DoD Peer Reviewed Alzheimer's, Quality of Life Research Award

Description

The PRARP Quality of Life Research Award (QUAL) mechanism was first offered in FY13. Since then, 38 QUAL applications have been received, and 16 have been recommended for funding.The intent of the research funded through this award is to (1) support research to alleviate, stabilize, or characterize the symptoms or deficits common to TBI and AD/ADRD, and (2) reduce the burden of care on the caregiver for individuals living with the common symptoms of TBI and AD/ADRD. Research may be proposed to either facet of the intent. Both are equally important. As part of the research strategy, all applications must include cognitive, neuropsychological, or otherwise appropriate measures.The FY17 PRARP QUAL is open to Principal Investigators (PIs) at or above the level of Assistant Professor (or equivalent) from any field or discipline. As part of the application, the PI should demonstrate that the study team has experience in both TBI and AD/ADRD research. Preliminary data, while not required, are encouraged. Preliminary data may come from the PI’s published work, pilot data, or from peer-reviewed literature. Applications should also address how all of the included study measures address the research strategy and the study’s hypothesis or hypotheses.The anticipated direct costs budgeted for the entire period of performance for an FY17 PRARP QUAL will not exceed $500,000. 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 QUAL 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 QUAL Overarching Challenges: This FY17 PRARP QUAL funding opportunity requires applications to address one or more of the following Overarching Challenges:• 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.• 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.• Quality of Life: The need for technologies, assessments, interventions, or devices to benefit individuals living with the common symptoms 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 symptoms of TBI and AD/ADRD.FY17 PRARP QUAL Focus Areas: In addition to addressing one or more of the specified FY17 PRARP QUAL Overarching Challenges, applications should address at least one of the following FY17 PRARP QUAL Focus Areas in support of the FY17 PRARP QUAL Overarching Challenges. An application that proposes research outside of these FY17 PRARP QUAL Focus Areas is acceptable, as long as the applicant provides a strong rationale:• Quality of Life: Research intended to alleviate, stabilize, or characterize the symptoms, or deficits, common to TBI, 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).• 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:• Pharmacologic 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.Information Regarding Common Data Elements and Data Sharing:Use of TBI Common Data Elements: Data elements must be reported using the National Institute of Neurological Disorders and Stroke (NINDS) TBI Common Data Elements (CDEs) or entered into the Federal Interagency TBI Research (FITBIR) data dictionary as new, unique data elements. For the most current version of the NINDS TBI CDEs, go to http://www.commondataelements.ninds.nih.gov. Assistance will be available to help researchers map their study variables to specific CDEs and ensure the formats of the CDEs collected are compatible with the FITBIR Informatics System. If the proposed research data cannot be entered in CDE format, the investigators must supply a proposal for an alternative data submission or data sharing vehicle and justification for its use. Use of the TBI CDEs is required wherever possible in an effort to create standardized definitions and guidelines about the kinds of data to collect and the data collection methods that should be used in clinical studies of TBI.FITBIR Reporting Requirement for Projects Producing TBI Datasets: The DoD requires that awardees make available to the TBI research community all data generated via this award mechanism by depositing de-identified research data into the FITBIR Informatics System on a quarterly basis. The FITBIR Informatics System is a free resource to the TBI community and is designed to accelerate comparative effectiveness research on brain injury diagnosis and treatment. Data reporting to FITBIR is an opportunity for investigators to facilitate their own research and to collaborate with others doing similar research. While there is no direct charge to users of the FITBIR Informatics System, a project estimation tool (https://fitbir.nih.gov/jsp/ contribute/fitbir-costs.jsp) is available to help estimate costs and manpower needs that may be associated with data submission. To contribute to FITBIR, researchers should contact the FITBIR Operations Center ahead of time to arrange for data entry support and to ensure all data have been made compatible with the system. FITBIR guidance and policies, as well as the considerable advantages of FITBIR use to the researcher, are detailed (http://fitbir.nih.gov/).FITBIR allows for de-identification and storage of data (medical imaging, clinical assessment, environmental and behavioral history, etc.) of various types (text, numeric, image, time series, etc.). Use of FITBIR’s Global Unique Identifier (GUID) system facilitates repeated and multi-user access to data without the need to personally identify data sources. FITBIR encourages collaboration among laboratories, as well as interconnectivity with other informatics platforms. Such community-wide sharing requires common data definitions and standards.The CDMRP intends that information, data, and research resources generated under awards funded by this Program Announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. For additional guidance, refer to the General Application Instructions, Appendix 2,

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