The FY16 TBDRP Investigator-Initiated Research Award (IIRA) 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

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further development in future studies.

This award funds highly rigorous, high-impact studies that have the potential to make important contributions to Lyme disease and other tick-borne disease research, patient care, and/or quality of life.

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 important aspects of the FY16 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 other tick-borne disease research, patient care, and/or quality of life.

• Preliminary Data:
Unpublished data from the laboratory of the Principal Investigator (PI) or collaborators named on the application, and/or data from the published literature that are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 are required.

Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this Program Announcement/Funding Opportunity.

A clinical trial is defined as a prospective accrual of patients in which 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 subject of that intervention or interaction.

For more information on clinical trials and clinical research overall, a Human Subject Resource Document is provided on the CDMRP electronic Biomedical Research Application Portal (eBRAP) system at https://ebrap.org/eBRAP/public/Program.htm.