DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award

The intent of the FY22 TBIPHRP CTA is to support the rapid implementation of clinical trials with the potential to have a significant impact on psychological health conditions and/or TBI through clinical applications, in...

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Deadline 1290 days ago Location Alabama Type grant Level Federal Closed posted Jul 15, 2022
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$70,520,000.
  • Next deadline: December 8, 2022.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
How was this generated?

The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

AI-generated. Always verify with the official source.

Deadline
1290 days ago
Dec 8, 2022
Total pool
$70.5M

About this opportunity

The intent of the FY22 TBIPHRP CTA is to support the rapid implementation of clinical trials with the potential to have a significant impact on psychological health conditions and/or TBI through clinical applications, including healthcare products, technologies, and/or practice guidelines. Proposed research can be aligned with TBI, psychological health, or both.Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), guidance, behavioral interventions, emerging approaches and technologies, and/or new indications for products currently FDA-approved or - cleared.Proposed projects may range from small proof-of-concept trials ( 0) to demonstrate feasibility or inform the design of more advanced trials through large- scale trials to determine efficacy in relevant patient populations. Proposals/applications proposing comparative effectiveness, implementation science, healthcare services research as the primary research objective should consider the FY22 TBIPHRP Patient-CenteredResearch Award (Funding Opportunity Number: W81XWH-22-TBIPHRP-PCRA).A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)- approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in Code of Federal Regulations, Title 32,Part 219 (32 CFR 219). For more information, see the Human Subject Resource Document.Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB review Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de- identified specimens or data, if these sources are publicly available. Studies seeking to conduct clinical research only but not a clinical trial do not meet the intent of the award mechanism and will not be funded.This BAA may not be used to support studies requiring an exception from informed consent (EFIC).Funding from this award mechanism must support a clinical trial and cannot be used for animal studies. Principal Investigators (PIs) seeking funding for a preclinical research project or a clinical research project that does not involve a clinical trial should consider one of applicable FY22 TBIPHRP program announcements or the other BAA being offered.If the proposed clinical trial involves the use of a drug that has not been approved by the FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND application is not required. If an IND application is required, evidence that an IND application has been submitted or IND authorization without clinical hold status has been secured must be included in the FY22 TBIPHRP CTA proposal/application.

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Who can apply

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Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

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Citation details

Source systemgrants.gov
Source ID342451
PostedJul 15, 2022

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