Opportunity Information: Apply for W81XWH 21 PCRP HDRA

The DoD Prostate Cancer Research Program (PCRP) Health Disparity Research Award (FY21; opportunity number W81XWH-21-PCRP-HDR A) is a Department of Defense funding opportunity meant to back research ideas that can materially reduce prostate cancer health disparities. The core goal is to eliminate inequities in prostate cancer incidence, morbidity, mortality, and survivorship by supporting projects that can produce meaningful, actionable advances rather than incremental findings. Proposals are expected to clearly align with one or more of the FY21 award Focus Areas and to explain, in plain terms, how the work will address a disparity-related problem. If a project does not neatly fit a listed Focus Area, it can still be competitive, but the applicant must justify why the project addresses an urgent disparity-related need in the context of the PCRP Overarching Challenges.

The program is intentionally broad about what kinds of science it will support. It welcomes a wide range of disciplines, including basic biology, engineering and technology development, bioinformatics and data science, population science and epidemiology, psycho-oncology, translational research, and health services or care-delivery research. Projects can be basic, translational, or clinical, and clinical trials are allowed with an important limitation: only small-scale, early-stage trials up through Phase 2 (or equivalent) are supported under this mechanism. Investigators who propose trials are encouraged to leverage the Prostate Cancer Clinical Trials Consortium (PCCTC) to speed start-up and execution. Preliminary data are encouraged but not required, and any unpublished preliminary results included should come from the PI or members of the research team.

A recurring theme in this award is community engagement and real-world relevance. Applicants are strongly encouraged to involve members of the affected population or community in shaping and carrying out the research when that makes sense for the project. If population- or community-based organizations will be used to recruit, advise, implement, or disseminate, that involvement should be concrete and documented through letters of support that spell out roles and commitments. The opportunity materials also point applicants toward a large set of potential resources and partners, such as the North Carolina-Louisiana Prostate Cancer Project (PCaP) biorepository, NIH and NCI health disparity networks, community-based participatory research programs, and advocacy organizations that work with disproportionately affected groups (including organizations focused on rural health and LGBT cancer equity).

The award also puts heavy weight on impact, innovation, and what happens after the project ends. Applicants are expected to propose work with a credible path to significantly addressing prostate cancer disparities, and higher innovation is viewed as a driver of larger potential impact. A required element is a detailed transition plan that explains how findings will move into the next stage of development after the award period, so the work keeps advancing toward clinical or public health impact even if immediate clinical change is not the endpoint of the funded aims. In practice, this means reviewers are looking for a strong story about follow-on validation, scale-up, implementation, regulatory steps, or subsequent trial planning.

Methodological rigor is treated as non-negotiable, particularly in disparity research where population definitions and study design decisions can strongly influence conclusions. For projects examining biological contributors to disparities across populations, applicants are explicitly asked to think carefully about how they stratify groups, including the implications of using genetic/genomic classification versus self-reported race, and to justify the chosen approach. Applications must include a robust statistical plan and a complete power analysis demonstrating that the sample size and analytic approach can actually answer the question posed. The announcement also encourages specific best practices that strengthen reproducibility and translational value, such as authenticating proposed cell lines, ensuring statistical rigor in animal studies (for example, randomization, blinding, and appropriate sample size estimation), and including experiments that test clinical relevance and translatability. Where specialized resources are essential (datasets, samples, facilities, models, or partner sites), applicants are encouraged to document access and availability with letters of support.

A dedicated New Investigator category is included to bring early-career researchers into prostate cancer disparity work. Under this track, early-stage faculty or investigators building independence can serve as PI, but they must include at least one experienced collaborator with a demonstrated track record in prostate cancer health disparity research (funding and publications). The application must explain why the collaboration is likely to work, what each party contributes, and how the partner(s) will strengthen the PI’s ability to address the question. Letters of collaboration are strongly encouraged to clarify the collaborator’s role, level of effort, and concrete responsibilities.

From an administrative and award-structure standpoint, awards are issued as assistance agreements, meaning they can be either grants or cooperative agreements depending on the anticipated level of DoD involvement during performance. If the agency expects no substantial involvement, a grant is used; if substantial involvement is anticipated (such as active collaboration, participation, or other intervention by the funder), a cooperative agreement is used, and the specific involvement is spelled out in the award. The opportunity emphasizes relevance to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public, and it encourages collaborations between military or VA institutions and civilian organizations to combine infrastructure, expertise, and access to unique patient populations.

The funding profile described for this cycle anticipates a direct cost cap of up to $750,000 over the full period of performance. Program-wide, CDMRP expected to allocate about $10.8 million to support roughly nine awards. Awards were expected to be made by September 30, 2022, and the FY21 funds associated with these awards were expected to remain available for use until September 30, 2027, reflecting the limited life of the appropriation. Eligibility is described as unrestricted (open to many organization types), subject to any clarifications in the full announcement.

Finally, the award carries the standard DoD human and animal research compliance requirements, which can meaningfully affect timelines. Human subjects research (including work with human anatomical substances or cadavers) requires review not only by a local IRB or ethics committee, but also by the USAMRDC Human Research Protection Office (HRPO) before research begins, and applicants are told to plan for roughly 2 to 3 months for that additional regulatory review. For multi-institution human studies, a plan for a single IRB arrangement is required, including identification of the lead institution responsible for the master protocol and consent materials. Animal studies similarly require review by both the local IACUC and the USAMRDC Animal Care and Use Review Office (ACURO), with an expected additional review window of about 3 to 4 months. For funded clinical trials, there is also a requirement to post the IRB-approved informed consent form on a public federal website consistent with 32 CFR 219. If investigators intend to use DoD or VA populations, databases, or other resources, the application must describe access plans up front and how access will be maintained through the project period.

  • 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, Health Disparity 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.
  • This funding opportunity was created on Apr 05, 2021.
  • Applicants must submit their applications by Jul 29, 2021. (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 9 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 21 PCRP HDRA

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FAQs: DoD PCRP Health Disparity Research Award (FY21) - W81XWH-21-PCRP-HDR A

What is the purpose of the PCRP Health Disparity Research Award?

The award supports research ideas intended to materially reduce prostate cancer health disparities. The stated goal is to eliminate inequities in prostate cancer incidence, morbidity, mortality, and survivorship by funding projects that can produce meaningful, actionable advances rather than incremental findings.

What kinds of disparities is this opportunity trying to address?

This mechanism is focused on disparity-related problems that contribute to inequities in prostate cancer outcomes, including differences in incidence, morbidity, mortality, and survivorship. Applications are expected to explain in plain terms what disparity-related problem is being tackled and how the project addresses it.

Do proposals have to fit specific Focus Areas?

Proposals are expected to clearly align with one or more of the FY21 award Focus Areas. If a project does not neatly fit a listed Focus Area, it can still be competitive, but the applicant needs to justify why the project addresses an urgent disparity-related need in the context of the PCRP Overarching Challenges.

What research disciplines and approaches are allowed?

The program is intentionally broad and welcomes work across many disciplines, including basic biology, engineering and technology development, bioinformatics and data science, population science and epidemiology, psycho-oncology, translational research, and health services or care-delivery research.

Are basic, translational, and clinical projects all eligible?

Yes. Projects can be basic, translational, or clinical under this mechanism.

Are clinical trials allowed under this award?

Yes, clinical trials are allowed with a key limitation: only small-scale, early-stage trials up through Phase 2 (or equivalent) are supported under this mechanism.

Is there a recommended way to speed up clinical trial start-up and execution?

Investigators proposing clinical trials are encouraged to leverage the Prostate Cancer Clinical Trials Consortium (PCCTC) to speed start-up and execution.

Is preliminary data required?

No. Preliminary data are encouraged but not required.

If unpublished preliminary results are included, whose data can they be?

Any unpublished preliminary results included in an application should come from the Principal Investigator (PI) or members of the research team.

How important is community engagement in this award?

Community engagement and real-world relevance are emphasized. Applicants are strongly encouraged to involve members of the affected population or community in shaping and carrying out the research when that makes sense for the project.

If we plan to work with community-based organizations, what documentation is expected?

If population- or community-based organizations will be used to recruit, advise, implement, or disseminate, that involvement should be concrete and documented through letters of support that spell out roles and commitments.

What kinds of external resources or partners are referenced as potentially helpful?

The opportunity points applicants toward multiple potential resources and partners, including the North Carolina-Louisiana Prostate Cancer Project (PCaP) biorepository, NIH and NCI health disparity networks, community-based participatory research programs, and advocacy organizations that work with disproportionately affected groups (including rural health and LGBT cancer equity organizations).

What review themes are most emphasized?

The materials emphasize impact, innovation, and what happens after the project ends. Reviewers are looking for a credible path to significantly addressing prostate cancer disparities, with innovation viewed as a driver of larger potential impact.

What is the required transition plan?

A detailed transition plan is required and must explain how findings will move into the next stage of development after the award period so the work continues advancing toward clinical or public health impact. This can include follow-on validation, scale-up, implementation, regulatory steps, or subsequent trial planning.

How is methodological rigor addressed, especially for disparity research?

Methodological rigor is treated as non-negotiable. Applicants must include a robust statistical plan and a complete power analysis showing that sample size and analytic methods can answer the question posed.

For biological contributors to disparities, how should populations be defined and stratified?

Applicants are asked to think carefully about group stratification, including the implications of using genetic/genomic classification versus self-reported race, and to justify the chosen approach.

Are there specific reproducibility or best-practice expectations for lab and animal work?

Yes. The announcement encourages best practices that improve reproducibility and translational value, such as authenticating proposed cell lines and ensuring statistical rigor in animal studies (for example, randomization, blinding, and appropriate sample size estimation). It also encourages experiments that test clinical relevance and translatability.

If our project depends on specialized datasets, samples, facilities, models, or partner sites, what should we provide?

Where specialized resources are essential, applicants are encouraged to document access and availability with letters of support.

Is there a New Investigator category?

Yes. The award includes a dedicated New Investigator category to bring early-career researchers into prostate cancer disparity research.

What is required for New Investigator applications regarding collaborators?

Early-stage faculty or investigators can serve as PI under the New Investigator track, but they must include at least one experienced collaborator with a demonstrated track record in prostate cancer health disparity research, including funding and publications.

What should the New Investigator collaboration explanation include?

The application should explain why the collaboration is likely to work, what each party contributes, and how the partner(s) will strengthen the PI's ability to address the question.

Are letters of collaboration expected for New Investigator submissions?

Letters of collaboration are strongly encouraged to clarify the collaborator's role, level of effort, and concrete responsibilities.

What type of award instrument does DoD use for this opportunity?

Awards are issued as assistance agreements, meaning they can be either grants or cooperative agreements depending on the anticipated level of DoD involvement during performance.

What determines whether the award is a grant or a cooperative agreement?

If the agency expects no substantial involvement, a grant is used. If substantial involvement is anticipated (such as active collaboration, participation, or other intervention by the funder), a cooperative agreement is used and the involvement is spelled out in the award.

Who is the research expected to be relevant to?

The opportunity emphasizes relevance to active-duty Service Members, Veterans, military beneficiaries, and/or the broader American public.

Are collaborations with military or VA institutions encouraged?

Yes. Collaborations between military or VA institutions and civilian organizations are encouraged to combine infrastructure, expertise, and access to unique patient populations.

What is the funding cap for this award?

The anticipated direct cost cap is up to $750,000 over the full period of performance.

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

Program-wide, CDMRP expected to allocate about $10.8 million to support roughly nine awards.

When were awards expected to be made?

Awards were expected to be made by September 30, 2022.

How long were FY21 funds expected to remain available?

The FY21 funds associated with these awards were expected to remain available for use until September 30, 2027, reflecting the limited life of the appropriation.

What is known about eligibility?

Eligibility is described as unrestricted (open to many organization types), subject to any clarifications in the full announcement.

What human subjects compliance reviews are required beyond local IRB approval?

Human subjects research (including work with human anatomical substances or cadavers) requires review by a local IRB or ethics committee and also by the USAMRDC Human Research Protection Office (HRPO) before research begins.

How much additional time should be planned for HRPO review?

Applicants are told to plan for roughly 2 to 3 months for the additional HRPO regulatory review.

Is a single IRB plan required for multi-institution human subjects studies?

Yes. For multi-institution human studies, a plan for a single IRB arrangement is required, including identification of the lead institution responsible for the master protocol and consent materials.

What animal research compliance reviews are required?

Animal studies require review by the local IACUC and also by the USAMRDC Animal Care and Use Review Office (ACURO).

How much additional time should be planned for ACURO review?

An expected additional ACURO review window of about 3 to 4 months is noted.

Is there any special requirement for informed consent documents in funded clinical trials?

Yes. For funded clinical trials, there is a requirement to post the IRB-approved informed consent form on a public federal website consistent with 32 CFR 219.

If we plan to use DoD or VA populations, databases, or other resources, what must be included in the application?

The application must describe access plans up front and explain how access will be maintained through the project period.

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