Opportunity Information: Apply for W81XWH 16 TBDRP IIRA

  • The DOD-AMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Tick-Borne Disease Investigator-Initiated Research Award" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
  • This funding opportunity was created on Jun 14, 2016 and posted on Jun 14, 2016.
  • Applicants must submit their applications by Nov 16, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The number of recipients for this funding is limited to 3 candidate(s).
  • Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
Apply for W81XWH 16 TBDRP IIRA

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Opportunity Summary:

The DoD Tick-Borne Disease Investigator-Initiated Research Award (IIRA) under the FY16 Tick-Borne Disease Research Program is a competitive funding opportunity designed to support investigator-driven studies that can meaningfully advance the science and real-world outcomes related to Lyme disease and other tick-borne diseases. The program is aimed at research spanning the full spectrum from basic discovery through translational work, with an emphasis on well-justified projects that can generate strong proof-of-principle results and set the stage for future development. This includes preclinical research in animal models, studies involving human subjects (as long as they do not meet the definition of a clinical trial), and correlative or companion studies that leverage samples or data associated with an existing clinical trial, where the proposed work helps interpret biology or mechanisms rather than testing a new intervention prospectively.

A central theme of the award is impact. Applicants are expected to clearly explain why the proposed work matters in both the short term and the long term, and how success would significantly move the field forward. In practical terms, that means the research should have a credible pathway to improving scientific understanding, informing better diagnostics or treatments, shaping clinical decision-making, or improving patient care and quality of life. The program is looking for high-impact, high-rigor studies rather than exploratory ideas without adequate support, so the application needs to connect the proposed aims to concrete advances in tick-borne disease research and outcomes.

The award also requires a strong scientific foundation, with a clearly articulated and testable hypothesis supported by a solid rationale. The hypothesis and approach should be built from logical reasoning, a critical analysis of relevant literature, and preliminary evidence that demonstrates feasibility and strengthens confidence in the direction of the work. Preliminary data are not optional here; applicants must provide unpublished data from the principal investigator or named collaborators and/or published findings that directly support the proposed project and its relevance to Lyme disease or other tick-borne diseases. In other words, reviewers will expect to see that the project is ready for rigorous execution and that key assumptions are grounded in data rather than speculation.

Human-focused research is allowed, including studies using human subjects or human anatomical substances, but the opportunity explicitly excludes clinical trials. The announcement uses a standard definition of a clinical trial: any prospective enrollment of patients where an intervention (such as a drug, biologic, device, surgery, rehabilitation method, behavioral intervention, or similar) is tested in humans with measurable outcomes tied to safety, effectiveness, or efficacy, reflecting a direct effect of that intervention. Projects that involve human participants must therefore be structured in a way that avoids prospective interventional testing as defined above, for example by focusing on observational, mechanistic, or correlative analyses rather than evaluating an intervention.

Administratively, this opportunity was issued by DOD-AMRAA (within the Congressionally Directed Medical Research Programs infrastructure) under Funding Opportunity Number W81XWH-16-TBDRP-IIRA. It falls under the Science and Technology and other Research and Development category (CFDA 12.420) and uses grant and cooperative agreement mechanisms. Eligibility is broadly open to applicants without restriction by organization type, subject to any additional eligibility clarifications in the full announcement. The posting date was June 14, 2016, and the closing date was November 16, 2016. The opportunity anticipated making about three awards, and the public listing shows an award ceiling value of 0, which typically indicates that the maximum budget is specified elsewhere in the full program announcement or in associated guidance rather than in the summary field.

Overall, the IIRA is structured for established, well-supported research ideas with a clear hypothesis, credible preliminary evidence, and a strong argument for why the work will produce meaningful advances in the tick-borne disease field. It rewards rigorous design and real potential for downstream benefit, while drawing a clear boundary around what counts as a clinical trial to ensure the funded projects remain within the program scope.

Frequently Asked Questions (FAQs)

What is the DoD Tick-Borne Disease Investigator-Initiated Research Award (IIRA)?

The Investigator-Initiated Research Award (IIRA) is a competitive Department of Defense funding opportunity under the FY16 Tick-Borne Disease Research Program. It supports investigator-driven research intended to meaningfully advance science and real-world outcomes related to Lyme disease and other tick-borne diseases, spanning basic discovery through translational research.

What diseases or topic areas does this opportunity focus on?

The opportunity focuses on Lyme disease and other tick-borne diseases. Proposed work must clearly connect to tick-borne disease relevance and intended impact.

What kinds of research are supported (basic vs. translational)?

The program supports research across the full spectrum from basic discovery through translational work. It emphasizes well-justified projects that can generate strong proof-of-principle results and position the work for future development.

What does the program mean by emphasizing “impact”?

Applicants are expected to explain why the research matters in both the short term and long term, and how success would significantly move the field forward. The program is looking for credible pathways to improved scientific understanding and downstream benefits such as informing diagnostics or treatments, shaping clinical decision-making, and improving patient care and quality of life.

Are exploratory or early-stage ideas appropriate for this award?

The award emphasizes high-impact, high-rigor studies rather than exploratory ideas without adequate support. Applications should tightly connect aims to concrete advances and be grounded in data rather than speculation.

Is a hypothesis required?

Yes. The award requires a clearly articulated, testable hypothesis supported by a solid rationale based on logical reasoning, critical analysis of relevant literature, and evidence supporting feasibility.

Are preliminary data required?

Yes. Preliminary data are not optional. Applicants must provide unpublished data from the principal investigator or named collaborators and/or published findings that directly support the proposed project and its relevance to Lyme disease or other tick-borne diseases.

What types of preliminary evidence are acceptable?

Acceptable preliminary evidence includes unpublished data generated by the PI or named collaborators and/or published findings that directly support the project direction and its relevance to Lyme disease or other tick-borne diseases.

Can the project include preclinical animal model research?

Yes. The opportunity explicitly includes preclinical research in animal models as part of the supported research spectrum.

Can the project involve human subjects?

Yes. Human-focused research is allowed, including studies involving human subjects or human anatomical substances, as long as the proposed work does not meet the definition of a clinical trial.

Are clinical trials allowed under this award?

No. The opportunity explicitly excludes clinical trials.

How does this opportunity define a “clinical trial”?

A clinical trial is defined as prospective enrollment of patients where an intervention (such as a drug, biologic, device, surgery, rehabilitation method, behavioral intervention, or similar) is tested in humans with measurable outcomes tied to safety, effectiveness, or efficacy, reflecting a direct effect of that intervention.

If a study includes humans, what kinds of designs may fit without being a clinical trial?

The opportunity indicates that human-participant projects must avoid prospective interventional testing. Examples that may fit include observational, mechanistic, or correlative analyses rather than prospectively evaluating an intervention.

Are correlative or companion studies connected to existing clinical trials allowed?

Yes. Correlative or companion studies that leverage samples or data associated with an existing clinical trial are allowed when the proposed work helps interpret biology or mechanisms rather than testing a new intervention prospectively.

What is the main goal of allowing correlative or companion studies?

The goal is to use existing clinical trial-associated samples or data to interpret underlying biology or mechanisms, rather than running a new prospective intervention test.

Who issued this funding opportunity?

The opportunity was issued by DOD-AMRAA within the Congressionally Directed Medical Research Programs (CDMRP) infrastructure.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is W81XWH-16-TBDRP-IIRA.

What category and CFDA number are associated with this opportunity?

The opportunity falls under the Science and Technology and other Research and Development category and is associated with CFDA 12.420.

What funding mechanisms are used?

The opportunity uses grant and cooperative agreement mechanisms.

Who is eligible to apply?

Eligibility is broadly open to applicants without restriction by organization type, subject to any additional eligibility clarifications in the full announcement.

When was the opportunity posted and when did it close?

The posting date was June 14, 2016, and the closing date was November 16, 2016.

How many awards were anticipated?

The opportunity anticipated making about three awards.

What is the maximum award amount (ceiling)?

The public listing shows an award ceiling value of 0, which typically indicates the maximum budget is specified elsewhere in the full program announcement or associated guidance rather than in the summary field.

What should applicants prioritize to be competitive?

Based on the opportunity description, competitive applications should present a high-rigor, well-supported research plan with a testable hypothesis, a strong rationale grounded in the literature, required preliminary data demonstrating feasibility, and a clear argument for near-term and long-term impact on tick-borne disease science and outcomes. Projects involving humans must be structured to avoid meeting the definition of a clinical trial.

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