Opportunity Information: Apply for W81XWH 09 PHTBIRP IIRA
Apply for W81XWH 09 PHTBIRP 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 "Psychological Health and Traumatic Brain 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 10, 2009 and posted on Jul 10, 2009.
- Applicants must submit their applications by Oct 28, 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 $10,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 7 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 Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program Investigator Initiated Research Award (IIRA) is a Department of Defense funding opportunity meant to support research that meaningfully advances knowledge, clinical practice, and/or patient care related to psychological health and traumatic brain injury within the FY09 PH/TBI topic areas. The central expectation is that proposed work has clear, stated military relevance and is responsive to the real-world health care needs of Service members, Veterans, and also the broader circle affected by these conditions, including families, caregivers, and communities. The program is open to a wide range of scientifically grounded ideas, including those sparked by basic lab discoveries, population-based findings, or practical clinical observations drawn from direct patient care, even when the earliest evidence includes clinician experience and anecdotal patterns. While the program prefers proposals supported by preliminary and/or published data closely tied to both the topic area and the planned approach, lacking that evidence does not automatically disqualify an application.
In terms of what can be funded, the IIRA is intentionally flexible about the stage of science. Projects may range from basic laboratory studies through translational research, so applicants are not limited to purely clinical trials or purely mechanistic work. However, regardless of where the work falls on the research spectrum, the application must directly connect the proposed aims to military needs and contexts. The opportunity explicitly encourages collaboration with military researchers and clinicians, and it also encourages applicants to align projects with existing DOD and VA research programs and infrastructure. The announcement points applicants toward a number of DOD and VA resources and organizations where current priorities and related efforts may be identified, reinforcing that this mechanism is designed to complement and strengthen ongoing military-facing research rather than operate in isolation.
A distinctive feature of this award is the Partnering PI option, which is designed to bring multiple investigators together in a genuinely shared scientific effort. Under this option, the project must be built through a reciprocal exchange of ideas, with equal intellectual input among partners into the design and execution of a single unified research plan. The program is explicit that this is not meant to be a superficial partnership where one “partner” simply provides samples, recruitment access, or routine services. The structure can include up to three principal investigators total: one Initiating PI and up to two Partnering PIs. The Initiating PI takes primary responsibility for submission and core administrative actions, while Partnering PIs complete their own required submission-related tasks. Importantly, separate awards are issued to each PI’s institution, which makes this mechanism workable for multi-institution teams. Additional collaborators can be included, but only the Initiating PI and up to two Partnering PIs are formally designated as PIs.
For multidisciplinary or multi-institution projects, the program allows broad teaming but expects applicants to plan for the practical realities of collaboration. Proposals should describe how investigators across sites will communicate, how data will be shared and transferred, and how study outputs like specimens and imaging products will be handled. Multi-institution efforts also require a separate intellectual and material property plan agreed upon by all participating institutions, and participating organizations must be willing to resolve potential intellectual property and material transfer issues early enough that these concerns do not become barriers to cooperation during the project. This emphasis is meant to prevent common collaboration breakdowns that can delay research, especially when multiple institutions and data types are involved.
Applications proposing clinical research in humans face additional expectations aimed at scientific rigor and operational feasibility. These submissions should present clearly defined and appropriate endpoints, a well-articulated statistical analysis plan, and a concrete discussion of how findings could impact patients with the relevant condition. The program also requires a named study coordinator for clinical studies, reflecting the complexity of DOD and multi-site clinical oversight. This coordinator is expected to shepherd the protocol through regulatory pathways such as IRB and Human Subjects Research Review Board processes, coordinate participating sites, and manage participant accrual, which is often a major risk factor for timelines in clinical research.
Because military relevance is a defining requirement, the announcement includes detailed guidance about using military and Veteran populations and how access is coordinated. If applicants plan to involve Active Duty, National Guard, Reserve troops, or military patient populations outside the CENTCOM area of responsibility and do not already have an established participant pool, access must be coordinated through the Congressionally Directed Medical Research Programs (CDMRP). Investigators are specifically instructed not to contact unit commanders during proposal preparation if they do not already have an established relationship or population access; instead, if funded, the program will provide guidance on how to obtain appropriate access. For CENTCOM-area populations, such as those in Iraq or Afghanistan (at the time of the solicitation), access is described as highly limited and tightly controlled, requiring coordination through CDMRP and additional in-theater approvals and oversight structures. The announcement notes that, given wartime operational constraints, investigators without existing, appropriate military collaborations are strongly encouraged to consider alternatives to conducting in-theater research, such as civilian or non-deployed military populations.
For studies involving Department of Veterans Affairs Medical Center patients or VA data systems, the applicant is responsible for coordinating access. If the proposing PI does not hold a VA appointment, the application must include a collaborator with a VA appointment who is willing to serve as the PI for the VA portion of the work. This requirement reflects the practical governance of VA research, including access to participants, records, and data platforms.
The opportunity also highlights the layered regulatory oversight required for human subjects research funded by the DOD. Any DOD-funded research involving human subjects or human biological substances must undergo review not only by local IRBs but also by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections/Human Research Protection Office (HRPO). Applicants are warned that DOD human subjects requirements are rigorous and may require more information than local IRBs typically request, and they are advised to plan for at least six months to complete regulatory review and approvals for human-subjects studies. This timeline is a practical planning point for applicants building project schedules and milestones.
Administratively, the opportunity is listed under Funding Opportunity Number W81XWH-09-PHTBIRP-IIRA, managed by the Department of the Army through USAMRAA, and categorized as science and technology/research and development. It was posted July 10, 2009, with an original and current closing date of October 28, 2009, and an archive date of November 27, 2009. The program anticipated approximately seven awards, with an estimated total funding amount of $10,000,000, and it did not require cost sharing or matching. Eligibility was described as unrestricted (open to any entity type, subject to any clarifications in the full announcement). For support, the announcement provided multiple help contacts, including PA HELP and eReceipt/CDMRP help desk resources for technical or submission-related issues.
Frequently Asked Questions (FAQs)
1) What is the PH/TBI Research Program Investigator Initiated Research Award (IIRA)?
The Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program Investigator Initiated Research Award (IIRA) is a Department of Defense (DOD) funding opportunity intended to support research that meaningfully advances knowledge, clinical practice, and/or patient care related to psychological health and traumatic brain injury within the FY09 PH/TBI topic areas.
2) What is the main purpose or expectation of this award?
The central expectation is that the proposed work has clear, stated military relevance and responds to real-world health care needs of Service members and Veterans, as well as affected families, caregivers, and communities.
3) What kinds of research ideas are considered appropriate for this mechanism?
The program is open to a wide range of scientifically grounded ideas, including those prompted by basic laboratory discoveries, population-based findings, and practical clinical observations from direct patient care. Early evidence can include clinician experience and anecdotal patterns, as long as the idea is scientifically grounded.
4) Do applicants need preliminary data or published results to apply?
The program prefers proposals supported by preliminary and/or published data closely tied to the topic area and planned approach. However, the absence of such evidence does not automatically disqualify an application.
5) What stages of research can be funded (basic, translational, clinical, etc.)?
The IIRA is intentionally flexible about stage of science. Projects may range from basic laboratory studies through translational research. Applicants are not limited to purely clinical trials or purely mechanistic work.
6) Is military relevance required even for basic or non-clinical research?
Yes. Regardless of where the project falls on the research spectrum, the application must directly connect the proposed aims to military needs and contexts.
7) Does the program encourage collaboration with military or VA researchers and clinicians?
Yes. The opportunity explicitly encourages collaboration with military researchers and clinicians and also encourages alignment with existing DOD and VA research programs and infrastructure.
8) What is the Partnering PI option?
The Partnering PI option is designed to bring multiple investigators together in a genuinely shared scientific effort. It requires reciprocal exchange of ideas and equal intellectual input among partners into the design and execution of a single unified research plan.
9) What is not considered an acceptable "partnering" arrangement under the Partnering PI option?
The program states this option is not meant to be a superficial partnership where one partner simply provides samples, recruitment access, or routine services.
10) How many Principal Investigators (PIs) can be included under the Partnering PI option?
Up to three total PIs may be included: one Initiating PI and up to two Partnering PIs.
11) What is the Initiating PI responsible for?
The Initiating PI takes primary responsibility for submission and core administrative actions.
12) What are Partnering PIs responsible for?
Partnering PIs complete their own required submission-related tasks.
13) How are awards handled for multi-institution Partnering PI projects?
Separate awards are issued to each PI's institution, which is intended to make the mechanism workable for multi-institution teams.
14) Can a project include additional collaborators beyond the listed PIs?
Yes. Additional collaborators can be included, but only the Initiating PI and up to two Partnering PIs are formally designated as PIs.
15) What collaboration planning details are expected for multidisciplinary or multi-institution projects?
Proposals should describe how investigators across sites will communicate, how data will be shared and transferred, and how outputs like specimens and imaging products will be handled.
16) Are there intellectual property (IP) or material transfer expectations for multi-institution projects?
Yes. Multi-institution efforts require a separate intellectual and material property plan agreed upon by all participating institutions, and participating organizations must be willing to resolve potential IP and material transfer issues early enough that they do not become barriers during the project.
17) What additional requirements apply to applications proposing clinical research in humans?
Applications proposing human clinical research should include clearly defined and appropriate endpoints, a well-articulated statistical analysis plan, and a concrete discussion of how findings could impact patients with the relevant condition.
18) Is a study coordinator required for clinical studies?
Yes. The program requires a named study coordinator for clinical studies.
19) What is the study coordinator expected to do?
The coordinator is expected to shepherd the protocol through regulatory pathways such as IRB and Human Subjects Research Review Board processes, coordinate participating sites, and manage participant accrual.
20) What guidance is provided about using Active Duty, National Guard, Reserve, or military patient populations?
If applicants plan to involve Active Duty, National Guard, Reserve, or military patient populations outside the CENTCOM area of responsibility and do not already have an established participant pool, access must be coordinated through the Congressionally Directed Medical Research Programs (CDMRP).
21) Should investigators contact unit commanders to arrange access during proposal preparation?
No. Investigators are specifically instructed not to contact unit commanders during proposal preparation if they do not already have an established relationship or established participant access. If funded, guidance will be provided on how to obtain appropriate access.
22) What does the opportunity say about research involving CENTCOM-area populations (for example, Iraq or Afghanistan at the time)?
Access is described as highly limited and tightly controlled, requiring coordination through CDMRP and additional in-theater approvals and oversight structures. Because of wartime operational constraints, investigators without existing, appropriate military collaborations are strongly encouraged to consider alternatives to conducting in-theater research (such as civilian or non-deployed military populations).
23) What if the study involves VA Medical Center patients or VA data systems?
The applicant is responsible for coordinating VA access. If the proposing PI does not hold a VA appointment, the application must include a collaborator with a VA appointment who is willing to serve as the PI for the VA portion of the work.
24) What regulatory oversight applies to DOD-funded human subjects research?
DOD-funded research involving human subjects or human biological substances must undergo review by local IRBs and also by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections/Human Research Protection Office (HRPO).
25) How long should applicants plan for DOD human subjects regulatory reviews and approvals?
Applicants are advised to plan for at least six months to complete regulatory review and approvals for human-subjects studies.
26) What is the Funding Opportunity Number (FON) for this award?
The Funding Opportunity Number is W81XWH-09-PHTBIRP-IIRA.
27) Which organization manages this opportunity?
The opportunity is managed by the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
28) What is the category of this funding opportunity?
It is categorized as science and technology/research and development.
29) When was the opportunity posted, and what were the key dates listed?
It was posted on July 10, 2009. The original and current closing date was October 28, 2009. The archive date was November 27, 2009.
30) How many awards and how much total funding were anticipated?
The program anticipated approximately seven awards with an estimated total funding amount of $10,000,000.
31) Is cost sharing or matching required?
No. The opportunity indicated that cost sharing or matching was not required.
32) Who is eligible to apply?
Eligibility was described as unrestricted (open to any entity type), subject to any clarifications in the full announcement.
33) What kinds of applicant support or help contacts were listed?
The announcement provided multiple help contacts, including PA HELP and eReceipt/CDMRP help desk resources for technical or submission-related issues.
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