DoD Epilepsy, Idea Development Award

Funding Opportunity ID: 295756
Opportunity Number: W81XWH-17-ERP-IDA
Opportunity Title: DoD Epilepsy, Idea Development Award
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Grant
Category of Funding Activity: Science and Technology and other Research and Development
Category Explanation:
CFDA Number(s): 12.420
Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Additional Information on Eligibility:
Agency Code: DOD-AMRAA
Agency Name: Department of Defense
Dept. of the Army — USAMRAA
Posted Date: Jul 21, 2017
Close Date: Sep 20, 2017
Last Updated Date: Jul 21, 2017
Award Ceiling:
Award Floor:
Estimated Total Program Funding: $4,800,000
Expected Number of Awards: 8
Description: The ERP Idea Development Award (IDA) mechanism was first offered in FY15. Since then, 64 IDA applications have been received, and 11 have been recommended for funding. The intent of the FY17 ERP IDA is to solicit research to understand the magnitude and underlying mechanisms of PTE. The FY17 ERP IDA offers two levels of funding. Funding Level I is intended to support high-risk or high-gain research from Principal Investigators (PIs) at or above the level of a postdoctoral fellow (or equivalent), but below the level of Assistant Professor (or equivalent). Note that PIs submitting Funding Level I applications will be required to verify their eligibility for this award. Funding Level II is intended to support a more mature, hypothesis-driven research project. To be considered for an FY17 ERP IDA Funding Level II, the PI must be an independent investigator at or above the level of Assistant Professor (or equivalent). While not required, applications to either Funding Level I or II should provide relevant preliminary data. Preliminary data for either Funding Level may come from the PI’s published work, pilot data, or from peer-reviewed literature. The requested budget level should be appropriate for the scope of research proposed. For Funding Level I: The anticipated direct costs budgeted for the entire period of performance for an FY17 ERP IDA award will not exceed $300,000. The maximum period of performance is 2 years. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. For Funding Level II: The anticipated direct costs budgeted for the entire period of performance for an FY17 ERP IDA award 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. FY17 ERP IDA Focus Areas: The research impact for the FY17 ERP IDA is expected to benefit the military, Veteran, and civilian communities. To this end, applications should address at least one of the following FY17 ERP IDA Focus Areas. An application that proposes research outside of these FY17 ERP IDA Focus Areas is acceptable, as long as the applicant provides a strong rationale. These should be carefully considered as part of the application process. • Epidemiology: Epidemiological characterization of PTE following TBI, which may include: ○ Risk factors such as demographics, genetic factors, organic head injury factors, or type of insult ○ Differentiation of PTE and psychogenic non-epileptic seizures (PNES) ○ Outcomes including latency to epilepsy, morbidities and comorbidities, and mortality ○ Pre-existing conditions including psychological and psychiatric risk factors Note: Applications proposing epidemiological research should be submitted under the Epidemiology Option. • Markers and Mechanisms: Identifying markers or mechanisms (via clinical prospective or preclinical models) that address PTE: ○ Early detection ○ Diagnosis ○ Prognosis ○ Morbidity ○ Comorbidity ○ Mortality ○ Risk stratification • Models of PTE: Development of new models or better characterization of existing etiologically relevant models for PTE, including repetitive TBI. • Psychogenic Non-Epileptic Seizures: Exploration of the epidemiology, mechanisms, risk factors, or markers of PNES subsequent to TBI. Note: Research focusing on interventional clinical trials (e.g., pharmacological interventions) is strongly discouraged. 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 Sharing Use of TBI Common Data Elements: Data elements must be reported using the National Institute of Neurological Disorders and Stroke (NINDS) 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. Note: In addition to the TBI CDEs, applicants are also strongly encouraged to consider developing a plan to incorporate the NINDS CDEs for epilepsy found at the link above. 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 at (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, Section K. Awards will be made no later than September 30, 2018. For additional information refer to Section II.F.1, Federal Award Notices.
Version: Synopsis 1

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