DoD Tuberous Sclerosis Complex Exploration-Hypothesis Development Award | Apply Online

Opportunity Summary:

The DoD Tuberous Sclerosis Complex Exploration-Hypothesis Development Award (EHDA) is a funding opportunity within the Department of Defense Tuberous Sclerosis Complex Research Program (TSCRP) designed to help researchers test bold new ideas at an early stage. Its main purpose is to support the initial exploration of innovative, high-risk, high-gain concepts that could lead to major advances in the tuberous sclerosis complex (TSC) field. Rather than funding incremental follow-on work, this mechanism is meant to help investigators generate the early evidence and conceptual foundation needed to open up new lines of investigation and position projects for larger future studies.

A central feature of the EHDA is that applicants must propose a well-formulated and testable hypothesis supported by strong scientific rationale and a solid study design. Even though the work is intended to be exploratory, it still needs to be logically constructed and feasible. Importantly, preliminary data and published supporting data are not required, which makes this award especially relevant for researchers proposing genuinely novel directions that may not yet have a large evidence base. At the same time, the proposal must clearly explain why the idea is scientifically grounded and how the approach will effectively test the hypothesis.

Innovation is the core review expectation. The DoD emphasizes that the proposed project must go beyond modest extensions of existing findings. The kind of innovation they are looking for includes introducing an entirely new paradigm, challenging widely held assumptions, approaching an established problem from a truly different angle, or using highly creative concepts or methods that could shift how the field thinks about TSC. Projects that mainly build incrementally on prior published data are described as not aligned with the intent of this mechanism. Because of that, the burden is on the Principal Investigator to directly and explicitly explain what makes the work innovative for TSC, why it is distinct from what has already been done, and how it could be “groundbreaking” if the hypothesis is supported.

The opportunity permits certain types of human subjects research and work with human anatomical substances, but only under limited regulatory pathways. Specifically, any human subjects component must qualify as exempt under 32 CFR 219.101(b) or be eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110. Whether a study qualifies is first determined by the applicant’s Institutional Review Board (IRB) of record, and applicants are expected to follow their institution’s submission requirements to obtain the appropriate determination. A critical administrative condition is that studies not qualifying for exempt or expedited review will be withdrawn, so applicants need to be careful to design any human-related work to fit those categories.

Clinical trials are not permitted under this funding announcement. The DoD points applicants to a human subjects resource document available through the eBRAP portal for additional guidance on clinical research definitions and requirements. Investigators who want support for a pilot clinical trial are directed to apply instead to a separate TSCRP mechanism, the FY16 Pilot Clinical Trial Award (W81XWH-16-TSCRP-PCTA), indicating that this EHDA mechanism is intended for hypothesis-driven discovery and early testing rather than interventional trial execution.

Administratively, the funding opportunity number is W81XWH-16-TSCRP-EHDA, and the agency is DOD-AMRAA. The funding instruments include grants and cooperative agreements, and it falls under CFDA number 12.420. Eligibility is listed as unrestricted (open to any type of entity, subject to any additional eligibility clarifications in the full announcement). The posting date and creation date were May 9, 2016, and the closing date was July 18, 2016. The announcement anticipated making about five awards, and the award ceiling was not specified in the provided source text.

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