DOD Tick-Borne Disease, Investigator-Initiated Research Award

Description

The FY19 TBDRP Investigator-Initiated Research Award (IIRA) intends to support highly rigorous, high-impact studies that have the potential to make important contributions to Lyme disease and other tick-borne diseases research, patient care, and/or quality of life. This award mechanism promotes a wide range of research from basic through translational, including preclinical studies in animal models or human subjects, as well as correlative studies associated with an existing clinical trial to establish proof-of-principle for further development in future studies. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale that is established through logical reasoning, preliminary data, and critical review and analysis of the literature. The following are key aspects of the FY19 TBDRP IIRA: •Impact: Applications should articulate both the short- and long-term impact of the proposed research. High-impact research will, if successful, significantly advance Lyme disease and/or other tick-borne diseases research, patient care, and/or quality of life. •Relevance: Applications should articulate how the proposed research is relevant to at least one of the FY19 TBDRP Focus Areas. Highly relevant research will address the current evidence-based burden of disease on public health, while also considering the healthcare needs and welfare of military Service members and their families. •Preliminary Data: Inclusion of preliminary data, such as unpublished data from the laboratory of the Principal Investigator (PI) or collaborators named on the application, and/or data from the published literature that are relevant to Lyme disease and other tick-borne diseases and support the proposed research project, is required. To leverage existing resources and maximize statistical power, Lyme and other tick-borne disease biorepositories and databases are important resources to consider if retrospectively collected human anatomical substances or correlated data are critical to the proposed studies. Investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of in vitro cellular studies and preclinical animal experiments; and validation in well-pedigreed cohorts of uniformly documented patients. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research, and/or studies that apply state-of-the art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The anticipated direct costs budgeted for the entire period of performance for an FY19 TBDRP Investigator-Initiated Research Award will not exceed $650,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $3.12M to fund approximately three Investigator- Initiated Research 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 FY19 funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025. Awards will be made no later than September 30, 2020. For additional information refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). The level of involvement on the part of the Department of Defense (DoD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. Government. An assistance agreement can take the form of a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.

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