DoD Tuberous Sclerosis Complex Exploration-Hypothesis Development Award by the Department of Defense

The proposed research project must be innovative, feasible, and supported by strong rationale. 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 Studies that do not qualify for exempt or expedited status will be administratively withdrawn.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 Program Announcement/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 FY16 TSCRP Pilot Clinical Trial Award mechanism (Funding Opportunity Number: W81XWH-16-TSCRP-PCTA).