the Clinical Trial Award, and are referred to CDMRP guidance for distinguishing clinical research from clinical trials.
There are also clear topic boundaries. Applications arguing that psychiatric disease or psychological stress is the primary cause of GWI are not eligible for funding under this announcement. Likewise, the program will not accept applications focused on amyotrophic lateral sclerosis (ALS), even though ALS rates are higher among Gulf War veterans; however, veterans with ALS may be included if the study is fundamentally about GWI symptomatology and ALS is encompassed within the GWI case definition being used.
Administratively, the opportunity is identified as Funding Opportunity Number W81XWH-12-GWIRP-IIRA, categorized as a discretionary science and technology research and development program (CFDA 12.420, Military Medical Research and Development). The instrument type is listed as a cooperative agreement/grant, with no cost sharing required and eligibility described as unrestricted (open broadly across entity types, subject to any additional eligibility text in the full announcement). For the posted cycle reflected in the source data, the anticipated number of awards was 2, with an estimated total funding level of $1,920,000. The opportunity was posted March 10, 2012, with a closing date of July 24, 2012, and an archive date of August 23, 2012. Assistance for accessing the full announcement was available through the CDMRP Help Desk (301-682-5507).
Frequently Asked Questions (FAQs)
1) What is the DOD Gulf War Illness Investigator Initiated Research Award (IIRA)?
The Investigator Initiated Research Award (IIRA) is a funding opportunity within the Department of the Army's Congressionally Directed Medical Research Programs (CDMRP), under the Gulf War Illness Research Program (GWIRP). It supports investigator-driven research intended to move Gulf War Illness (GWI) science forward.
2) What is the main goal of this award?
The core purpose is to improve how Gulf War Illness is defined and diagnosed, better characterize its symptoms, and deepen understanding of its underlying biology (pathobiology). The award emphasizes objective indicators that can distinguish ill Gulf War veterans from healthy veterans (for example, biomarkers or other measurable findings).
3) What does it mean that the IIRA is a "proof-of-principle" mechanism?
It means the award is intended to generate strong early evidence (proof-of-principle) that can justify and support larger, follow-on studies later. The mechanism is positioned to help establish feasibility or early biological/clinical signals rather than to serve as a late-stage confirmatory effort.
4) What types of research are encouraged (basic, clinical, or both)?
The program encourages research spanning basic to clinical domains, as long as the focus stays clearly on Gulf War Illness and ill Gulf War veterans.
5) Does this award require preliminary data?
No. The IIRA is designed to foster new ideas and does not require preliminary data. However, proposals without preliminary results are still expected to be supported by a solid scientific rationale, which may be grounded in clinical observations or in translating findings from related chronic multi-symptom illnesses into the GWI context.
6) Who or what must the research focus on?
Proposals must keep the focus clearly on ill Gulf War veterans. The principal investigator is expected to explicitly describe the project's likely impact on Gulf War Illness.
7) Are studies of exposures relevant to the Gulf War included?
Yes. The opportunity explicitly welcomes studies examining the long-term, chronic effects of neurotoxic exposures at levels comparable to those encountered during the Gulf War, reflecting concerns that exposures may contribute to persistent illness.
8) What kinds of outcomes or measurements does the program emphasize?
A major emphasis is on objective indicators of biological processes, rather than purely descriptive symptom reporting. Examples mentioned include biomarkers or other measurable indicators that can differentiate ill veterans from healthy veterans and help clarify biological mechanisms.
9) What scientific areas of interest are highlighted?
The announcement lists priority topics centered on measurable biological abnormalities that could explain or track GWI, including:
- Central nervous system structure and function
- Glial biology (including astrocytes and microglia)
- Central neuroinflammatory processes
- Autonomic nervous system dysfunction
- Neuroendocrine measures
- Immune parameters and indicators of chronic infection
- Gastrointestinal complaints
- Genetic, genomic, proteomic, and metabolic characteristics
- Respiratory symptoms
- Sexual dysfunction
Across these topics, the common thread is a push toward measurable, objective indicators tied to underlying biology.
10) Does the award support identifying treatment targets?
Yes. Projects that help identify plausible treatment targets are encouraged. However, the award restricts the kind of human research it will support (it permits clinical research but does not allow clinical trials).
11) Are human participant studies allowed?
Yes. For studies involving human participants, the award permits clinical research, subject to the restriction that clinical trials are prohibited under this mechanism.
12) Are clinical trials allowed under this award?
No. Clinical trials are not permitted under this award.
13) How does the announcement define a "clinical trial" for this opportunity?
In this context, a clinical trial is defined as prospective enrollment of human subjects where an intervention is tested for outcomes related to safety, effectiveness, or efficacy. Interventions include (but are not limited to) drugs, devices, biologics, surgery, rehabilitation approaches, and behavioral interventions.
14) Are non-interventional or retrospective human studies allowed?
Yes. Non-interventional designs such as retrospective studies are described as acceptable.
15) If an investigator wants to run an interventional trial, what should they do?
Investigators seeking to run an interventional trial are directed to other GWIRP mechanisms, including the Innovative Treatment Evaluation Award or the Clinical Trial Award. The announcement also refers applicants to CDMRP guidance for distinguishing clinical research from clinical trials.
16) Are applications eligible if they argue psychiatric disease or psychological stress is the primary cause of GWI?
No. Applications that argue psychiatric disease or psychological stress is the primary cause of Gulf War Illness are not eligible for funding under this announcement.
17) Are applications focused on ALS (amyotrophic lateral sclerosis) eligible?
No. The program will not accept applications focused on ALS.
18) Can veterans with ALS be included in a study under this award?
Yes, but only in a limited way. Veterans with ALS may be included if the study is fundamentally about Gulf War Illness symptomatology and ALS is encompassed within the GWI case definition being used.
19) What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is W81XWH-12-GWIRP-IIRA.
20) What is the CFDA number and program category listed?
The opportunity is categorized as a discretionary science and technology research and development program under CFDA 12.420, Military Medical Research and Development.
21) What type of funding instrument is used?
The instrument type is listed as a cooperative agreement/grant.
22) Is cost sharing required?
No cost sharing is required.
23) Who is eligible to apply?
Eligibility is described as unrestricted (open broadly across entity types), subject to any additional eligibility text in the full announcement.
24) How many awards and how much total funding were anticipated for the posted cycle?
For the posted cycle reflected in the source data, the anticipated number of awards was 2, with an estimated total funding level of $1,920,000.
25) When was this opportunity posted, and what were the closing and archive dates?
The opportunity was posted on March 10, 2012. The closing date was July 24, 2012, and the archive date was August 23, 2012.
26) Where could applicants get help accessing the full announcement?
Assistance for accessing the full announcement was available through the CDMRP Help Desk at 301-682-5507.
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