Newswire (Published: Tuesday, April 6, 2021, 10:18:00 AM CDT, Received: Wednesday, April 7, 2021, 6:03:53 AM CDT)
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The agency description of the grant/cooperative agreement states: "
* 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 Any unpublished, preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team.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 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
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 level of involvement on the part of the
A congressionally mandated
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
Awards will be made no later than
The CDMRP expects to allot approximately
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.
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
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 (
The estimated total program funding available was cited as
The funding opportunity (W81XWH-21-PCRP-IDA, CFDA 12.420) was posted on
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