DoD Gulf War Illness, Idea Award for Innovative Treatments and Research

The FY20 GWIRP Idea Award supports innovative, high-risk/high-reward research in the earliest stages of development that will contribute to markers or treatments for GWI. The Idea Award targets the Discovery phase of the research pipeline as outlined in Section II.A.2.

Innovation: Research deemed innovative may represent a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other highly creative qualities. Adaptation of concepts from symptom-based disorders with some overlapping symptomatic features, such as chronic fatigue syndrome or fibromyalgia, to GWI may also be deemed innovative. Multidisciplinary projects are especially encouraged.

Preliminary Data: To foster research with clearly defined potential to yield new avenues of investigation, presentation of preliminary data is not required. Any unpublished, preliminary data that are provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team. Whether or not preliminary data are included, applications should be based on a sound scientific rationale that is established through logical reasoning and/or critical review and analysis of the literature.

Impact: Applications must articulate how results will lead to a clinical impact for Veterans with GWI even if a clinical impact is not an immediate outcome. All applications must focus on features of GWI and Veterans of the 1990-1991 Gulf War affected by GWI. The application should clearly and explicitly articulate the project’s potential impact on GWI.

FY20 GWIRP Idea Award Areas of Emphasis: The FY20 GWIRP Idea Award has a special interest in the exploration of the topics listed below. Applicants are not restricted to this list and may propose studies in any other GWI research area relevant to the mission of the GWIRP and in the context of the FY20 GWIRP Overarching Challenges.

• Innovative treatments for GWI

• Identification of the causes of and treatment targets for dysregulated biological system function. Emphasis should be placed on:

○ Cognitive difficulties to include memory deficits, mood and behavior disturbances

○ Non-restorative sleep or sleep disturbances

○ Chronic wide-spread pain

○ Chronic debilitating fatigue

○ Gastrointestinal effects including dietary intolerances, gastroesophageal reflux disease (GERD), and functional gastrointestinal disorders (FGIDs)

○ Sinus and respiratory effects

○ Headaches

○ Dermatological issues

○ Neurological dysfunction (central, peripheral, autonomic, and/or neuromuscular)

○ Immune system dysfunction

○ Endocrine, exocrine, and/or excretory system dysfunction, with special attention to kidney and liver (e.g., Cytochrome P450 abnormalities)

○ Microbiome variants

○ The impact of stresses (e.g., exertion, immune challenge) on the severity and duration of the symptoms

○ Disordered system crosstalk (e.g., immunological dysfunction that alters the nervous system, autonomic dysfunction that impacts functioning of the gastrointestinal tract)that contributes to malfunction in several physiological systems

• Identification of molecular signatures (e.g., genomic, proteomic, metabolic, and epigenetic) underlying symptoms and the grouping of symptom sets based on common underlying pathobiology

• Investigation of comorbidities, mortality, sex or ethnic differences

Biorepository Contribution Option: In FY17, the GWIRP awarded infrastructure support for a GWI Biorepository. The Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI has now been established for the retention and distribution of Gulf War Veteran biospecimens and/or data related to GWI research. Applicants to the FY20 GWIRP are encouraged to contribute Gulf War Veteran biospecimens and data to this repository network. The FY20 GWIRP Idea Award offers a nested Biorepository Contribution Option with higher levels of funding for qualified applications as described in Section II.D.5, Funding Restrictions. See Attachment 11, Options Statements for additional submission requirements. For additional details about BBRAIN, refer to the section below titled, Access to Data and/or Previously Collected Biospecimens from Veterans of the 1990-1991 Gulf War.

The anticipated direct costs budgeted for the entire period of performance for an FY20 GWIRP Idea Award will not exceed $150,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. If applying under the Biorepository Contribution Option, direct costs will not exceed $170,000.

Activities not supported under this Program Announcement include:

• Studies focusing on psychiatric disease or psychological stress as the primary cause of GWI.

• Applications focusing on amyotrophic lateral sclerosis (ALS) research. However, applications that focus on GWI symptomatology may include Gulf War Veterans with ALS if the latter disorder is included in the study’s GWI case definition. For those interested in pursuing ALS-focused studies, the CDMRP offers funding opportunities through the ALS Research Program (see https://cdmrp.army.mil/alsrp).

• Clinical trials. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Investigators interested in clinical trials should consider applying under the FY20 GWIRP Clinical Evaluation Award or Therapeutic/Biomarker Trial Award (Funding Opportunity Numbers: W81XWH-20-GWIRP-CEA and W81XWH-20-GWIRP-TBTA, respectively). For information about these award mechanisms, see https://cdmrp.army.mil/funding/gwirp.

The anticipated direct costs budgeted for the entire period of performance for an FY20 GWIRP Idea Award will not exceed $150,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2021. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $720,000 to fund approximately three Idea Award applications. Funding of applications received is contingent upon the availability of Federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the Government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY20 funding opportunity will be funded with FY20 funds, which will expire for use on September 30, 2026.