Opportunity Information: Apply for W81XWH 10 SCIRP IIRA
Apply for W81XWH 10 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 Jun 18, 2010 and posted on Jun 18, 2010.
- Applicants must submit their applications by Dec 1, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $11,250,000.00 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.
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Opportunity Summary:
The DoD Spinal Cord Injury Investigator Initiated Research Award (IIRA) is a funding opportunity under the Department of the Army and the Congressionally Directed Medical Research Programs (CDMRP) Spinal Cord Injury Research Program (SCIRP) designed to support innovative, investigator-driven research that could meaningfully advance spinal cord injury (SCI) science and/or improve patient care. The award mechanism was introduced in FY09, and by the time of this FY10 posting the program had received 70 applications and recommended 13 for funding, which signals a competitive process aimed at backing projects with clear potential impact rather than incremental work. Projects are expected to be responsive to designated “Areas of Encouragement” and, critically, to be relevant to the health care needs of the Armed Forces, military family members, and/or U.S. veterans; proposals must explicitly and convincingly explain that military relevance rather than treating it as a generic or add-on statement.
The IIRA can support a broad range of research stages, spanning basic research through translational efforts. That includes preclinical work in animal models, human subject research that is not a clinical trial, and correlative or ancillary studies connected to an existing clinical trial (for example, biomarker or mechanistic analyses that leverage samples or data generated by a separate, ongoing trial). The program emphasizes that good ideas may come from many sources, including laboratory discoveries, population-based studies, direct clinical experience with SCI patients, or even anecdotal observations, as long as the application turns those observations into a rigorous research plan. A key requirement is that proposals must include preliminary and/or published data generated by the PI, the research team, or partners that directly supports the feasibility and rationale of the proposed work; in practice, the opportunity is not meant for projects that are purely speculative without evidence in hand.
A major boundary for this mechanism is that clinical trials are not permitted. The announcement defines a clinical trial in straightforward terms as prospective enrollment of patients where an intervention is tested in humans for measurable safety and/or efficacy outcomes, typically requiring informed consent and potentially involving identifiable information. Applicants intending to run a rehabilitation-focused clinical trial are directed instead to the SCIRP Clinical Trial Award - Rehabilitation mechanism. This distinction matters because the IIRA can still involve human subjects, but it cannot cross the line into prospective interventional testing intended to evaluate safety or efficacy.
For projects that do involve human participants or human biological substances, the regulatory expectations are strict and can affect timelines. In addition to local Institutional Review Board (IRB) approvals, all DoD-funded human subjects research must be reviewed by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), specifically the Human Research Protection Office (HRPO). The HRPO review is driven by DoD-specific laws and directives that often require additional documentation beyond what a local IRB collects, and applicants are advised to plan for at least six months to complete the regulatory review and approval process. This is a practical planning issue for milestones, staffing, and project start dates, particularly for studies involving recruitment, consent, or handling of identifiable data or specimens.
The program also encourages collaboration, especially partnerships that bridge basic science and clinical research, academia and biotech/pharma, or that bring new disciplinary perspectives or new investigators into the SCI field. There is an “Optional Qualified Collaborator” pathway that can make an application eligible for a higher funding level, but only when the collaboration is substantive and essential. To qualify, the PI must submit a Statement of Collaboration naming the collaborator and explaining how the criteria are met, and the collaborator must submit a letter detailing their role. The collaboration must be integral in the sense that the project could not be completed without the collaborator’s unique contributions; simply providing tissue samples or access to patients is explicitly not sufficient. Additional requirements include demonstrated SCI research experience by either the PI or collaborator (via publications and/or funding), collaborator seniority at or above Assistant Professor (or equivalent), and at least 10 percent level of effort by the collaborator, which must be reflected in the budget.
Administratively, this opportunity (Funding Opportunity Number W81XWH-10-SCIRP-IIRA) was posted June 18, 2010, with an original and current closing date of December 1, 2010, and an archive date of December 31, 2010. It falls under CFDA 12.420 (Military Medical Research and Development), uses grant and cooperative agreement funding instruments, and lists an estimated total funding amount of $11,250,000 with an expectation of approximately three awards. Eligibility is listed as unrestricted, meaning it is broadly open to different entity types unless further limited by details in the full announcement. For applicant support, the posting provides contact points for CDMRP and eReceipt technical assistance, reflecting the program’s typical two-track submission and help structure.
DoD Spinal Cord Injury Investigator Initiated Research Award (IIRA) - FAQs
What is the DoD Spinal Cord Injury Investigator Initiated Research Award (IIRA)?
The IIRA is a funding opportunity within the Department of the Army's Congressionally Directed Medical Research Programs (CDMRP), under the Spinal Cord Injury Research Program (SCIRP). It is intended to support innovative, investigator-driven research that could meaningfully advance spinal cord injury (SCI) science and/or improve patient care.
Who is running and administering this opportunity?
The opportunity is offered through the Department of the Army and CDMRP under SCIRP. For human subjects research oversight, DoD-funded studies must also be reviewed by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), specifically the Human Research Protection Office (HRPO).
What kinds of projects does the IIRA support?
The IIRA supports a broad range of SCI research stages, from basic research through translational work. Examples described in the posting include preclinical studies in animal models, human subject research that is not a clinical trial, and correlative or ancillary studies linked to an existing clinical trial (such as biomarker or mechanistic analyses using samples or data from a separate ongoing trial).
Are clinical trials allowed under the IIRA?
No. Clinical trials are not permitted under this mechanism.
How does the announcement define a clinical trial for this award?
The posting describes a clinical trial as prospectively enrolling patients where an intervention is tested in humans for measurable safety and/or efficacy outcomes, typically involving informed consent and potentially involving identifiable information.
If my project is a rehabilitation-focused clinical trial, where should I apply instead?
The announcement directs applicants who intend to run a rehabilitation-focused clinical trial to apply to the SCIRP Clinical Trial Award - Rehabilitation mechanism rather than the IIRA.
Can I include human subjects research at all if clinical trials are not allowed?
Yes. The IIRA can involve human subjects research, as long as it does not cross into prospective interventional testing intended to evaluate safety and/or efficacy (as defined in the posting).
Can I propose work connected to an existing clinical trial?
Yes. The IIRA can support correlative or ancillary studies connected to an existing clinical trial, such as biomarker studies or mechanistic analyses that leverage samples or data generated by a separate ongoing trial.
Does the program require projects to align with specific topic priorities?
Yes. Projects are expected to be responsive to designated Areas of Encouragement, as described in the opportunity.
What does "military relevance" mean for this award?
Applications must be relevant to the health care needs of the Armed Forces, military family members, and/or U.S. veterans. The posting emphasizes that the proposal must explicitly and convincingly explain this military relevance rather than treating it as a generic statement or an add-on.
Is preliminary data required?
Yes. The opportunity requires preliminary and/or published data generated by the PI, the research team, or partners that directly supports the feasibility and rationale of the proposed work. The posting indicates the mechanism is not intended for projects that are purely speculative without evidence in hand.
Where can the research idea come from?
The program notes that strong ideas may come from many sources, including laboratory discoveries, population-based studies, direct clinical experience with SCI patients, or anecdotal observations, as long as the application turns those observations into a rigorous research plan and includes supporting data for feasibility and rationale.
What approvals are required for studies involving human subjects or human biological substances?
In addition to local Institutional Review Board (IRB) approvals, all DoD-funded human subjects research must be reviewed by USAMRMC ORP HRPO. The posting notes the HRPO review is driven by DoD-specific laws and directives and may require additional documentation beyond local IRB requirements.
How long should applicants plan for the DoD human subjects regulatory review?
The announcement advises applicants to plan for at least six months to complete the regulatory review and approval process.
Why does the HRPO review timeline matter for project planning?
The posting highlights that HRPO requirements can affect timelines and should be accounted for in milestones, staffing, and project start dates, particularly for studies involving recruitment, consent, or handling of identifiable data or specimens.
Does the program encourage collaboration?
Yes. The opportunity encourages collaboration, including partnerships that bridge basic science and clinical research, academia and biotech/pharma, and efforts that bring new disciplinary perspectives or new investigators into the SCI field.
What is the "Optional Qualified Collaborator" pathway?
The IIRA includes an Optional Qualified Collaborator pathway that can make an application eligible for a higher funding level, but only when the collaboration is substantive and essential to completing the project.
What documentation is required to use the Optional Qualified Collaborator pathway?
The PI must submit a Statement of Collaboration naming the collaborator and explaining how the criteria are met, and the collaborator must submit a letter detailing their role in the project.
What makes a collaborator "qualified" for the optional pathway?
Based on the posting, the collaboration must be integral (the project could not be completed without the collaborator's unique contributions). Simply providing tissue samples or access to patients is explicitly stated as not sufficient. Additional requirements include demonstrated SCI research experience by either the PI or the collaborator (via publications and/or funding), collaborator seniority at or above Assistant Professor (or equivalent), and at least 10 percent level of effort by the collaborator reflected in the budget.
Is providing samples or patient access enough to count as a qualified collaboration?
No. The announcement explicitly says that simply providing tissue samples or access to patients is not sufficient for the Optional Qualified Collaborator pathway.
What is the Funding Opportunity Number (FON) for this IIRA posting?
The Funding Opportunity Number is W81XWH-10-SCIRP-IIRA.
When was this funding opportunity posted and when did it close?
The posting date is June 18, 2010. The original and current closing date is December 1, 2010. The archive date is December 31, 2010.
What is the CFDA number for this opportunity?
The opportunity is listed under CFDA 12.420 (Military Medical Research and Development).
What funding instruments are used for this opportunity?
The posting indicates grant and cooperative agreement funding instruments are used.
How much total funding is estimated, and how many awards are expected?
The estimated total funding amount is $11,250,000, with an expectation of approximately three awards.
How competitive is the IIRA mechanism based on prior application activity?
The posting notes that since the mechanism was introduced in FY09, by the time of the FY10 posting the program had received 70 applications and recommended 13 for funding, indicating a competitive process focused on projects with clear potential impact rather than incremental work.
Who is eligible to apply?
Eligibility is listed as unrestricted, meaning it is broadly open to different entity types unless further limited by details in the full announcement.
Where can applicants get help with submission or technical issues?
The posting provides contact points for CDMRP and eReceipt technical assistance, reflecting the program's two-track submission and support structure.
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