DOD Gulf War Illness Investigator-Initiated Research Award

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The GWIRP Investigator-Initiated Research Award mechanism was first offered in FY06. Since then, 131 Investigator-Initiated Research Award applications have been received, and 36 have been recommended for funding. The IIRA supports research focusing on the complex of symptoms known as Gulf War Illness (GWI), improving its definition and diagnosis, characterizing disease symptoms, and better understanding its pathobiology. It is intended to encourage basic through clinical research aimed at identification of objective measures to distinguish ill from healthy veterans (e.g., biomarkers), elucidate potential treatment targets for GWI, or improve understanding of the pathobiology underlying GWI symptoms. In addition, studies that characterize chronic effects of neurotoxic exposures at dosage comparable to that encountered during the Gulf War are acceptable. The IIRA provides investigators a mechanism to establish proof of principle for further development in future studies. Particular areas of interest include research on objective indicators of biological processes, or abnormalities in GWI associated with: • Central nervous system structure and function, in particular, the role of glial cells, astrocytes, and microglia in GWI symptomatology • Central neuroinflammatory processes • Autonomic nervous system function • Neuroendocrine measures • Immune parameters/Indicators of chronic infection • Gastrointestinal complaints/symptoms • Genetic, genomic, proteomic, or metabolic characteristics • Respiratory symptoms • Sexual dysfunction The IIRA is designed to promote new ideas in GWI research. Applications are not required to include preliminary data; however, preliminary data may be used to support the objectives of an application. These data are not required to have come from the GWI research field. Applications not supported by preliminary data should be based on a sound scientific rationale and may reflect clinical observations or seek to evaluate GWI discoveries made in relation to other chronic multi-symptom illnesses. Regardless of the approach, the focus should be clearly on ill Gulf War veterans. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate the project’s potential impact on GWI. PIs proposing clinical research must provide a published case definition they intend to use to define their GWI population. Any case definition must recognize the multi-symptom nature of GWI. PIs proposing studies using animal models should focus on long-term and latent effects of toxic exposures to closely represent the current status of GWI patients. NOTE: The 2008 report of the Research Advisory Committee on Gulf War Veterans’ Illnesses, Gulf War Illness and the Health of Gulf War Veterans, provides information on GWI case definitions (pp. 29-30, p. 57), previous treatment research in Gulf War veterans (pp. 36-39), and treatment research related to other multi-symptom conditions (pp. 285-287). The report can be found online at: http://www1.va.gov/RAC-GWVI/. Research involving human subjects is permitted under this funding opportunity but is restricted to studies without clinical trials. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. For more information on clinical research, see Human Subject Resource Document at https://cdmrp.org/Program_Announcements_and_Forms/. PIs interested in applying for funding for a clinical trial should utilize either the Innovative Treatment Evaluation Award or the Clinical Trial Award mechanisms (for information about those mechanisms, see http://cdmrp.army.mil/gwirp). Refer to the Human Subject Resource Document at https://cdmrp.org/Program_Announcements_and_Forms/ for helpful information about distinguishing clinical trials and clinical research. Retrospective studies or other non-interventional designs are acceptable under the IIRA award mechanism. Studies whose principal focus is on psychiatric disease or psychological stress as the primary cause of GWI will not be funded under this Program Announcement/Funding Opportunity. While Gulf War veterans are affected by Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease) at twice the rate of veterans who did not serve in the Gulf War, the GWIRP will not accept applications focusing on ALS research. However, applications that focus on GWI symptomatology may include GW veterans with ALS if the latter disorder is included in the study’s GWI case definition. The Office of the Congressionally Directed Medical Research Programs (CDMRP) has offered a separate ALS Research Program (see http://cdmrp.army.mil/alsrp).

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