Opportunity Information: Apply for HT9425 23 PCRP EHDA
The DoD Prostate Cancer Research Program (PCRP) Exploration-Hypothesis Development Award (FY23; opportunity number HT9425-23-PCRP-EHDA) is a Department of Defense funding mechanism meant for very early-stage, high-risk ideas in prostate cancer research. The central purpose is to let investigators test highly innovative, largely unproven concepts that could pay off in a big way if they work, especially ideas that tackle an important problem tied to one or more of the FY23 PCRP Overarching Challenges. This is the kind of award built for exploring new theories, methods, or paradigms, and it is also explicitly positioned to support follow-up on unexpected or serendipitous observations that could open up entirely new directions. The expected outcome is not a fully developed project with extensive supporting evidence, but rather a scientific premise for a new hypothesis or an initial proof-of-principle that can justify bigger, more definitive studies later.
A defining feature of this opportunity is that preliminary data is strongly discouraged because it runs against the intent of the mechanism. Instead, applicants are expected to make a compelling case through logical reasoning and a sound scientific rationale, explaining why the idea is worth testing and how the approach could plausibly work. Another important feature is that peer review is conducted with reviewer blinding to the identity of the Principal Investigator, collaborators, and their institutions, which is designed to keep the evaluation focused on the idea and the proposed work rather than reputation or organizational prestige.
The award has firm boundaries around human research. Projects involving human subjects or human specimens are generally not supported unless they fall under an Institutional Review Board (IRB) category that is exempt or eligible for expedited review. Applicants are expected to understand and follow their institution's IRB processes and to align with the relevant federal regulations (for example, exempt status under 32 CFR 219.104(d) or expedited review under 21 CFR 56.110). If an application proposes human subjects or specimen work that does not qualify for exempt or expedited status, it will be administratively withdrawn rather than reviewed. On top of that, CDMRP-defined clinical research is not allowed, and neither are clinical trials. The program uses a broad definition of clinical research that includes patient-oriented research involving direct interaction with people, studies of disease mechanisms in humans when the investigator directly interacts with subjects, therapeutic intervention studies, and also epidemiologic, behavioral, outcomes, and health services research. An important nuance is that certain work that meets IRB Exemption 4 (research using existing, de-identified specimens or data that are publicly available) is not considered clinical research under CDMRP rules, which creates a narrow pathway for some human-derived data/specimen use as long as it stays within those constraints.
From an administrative and funding standpoint, awards are issued as federal assistance agreements, meaning they will be structured either as a grant or a cooperative agreement. The difference depends on how involved DoD expects to be during the project. If there is no substantial federal involvement anticipated, the award will be a grant (consistent with 31 USC 6304). If substantial involvement is anticipated, such as collaboration or participation by the agency in the research, the award will be a cooperative agreement (31 USC 6305), and the specific areas of involvement would be spelled out in the award. The final award type and start date are determined during negotiations.
Budget-wise, the anticipated direct costs for the entire period of performance are expected not to exceed $100,000, positioning this as a small, targeted investment aimed at generating the earliest signals that an unconventional idea is worth further development. Program-wide, the CDMRP expected to allocate about $2.24 million total to fund approximately 14 awards, though actual funding depends on federal fund availability, the number of applications received, and scientific/programmatic merit. The agency indicated awards would be made no later than September 30, 2024. Funds for awards made from this FY23 opportunity were anticipated to be FY23 funds, with an expiration for use on September 30, 2029, reflecting the limited period during which those appropriated dollars can be spent.
The opportunity also reflects broader DoD cancer research priorities and partnerships. Applicants are encouraged to consider recommendations from the congressionally mandated Metastatic Cancer Task Force, particularly ideas that could help accelerate progress for advanced or recurrent disease, as long as the proposed work still fits the rules and priorities of this specific funding mechanism. Collaboration is strongly encouraged, especially partnerships that connect military or Veteran institutions with non-military organizations, leveraging complementary strengths such as infrastructure, expertise, and access to unique populations, with the overarching goal of producing prostate cancer research that matters to the Warfighter, military families, and the general public.
Finally, the announcement highlights special considerations for access and compliance. If the project depends on Department of Defense or Department of Veterans Affairs resources, databases, or access to active-duty or VA populations, the application needs to describe that access up front and include a plan to maintain it throughout the work. For animal studies, IACUC approval is not required at the time of submission, but any funded animal research must go through both local IACUC review and DoD-level review by the USAMRDC Animal Care and Use Review Office (ACURO). Investigators are advised to plan for the regulatory timeline, with ACURO review and approval commonly taking 3 to 4 months, which can affect how quickly experimental work can begin after award.Apply for HT9425 23 PCRP EHDA
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Prostate Cancer, Exploration-Hypothesis Development Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Apr 03, 2023.
- Applicants must submit their applications by Jul 13, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 14 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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FAQs: DoD Prostate Cancer Research Program (PCRP) Exploration-Hypothesis Development Award (FY23) - HT9425-23-PCRP-EHDA
What is the PCRP Exploration-Hypothesis Development Award (EHDA) meant to fund?
This mechanism supports very early-stage, high-risk prostate cancer research ideas. It is designed to let investigators explore highly innovative, largely unproven concepts that could deliver major impact if they work, particularly when the idea addresses an important problem connected to one or more FY23 PCRP Overarching Challenges.
What kinds of projects are a good fit for this award?
Projects that propose exploring new theories, methods, or paradigms in prostate cancer research are a strong fit. The opportunity is also explicitly positioned to support follow-up on unexpected or serendipitous observations that could open entirely new research directions.
What outcome is the EHDA trying to achieve?
The expected outcome is not a fully developed project supported by extensive preliminary evidence. Instead, the goal is to generate a scientific premise for a new hypothesis or an initial proof-of-principle that can justify larger, more definitive studies later.
Is preliminary data required?
No. Preliminary data is strongly discouraged because it runs against the intent of the mechanism. Applicants are expected to build a compelling case using logical reasoning and a sound scientific rationale for why the idea is worth testing and how the approach could plausibly work.
How will applications be evaluated if preliminary data is discouraged?
Based on the announcement, applicants should focus on clear reasoning, a coherent scientific premise, and a well-justified approach that explains why the hypothesis is plausible and why testing it could matter, especially in relation to an FY23 PCRP Overarching Challenge.
Is the peer review process blinded?
Yes. Peer review is conducted with reviewer blinding to the identity of the Principal Investigator, collaborators, and their institutions. The intent is to keep evaluation focused on the idea and proposed work rather than investigator reputation or institutional prestige.
Are projects involving human subjects allowed?
Human subjects research is generally not supported unless it fits an Institutional Review Board (IRB) category that is exempt or eligible for expedited review. Applications proposing human subjects work that does not qualify for exempt or expedited status will be administratively withdrawn rather than reviewed.
Are projects involving human specimens allowed?
Projects involving human specimens are generally not supported unless the work falls under IRB exempt or expedited categories. If the proposed human specimen work does not qualify as exempt or expedited, the application will be administratively withdrawn.
What regulations are referenced for IRB exempt or expedited categories?
The announcement references exempt status under 32 CFR 219.104(d) and expedited review under 21 CFR 56.110 as examples of relevant federal regulatory pathways. Applicants are expected to follow their institution's IRB processes and align with applicable federal requirements.
What happens if an application includes human subjects or specimens that are not exempt or eligible for expedited review?
The application will be administratively withdrawn and will not proceed to peer review.
Is CDMRP-defined clinical research allowed under this mechanism?
No. CDMRP-defined clinical research is not allowed under this opportunity.
Are clinical trials allowed?
No. Clinical trials are not allowed.
What does the program consider "clinical research"?
The program uses a broad definition of clinical research that includes patient-oriented research involving direct interaction with people; studies of disease mechanisms in humans when the investigator directly interacts with subjects; therapeutic intervention studies; and epidemiologic, behavioral, outcomes, and health services research.
Is any human-derived data or specimen use possible without being considered CDMRP clinical research?
There is a narrow pathway. The announcement notes that certain work meeting IRB Exemption 4 (research using existing, de-identified specimens or data that are publicly available) is not considered clinical research under CDMRP rules, as long as the work stays within those constraints.
What type of award instrument will be used (grant vs cooperative agreement)?
Awards will be issued as federal assistance agreements, structured either as a grant or a cooperative agreement. The selection depends on how involved the DoD expects to be during the project.
When would this award be a grant?
If no substantial federal involvement is anticipated, the award will be a grant (consistent with 31 USC 6304).
When would this award be a cooperative agreement?
If substantial federal involvement is anticipated (for example, collaboration or participation by the agency in the research), the award will be a cooperative agreement (31 USC 6305), and the specific areas of involvement would be described in the award.
Is the award type finalized at the time of application?
No. The final award type and the project start date are determined during negotiations.
What is the maximum budget for this award?
The anticipated direct costs for the entire period of performance are expected not to exceed $100,000.
How many awards does the program expect to fund?
Program-wide, CDMRP expected to allocate about $2.24 million total to fund approximately 14 awards, although actual funding depends on federal fund availability, the number of applications received, and scientific and programmatic merit.
When were awards expected to be made?
The agency indicated awards would be made no later than September 30, 2024.
What fiscal year funds are associated with this opportunity, and how long are they available?
Funds for awards made from this FY23 opportunity were anticipated to be FY23 funds, with an expiration for use on September 30, 2029. This reflects the limited period during which those appropriated dollars can be spent.
Are applicants encouraged to align with broader DoD cancer research priorities?
Yes. Applicants are encouraged to consider recommendations from the congressionally mandated Metastatic Cancer Task Force, particularly ideas that could accelerate progress for advanced or recurrent disease, as long as the proposed work still fits the rules and priorities of this specific mechanism.
Is collaboration encouraged?
Yes. Collaboration is strongly encouraged, especially partnerships connecting military or Veteran institutions with non-military organizations, to leverage complementary strengths such as infrastructure, expertise, and access to unique populations.
Who is the research intended to benefit?
The overarching goal is to produce prostate cancer research that matters to the Warfighter, military families, and the general public.
What if a project relies on Department of Defense or Department of Veterans Affairs resources or populations?
If a project depends on DoD or VA resources, databases, or access to active-duty or VA populations, the application needs to describe that access upfront and include a plan to maintain it throughout the work.
Is IACUC approval required at the time of application for animal studies?
No. IACUC approval is not required at the time of submission.
What animal research approvals are required if the project is funded?
Any funded animal research must go through both local IACUC review and DoD-level review by the USAMRDC Animal Care and Use Review Office (ACURO).
How long can ACURO review take, and why does that matter?
Investigators are advised to plan for the regulatory timeline, since ACURO review and approval commonly takes 3 to 4 months. This can affect how quickly experimental work can begin after an award is made.
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