DoD Tuberous Sclerosis Complex Exploration Hypothesis Development Award | Apply Online

Opportunity Summary:

The DoD Tuberous Sclerosis Complex Research Program (TSCRP) Exploration Hypothesis Development Award (EHDA) is a U.S. Army Medical Research Acquisition Activity (USAMRAA) funding opportunity designed to kick-start bold, early-stage ideas in tuberous sclerosis complex (TSC) research. It specifically targets projects that are high risk but potentially high reward, with the expectation that funded work will open new directions in the field and generate a foundation for future, more extensive studies. This mechanism has been offered since FY07 and, by the time of this FY14 announcement, it had received 93 applications with 26 recommended for funding, reflecting a competitive, selective program focused on novelty and impact.

The core purpose of the award is hypothesis-driven exploration. Applicants are expected to propose a well-formulated, testable hypothesis supported by strong scientific rationale and a solid study design. Preliminary data and prior publications can be included and may strengthen the rationale, but they are not required, which signals that the program is willing to consider genuinely new concepts that may not yet have an extensive evidence base. At the same time, the proposal cannot be vague or purely speculative; it still needs a clear hypothesis and a credible plan to test it.

A major emphasis of the EHDA is innovation. The program is looking for research that introduces a new paradigm, challenges prevailing assumptions, reframes known problems from a different angle, or otherwise demonstrates substantial creativity. The announcement is explicit that incremental extensions of existing published work are not considered innovative and do not align with the intent of this mechanism. Because of that, the Principal Investigator is responsible for directly explaining, in plain terms, what makes the approach groundbreaking within TSC research and why it is more than a routine next step.

Human subjects research is allowed, but only under limited regulatory pathways. Studies involving human participants or human anatomical substances 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. The applicant’s Institutional Review Board (IRB) makes the initial determination of whether the study is exempt or qualifies for expedited review, and investigators must follow their institution’s IRB submission requirements accordingly. Any project that does not meet exempt or expedited criteria will be administratively withdrawn, meaning it will not proceed through review or funding consideration. Importantly, clinical trials are not permitted under this opportunity; investigators interested in pilot clinical trials are directed instead to a separate TSCRP Pilot Clinical Trial Award mechanism listed in the notice.

Administratively, this FY14 funding opportunity is listed as Funding Opportunity Number W81XWH 14 TSCRP EHDA, categorized as discretionary funding, and offered through grants and cooperative agreements under the Science and Technology and other Research and Development activity category. The program anticipated making about 7 awards with an estimated total funding pool of $1,120,000, and it did not require cost sharing or matching funds. Eligibility was described as unrestricted, meaning it was generally open to a wide range of applicant organization types, subject to any additional eligibility clarifications contained in the full announcement. The opportunity was posted May 27, 2014, with a closing date of July 24, 2014, and it was associated with CFDA number 12.420 (Military Medical Research and Development).

For applicants needing help accessing or navigating the announcement and submission systems, the notice points to the CDMRP help resources available through eBRAP (the electronic Biomedical Research Application Portal) and provides the help desk contact information (help@eBRAP.org, 301-682-5507).

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