Epilepsy Research Program Research Partnership Award (RPA)

Epilepsy Research Program Research Partnership Award (RPA) is sponsored by Department of the Army -- USAMRAA (Congressionally Directed Medical Research Programs - CDMRP). This opportunity supports mission-aligned projects and measurable outcomes.

The intent of the FY21 ERP RPA is to create an avenue for collaborative research partnerships between/among investigators to address a research problem or question in a manner that would be unachievable through separate efforts.

Applications must describe how the anticipated outcome(s) can be attributable to the results of the proposed research (short-term gains), as well as consider the long-term scientific gains from the proposed research project. The research impact for the FY21 ERP RPA is expected to benefit the military, Veteran, and civilian communities. Applications must be impact-based.

FY21 ERP RPA Focus Areas: The Focus Areas below are specific to the FY21 ERP RPA. Applicants to the FY21 ERP RPA must select from the relevant Funding Level I or Funding Level II Focus Areas.

 Markers and Mechanisms (Funding Level I Only): Identifying markers or mechanisms via preclinical models that address PTE, which may include the following: ○ Biomarkers (acute and chronic)  Epidemiology (Funding Level I Only): Epidemiological characterization of PTE following TBI, which may include the following: ○ Risk factors such as demographics, genetics, anatomy, pathology, or type of injury ○ Outcomes including latency to epilepsy, comorbidities, and mortality ○ Pre-existing conditions including psychological and psychiatric risk factors ○ Treatment and healthcare outcomes research ○ Differentiation of PTE and psychogenic non-epileptic seizures (PNES)  Longitudinal Studies (Funding Level II Only): Studies of the evolution of PTE, which may include the following: ○ Seizure frequency and semiology ○ Demographics, genetics, anatomy, pathology, or type of injury ○ Comorbidities (e.g., depression, functional deficits, sleep disorders, major illness) ○ Latency between type of injury and PTE ○ Treatment and healthcare outcomes research The FY21 ERP RPA offers two levels of funding.

The application requirements for each funding level are detailed below. Funding Level I is intended to support preclinical or pre-validation research. Funding Level II requires access to a patient cohort for a prospective study and must be the focus of the application.

Funding Level II applications that evaluate the feasibility of using combinations of measures (e.g., neuropsychological assessments, imaging, and genomics) are encouraged. Furthermore, Funding Level II applications should describe how the association of TBI and subsequent PTE will be assessed or characterized to include a description of the nature of the TBIs in the cohort.

The description of the TBI characterization should discuss how the TBIs will be studied using statistical methods as part of the statistical plan for Level II Applications. Given the patient-centered nature of this funding level, animal research is prohibited for FY21 ERP RPA Funding Level II Applications.

Additionally, applications proposing retrospective study aims or epidemiologically-based research (e.g., analyses of pre-existing datasets or analyses of existing biorepository data or specimens) are prohibited for FY21 ERP RPA Funding Level II Applications given the longitudinal focus of this funding level. The application should demonstrate the study team’s experience in both TBI and epilepsy research.

The FY21 ERP RPA requires that a minimum of 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. Any partner may submit as the Initiating Principal Investigator (PI); the other partner(s) will be designated as the Co-PI(s).

Multi-institutional research is encouraged but not required. The named PI will be required to attend an annual, one-day In-Progress Review (IPR) meeting beginning in year 2 of the award and throughout the remaining period of performance to present project information or disseminate project results. 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 ERP’s mission (see Section II. A, Program Description) toward clinical applications. The proposed study must include clearly stated plans for interactions between/among 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) or objectives are required.

Preliminary data may be derived from a laboratory discovery, clinical observation, population-based studies, or from the peer-reviewed literature. 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. The anticipated total costs budgeted for the entire period of performance for a Funding Level I FY21 ERP RPA will not exceed $1,300,000. Refer to Section II.

D. 5, Funding Restrictions, for detailed funding information. The anticipated total costs budgeted for the entire period of performance for a Funding Level II FY21 ERP RPA Award will not exceed $3,100,000.

Refer to Section II. D. 5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2022. For additional information refer to Section II. F.

1, Federal Award Notices. The CDMRP expects to allot approximately $1. 3M to fund approximately one Research Partnership Award Funding Level I application and approximately $3.

10M to fund approximately one Research Partnership Award Funding Level II application. 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.