Opportunity Information: Apply for W81XWH 22 PCRP EHDA

The FY22 Department of Defense (DoD) Prostate Cancer Research Program (PCRP) Exploration-Hypothesis Development Award (EHDA) is a small, early-stage research funding opportunity meant for investigators who want to test bold, unproven ideas in prostate cancer. Its main purpose is to support highly innovative, high-risk/high-reward concepts, new theories, unconventional approaches, or new methods that could open up entirely new directions in the field. The program is especially geared toward projects sparked by "serendipitous observations" or intriguing scientific clues that have not yet been developed into a mature hypothesis. Rather than rewarding applicants who already have extensive supporting evidence, this mechanism is set up to help generate the scientific premise for a new hypothesis or provide initial proof-of-principle data that can justify a larger follow-on project later.

A defining feature of this award is that preliminary data is strongly discouraged, because it signals the project may already be too developed for the intent of the mechanism. Instead, applicants are expected to make a convincing case using logical reasoning, a sound scientific rationale, and a clearly articulated plan showing how the proposed studies could yield important insights relevant to one or more of the FY22 PCRP Overarching Challenges. In other words, the grant is designed to fund exploratory work that is still at the "could this be true, and how would we find out?" stage, as long as the idea is well reasoned and the approach is credible.

The review process is set up to reduce bias by using a blinded format: reviewers will not know the identity of the Principal Investigator, collaborators, or their institutions during scientific review. This puts the emphasis on the strength of the concept, rationale, and approach rather than reputation or institutional prestige. Applicants must therefore write proposals that stand fully on their own merits without relying on name recognition.

There are strict limitations around human research. Because this mechanism is intended for preliminary investigations, studies involving human subjects or human specimens are generally not supported unless they qualify for Institutional Review Board (IRB) exemption or expedited review. Applicants are expected to understand and follow the applicable federal regulations for exempt status (such as 32 CFR 219.104(d)) or expedited review (such as 21 CFR 56.110). If an application proposes human subjects or specimen work that does not meet exempt or expedited criteria, it will be administratively withdrawn before it can be reviewed for merit. In addition, the opportunity explicitly prohibits clinical research and clinical trials. Clinical research is defined broadly to include patient-oriented research with direct interaction with people, work on identifiable human-origin materials, epidemiologic or behavioral studies, and outcomes or health services research. One notable carve-out is that certain studies using existing, de-identified specimens or datasets may fall under IRB Exemption 4, and those are not considered "clinical research" under the CDMRP definition when the sources are publicly available and de-identified.

Awards under this announcement are made as federal assistance agreements, meaning the government is providing support to advance a public purpose rather than buying a deliverable for direct government use. The award may be issued as either a grant or a cooperative agreement depending on how much involvement the DoD anticipates having during the project. If no substantial involvement is expected, it is typically a grant; if the agency expects substantial involvement (such as collaboration, participation, or other forms of engagement in the research), it may be structured as a cooperative agreement. The final determination is made during award negotiations, and the agreement will specify any substantial involvement if applicable.

Programmatically, the PCRP emphasizes relevance to military and public health needs. Proposed work must be clearly relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public. The announcement also strongly encourages collaboration between military or Veterans Affairs (VA)-connected institutions and non-military institutions, highlighting the value of combining specialized populations, infrastructure, and expertise to move prostate cancer research forward in ways that matter to the Warfighter and military families as well as civilians. Applicants are also encouraged to consider the recommendations of the congressionally mandated Metastatic Cancer Task Force, particularly where ideas can accelerate progress for advanced or recurrent disease, as long as the proposed work fits within the EHDA scope and restrictions.

From a budgeting and scale standpoint, this is a relatively small award intended to fund focused exploratory studies. The anticipated maximum for direct costs over the full project period is $100,000. Overall, the program expected to allocate about $3.2 million to support roughly 20 awards in this cycle, though the actual number funded depends on federal funding availability and the merit of submitted applications. Awards were expected to be made by no later than September 30, 2023, and the funds associated with FY22 appropriations were anticipated to remain available for obligation/use only within the applicable federal time limits, with FY22 funds expected to expire for use on September 30, 2028.

The announcement also outlines operational and compliance expectations. If a project requires access to DoD or VA resources, databases, or active-duty military populations, the application must describe that access at the time of submission and include a realistic plan for maintaining access throughout the project. For animal research, investigators must obtain local IACUC review and also secure approval through the USAMRDC Animal Care and Use Review Office (ACURO). Importantly, IACUC approval does not need to be in hand at submission, but applicants should plan for the additional ACURO timeline, which can take roughly 3 to 4 months for regulatory review and approval.

Finally, even though the award supports exploratory science, it still expects strong rigor and reproducibility practices, especially for preclinical work. Applicants are directed toward widely recognized standards for transparent reporting and robust study design, including principles such as randomization, blinding, sample size estimation, and clear data handling procedures. The opportunity specifically points applicants to the Landis et al. recommendations on preclinical study reporting and the ARRIVE 2.0 guidelines for animal research, signaling that the program wants innovative ideas tested in a way that produces results others can trust and build on.

  • 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 04, 2022.
  • Applicants must submit their applications by Jun 23, 2022. (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 20 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.
Apply for W81XWH 22 PCRP EHDA

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FAQs: FY22 DoD Prostate Cancer Research Program (PCRP) Exploration-Hypothesis Development Award (EHDA)

What is the PCRP Exploration-Hypothesis Development Award (EHDA)?

The EHDA is a small, early-stage research funding opportunity within the FY22 Department of Defense (DoD) Prostate Cancer Research Program (PCRP). It is designed to support exploratory studies that test bold, unproven ideas in prostate cancer and help generate the scientific premise for a new hypothesis or initial proof-of-principle results.

What is the main goal of this award mechanism?

The main goal is to enable highly innovative, high-risk/high-reward concepts, new theories, unconventional approaches, or new methods that could open entirely new directions in prostate cancer research. It is especially intended for projects that are still at the "could this be true, and how would we find out?" stage.

What kinds of project ideas are a strong fit for EHDA?

Projects sparked by serendipitous observations or intriguing scientific clues that have not yet been developed into a mature hypothesis are particularly aligned with this mechanism. The program is oriented toward early testing and hypothesis development rather than mature, heavily validated research programs.

Is preliminary data required for an EHDA application?

No. Preliminary data is strongly discouraged. Including substantial preliminary data may signal that the project is already too developed for the intent of the mechanism, which is meant to fund exploratory work that still needs a scientific premise or initial proof-of-principle support.

If preliminary data is discouraged, what should an application rely on instead?

Applicants are expected to make a convincing case using logical reasoning, a sound scientific rationale, and a clearly articulated plan. The application should show how the proposed studies could yield important insights relevant to one or more FY22 PCRP Overarching Challenges.

How does the scientific review reduce bias?

The scientific review uses a blinded format. Reviewers will not know the identity of the Principal Investigator (PI), collaborators, or institutions during scientific review. This approach is intended to keep the focus on the strength of the concept, rationale, and approach rather than reputation or institutional prestige.

What does a blinded review mean for how the proposal should be written?

Because reviewers will not see investigator or institutional identities during scientific review, the proposal needs to stand fully on its own merits. The concept, reasoning, and approach should be clear and persuasive without relying on name recognition.

Are studies involving human subjects allowed under EHDA?

Human subjects or human specimen studies are generally not supported unless they qualify for Institutional Review Board (IRB) exemption or expedited review. If proposed human work does not meet exempt or expedited criteria, the application will be administratively withdrawn before merit review.

What regulatory pathways are referenced for allowable human research under this mechanism?

The announcement points applicants to federal regulations relevant to exempt status (for example, 32 CFR 219.104(d)) and expedited review (for example, 21 CFR 56.110). Applications proposing human subjects/specimens are expected to follow the applicable federal requirements for exemption or expedited review.

What happens if a proposal includes human subjects or specimens that do not qualify as exempt or expedited?

The application will be administratively withdrawn prior to scientific merit review if the proposed human subjects or specimen work does not meet exempt or expedited criteria.

Are clinical research or clinical trials permitted?

No. The opportunity explicitly prohibits clinical research and clinical trials.

How does the announcement define "clinical research" for purposes of this award?

Clinical research is defined broadly and includes patient-oriented research with direct interaction with people; work on identifiable human-origin materials; epidemiologic or behavioral studies; and outcomes or health services research.

Are there any exceptions related to existing de-identified human specimens or datasets?

Yes. Certain studies using existing, de-identified specimens or datasets may fall under IRB Exemption 4. When sources are publicly available and de-identified, those studies are not considered "clinical research" under the CDMRP definition, as described in the announcement.

What type of award instrument is used for EHDA funding?

Awards are made as federal assistance agreements, meaning the government is providing support to advance a public purpose rather than purchasing a deliverable for direct government use.

What is the difference between a grant and a cooperative agreement in this program?

The award may be issued as a grant or a cooperative agreement depending on anticipated DoD involvement during the project. If no substantial involvement is expected, it is typically a grant. If substantial involvement is anticipated (such as collaboration, participation, or other engagement), it may be structured as a cooperative agreement.

When is the decision made about whether the award is a grant or cooperative agreement?

The final determination is made during award negotiations, and the assistance agreement will specify any substantial involvement if applicable.

Who should benefit from the research supported by this award?

Proposed work must be clearly relevant to military and public health needs, including active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public.

Does the program encourage collaboration with military or VA institutions?

Yes. The announcement strongly encourages collaboration between military or Veterans Affairs (VA)-connected institutions and non-military institutions, emphasizing the value of combining specialized populations, infrastructure, and expertise.

Is there guidance on aligning ideas with broader national recommendations?

Applicants are encouraged to consider recommendations of the congressionally mandated Metastatic Cancer Task Force, particularly where ideas can accelerate progress for advanced or recurrent disease, as long as the work fits the EHDA scope and restrictions.

What is the maximum budget allowed for this award?

The anticipated maximum is $100,000 in direct costs over the full project period.

How much total funding and how many awards were expected in this cycle?

The program expected to allocate about $3.2 million to support roughly 20 awards, depending on federal funding availability and the merit of submitted applications.

When were awards expected to be made?

Awards were expected to be made no later than September 30, 2023.

How long were FY22 funds expected to remain available?

Funds associated with FY22 appropriations were anticipated to remain available only within applicable federal time limits, with FY22 funds expected to expire for use on September 30, 2028.

If a project needs access to DoD or VA resources or populations, what must be included in the application?

If access to DoD or VA resources, databases, or active-duty military populations is required, the application must describe that access at submission and include a realistic plan for maintaining access throughout the project.

Are animal studies allowed, and what approvals are required?

Animal research is addressed through required oversight. Investigators must obtain local IACUC review and also secure approval through the USAMRDC Animal Care and Use Review Office (ACURO).

Is IACUC approval required at the time of application submission?

No. IACUC approval does not need to be in hand at submission. However, applicants should plan for ACURO review and approval timelines in addition to local IACUC review.

How long can ACURO review take for animal research approvals?

The announcement notes that ACURO regulatory review and approval can take roughly 3 to 4 months.

Does the program expect rigor and reproducibility even for exploratory research?

Yes. The opportunity emphasizes strong rigor and reproducibility practices, particularly for preclinical work, so that exploratory findings are credible and useful as a foundation for follow-on research.

What rigor and reporting practices are specifically highlighted?

The announcement points to widely recognized standards and practices, including randomization, blinding, sample size estimation, and clear data handling procedures. It also cites the Landis et al. recommendations for preclinical study reporting and the ARRIVE 2.0 guidelines for animal research.

What is the intended outcome of an EHDA-funded project?

The mechanism is designed to help generate the scientific premise for a new hypothesis or produce initial proof-of-principle data that can justify a larger follow-on project later, rather than completing a fully mature research program.

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