The FY21 Defense Appropriations Act provides funding to the Department of Defense Gulf War Illness Research Program (GWIRP) to support research addressing Gulf War Illness treatment, diagnosis and pathobiology underlying symptoms of disease. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).
The FY21 GWIRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website.
Applications submitted to the FY21 GWIRP must address one or more of the following overarching challenges:
- Treatments: Eliminate the health consequences associated with Gulf War Illness (GWI) and/or revolutionize treatment
- Diagnosis: Better define and diagnose GWI
- Subtyping: Distinguish subtypes to better target treatments; or monitor therapy; or identify severity of GWI; or why GWI is worse for some Veterans than for others
- Determinants: Identify and validate determinants of GWI, latency, and impacts on organs and systems
- Consequences: Determine whether GWI alters risk for developing neurological conditions, cancers, or other serious conditions; or whether GWI alters outcomes of other infections/diseases
- Communicate & Educate: Help Veterans, their caregivers, and clinicians communicate effectively about GWI, its symptoms, and potential treatments
https://cdmrp.army.mil/funding/gwirp
Idea Award – Preproposal due May 7, 2021
Independent investigators at all academic levels
· Supports high-risk/high-reward research in the earliest stages of development that will contribute to markers or treatments for Gulf War illness (GWI).
· Emphasis is on impact and innovation; 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.
· Preliminary data are not required.
· Clinical trials are not allowed.
· Submission of a pre-application is required; application submission is by invitation only.
· Biorepository Contribution Options:
· Supports additional costs associated with submission of samples and data to the GWIRP-supported Biorepository Resource Network
· Applicants must submit a Biorepository Contribution Statement providing a detailed accounting of proposed costs and a commitment to work with the GWIRP-supported Biorepository Resources Network.
· Application to this option is not a requirement for Idea Award submission.
· Maximum funding of $200,000 for direct costs (plus indirect costs)
· Maximum funding of $220,000 for direct costs with the Biorepository Contribution Option (plus indirect costs).
· Maximum period of performance is 2 years
Research Advancement Award – Preproposal due May 7, 2021
Independent investigators at all academic levels
- Supports applied research in GWI aimed at continued expansion and validation of markers and treatments that are supported evidence in the GWI field.
- Preliminary data in the field of GWI and other supporting information is required.
- 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.
- Clinical trials are not allowed.
- Submission of a pre-application is required; application submission is by invitation only.
· Biorepository Contribution Option:
· Supports additional costs associated with submission of samples and data to the GWIRP-supported Biorepository Resource Network.
· Applicants must submit a Biorepository Contributions Statement providing a detailed accounting of proposed costs and a commitment to work with the GWIRP-supported Biorepository Resource Network
· Application to this option is not a requirement for Research Advancement Award submission.
· Maximum funding of $600,000 for direct costs (plus indirect costs)
· Maximum funding of $620,000 for direct costs with the Biorepository Contribution Option (plus indirect costs)
· Maximum period of performance is 3 years
Clinical Evaluation Award – Preproposal due May 7, 2021
Independent investigators at all academic levels
- Supports translation of validated GWI research, including qualified and replicated preclinical findings, to a Gulf War Veteran population.
- Statistically powered biomarker trials with the potential to validate use of biomarkers as clinical endpoints or proof-of-concept intervention trials (e.g., pilot, first in human, Phase I-IIa) are encouraged under this funding opportunity.
- Preliminary data are required.
- Funding for this award mechanism must support research in a Gulf War Veteran population. Proof of availability and access to necessary cohort(s) and/or critical regents must be provided.
- Submission of a pre-application is required application submission is by invitation only.
- Biorepository Contribution Option:
- Supports additional costs associated with submission of samples and data to the GWIRP-supported Biorepository Resource Network.
- Applicants must submit a Biorepository Contribution Statement providing a detailed accounting of proposed costs and a commitment to work with the GWIRP-supported Biorepository Resource Network.
- Application to this option is not a requirement for Clinical Evaluation Award submission.
- Clinical Consortium Collaboration Option:
- Supports additional costs associated with collaboration with the GWIRP-support Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC).
- Applicants must submit a Clinical Consortium Collaboration Statement providing a detailed accounting of proposed costs and clearly articulating the qualifications of the research team and institutions to participate as a new Clinical Research Site in the Consortium.
- Application to this option is not a requirement for Clinical Evaluation Award submission.
- Pre-application is required; full application submission is by invitation only.
- Maximum funding of $1,500,000 for direct costs (plus indirect costs)
- Maximum funding of $1,520,000 for direct costs with the Biorepository Contribution Option (plus indirect costs).
· Maximum funding of $1,700,000 for direct costs with the Clinical Consortium Collaboration Option (plus indirect costs)
· Maximum period of performance is 3 years
Therapeutic/Biomarker Trial Award – Preproposal due May 7, 2021
Independent investigators at all academic levels
- Supports large-scale, pivotal (Phase IIb or III) trials that revolutionize the clinical management of GWI.
- Proposed research should lead to an approach that is fundamentally better than interventions already approved or in clinical development.
- Objective biomarkers to measure the biological effect of an investigational therapeutic or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual Gulf War Veteran or Gulf War Veteran subgroup must be included in the trial design.
- Investigators must have experience in successfully leading large-scale projects and demonstrated the ability to implement a clinical project successfully.
- Funding must be used to support a clinical trial.
- Proposal submission is required: application submission is by invitation only.
- Biorepository Contribution Option:
- Supports additional costs associated with submission of samples and data to the GWIRP-supported Biorepository Resource Network
- Applicants must submit a Biorepository Contribution Statement providing a detailed accounting of proposed costs and a commitment to work with the GWIRP-supported Biorepository Resource Network.
- Application to this option is not a requirement for Therapeutic/Biomarker Trial Award submission.
- Clinical Consortium Collaborative Option:
- Supports additional costs associated with collaboration with the GWIRP-supported Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC).
- Applicants must submit a Clinical Consortium Collaborative Statement providing a detailed accounting of proposed costs and clearly articulates the qualifications of the research team and institution to participate as a new Clinical Research Site in the Consortium.
- Application to this option is not a requirement for Therapeutic/Biomarker Trial Award submission.
· Maximum funding of $5,000,000 for direct costs (plus indirect costs)
· Maximum funding of $5,020,000 for direct costs with the Biorepository Contribution Option (plus indirect costs).
· Maximum funding of $5,500,000 for direct costs with the Clinical Consortium Collaboration Option (plus indirect costs).
· Maximum period of performance is 3 years
New Investigator Award – Preproposal due May 7, 2021
PIs may apply under one of the following three eligibility categories:
Transitioning Postdoctoral Fellow: Senior postdoctoral fellows with at least 3 years of postdoctoral training
Early-Career Investigator: Independent investigators within 5 years of last training position
New GWI Researcher: Established independent investigators who have received less than $300,000 in federally funded, non-mentored GWI research
- Encourages applications from early-stage and established investigators new to the field of GWI research.
- Previous experience in GWI research is not required; however, collaborations with experienced GWI researchers is strongly encouraged.
- Preliminary data are not required.
- Clinical trials are not allowed.
- Preproposal submission is required; application submission is by invitation only.
- Biorepository Contribution Option:
- Supports additional costs associated with submission of samples and data to the GWIRP-supported Biorepository Resource Network.
- Applicants must submit a Biorepository Contribution Statement providing a detailed accounting of proposed costs and a commitment to work with the GWIRP-supported Biorepository Resource Network.
- Application to this option is not a requirement for New Investigator Award submission.
· Maximum funding of $500,000 for direct costs (plus indirect costs)
· Maximum funding of $520,000 for direct costs with the Biorepository Contribution Option (plus indirect costs)
· The maximum period of performance is 3 years
A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.
For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the GWIRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).
Point of Contact:
CDMRP Help Desk
301-682-5507
help@eBrap.org