Opportunity Information: Apply for W81XWH 09 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 "Spinal Cord Injury Research Program 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 14, 2009 and posted on Jul 14, 2009.
  • Applicants must submit their applications by Dec 10, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $6,400,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 8 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 09 SCIRP IIRA

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Opportunity Summary:

The Spinal Cord Injury Research Program (SCIRP) Investigator Initiated Research Award (IIRA) is a Department of Defense funding opportunity meant to support spinal cord injury (SCI) studies that can make a meaningful, defensible contribution to SCI science and/or to the way patients are cared for. The program is explicitly oriented toward the health needs of military service members, their families, and US veterans, so applicants are expected to do more than mention this audience in passing. Every application has to clearly explain why the proposed work matters to military or veteran populations and how the outcomes could realistically translate to their health care needs.

The scope of research supported is broad across the research pipeline, as long as the work aligns with one of the program's stated Areas of Encouragement. Projects can be basic, translational, or preclinical, and may involve animal models or human subjects. The announcement also allows correlative studies tied to an existing clinical trial, which is a useful option for teams that want to leverage ongoing trials without running a new interventional study themselves. Research ideas can originate from many sources, including laboratory findings, population-based observations, or direct clinical experience, including patterns seen in patient care and well-grounded anecdotal observations that lead to a testable hypothesis. A key expectation is that proposals are not purely speculative: applicants must include preliminary and/or published data that is directly relevant to both the topic area and the specific work proposed.

A major boundary of this mechanism is that clinical trials are not permitted. Investigators who want to run a clinical trial, particularly in rehabilitative medicine, are directed instead to the SCIRP Clinical Trial Award - Rehabilitation mechanism through CDMRP. The announcement also points applicants to the general application guidance (Appendix 6) for how the program distinguishes clinical trials from other forms of clinical research, which matters because studies involving humans can drift into "clinical trial" territory depending on design and intent. In other words, teams planning human research need to be careful that their protocol fits within what the IIRA will accept.

For projects that involve human subjects or human biological substances, the regulatory expectations are significant. In addition to local Institutional Review Board (IRB) oversight, all DOD-funded work in this space must be reviewed and approved by the US Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), through the Human Research Protection Office (HRPO). The HRPO review is driven by specific laws and DOD directives and often requires documentation and detail beyond what a local IRB requires. The opportunity text advises applicants to plan for at least six months to complete the regulatory review and approval process for human subjects work, which has practical implications for project timelines, milestones, and feasibility.

Because military relevance is central, the program encourages applicants to align their work with current DOD research priorities and, where feasible, to collaborate with military researchers and clinicians. The announcement provides a set of resources to help applicants understand active DOD and related federal research efforts, including CDMRP itself, DTIC, USAMRMC, service research labs (Army, Air Force, Navy), DARPA, the VA Office of Research and Development, and several other defense research and acquisition organizations. The intent is to help applicants position their ideas within an existing ecosystem, avoid duplication, and build partnerships that increase the likelihood the work will matter operationally and clinically for military-connected populations.

The opportunity also places special emphasis on meaningful collaboration, including cross-disciplinary teams, partnerships between basic scientists and clinicians, and collaborations that bring in biotechnology or pharmaceutical industry expertise. Importantly, the program describes an optional "qualified collaborator" pathway that can make an application eligible for a higher level of funding (as referenced in the full program details). To qualify, the collaboration must be essential to the work, not superficial. A collaborator who only provides samples or access to patients does not meet the intent. The collaborator must contribute unique skills such that the project could not be completed without them, and this must be documented through a Statement of Collaboration from the PI plus a letter from the collaborator describing their role. The collaborator must be at or above the Assistant Professor level (or equivalent), at least one partner (PI or collaborator) must have demonstrable SCI research experience through publications and/or funding history, and the collaborator must commit at least 10 percent level of effort. The collaborator's contribution is also expected to be reflected in the project budget, reinforcing that this is intended to be a true scientific partnership.

From an administrative standpoint, this FY09 opportunity (Funding Opportunity Number W81XWH-09-SCIRP-IIRA) was posted July 14, 2009, with an application deadline of December 10, 2009, and it anticipated making about eight awards. Total estimated funding was about $6.4 million. The funding instrument is listed as a cooperative agreement and/or grant under the broader category of military medical research and development (CFDA 12.420), with no cost sharing or matching requirement and broadly unrestricted eligibility (open to many entity types, subject to any eligibility clarifications in the full announcement). The sponsoring agency is the Department of the Army, US Army Medical Research Acquisition Activity (USAMRAA), and the CDMRP help desks are provided for application access and submission support.

FAQs: SCIRP Investigator Initiated Research Award (IIRA)

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 funding opportunity intended to support spinal cord injury (SCI) research that makes a meaningful, defensible contribution to SCI science and/or improves how patients are cared for.

Who is the sponsoring agency for this opportunity?

The sponsoring agency is the Department of the Army, through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the funding opportunity number for this announcement?

The Funding Opportunity Number is W81XWH-09-SCIRP-IIRA.

When was this opportunity posted and what was the application deadline?

This FY09 opportunity was posted on July 14, 2009, and the application deadline was December 10, 2009.

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

The announcement anticipated making about eight awards, with total estimated funding of about $6.4 million.

What type of funding instrument is used?

The funding instrument is listed as a cooperative agreement and/or grant.

Is cost sharing or matching required?

No cost sharing or matching requirement is stated for this opportunity.

What CFDA program category is associated with this award?

This opportunity is associated with CFDA 12.420, within the broader category of military medical research and development.

What is the core purpose or expectation for impact?

Projects are expected to make a meaningful, defensible contribution either to SCI science or to the way SCI patients are cared for, rather than being purely exploratory or speculative.

How important is military relevance in this program?

Military relevance is central. Applications are expected to do more than mention service members, their families, or U.S. veterans in passing. Every application must clearly explain why the proposed work matters to military or veteran populations and how outcomes could realistically translate to their health care needs.

What kinds of research are allowed under the IIRA?

The scope is broad across the research pipeline as long as the work aligns with one of the program's stated Areas of Encouragement. The announcement allows basic, translational, or preclinical projects, and studies may involve animal models or human subjects.

Are studies involving human subjects allowed?

Yes. Human subjects research is allowed, but it comes with significant regulatory expectations and must be designed carefully to avoid becoming a prohibited clinical trial under this mechanism.

Are animal model studies permitted?

Yes. The announcement explicitly notes that projects may involve animal models.

Does the IIRA allow correlative studies connected to an existing clinical trial?

Yes. The announcement allows correlative studies tied to an existing clinical trial, which can help teams leverage ongoing trials without running a new interventional study.

Are clinical trials permitted under this award?

No. Clinical trials are not permitted under the IIRA mechanism.

Where should investigators apply if they want to run a clinical trial, especially in rehabilitation?

Investigators seeking to run a clinical trial, particularly in rehabilitative medicine, are directed to the SCIRP Clinical Trial Award - Rehabilitation mechanism through CDMRP.

How does the program distinguish a clinical trial from other human research?

The announcement points applicants to general application guidance (Appendix 6) for how the program distinguishes clinical trials from other forms of clinical research. This matters because some human studies can drift into "clinical trial" territory depending on design and intent.

Is preliminary or published data required?

Yes. A key expectation is that proposals are not purely speculative. Applicants must include preliminary and/or published data directly relevant to both the topic area and the specific work proposed.

What are acceptable sources of research ideas for an IIRA application?

Research ideas can originate from laboratory findings, population-based observations, or direct clinical experience, including patterns observed in patient care and well-grounded anecdotal observations that lead to a testable hypothesis.

What additional oversight is required for DOD-funded human subjects research?

In addition to local Institutional Review Board (IRB) oversight, all DOD-funded work involving human subjects or human biological substances must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), through the Human Research Protection Office (HRPO).

How long should applicants plan for the DOD human research regulatory review process?

The opportunity text advises applicants to plan for at least six months to complete the regulatory review and approval process for human subjects work.

Why does HRPO review often require extra time and documentation?

HRPO review is driven by specific laws and DOD directives and may require documentation and detail beyond what a local IRB requires.

What does the program encourage regarding alignment with DOD priorities?

Because military relevance is central, the program encourages applicants to align their work with current DOD research priorities and, where feasible, to collaborate with military researchers and clinicians.

What kinds of collaborations does the IIRA emphasize?

The opportunity places special emphasis on meaningful collaboration, including cross-disciplinary teams, partnerships between basic scientists and clinicians, and collaborations that bring in biotechnology or pharmaceutical industry expertise.

What is the optional "qualified collaborator" pathway?

The program describes an optional qualified collaborator pathway that can make an application eligible for a higher level of funding (as referenced in the full program details). The collaboration must be essential to the work and not superficial.

What does NOT count as a qualified collaborator relationship under this announcement?

A collaborator who only provides samples or access to patients does not meet the intent described in the announcement.

What makes a collaborator "essential" according to the announcement?

The collaborator must contribute unique skills such that the project could not be completed without them, and this must be clearly documented.

What documentation is required for the qualified collaborator pathway?

The announcement specifies documentation through a Statement of Collaboration from the PI plus a letter from the collaborator describing their role.

Are there role or seniority requirements for a qualified collaborator?

Yes. The collaborator must be at or above the Assistant Professor level (or equivalent).

Is there a minimum effort commitment for a qualified collaborator?

Yes. The collaborator must commit at least 10 percent level of effort.

Does the program require SCI experience on the team for the qualified collaborator pathway?

Yes. At least one partner (the PI or the collaborator) must have demonstrable SCI research experience through publications and/or funding history.

Should the collaborator's work appear in the budget?

Yes. The announcement expects the collaborator's contribution to be reflected in the project budget, reinforcing that this is intended to be a true scientific partnership.

What resources are suggested to understand current DOD and related federal research efforts?

The announcement lists resources such as CDMRP, DTIC, USAMRMC, service research labs (Army, Air Force, Navy), DARPA, the VA Office of Research and Development, and other defense research and acquisition organizations.

Why does the announcement point applicants to these resources?

The intent is to help applicants position their ideas within an existing ecosystem, avoid duplication, and build partnerships that increase the likelihood the work will matter operationally and clinically for military-connected populations.

Who can apply (eligibility)?

The announcement describes broadly unrestricted eligibility (open to many entity types), subject to any eligibility clarifications in the full announcement.

What support is mentioned for application access and submission questions?

The opportunity notes that CDMRP help desks are provided for application access and submission support.

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