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SCIRP Exploration Hypothesis Development Award (EHDA) - Frequently Asked Questions

What is the SCIRP Exploration Hypothesis Development Award (EHDA)?

The Exploration Hypothesis Development Award (EHDA) is a funding opportunity under the Department of the Army Spinal Cord Injury Research Program (SCIRP), administered through USAMRAA. It is designed to support early-stage, exploratory spinal cord injury (SCI) research that tests bold, innovative, and unproven ideas.

What is the main purpose of this award mechanism?

The EHDA is intended to give investigators room to explore high-risk, high-payoff concepts in SCI research. The aim is not to fund a fully developed, low-risk project with extensive supporting evidence, but to help researchers investigate novel directions that could lead to major advances.

Is this award meant for mature projects with extensive preliminary evidence?

No. This mechanism is specifically positioned for exploratory work where the scientific rationale may still have gaps because key information is not yet available. It is meant to enable testing of innovative and untested concepts rather than supporting mature research programs.

Can projects based on unexpected or serendipitous observations be supported?

Yes. The opportunity explicitly notes that potentially groundbreaking directions can include work that grows out of unexpected or serendipitous observations, even when the rationale is not yet fully built out.

What kinds of outcomes are expected from EHDA-funded projects?

Projects are expected to generate early evidence that can serve as a launching pad for the next step in research. In practical terms, results should either (1) provide scientific rationale supporting the formation of a new hypothesis, or (2) establish initial principles that define and justify a novel hypothesis.

Is preliminary data required to apply?

No. Preliminary data may be included if available, but it is not required. This reinforces that the EHDA is intended for exploratory hypothesis development rather than fully supported, later-stage projects.

Are studies involving human subjects allowed under this award?

Only in a limited way. Research involving human subjects or human specimens is permitted only if it qualifies as exempt under applicable human subjects regulations (Title 32 CFR Part 219, Section 101(b)) or is eligible for expedited review (32 CFR 219.110 or 21 CFR 56.110).

What happens if a proposed human subjects study does not qualify as exempt or expedited?

If a proposed study does not qualify for exempt or expedited status at any point in the review process, the application will be administratively withdrawn and will not be funded under this mechanism.

Why is there a strict limitation on human subjects or human specimens?

The EHDA is intended for preliminary investigations, and the program limits supported human research to exempt or expedited categories. This aligns with the exploratory nature of the mechanism and its role as a stepping stone to larger follow-on efforts.

What should applicants do to confirm whether their human subjects work is exempt or expedited?

Applicants are encouraged to consult their local Institutional Review Board (IRB) to confirm how the proposed work will be categorized (exempt, expedited, or neither).

If a project uses only commercially available or de-identified specimens, what documentation may be expected?

For work relying only on commercially available or de-identified specimens, applicants should expect to provide a Claim of Exemption Form, as referenced in the opportunity.

Where can applicants find more information about exemptions related to human research protections?

The opportunity points applicants to the USAMRMC Human Research Protection Office for more details on exemptions.

If a study requires more than minimal risk review, is there an alternative SCIRP mechanism mentioned?

Yes. If applicants determine their human subjects plans will not meet the exempt or expedited threshold, the notice suggests considering the SCIRP Investigator Initiated Research Award mechanism, which may be more appropriate for studies requiring review beyond minimal risk categories.

What is the Funding Opportunity Number for this announcement?

The Funding Opportunity Number listed is W81XWH-09-SCIRP-EHDA.

When was this funding opportunity posted?

The announcement was posted on July 13, 2009.

What was the application closing date?

The application closing date was November 20, 2009.

When was the archive date for the opportunity?

The archive date was December 20, 2009.

What types of funding instruments are used for this opportunity?

The funding instrument type allows for either a cooperative agreement or a grant.

How is the activity category described?

The activity category is described as Science and Technology and other Research and Development.

How many awards were anticipated and what was the estimated total funding level?

The program anticipated making about 10 awards, with an estimated total funding level of $1.6 million.

Is cost sharing or matching required?

No. The opportunity did not require cost sharing or matching.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning a wide range of organizations could apply, subject to any clarifications provided in the full announcement.

Where can applicants get help with accessing the announcement or submitting an application?

The listing includes help contacts for announcement access and submission support through the CDMRP help desks, including phone and email points of contact.