DoD Peer Reviewed Alzheimer's, Research Partnership Award

Description

The PRARP Research Partnership Award (RPA) mechanism is being offered for the first time in FY17.The intent of the RPA is to create an avenue for collaborative research partnerships between investigators to address a research problem or question in a manner that would be unachievable through separate efforts. In addition to supporting basic research, applications proposing preclinical research are acceptable under this mechanism.The FY17 PRARP RPA is open to Principal Investigators (PIs) at or above the level of Assistant Professor (or equivalent) from any field or discipline. The FY17 PRARP RPA requires that two investigators (i.e., partners) jointly design a single research project. It should be clear that each partner had equal intellectual input into the design of the research project. Either partner may submit as the PI; the other partner will be designated as the Co-PI. Multi-institutional research is encouraged but not required. The success of the project must be supported by the unique skills and contributions of each partner. The proposed studies must demonstrate how they will accelerate research that addresses the PRARP’s mission (see Section II.A, Program Description) into clinical applications. Applications MUST include a Collaboration Statement (Attachment 9).The proposed study must include clearly stated plans for interactions between the partners. The plans must include communication, decision-making, allocation of resources, coordination of research progress and results, and sharing of data among all investigators and organizations participating in the project. 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.Preliminary data to support the feasibility of the research hypothesis (or hypotheses) and research approaches are required. Preliminary data may be derived from a laboratory discovery, clinical observation, or population-based studies.The anticipated total costs budgeted for the entire period of performance for an FY17 PRARP RPA will not exceed $1,300,000. The maximum period of performance is 3 years. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.The research impact is expected to benefit the military, Veteran, and civilian communities. To this end, the PRARP has identified RPA Overarching Challenges and Focus Areas by which the intent of this mechanism can be facilitated. These should be carefully considered as part of the application process.FY17 PRARP RPA Overarching Challenges: This FY17 PRARP RPA funding opportunity requires applications to address one or more of the following FY17 PRARP RPA Overarching Challenges:• Paucity of Research Resources: The paucity of research resources to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities.• Paucity of Clinical Studies: The paucity of clinical studies to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities. This includes research into risk factors that may predispose individuals to AD/ADRD subsequent to TBI.• Diagnostic Technologies, Tests, Biomarkers, or Devices: The need for technologies, tests, or devices to detect or prognose the progression to AD/ADRD subsequent to TBI. This includes research into risk factors that may predispose individuals to AD/ADRD subsequent to TBI.• Quality of Life: The need for technologies, assessments, interventions, or devices to benefit individuals living with the common symptoms or deficits of TBI and AD/ADRD. Caregiver Burden: The need for technologies, assessments, interventions, or devices with the goal of reducing burden for caregivers of individuals living with the common symptoms or deficits of TBI and AD/ADRD.• Epidemiology: The paucity of epidemiological research to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities. This includes research into risk factors that may predispose individuals to AD/ADRD subsequent to TBI.FY17 PRARP RPA Focus Areas: In addition to addressing one or more of the specified FY17 PRARP RPA Overarching Challenges, applications should address at least one of the following FY17 PRARP RPA Focus Areas in support of the FY17 PRARP RPA Overarching Challenges. An application that proposes research outside of the FY17 PRARP RPA Focus Areas is acceptable, as long as the applicant provides a strong rationale.• Genomics/Proteomics: Studies or technologies (e.g., genetic, proteomic, bioinformatics, and epigenetic strategies) intended to characterize neurological change(s) associated with TBI and subsequent AD/ADRD. In addition, relevant technologies or tests may be considered under this Focus Area.• Mechanisms of Pathogenesis: Identification of contributing mechanisms (e.g., pathology of Tau, non-neuronal cells, inflammatory factors, and vascular contributions) associated with TBI and subsequent AD/ADRD pathogenesis.• Quality of Life: Research intended to alleviate, stabilize, or characterize the symptoms or deficits common to TBI and AD/ADRD. Examples of research in this Focus Area include identification and management of comorbidities and modifiable risk factors (e.g., sleep apnea, obesity), cognitive training interventions, studies of health and wellness, and behavioral interventions.• Caregiver Support: Research intended to reduce the burden of care on the caregiver for individuals living with the common symptoms or deficits of TBI and AD/ADRD. Examples of research in this Focus Area include caregiver training, home-based support, behavioral interventions, and relationship interventions.• Biomarkers: Development of strategies to diagnose, prognose, or characterize neurological changes or risk factors associated with TBI and subsequent AD/ADRD (e.g., fluid-based, imaging, physiological, and clinical approaches).• Novel Target Identification: Basic research (non-human) directly leading to the identification of new targets for the development of existing or new investigational medicines, drugs, or agents.• Epidemiological Research: Research focusing on the incidence, distribution, and other factors relating to the health of individuals affected by TBI and subsequent AD/ADRD. The following is specifically discouraged under the FY17 PRARP:Pharmacological Interventions: Clinical research requiring investigational or U.S. Food and Drug Administration (FDA)-approved drugs or medicines.Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All Department of Defense (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. 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. Submission to HRPO of protocols covering more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol as DoD-supported research and may include extensive modifications to meet DoD human subjects protection requirements. 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.A clinical trial is defined as a prospective accrual of patients (human subjects) in whom an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction.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. Information Regarding Common Data Elements and Data SharingUse of TBI

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