DoD Prostate Cancer, Health Disparity Research Award | W81XWH 19 PCRP HDRA

FAQs: DoD Prostate Cancer Research Program (PCRP) Health Disparity Research Award (HDRA), FY19

1) What is the purpose of the PCRP Health Disparity Research Award (HDRA)?

The FY19 PCRP HDRA supports promising, high-impact prostate cancer research aimed at reducing and ultimately eliminating disparities across the full continuum of disease. This includes differences in incidence, morbidity, mortality, and survivorship. Proposals are expected to focus on a clearly defined disparity problem and explain how the work could meaningfully change outcomes for populations experiencing worse prostate cancer burdens.

2) Who is running and administering this funding opportunity?

This is a Department of Defense (DoD) funding opportunity under the DoD Prostate Cancer Research Program (PCRP), administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

3) What kinds of health disparities does the program consider responsive?

The program uses a broad, multi-factor view of prostate cancer health disparities and is receptive to projects examining different drivers of unequal outcomes. Examples described in the opportunity include:

• Access-to-care barriers (e.g., geography, insurance status, financial constraints, and other structural barriers affecting screening, diagnosis, or treatment)
• Social and cultural influences (e.g., trust in the health system, community norms, support networks, psychological health, and cultural or religious practices affecting screening and treatment decisions)
• Environmental contributors (e.g., exposures or dietary patterns that may influence risk or progression in particular groups)
• Biological contributors (e.g., genetic or molecular differences associated with disparate outcomes)

4) Do applicants have to explicitly define the disparity they are addressing?

Yes. A key expectation is that each application explicitly defines the specific health disparity being addressed and clearly states which disparity pathway(s) are being targeted and why that approach is likely to matter.

5) What is meant by “across the full continuum of disease”?

The opportunity frames disparities broadly, including differences in prostate cancer incidence, morbidity, mortality, and survivorship. Projects may focus on one or more points along this continuum as long as the work is tightly aligned with prostate cancer health disparities.

6) Is community engagement required?

Community engagement is strongly encouraged, particularly when it improves relevance, feasibility, recruitment, and real-world uptake of findings. Investigators are urged to involve members of the population or community being studied in design and execution when appropriate.

7) If community-based or advocacy organizations are involved, what documentation is expected?

Applications should document organizational involvement through letters of support that clearly spell out what the organization(s) will do and how they will contribute to the project.

8) What does the program mean by emphasizing “impact and innovation”?

The intent is not simply to generate descriptive data, but to produce findings that can drive real progress in closing gaps in prostate cancer outcomes. Applications are evaluated with strong emphasis on the potential for meaningful impact and innovation related to disparity reduction.

9) What is the required “transition plan,” and why does it matter?

Applicants must include a detailed transition plan describing what happens after the award ends. The plan should present a realistic pathway to the next stage of development, such as follow-on studies, scaling an intervention, advancing a diagnostic or prognostic tool, moving toward broader validation, or progressing toward clinical or implementation impact even if the funded work is not the final step to a clinical endpoint.

10) What types of research are supported (basic, translational, clinical)?

The HDRA supports basic, translational, and clinical research, including clinical trials, provided the work remains tightly aligned with prostate cancer health disparities.

11) Are clinical trials allowed under this award?

Yes, but only if they are small-scale and early stage, up to and including Phase II (or an equivalent stage). The announcement also encourages investigators planning a trial to consider using the PCRP Prostate Cancer Clinical Trials Consortium (PCCTC) to help start and complete trials efficiently.

12) How does the FY19 announcement define a “clinical trial”?

Under the FY19 definition, a clinical trial is any research study in which one or more human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate the effects on biomedical or behavioral health-related outcomes.

13) Is preliminary data required to apply?

Preliminary data are not required, but they can strengthen an application. If unpublished preliminary results are included, they should come from the PI or members of the research team.

14) What study design and rigor practices does the opportunity encourage?

The announcement encourages design practices that improve credibility and translational value, including authentication of proposed cell lines, statistical rigor in animal studies, and deliberate experiments that test clinical relevance and translatability.

15) Are there recommended resources for human specimens or linked data?

Yes. When human specimens or linked data are important, applicants are pointed to established PCRP-supported resources such as the Prostate Cancer Biorepository Network (PCBN) and the North Carolina to Louisiana Prostate Cancer Project (PCaP).

16) Does the program encourage use of large datasets and modern analytics?

Yes. The announcement encourages use of large, well-annotated patient datasets with long-term records and biospecimen repositories, particularly when paired with genomic/proteomic approaches, bioinformatics, and mathematical modeling.

17) What applicant tracks are available?

The opportunity has two tracks: a New Investigator category and an Established Investigator category. The New Investigator track is intended to allow early-career investigators building independence to compete within a separate pool rather than directly against more senior applicants.

18) What collaboration expectations apply to New Investigator applications?

New Investigator applications are expected to include one or more collaborators with demonstrated experience in prostate cancer health disparity research, supported by a record of funding and publications. The application should explain why the collaboration is likely to work and how it strengthens the PI’s ability to address the disparity-focused question.

19) How is New Investigator eligibility determined?

New Investigator eligibility is governed by specific criteria described in the full program materials (not detailed in the summary provided).

20) Who is eligible to apply (by organization type)?

Eligible applicants are described as broadly unrestricted by entity type, subject to any additional eligibility clarifications in the full announcement.

21) What populations must the research be relevant to?

The research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public, reflecting the DoD’s mission-driven perspective on research benefit.

22) What award mechanisms are used (grant vs cooperative agreement)?

Funding is provided through assistance agreements, meaning awards will be made as either grants or cooperative agreements. The deciding factor is how much substantial involvement the DoD expects during project performance: minimal involvement typically leads to a grant, while anticipated meaningful collaboration/participation/intervention leads to a cooperative agreement with the nature of involvement specified.

23) What are the budget caps for this opportunity?

Budget caps are stated as anticipated direct costs over the full period of performance: up to $600,000 for the New Investigator category and up to $750,000 for the Established Investigator category.

24) How much total funding was planned, and how many awards were expected?

The program planned to allocate about $9.84 million total to fund roughly four New Investigator awards and five Established Investigator awards. Final funding depends on federal availability and the quality and fit of submitted applications.

25) What were the key dates for the FY19 cycle?

The opportunity was posted May 3, 2019, with an original closing date of July 18, 2019. Awards were expected no later than September 30, 2020.

26) What does it mean that FY19 funds were expected to expire on September 30, 2025?

The announcement notes that FY19 funds were expected to expire for use on September 30, 2025, which relates to the government’s obligation and spending window.

27) What human subjects and human materials approvals are required before starting research?

Any DoD-funded research involving human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO) before research can begin. This HRPO review is in addition to local IRB or ethics committee review.

28) Is local IRB approval required at the time of application submission?

No. The announcement states that local IRB approval is not required at the time of application submission.

29) How long can HRPO review take?

The HRPO process can take a minimum of 2 to 3 months and may take longer for international clinical studies.

30) Why does the announcement recommend stand-alone protocols for the DoD-funded scope?

The DoD encourages applicants to write protocols that match the DoD-funded scope as stand-alone studies when possible. Submitting broader protocols that combine DoD and non-DoD work can trigger HRPO review requirements for the entire protocol and cause DoD protection requirements to apply to non-DoD components.

31) What enrollment planning is required for studies recruiting human subjects?

For studies recruiting human subjects, the application must include quarterly enrollment targets across sites in the Statement of Work. Funded teams will establish recruitment milestones with USAMRAA, and continued support can depend on meeting those milestones.

32) Are there special public posting requirements for clinical trial informed consent forms?

Yes. Clinical trial teams must post the informed consent form used for enrollment on a publicly available federal website, as required by federal rules.

33) What is required if a project needs access to active duty populations or DoD databases/resources?

If access to active duty populations or DoD databases/resources is required, the application must describe how access will be obtained and maintained, and it should include a confirming letter of support signed by the appropriate approving authority.

34) What is required if a project needs access to VA populations or VA resources?

Similar requirements apply for VA populations and resources, including letters from VA facility leadership (or designees such as the Associate Chief of Staff (ACOS) for Research and Development).

35) Are there risks if DoD or VA access is not confirmed?

Yes. The announcement flags that certain DoD or VA populations and databases may only be accessible through collaboration with DoD or VA investigators who can legitimately access those resources. If access is not confirmed, the government can withdraw or revoke funding until access is demonstrated.

36) Does the opportunity reference any additional strategic recommendations?

CDMRP encourages applicants to consider recommendations from the Congressionally mandated Metastatic Cancer Task Force, particularly ideas that accelerate clinical and translational research for advanced and recurrent cancers, as long as proposals stay within the limits of the award and align with FY19 PCRP priorities.

37) What disciplines are encouraged to apply?

The opportunity encourages applications from a wide range of disciplines, including laboratory science, engineering, bioinformatics, population science, psycho-oncology, health services research, translational research, and clinical research.