Department of Defense (DoD) Gulf War Illness, New Investigator Award

The FY20 GWIRP New Investigator Award supports investigators new to the field of GWI research at different stages of career development. This award enables such investigators to compete for funding separately from investigators with established programs of GWI research. The New Investigator Award aligns to the Discovery or Qualification phase as outlined in Section II.A.2. Previous experience in GWI research is allowed, but not required. However, applications naming a Principal Investigator (PI) with limited background in GWI research are strongly encouraged to include collaboration with investigators who are experienced in GWI research and/or possess other relevant expertise to strengthen the application. The application should describe how the collaboration(s) will augment the PI’s ability to address the research question.

PIs must meet specific eligibility criteria under one of the following categories, as described in Section II.C, Eligibility Information.

• Transitioning Postdoctoral Fellow

• Early-Career Investigator

• New GWI Researcher

Research Scope: The New Investigator Award is designed to promote new ideas in GWI research and establish proof of principle for further development in future studies. Basic through clinical research is allowed under this award mechanism.

Preliminary Data: Applications are not required to include preliminary data; however, preliminary data may be used to support the objectives of the proposed project. These data are not required to have come from the GWI research field. Applications not supported by preliminary data should be based on sound scientific rationale and may reflect clinical observations or discoveries made in other illnesses with symptomology relevant to GWI.

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 New Investigator Award Areas of Emphasis: The FY20 GWIRP 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.

• Identification, replication, and validation of treatments that show promise for GWI

• Identification, replication, and/or validation 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 widespread 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 New Investigator 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.

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 New Investigator Award will not exceed $500,000. 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 $800,000 to fund approximately one New Investigator Award application. 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.