DoD Prostate Cancer, Exploration-Hypothesis Development Award

The FY22 PCRP Exploration – Hypothesis Development Award supports the exploration of highly innovative, untested, potentially high-gain concepts, theories, paradigms, and/or methods that address an important problem relevant to one or more of the FY22 PCRP Overarching Challenges. This award is designed to provide investigators the opportunity to pursue serendipitous observations that may reveal entirely new avenues for investigation. Results of studies conducted through this award may provide the scientific premise upon which a new hypothesis can be based or initial proof-of-principle of an innovative hypothesis, laying the groundwork for future avenues of scientific investigation. Presentation of preliminary data is inconsistent with the intent of this award mechanism and is therefore strongly discouraged. However, logical reasoning and a sound scientific rationale for the proposed work must be described.Reviewers will be blinded to the identity of the Principal Investigator (PI), collaborator(s), and their organization(s). Refer to Section II.D.2.b.i, Full Application Guidelines, for more information.Because these awards are designed for preliminary investigations, projects involving human subjects or specimens will not be supported unless they are exempt from Institutional Review Board (IRB) approval or eligible for expedited review. Investigators must review their institutional requirements and guidelines for filing with the IRB for exempt or expedited status. Information can be found in the Code of Federal Regulations, Title 32, Section 219.104(d) (32 CFR 219.104[d]) for exempt status or 21 CFR 56.110 for expedited status. Applications proposing studies involving human subjects or specimens that do not qualify for exempt or expedited status will be administratively withdrawn.Clinical research is not allowed. 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. (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 a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.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 FY22 PCRP prioritiesThe 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 FY22 PCRP Exploration – Hypothesis Development Award will not exceed $100,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information, refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $3.2M to fund approximately 20 FY22 PCRP Exploration – Hypothesis 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 FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.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 research funded by the FY22 [PCRP award mechanism] involving new and ongoing research with animals must be reviewed and approved by the USAMRDC Office of Research Protections, 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 2.0 (Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE 2.0 guidelines can be found at https://arriveguidelines.org/arrive-guidelines.II.C.
Categories: Science and Technology and other Research and Development.