DoD Psychological Health and Traumatic Brain Injury, Federal Interagency Traumatic Brain Injury Research Analysis Award

Description

The intent of the FY19 FITBIR Analysis Award is to leverage this data to identify actionable insights for the diagnosis, management, and treatment of TBI. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The anticipated total costs budgeted for the entire period of performance for an FY19 JPC-6/CCCRP PH/TBI FITBIR Analysis Award will not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The JPC-6/CCCRP expects to allot approximately $3M of the FY19 PH/TBIRP appropriation to fund approximately 4 FITBIR Analysis Award applications. 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 FY19 FITBIR Analysis Award funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025. Awards will be made no later than September 30, 2020. For additional information refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). The level of involvement on the part of the DoD during project performance is the key factor in determining whether to award a grant or cooperative agreement. An assistance agreement (grant or cooperative 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. 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 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. Proposed research must analyze existing FITBIR data. Funding from the FITBIR Analysis Award will not support animal research or prospective (active) enrollment of human subjects. Applications may supplement FITBIR data with other public or private data sources. Applicants are expected to demonstrate access to shared data or restricted data within FITBIR at the time of application submission. Proof of an approved FITBIR Data Access Request is required at the time of application submission (Attachment 7). The FITBIR Data Access Request form can be found at https://fitbir.nih.gov/content/get-account. Research Involving Human Subjects Data: All DoD-funded research involving the use, access, or analysis of human subjects data or records must be reviewed and approved by the 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. The use of deidentified human subject data/records may be exempt from IRB review. Exemption must be determined by the office of the institution’s IRB of record and confirmed by USAMRMC HRPO. Local IRB/EC approval at the time of submission is not required. Investigators must review their institutional requirements and guidelines for filing with the IRB for exempt status. The HRPO is mandated to comply with specific laws and requirements governing all research involving human subjects 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. Additional time for regulatory reviews may be needed for research taking place in international settings. When possible, protocols should be written for research with human subjects data/records that are specific to the DoD-supported effort outlined in the submitted application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Refer to the General Application Instructions, Appendix 1, and “Information for Investigators –Research with Data/Specimens” document at https://mrmc.amedd.army.mil/assets/docs/orp/ Investigator_Guidance_on_HRPO_Review_of_Use_of_Data_Specimens_07Jun2018.pdf for additional information. Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research supplements FITBIR data with other DoD resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Access to DoD resource(s) or database(s) should be confirmed by including a letter of support, signed by the lowest-ranking person with approval authority. If the proposed research supplements FITBIR data with VA study resources and databases, and/or VA research space and equipment, VA Principal Investigators (PI)s/co-PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA resources and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for administering the funds, the application should include a letter from the VA ACOS/R&D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research. Access to certain DoD or VA resources or databases may only be obtained by collaboration with a DoD or VA investigator who has a substantial role in the research and may not be available to a non-DoD or non-VA investigator if the resource is restricted to DoD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DoD or non-VA investigator collaborating with the DoD and/or VA. If access cannot be confirmed at the time of application submission, the Government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s). Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. 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.

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