Newswire (Published: Tuesday, April 6, 2021, 10:18:00 AM CDT, Received: Wednesday, April 7, 2021, 6:03:53 AM CDT)

Word Count: 1925

WASHINGTON, April 7 -- The U.S. Army Medical Research Acquisition Activity announced that it expects to award up to 30 grants or cooperative agreements for prostate cancer research.

The agency description of the grant/cooperative agreement states: "The FY21 PCRP Idea Development Award is intended to support new ideas that represent innovative approaches to prostate cancer research and have the potential to make an important contribution to the PCRP Mission. The key components of this award mechanism are:

* Innovation: Research deemed innovative may represent a new paradigm, challenge current paradigms, look at existing problems from new perspectives, leverage unique study populations, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative. Projects involving multidisciplinary and/or data science approaches are especially encouraged.

* Impact: Applications are required to address and provide a solution to one or more of the FY21 PCRP Overarching Challenges. The potential impact of the research, both short-term and long-term, in addressing the FY21 PCRP Overarching Challenge(s) should be clearly described. High-impact research will, if successful, significantly advance prostate cancer research and/or patient care.

* Preliminary Data: Due to this award's emphasis on innovation, the presentation of preliminary data relevant to prostate cancer and the proposed project is encouraged, but not required. Any unpublished, preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team. Regardless of whether preliminary data are included, applications should be based on a sound scientific rationale that is established through logical reasoning and/or critical review and analysis of the literature.

To maximize the potential for impact, investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of preclinical animal experiments and epidemiological studies; incorporation of experiments to assess clinical relevance and translatability of findings; and validation in patient cohorts. Investigators considering use of resources are highly encouraged to provide a letter of support indicating access to and the availability of the desired resources to support the study.

New Investigator category: The FY21 PCRP Idea Development Award mechanism encourages research ideas from investigators in the early stages of their careers. The New Investigator category of this award mechanism is designed to allow applicant organizations to name PIs who are early in their faculty appointments or in the process of developing independent research careers. Applications submitted to the New Investigator category will be assessed using different review criteria for personnel (refer to Section II.E.1.a., Peer Review), and are required to include a collaborator (or collaborators) who has (have) experience in prostate cancer research, as demonstrated by a record of funding and publications.

The application must describe the potential of the collaboration(s) to be successful and how the collaboration(s) will augment the PI's expertise to better address the research question. In addition, applicants are strongly encouraged to provide a letter of collaboration from the collaborator(s) describing the collaborator(s) involvement in the proposed work. All applicants for the New Investigator category must meet specific eligibility criteria described in Section II.C, Eligibility Information.

Multidisciplinary projects are encouraged, and multi-institutional projects are allowed. Each proposed study must include a clearly stated plan for interactions among all team members and organizations involved. The plan must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.

Research involving human subjects is permitted under this funding opportunity; however, clinical trials are not allowed. Correlative studies associated with an existing clinical trial are particularly encouraged. Any studies requiring the prospective recruitment or use of human subjects through clinical research must be 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 Idea Development 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 (https://www.grants.gov/custom/viewOppDetails.jsp#relatedDocumentsTab).

The CDMRP expects to allot approximately $36.0M to fund approximately 30 Idea Development 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."

The estimated total program funding available was cited as $36 million. The category of funding activity is science and technology and other research and development.

The funding opportunity (W81XWH-21-PCRP-IDA, CFDA 12.420) was posted on April 5 with an application closing date of Sept. 23.

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