DoD Ovarian Cancer Pilot Award | W81XWH 18 OCRP PA

DoD OCRP Pilot Award (W81XWH-18-OCRP-PA) FAQs

1) What is the DoD Ovarian Cancer Research Program (OCRP) Pilot Award?

The OCRP Pilot Award is a Department of Defense funding opportunity intended to jump-start bold, high-impact ovarian cancer research ideas. It is designed for early-stage, innovative concepts (including proof-of-concept work) that could change how the field approaches preventing, detecting, treating, or curing ovarian cancer.

2) What is the main goal of this award mechanism?

The core goal is to support innovative, testable ideas that can generate strong preliminary data. That preliminary data should position the project for larger follow-on studies and future grant applications, and ideally help expand or reshape current thinking in ovarian cancer research.

3) How important is innovation for this award?

Innovation is identified as the most important review criterion. The program emphasizes that the proposed work should act as a catalyst for new directions in ovarian cancer research rather than simply extending established work.

4) What types of research topics or approaches are considered a good fit?

Projects must have a clear and direct focus on ovarian cancer and can involve ovarian cancer tissues, established or newly generated cell lines, relevant datasets, or appropriate animal models. The approach should be logically grounded, scientifically well-rationalized, and based on a testable hypothesis.

5) Are there examples of projects that may be considered not innovative enough?

Yes. The announcement provides examples of approaches generally viewed as insufficiently innovative, including: repeating a previously tested hypothesis in a different cell line or population; running standard published in vitro assay batteries simply to further characterize a model; adding already-known biomarkers into in vivo or clinical models without a truly novel angle; proposing the next incremental step from an existing project; or offering only modest extensions of published findings.

6) Is preliminary data required to apply?

No. Preliminary data may be included if available, but it is not required. Reviewers are expected to weigh the strength of the scientific rationale, the logic of the approach, and whether the hypothesis is testable and well-grounded.

7) What is the expected outcome of the funded project?

A key expectation is that the project will generate strong preliminary data that can serve as a springboard for larger, follow-on studies and future grant applications, while advancing innovative ideas that could influence the ovarian cancer field in a meaningful way.

8) Does the research have to relate to military or public health priorities?

Yes. Applications must show relevance to active duty Service members, Veterans, military beneficiaries, and/or the American public. The study does not need to be conducted within the military health system, but the application should clearly explain why the research question matters and how it could translate into meaningful advances for the populations served by the DoD.

9) What is the maximum funding amount?

The anticipated maximum for direct costs across the entire project period is capped at $250,000 (FY18). Applicants are expected to propose a tightly scoped, high-yield project that can produce compelling preliminary results within that budget.

10) Are clinical trials allowed under this Pilot Award?

No. Clinical trials are explicitly not allowed. The opportunity uses a standard definition of a clinical trial as prospective enrollment of human subjects where an intervention (such as a drug, device, biologic, surgery, behavioral program, or other intervention) is tested for measurable outcomes related to safety, effectiveness, or efficacy.

11) Can the project still involve human subjects or human specimens?

Yes. Research can involve human subjects, human specimens, and human anatomical substances, but it must not meet the definition of a clinical trial (i.e., it must not prospectively test an intervention in enrolled human subjects for outcomes related to safety, effectiveness, or efficacy).

12) What additional oversight applies to DoD-funded human subjects research?

If the work involves human subjects, human anatomical substances, or human cadavers, it requires additional DoD oversight beyond the institution's ethics review. Before any research activities can begin, the work must receive approval from the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections, Human Research Protection Office (HRPO).

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

No. Local IRB/Ethics Committee approval is not required at the time of application submission. However, it will be required later if the project is selected for funding, and HRPO review is separate and additive to local review.

14) How long should applicants plan for the HRPO process?

The announcement advises budgeting time for HRPO review, typically at least 2 to 3 months, before human-subjects-related research activities can begin.

15) Are there recommendations to avoid HRPO delays?

Yes. The announcement recommends writing protocols that are specific to the DoD-funded scope. Broader protocols can trigger more extensive DoD compliance review and may increase the likelihood of delays.

16) Is animal research allowed under this opportunity?

Yes. Animal research is permitted, but it triggers DoD-level review requirements in addition to the institution's IACUC process.

17) What additional oversight applies to DoD-funded animal research?

Any DoD-funded animal work must be reviewed and approved by the Animal Care and Use Review Office (ACURO), in addition to the institution's IACUC.

18) Is IACUC approval required at the time of application submission?

No. IACUC approval is not required at the time of application submission, but it will be required if the project is selected for funding. ACURO approval is also required before animal work can begin.

19) How long should applicants plan for the ACURO process?

The announcement notes the ACURO process can take 2 to 3 months. Investigators should plan the project timeline accordingly.

20) What documentation may be needed before animal work can start?

Investigators should be prepared to submit the animal use protocol, proof of IACUC approval, and required supporting appendices before initiating animal research activities.

21) What type of award instrument will be used (grant vs cooperative agreement)?

Awards are issued as assistance agreements, meaning funding will be provided as either a grant or a cooperative agreement. The instrument depends on how much involvement the DoD anticipates during the project.

22) How is it decided whether an award is a grant or a cooperative agreement?

Minimal DoD involvement typically results in a grant. Substantial involvement (such as collaboration, participation, or intervention in the research) may lead to a cooperative agreement.

23) Are there expectations for data and resource sharing?

Yes. The program signals an expectation that data, results, and research resources generated with these funds should be made available to the broader research community and, where appropriate, to the public, consistent with CDMRP sharing expectations.

24) Who ran this funding opportunity?

The opportunity was run by the Department of Defense, Department of the Army (USAMRAA), with oversight processes involving USAMRMC offices (HRPO for human research protections and ACURO for animal research oversight).

25) What is the funding opportunity number and CFDA listing?

The Funding Opportunity Number is W81XWH-18-OCRP-PA, and the CFDA listing is 12.420.

26) Who is eligible to apply?

Eligibility is broadly listed as unrestricted (open to any entity type), subject to any additional eligibility notes in the full announcement.

27) When was the opportunity posted and when did it close?

The original posting date was April 11, 2018, and the application closing date was August 22, 2018.

28) How many awards were expected and when were awards anticipated?

The program anticipated making about 9 awards, with awards expected no later than September 30, 2019.

29) Does the project need to be strictly limited to ovarian cancer?

Yes. Projects must have a clear and direct focus on ovarian cancer. The work can use a range of ovarian-cancer-relevant materials and models (tissues, cell lines, datasets, animal models), but the central question and impact must be ovarian cancer focused.

30) What should applicants prioritize when designing a project for this mechanism?

Applicants should prioritize a tightly scoped project that is highly innovative, logically justified, and capable of producing strong preliminary data within the $250,000 direct cost cap, while also planning time for any required DoD oversight reviews (HRPO and/or ACURO) if applicable.