DoD Tuberous Sclerosis Complex Exploration-Hypothesis Development Award

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The TSCRP Exploration – Hypothesis Development Award mechanism was first offered in FY07. Since then, 93 Exploration – Hypothesis Development Award applications have been received, and 26 have been recommended for funding.The Exploration – Hypothesis Development Award supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in the TSC research field. The studies supported by this award mechanism are expected to lay the groundwork for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on strong scientific rationale and study design. The presentation of preliminary and/or published data is encouraged, but not required.The proposed research project should be innovative. Innovative research may introduce a novel paradigm, challenge existing paradigms, look at existing problems from novel perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative and is not consistent with the intent of this award mechanism. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate how the proposed research project is innovative in the field of TSC.Research involving human subjects and human anatomical substances is permitted; however, studies must be exempt under Title 32 of the Code of Regulations, Part 219.101(b) (32 CFR 219.101(b)) or eligible for expedited review (32 CFR 219.110 or 21 CFR 56.110). Exemption or expedited status is first determined by the Institutional Review Board (IRB) of record. Investigators must review their institutional requirements and guidelines for filing with the IRB for exempt or expedited status. Studies that do not qualify for exempt or expedited status will be administratively withdrawn. Clinical trials are not allowed under this funding opportunity. For more information on clinical trials and clinical research overall, a Human Subject Resource Document is provided on the electronic Biomedical Research Application Portal (eBRAP) system at https://ebrap.org/eBRAP/public/Program.htm. PIs wishing to apply for funding for a pilot clinical trial should utilize the FY14 TSCRP Pilot Clinical Trial Award mechanism (Funding Opportunity Number: W81XWH-14-TSCRP-PCTA).

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