DOD Epilepsy Research Partnership Award: Supporting Collaborative Research for Post-Traumatic Epilepsy

The intent of the FY22 ERP RPA is to create an avenue to support new or existing collaborative research partnerships between/among investigators to address a research problem or question in a manner that would be unachievable through separate efforts. It is expected that investigators utilize their distinct but complementary perspectives to synergistically address a central problem or question critical to PTE research and those living with PTE, their families, and/or their care partners.

Important aspects of this award mechanism include:

• Partnership: The FY22 ERP RPA requires that a minimum of two investigators partner in one overarching study. The investigators may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application.

The application should demonstrate how the unique skills and contributions of the Principal Investigator (PI) and Co-PI(s) will support the meaningful and synergistic success of the project.  A proposed project in which a partner merely supplies tissue or access to patients will not meet 

the intent of this award mechanism.

•   Impact: Applications should articulate the short- and long-term impact of the proposed research on the PTE research field, patient care, and those living with PTE. Projects should address one or more of the FY22 ERP Focus Areas or provide a strong justification as to why the alternative topic is critical to advance understanding of PTE and addresses the ERP mission.  Applicants are encouraged to consult with individuals living with PTE during the development and 

execution of the proposed research project, to ensure research outcomes maximize translational and impact potential.

•   Relevance to Military Health: Projects must be relevant to military Service Members, their families, and Veterans with PTE. Collaboration with military and VA researchers and clinicians is encouraged.

•   Experience in PTE Research: The PI and Co-PI(s) on the application can be from any field or discipline; however, it is CRITICAL that the application demonstrate the study team’s experience in PTE research, including expertise in the fields of BOTH TBI and epilepsy.

•   Preliminary Data: Applications must include preliminary and/or published data that support the proposed research project. Preliminary data may be derived from a laboratory discovery, clinical observation, population-based studies, or from the peer-reviewed literature.

The intent of the FY22 ERP RPA is to create an avenue to support new or existing collaborative research partnerships between/among investigators to address a research problem or question in a manner that would be unachievable through separate efforts. It is expected that investigators utilize their distinct but complementary perspectives to synergistically address a central problem or question critical to PTE research and those living with PTE, their families, and/or their care partners.

Important aspects of this award mechanism include:

 Partnership: The FY22 ERP RPA requires that a minimum of two investigators partner in one overarching study. The investigators may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application.

The application should demonstrate how the unique skills and contributions of the Principal Investigator (PI) and Co-PI(s) will support the meaningful and synergistic success of the project. A proposed project in which a partner merely supplies tissue or access to patients will not meet the intent of this award mechanism.

 Impact: Applications should articulate the short- and long-term impact of the proposed research on the PTE research field, patient care, and those living with PTE. Projects should address one or more of the FY22 ERP Focus Areas or provide a strong justification as to why the alternative topic is critical to advance understanding of PTE and addresses the ERP mission. Applicants are encouraged to consult with individuals living with PTE during the development and execution of the proposed research project, to ensure research outcomes maximize translational and impact potential.

 Relevance to Military Health: Projects must be relevant to military Service Members, their families, and Veterans with PTE. Collaboration with military and VA researchers and clinicians is encouraged.

 Experience in PTE Research: The PI and Co-PI(s) on the application can be from any field or discipline; however, it is CRITICAL that the application demonstrate the study team’s experience in PTE research, including expertise in the fields of BOTH TBI and epilepsy.

 Preliminary Data: Applications must include preliminary and/or published data that support the proposed research project. Preliminary data may be derived from a laboratory discovery, clinical observation, population-based studies, or from the peer-reviewed literature.

Clinical trials are not allowed under this funding opportunity. Permitted research includes preclinical studies in animal models, observational research with human subjects, or research involving human anatomical substances or data, as well as ancillary studies associated with an existing clinical trial. When appropriate, applicants are encouraged to leverage ongoing cohort studies, such as Transforming Research and Clinical Knowledge in TBI (TRACK-TBI), TBI-Model Systems, and Long-Term Impact of Military-Relevant Brain Injury Consortium Chronic Effects of Neurotrauma Consortium (LIMBIC-CENC).

Employing community collaborations to optimize research impact is encouraged but NOT required. Research funded by the FY22 ERP should be responsive to the needs of people with PTE, their families, and/or their care partners. Research teams are therefore encouraged to establish and utilize effective and equitable collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research. Collaborative research approaches such as community-based participatory research (CBPR), participatory action research (PAR), and integrated knowledge transition (IKT), create partnerships between scientific researchers and community members to create knowledge useable by both sets of stakeholders. Recognizing the strength of each partner, scientific researchers and community members collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of community members within the research team. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy. These methods are critically important for community-level interventions and can also have important impacts on translational research and prototype development to identify and augment the potential impact of a research program on people living with PTE, their families, and/or their care partners. Collaborative research approaches are characterized by the equitable collaboration between community members and researchers. These collaborative relationships are often established through integrating community members into research teams as co-researchers, advisors, and/or consultants. Some examples for implementing collaborative research approaches include:  Lived Experience Consultation: The research team includes at least one project advisor with lived PTE experience who will provide advice and consultation throughout the planning and implementation of the research project. Lived experience consultants may include individuals with PTE, their family members, or their care partners.

 Partnership with a community-based organization: The research team establishes partnerships with at least one community-based organization that provides advice and consultation throughout the planning and implementation of the research project. Community-based organizations may include advocacy groups, service providers, policy makers, or other formal organizational stakeholders.

 Community Advisory Board: A community advisory board is composed of multiple community stakeholders and can take many forms, from a board of Lived Experience Consultants to a coalition of community-based organizations or any combination thereof. As with Lived Experience Consultants and organizational partners, the community advisory board provides advice and consultation throughout planning and implementation of the research project.

Additional information on collaborative research approaches can be found here:  Wallerstein N and Duran B. 2010. Community-based participatory research contributions to intervention research: The intersection of science and practice to improve health equity. American Journal of Public Health 100(S1):S40-S46. doi: 10.2105/AJPH.2009.184036.  Jull J, Giles A, Graham ID. 2017. Community-based participatory research and integrated knowledge translation: advancing the co-creation of knowledge. Implementation Science 12(1):150. doi: 10.1186/s13012-017-0696-3.

Experimental design should maximize rigor and reproducibility. All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core standards are described in Landis, S.C., et al., A call for transparent reporting to optimize the predictive value of preclinical research. Nature 2012, 490:187-191 (https://www.nature.com/articles/nature11556). 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.

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 an FY22 ERP Research Partnership Award will not exceed $1,300,000. 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 $1.3M to fund approximately one Research Partnership Award 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 FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.