Opportunity Information: Apply for W81XWH 12 SCIRP IIRA

  • The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Spinal Cord Injury Investigator Initiated Research Award" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
  • This funding opportunity was created on Jul 3, 2012 and posted on May 31, 2012.
  • Applicants must submit their applications by Oct 1, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,920,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 3 candidate(s).
  • Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
Apply for W81XWH 12 SCIRP IIRA

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Opportunity Summary:

The DoD Spinal Cord Injury Research Program (SCIRP) Investigator Initiated Research Award (IIRA) is a U.S. Army-administered funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP) that supports innovative spinal cord injury (SCI) research proposals conceived and led by investigators. First offered in FY09, the mechanism is designed to back studies that can make a meaningful contribution to SCI science and/or improve patient care. The program’s emphasis is not only on scientific merit, but also on practical impact for military-relevant populations, specifically Service members, Veterans, and, where appropriate, their family members and caregivers. A central requirement is that every application must clearly and specifically explain the military relevance of the work, rather than leaving the connection implied. Collaboration with military clinicians and researchers is encouraged, reflecting the program’s interest in projects that are informed by real-world military medicine and rehabilitation needs.

From a research scope standpoint, the IIRA is broad and can support work across the research pipeline, from basic discovery through translational and preclinical development. Proposed projects may involve animal models, studies with human subjects, and research using human anatomical substances. The mechanism can also support correlative or ancillary studies that leverage data or specimens tied to an existing clinical trial, as long as the proposed work itself is not a clinical trial. The program recognizes that strong research ideas can originate in different ways, including laboratory findings, population-based analyses, a clinician’s direct observations of patient needs and outcomes, or even well-founded anecdotal observations that motivate a testable hypothesis. However, applications are expected to be grounded in evidence: preliminary data relevant to SCI and directly related to the proposed project is required, signaling that the program wants proposals that are both innovative and realistically positioned to succeed.

A key restriction is that clinical trials are not permitted under this specific award. The opportunity uses a formal definition of a clinical trial: a prospective study that accrues human subjects and tests an intervention (such as a drug, device, biologic, surgery, rehabilitation approach, behavioral intervention, or similar) with a measurable outcome tied to safety, effectiveness, efficacy, or exploratory endpoints. In other words, if the project prospectively assigns or administers an intervention to people and evaluates outcomes as a direct effect of that intervention, it falls under the clinical trial category and is not allowed here. Investigators who want to run a clinical trial are directed instead to the SCIRP Clinical Trial Award mechanism.

Administratively, this opportunity (Funding Opportunity Number W81XWH-12-SCIRP-IIRA) is offered by the Department of the Army through USAMRAA and uses grant and cooperative agreement funding instruments within the “Science and Technology and other Research and Development” activity category. Eligibility is listed as unrestricted, meaning it is broadly open to different types of applicant organizations unless additional eligibility clarifications are stated in the full announcement. The opportunity anticipated making about three awards, with an estimated total funding level of $1,920,000, and it does not require cost sharing or matching funds. The posting date was May 31, 2012, with an application closing date of October 1, 2012 (archived October 31, 2012). Applicants were also directed to CDMRP’s Human Subject Resource Document for guidance on distinguishing clinical research from clinical trials and for related compliance expectations. For technical help accessing the full announcement, the CDMRP Help Desk was provided as the primary contact.

Frequently Asked Questions (FAQs)

What is the SCIRP Investigator Initiated Research Award (IIRA)?

The Spinal Cord Injury Research Program (SCIRP) Investigator Initiated Research Award (IIRA) is a Department of Defense (DoD) funding opportunity administered by the U.S. Army under the Congressionally Directed Medical Research Programs (CDMRP). It supports innovative spinal cord injury (SCI) research proposals that are conceived and led by investigators and are intended to make a meaningful contribution to SCI science and/or improve patient care.

Who offers and administers this funding opportunity?

This opportunity is offered by the Department of the Army through USAMRAA under CDMRP.

What is the Funding Opportunity Number for this award?

The Funding Opportunity Number is W81XWH-12-SCIRP-IIRA.

When was the IIRA first offered?

This award mechanism was first offered in FY09.

What is the main goal of the IIRA mechanism?

The mechanism is designed to support studies that can meaningfully advance spinal cord injury science and/or improve patient care, with an emphasis on both scientific merit and practical impact.

What populations does the program prioritize for impact?

The program emphasizes relevance and impact for military-relevant populations, specifically Service members and Veterans, and, where appropriate, their family members and caregivers.

What does "military relevance" mean for an application?

Every application must clearly and specifically explain the military relevance of the work. The connection to military medicine or military-relevant populations must be explicit rather than implied.

Is collaboration with military clinicians or researchers required?

Collaboration is encouraged (not stated as required). The program indicates an interest in projects informed by real-world military medicine and rehabilitation needs, and collaboration with military clinicians and researchers aligns with that emphasis.

What research areas and stages are supported under this award?

The IIRA has a broad scope and can support work across the research pipeline, from basic discovery through translational and preclinical development.

Are animal model studies allowed?

Yes. Proposed projects may involve animal models.

Are studies with human subjects allowed?

Yes, studies with human subjects may be supported, as long as the proposed work is not a clinical trial under the opportunity's definition.

Is research using human anatomical substances allowed?

Yes. Research using human anatomical substances is included as an allowable approach, provided the work does not meet the definition of a clinical trial.

Can this award support correlative or ancillary studies connected to an existing clinical trial?

Yes. The mechanism can support correlative or ancillary studies that leverage data or specimens tied to an existing clinical trial, as long as the proposed work itself is not a clinical trial.

Are clinical trials allowed under the IIRA?

No. Clinical trials are not permitted under this specific award mechanism.

How does this opportunity define a clinical trial?

A clinical trial is defined as a prospective study that accrues human subjects and tests an intervention with a measurable outcome tied to safety, effectiveness, efficacy, or exploratory endpoints. Interventions can include a drug, device, biologic, surgery, rehabilitation approach, behavioral intervention, or similar.

What kinds of projects would be considered a clinical trial and therefore not allowed?

If a project prospectively assigns or administers an intervention to people and evaluates outcomes as a direct effect of that intervention (for example, to assess safety, effectiveness, efficacy, or exploratory endpoints), it falls under the clinical trial category and is not allowed under the IIRA.

Where should investigators apply if they want to conduct a clinical trial?

Investigators who want to run a clinical trial are directed to the SCIRP Clinical Trial Award mechanism.

Is preliminary data required?

Yes. Preliminary data relevant to spinal cord injury and directly related to the proposed project is required.

What kinds of idea sources are recognized as valid starting points for proposals?

The program recognizes that strong ideas may originate from laboratory findings, population-based analyses, clinician observations of patient needs and outcomes, or well-founded anecdotal observations that motivate a testable hypothesis. Even so, applications are expected to be grounded in evidence through relevant preliminary data.

What type of funding instruments are used?

The opportunity uses grant and cooperative agreement funding instruments.

What is the activity category for this award?

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

Who is eligible to apply?

Eligibility is listed as unrestricted, meaning it is broadly open to different types of applicant organizations unless additional eligibility clarifications are stated in the full announcement.

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

The opportunity anticipated making about three awards, with an estimated total funding level of $1,920,000.

Is cost sharing or matching required?

No. The opportunity does not require cost sharing or matching funds.

What were the key dates for this opportunity?

The posting date was May 31, 2012. The application closing date was October 1, 2012. The opportunity was archived on October 31, 2012.

Where can applicants find guidance on distinguishing clinical research from clinical trials?

Applicants were directed to CDMRP's Human Subject Resource Document for guidance on distinguishing clinical research from clinical trials and for related compliance expectations.

Who should applicants contact for technical help accessing the full announcement?

For technical help accessing the full announcement, the CDMRP Help Desk was provided as the primary contact.

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