CDMRP Early Investigator Research Award for Prostate Cancer Research

The Early Investigator Research Award supports prostate cancer-focused research opportunities for individuals in the early stages of their careers, under the guidance of one or more designated

Mentors. This opportunity allows for early-career investigators to develop a research project,

investigate a problem or question in prostate cancer research, and further their intellectual

development as prostate cancer researchers of the future.  All application components for the

Early Investigator Research Award are to be written by the Principal Investigator (PI), with

appropriate direction from the Mentor(s).

Key elements of this award mechanism are as follows:

Principal Investigator: The postdoctoral investigator is considered the PI of the application and

must exhibit strong potential for, and commitment to, pursuing a career as an investigator at the

forefront of prostate cancer research; however, the PI is not required to have previous prostate

cancer research experience.  The PI must have 3 years or less of postdoctoral research experience (excluding clinical residency or clinical fellowship training) as of

March 31, 2020.  The PCRP strongly encourages applications from PIs who demonstrate a

commitment to pursuing a career focused in prostate cancer health disparity research.

Mentor(s): Applications must include at least one Mentor, appropriate to the proposed research

project, who has experience in prostate cancer research and mentoring as demonstrated by a record of active funding, recent publications, and successful mentorship. The primary Mentor can be a junior faculty member, in which case the PI is encouraged to include a secondary Mentor with a more robust track record in prostate cancer research and mentorship. Applications that focus on prostate cancer health disparity should include at least one mentor with experience in prostate cancer health disparity research. The selected Mentor(s) should also demonstrate a clear commitment to the development of the PI toward independence as a prostate cancer researcher.

Research Approach: Proposed research ideas are required to address one or more of the FY19 PCRP Overarching Challenges. Projects that specifically address the FY19 PCRP Overarching Challenge to reduce lethal prostate cancer in African Americans, Veterans, and other high-risk populations are strongly encouraged. The scientific rationale and experimental methodology should demonstrate in-depth analysis of the research problem presented. The feasibility of the research design and methods should be well defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved. The inclusion of preliminary data relevant to prostate cancer and the proposed project is encouraged but not required. Any preliminary data provided should be from the PI, Mentor(s), or member(s) of the collaborating team.  Additionally, required resources should be identified and supported through documentation.

Researcher Development Plan:  The PI must outline an individualized, prostate cancer-

focused researcher development plan, which should include a clearly articulated strategy for

acquiring the necessary skills, competence, and expertise that will enable the PI to successfully

complete the proposed research project and foster the PI’s development as an independent prostate cancer researcher. An environment appropriate to the proposed mentoring and research project must be clearly described, although any deficiencies of resources and/or mentorship at the PI’s institution can be mitigated through collaboration(s) with other institutions. If the PI will be

utilizing resources at another institution to successfully complete the proposed project, then the

PI is strongly encouraged to designate a co-Mentor at the collaborating institution.

Investigators are strongly encouraged to incorporate the following components into their study

design, where appropriate, to maximize the potential impact of the proposed research project:

authentication of proposed cell lines, statistical rigor of preclinical animal experiments, and

incorporation of experiments to assess clinical relevance and translatability of findings. As such,

the PCRP-funded Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org) and/or the North Carolina – Louisiana Prostate Cancer Project (PCaP) (https://pcap.bioinf.unc.edu/) are important resources to consider if retrospectively collected human anatomical substances or correlated data are critical to the proposed studies. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and that apply state-of-the-art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are

also encouraged.

A Congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients.  As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations

(https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-

Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY19 PCRP priorities.

The proposed research must be relevant to active duty Service members, Veterans, military

beneficiaries, and/or the American public.

The anticipated direct costs budgeted for the entire period of performance for an FY19 PCRP Early Investigator Research Award will not exceed $200,000.  Refer to Section II.D.5, Funding

Restrictions, for detailed funding information.

The CDMRP expects to allot approximately $7.68M to fund approximately 24 Early Investigator

Research Award applications. Funding of applications received is contingent upon the availability

of Federal funds for this program as well as the number of applications received, the quality and

merit of the applications as evaluated by scientific and programmatic review, and the requirements of the Government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY19 funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025.

Awards will be made no later than September 30, 2020. For additional information refer to Section II.F.1, Federal Award Notices.

The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). The level of involvement on the part of the Department of Defense (DoD) during project performance is the key factor in determining whether to award a

grant or cooperative agreement.

An assistance agreement (grant or cooperative agreement) is appropriate when the Federal

Government transfers a “thing of value” to a “state, local government,” or “other recipient” to

carry out a public purpose of support or stimulation authorized by a law of the United States,

instead of acquiring property or service for the direct benefit and use of the U.S. Government. An

assistance agreement can take the form of a grant or cooperative agreement. If “no substantial

involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award.  The award type,

along with the start date, will be determined during the negotiation process.

Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army

Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol.  Applications that involve recruitment of human subjects must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subjects recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

Clinical trials are not allowed.

New FY19 definition: A clinical trial is a research study in which one or more human subjects are

prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related

outcomes.

Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research involves

access to active duty military patient populations and/or DoD resources or databases, the

application must describe the access at the time of submission and include a plan for maintaining

access as needed throughout the proposed research. Access to target active duty military patient

population(s) and/or DoD resource(s) or database(s) should be confirmed by including a letter of

support, signed by the lowest-ranking person with approval authority.

If the proposed research involves access to VA patient populations, VA study resources and

databases, and/or VA research space and equipment, VA PIs/co-PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA patients, resources, and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for

administering the funds, the application should include a letter from the VA ACOS/R&D confirming this arrangement and identifying the institution that will administer the funds

associated with the proposed research.

Access to certain DoD or VA patient populations, resources, or databases may only be obtained by collaboration with a DoD or VA investigator who has a substantial role in the research and may not be available to a non-DoD or non-VA investigator if the resource is restricted to DoD or VA

personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DoD or non-VA investigator collaborating with the DoD and/or VA. If access cannot be confirmed at the time of application submission, the Government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s).  Refer to Section II.D.2.b.ii, Full

Application Submission Components, for detailed information.

Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRMC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects.  PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled, “Research Involving Animals.” Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies.  Refer to the General Application Instructions, Appendix 1, for additional information.

All projects should adhere to a core set of standards for rigorous study design and reporting to

maximize the reproducibility and translational potential of preclinical research.  The standards

are described in Landis, S.C., et al., A call for transparent reporting to optimize the predictive

value of preclinical research. Nature 2012, 490:187-191 (www.nature.com/nature/journal/

v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the

basic principles of randomization, blinding, sample-size estimation, and data handling derive

from well-established best practices in clinical studies. Applicants should consult the ARRIVE

(Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines can be found at http://www.elsevier.com/ data/promis_misc/622936arrive_ guidelines.pdf. The CDMRP intends that information, data, and research resources generated under awards funded by this Program Announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K.

CDMRP Help Desk

Phone: 301-682-5507

Email: help@eBRAP.org
Email:help@eBRAP.org