Opportunity Information: Apply for W81XWH 09 PHTBIRP CA
Apply for W81XWH 09 PHTBIRP CA
- 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 Traumatic Brain Injury Research Program Concept 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 Aug 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 $3,000,000.00 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/Traumatic Brain Injury (PH/TBI) Research Program Concept Award (FY09) is a U.S. Department of the Army funding opportunity administered through USAMRAA/CDMRP that is meant to spark bold, early-stage research ideas in psychological health and traumatic brain injury. The central purpose is to fund the exploration of a highly innovative concept or an untested theory that targets an important problem tied to one or more of the FY09 PH/TBI topic areas. It is explicitly designed for high-risk, potentially high-payoff work, including projects that grow out of unexpected or serendipitous observations. In other words, this mechanism is not meant to be the next logical step in an already well-established line of research; it is meant to test new directions that could open up entirely new avenues for investigation or significantly reshape what is known in the PH/TBI space. A strong application needs to make a clear case for how the idea will add to existing PH/TBI knowledge or create a genuinely new path forward, and it should be positioned as work that can generate preliminary data that later supports a larger, follow-on research proposal.
Military relevance is treated as non-negotiable. Every application is required to clearly and specifically explain why the proposed work matters to the military, and the program strongly encourages collaboration with military researchers and clinicians. The announcement also pushes applicants to align with, integrate into, or collaborate with existing Department of Defense (DOD) and/or Department of Veterans Affairs (VA) laboratories and programs, reflecting an expectation that the work should connect to real-world military health needs and ideally be informed by military operational or clinical contexts. The notice provides a long list of DOD, VA, and related research organizations and portals (for example, DTIC, DCoE, DVBIC, DARPA, service research labs, and VA R&D) as starting points for understanding ongoing efforts and identifying potential partners or alignment opportunities.
A key constraint of this award is its focus on limited-risk human research. Projects involving human subjects or human biological substances must fit within research categories eligible for either IRB Exempt status or IRB Expedited Review under applicable DOD directives and federal regulations. Studies that do not qualify as exempt or expedited at any stage of review are not simply scored lower; they are administratively withdrawn and will not be funded. This is an important design feature of the mechanism: it aims to support innovative human-focused ideas, but within regulatory pathways that are typically associated with lower-risk protocols. The opportunity points applicants to DOD Human Research Protection Office resources and HHS OHRP policy materials for additional guidance and emphasizes the need to plan accordingly so the protocol remains within allowable review categories.
The announcement also lays out practical rules for accessing military and VA populations. For Active Duty, National Guard, Reserve troops, and other military patient populations (outside CENTCOM theaters), investigators without an already established study population are expected to coordinate access through CDMRP rather than contacting unit commanders while preparing the proposal. For CENTCOM areas of responsibility (notably Iraq and Afghanistan, as framed in the FY09 notice), access is described as very limited and subject to additional layers of in-theater oversight and approvals, including coordination through deployed combat casualty research teams and approval by the relevant command and designated IRBs. Because wartime operational constraints can make in-theater research difficult, the announcement advises investigators who lack an existing collaboration with an appropriate military investigator to consider alternatives such as civilian or non-deployed military populations. It also notes that DOD-supported human subjects research can only be conducted by institutions with approved Federal Assurances of Compliance from the Human Research Protection Office. For VA Medical Center populations or VA data systems, coordination is the responsibility of the PI, and if the PI lacks a VA appointment, the proposal must include a collaborator with a VA appointment who is willing to serve as PI for the VA component.
Administratively, this was a discretionary science and technology/R&D funding opportunity (CFDA 12.420, Military Medical Research and Development) offered as grants and cooperative agreements. The opportunity (Funding Opportunity Number W81XWH-09-PHTBIRP-CA) was posted July 10, 2009, with an original/current closing date of August 28, 2009, and an estimated total program funding level of $3,000,000 with an expected 7 awards. Cost sharing was not required, eligibility was broadly open (unrestricted, subject to any clarifications in the full text), and the sponsoring agency was the Department of the Army via USAMRAA. The announcement also provides help desk contacts for applicants who encounter issues accessing the solicitation or using CDMRP submission systems.
FAQs: PH/TBI Research Program Concept Award (FY09)
What is the PH/TBI Research Program Concept Award (FY09)?
The Psychological Health/Traumatic Brain Injury (PH/TBI) Research Program Concept Award (FY09) is a U.S. Department of the Army funding opportunity administered through USAMRAA/CDMRP. It is intended to spark bold, early-stage research ideas in psychological health and traumatic brain injury.
What is the main purpose of this Concept Award?
The central purpose is to fund exploration of a highly innovative concept or an untested theory that targets an important problem aligned with one or more FY09 PH/TBI topic areas. The award is designed to support work that can generate preliminary data suitable for a later, larger follow-on proposal.
What kind of research is this award trying to encourage?
This mechanism is explicitly designed for high-risk, potentially high-payoff research, including projects that may arise from unexpected or serendipitous observations. It is not meant to fund the next logical step in an already well-established line of research; it is meant to test new directions that could open new avenues or significantly reshape what is known in the PH/TBI space.
How should an applicant justify innovation in the application?
A strong application should make a clear case for how the idea will add to existing PH/TBI knowledge or create a genuinely new path forward, and should be positioned as early-stage work that can produce preliminary data to support future, larger-scale research.
Is military relevance required?
Yes. Military relevance is treated as non-negotiable. Every application is required to clearly and specifically explain why the proposed work matters to the military.
Is collaboration with military researchers or clinicians expected?
The program strongly encourages collaboration with military researchers and clinicians. The announcement also encourages applicants to align with, integrate into, or collaborate with existing Department of Defense (DOD) and/or Department of Veterans Affairs (VA) laboratories and programs.
What kinds of DOD/VA resources or organizations are referenced as starting points?
The notice provides examples of DOD, VA, and related research organizations and portals to help applicants understand ongoing efforts and identify alignment or partnership opportunities (for example: DTIC, DCoE, DVBIC, DARPA, service research labs, and VA R&D).
Does the award allow research involving human subjects or human biological substances?
Yes, but with a major constraint. Projects involving human subjects or human biological substances must fit within research categories eligible for either IRB Exempt status or IRB Expedited Review under applicable DOD directives and federal regulations.
What happens if a proposed human research study does not qualify as exempt or expedited?
If a study does not qualify as exempt or expedited at any stage of review, it is administratively withdrawn and will not be funded. This is not a scoring issue; it is a hard eligibility constraint for this mechanism.
Where does the announcement point applicants for human research protection guidance?
Applicants are pointed to DOD Human Research Protection Office resources and to HHS Office for Human Research Protections (OHRP) policy materials for additional guidance, with an emphasis on planning the project so it remains within allowable exempt or expedited categories.
If an investigator wants access to Active Duty, National Guard, or Reserve populations, what does the notice say?
For Active Duty, National Guard, Reserve troops, and other military patient populations (outside CENTCOM theaters), investigators who do not already have an established study population are expected to coordinate access through CDMRP rather than contacting unit commanders while preparing the proposal.
What does the notice say about doing research in CENTCOM areas of responsibility (e.g., Iraq and Afghanistan as referenced in FY09)?
Access is described as very limited and subject to additional in-theater oversight and approvals, including coordination through deployed combat casualty research teams and approval by the relevant command and designated IRBs. Because operational constraints can make in-theater research difficult, investigators without an existing collaboration with an appropriate military investigator are advised to consider alternatives such as civilian or non-deployed military populations.
Are there institutional requirements for conducting DOD-supported human subjects research?
Yes. The notice states that DOD-supported human subjects research can only be conducted by institutions with approved Federal Assurances of Compliance from the Human Research Protection Office.
What are the rules for accessing VA Medical Center populations or VA data systems?
Coordination is the responsibility of the Principal Investigator (PI). If the PI does not have a VA appointment, the proposal must include a collaborator with a VA appointment who is willing to serve as PI for the VA component.
What is the funding opportunity number for this award?
The Funding Opportunity Number is W81XWH-09-PHTBIRP-CA.
Which agency sponsors and administers this opportunity?
The sponsoring agency is the Department of the Army via USAMRAA, and it is administered through USAMRAA/CDMRP.
What is the CFDA number and program name associated with this opportunity?
The opportunity is associated with CFDA 12.420, Military Medical Research and Development.
What type of funding instrument is used (grant, cooperative agreement, etc.)?
The notice describes the opportunity as a discretionary science and technology/R&D funding opportunity offered as grants and cooperative agreements.
When was the opportunity posted and what was the closing date?
The opportunity was posted on July 10, 2009. The original/current closing date listed is August 28, 2009.
How much total funding was estimated, and how many awards were expected?
The estimated total program funding level was $3,000,000, with an expectation of 7 awards.
Is cost sharing required?
No. Cost sharing was not required.
Who is eligible to apply?
Eligibility was described as broadly open (unrestricted), subject to any clarifications in the full text of the solicitation.
What should applicants do if they have trouble accessing the solicitation or using CDMRP submission systems?
The announcement provides help desk contacts for applicants who encounter issues accessing the solicitation or using CDMRP submission systems.
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