The Investigator-Initiated Focused Research Award is being offered for the first time in FY16; however, this mechanism is derived from the previously offered FY06-FY15 GWIRP Investigator-Initiated Research Award (IIRA).

The Investigator-Initiated Focused Research Award supports research to promote

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new ideas or continued development of applied research in GWI that is aimed at diagnosis or therapeutic advancement.

Applications must articulate the pathway to making a clinical impact for Veterans with GWI even if a clinical impact is not an immediate outcome.

All applications must focus on Veterans of the 1990-1991 Persian Gulf War affected by GWI.

It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate the project’s potential impact on GWI.

This award supports projects at different stages of development.

PIs should apply to the Investigator-Initiated Focused Research Award under one of three different Tiers.

It is the responsibility of the applicant to select the Tier that is most appropriate for the research proposed.

This choice should be based on the scope of the research proposed and not the funding level.

The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each Tier:
 Tier 1 – Discovery:
Tier 1 is intended to support innovative, high-risk/ high-reward research that is in the earliest stages of development.

Research should have the potential to yield new approaches for diagnosis or treatment specific to GWI.

Innovation is an important component of the Tier 1 award.

An application may demonstrate innovation not only by investigating a novel approach to therapy or diagnostics specific for GWI, but also by studying a concept that has been shown to be effective for other illnesses, but has not yet been studied in Veterans with GWI.

Preliminary data are not required; however, the project should include well-formulated objectives and a study design based on a strong scientific rationale.

Examples of activities supported by Tier 1 include:
investigations characterizing basic GWI pathobiology or symptom clustering aimed at molecular characterization.

 Tier 2 – Applied Research:
Tier 2 is intended to promote the investigation of more mature ideas aimed at therapeutic or diagnostic advancement that are supported by evidence in the GWI field.

This research must accelerate progress toward treatment or diagnosis of GWI.

All proposed research projects should include a well-formulated, testable hypothesis based on preliminary data and hold translational potential to improve GWI treatment and/or diagnosis.

The types of activities supported by Tier 2 include, but are not limited to:
clinical development of diagnostic approaches, active compound screening, or development of methods to measure target binding and/or the potential for undesirable effects at related but unintended targets.

Presentation of preliminary data in the field of GWI is required.

 Tier 3 – Preclinical Validation:
Tier 3 is intended to support activities aimed at validating and optimizing promising candidates for GWI treatment.

Studies to collect data required for repurposing an existing U. S. Food and Drug Administration (FDA)-approved drug or therapy for a new indication related to GWI are also of interest.

Applications must include preliminary data and other supporting information relevant to the proposed phase of research for GWI.

These data are not required to have come from the GWI research field.

The proposed studies are expected to be empirical in nature and product-driven.

Applications must include an identified bioactive lead (or limited class of leads) and background data supporting a putative mechanism of action, proof of identity and purity of compounds, availability of bioactivity assays and preclinical GWI models to assess in vivo efficacy or desirable mechanism-specific activity at the intended therapeutic target.

Examples of activities that will be supported by Tier 3 include, but are not limited to:
secondary validation of lead compounds, optimization of pharmacological properties, studies on formulation and stability, development of Good Manufacturing Practices (GMP) production methods, and collection of various data required for Investigational New Drug submission.

Applications Proposing Biomarker(s) Research:
Applicants must present a rationale for why the proposed biomarkers would be specific for Gulf War-related exposures and not induced by unrelated factors or events subsequent to Gulf War deployment.

Investigations involving derivation of GWI diagnostic biomarkers from animal models will not be supported.

Research involving human subjects is permitted under this Program Announcement/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 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 use the FY16 GWIRP Treatment Evaluation Award mechanism.

For information about that mechanism, see http://cdmrp.army.mil/funding/gwirp.shtml.

Retrospective studies or other non-interventional clinical studies involving human subjects are acceptable under the Investigator-Initiated Focused Research Award.