The FY21 PCRP Physician Research Award supports a mentored research experience to prepare physicians with clinical duties and/or responsibilities for productive careers in prostate cancer research. The mentored physician is considered the Principal Investigator (PI) of the application. This award emphasizes equally the quality of the proposed research project and the career development of the PI, which should prepare physicians for careers in basic, population science, translational, or clinical prostate cancer research. All applications for the FY21 PCRP Physician Research Award are to be written by the PI, with appropriate direction from the mentor(s).
Key elements of this award mechanism are as follows:
• Principal Investigator: Physicians with clinical duties and/or responsibilities who, at the application submission deadline, are either in the last year of an accredited graduate medical education program as a resident or fellow, or within 5 years of having initiated a faculty appointment (including Instructor positions), are eligible to apply. The PI must demonstrate a commitment to a career as an investigator at the forefront of prostate cancer research and clinical practice; however, the PI is not required to have previous prostate cancer research experience. The award is intended to provide protection of the PI’s time for prostate cancer research. Applications are strongly encouraged to demonstrate protection of at least 40% of the PI’s time for prostate cancer research, which is not required to be exclusive to this award but can include effort dedicated to other prostate cancer research projects.
• Mentor(s): This award requires the involvement of at least one designated mentor with an established research program in prostate cancer, as evidenced by recent publications, active funding, and successful mentorship. In addition, the mentor(s) must demonstrate a commitment to advancing the PI’s career in prostate cancer research.
• Research Approach: Proposed research ideas are required to address one or more of the FY21 PCRP Overarching Challenges. 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: An individualized researcher development plan is required and should be prepared with appropriate guidance from the mentor(s). The researcher development plan 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.
• Impact: The proposed research must address and provide a solution to one or more of the FY21 PCRP Overarching Challenges and ultimately should have the potential to make a significant impact on the program’s Mission of eliminating death from prostate cancer and enhancing the well-being of Service Members, Veterans, and all the men and their families who are experiencing the impact of the disease.
Investigators are strongly encouraged to incorporate the following components into their study design, where appropriate, in order 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. Studies utilizing data that are derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and apply state-of-the-art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. Investigators are highly encouraged to provide a letter of support indicating access to and the availability of any resources required to support the study.
Research involving human subjects is permitted under this funding opportunity, but is restricted to studies without clinical trials. Correlative studies associated with an existing clinical trial are particularly encouraged, provided they are determined to be no greater than minimal risk by the Institutional Review Board (IRB) of record and the U.S. Army Medical Research and Development Command (USAMRDC) Office of Research Protections (ORP), Human Research Protection Office (HRPO).
The types of awards made under the program announcement will be assistance agreements. An assistance 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. 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. 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, but is not limited to, 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.
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, the 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 FY21 PCRP priorities.
The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military families, and the American public.
The anticipated direct costs budgeted for the entire period of performance for an FY21 PCRP Physician Research Award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.
The CDMRP expects to allot approximately $7.2M to fund approximately six FY21 PCRP Physician 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.
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 USAMRDC ORP HRPO prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview 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.
If the proposed research is cooperative (i.e., involving more than one institution), a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.
Clinical research is defined as: (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.
Clinical trials are not allowed: A clinical trial is defined as 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 or VA 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. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.
Research Involving Animals: All DOD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC 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. Allow at least 3 to 4 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 SC, et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature, 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.