Department of Defense (DOD) Fiscal Year 2006 (FY06) Tuberous Sclerosis Complex Research Program (TSCRP) Clinical Resource Development Award

The summary for the Department of Defense (DOD) Fiscal Year 2006 (FY06) Tuberous Sclerosis Complex Research Program (TSCRP) Clinical Resource Development Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.

Department of Defense (DOD) Fiscal Year 2006 (FY06) Tuberous Sclerosis Complex Research Program (TSCRP) Clinical Resource Development Award: The TSCRP recognizes that the successful design, implementation, and interpretation of TSC-relevant therapeutic clinical trials is dependent upon the availability of standardized tools for assessing TSC symptom severity or changes over time. Consequently, the Clinical Resource Development Award has been established to fund the development, validation, and/or pilot testing of novel tools/resources for measuring clinical and/or surrogate endpoints that are relevant to the variety of lesions and clinical manifestations seen in individuals with TSC. Due to the developmental nature of this award, preliminary data are not required but may be included, if available, to address the feasibility of the tool/resource to be developed. Applicants must explain clearly how the proposed products are directly relevant and applicable to future clinical trials for individuals with TSC. It is anticipated that projects involving human subjects will be most relevant for this mechanism. Examples of tools/resources eligible for funding under this award include but are not limited to: Magnetic resonance imaging-based or other protocols for measuring tumor volumes in affected organs, Biomarkers of cognitive function, TSC-specific behavioral assessments, and Protocols/methods for quantitative assessment of seizure severity. A clinical protocol and associated clinical documents must be included with the submission if the applicant plans to use funding from this award to support clinical studies with human subjects. It is expected that any proposed clinical studies will be initiated within 6 months of the award date. Please note that all DOD-funded research involving human subjects, human anatomical substances, cadavers, and/or laboratory animals must be reviewed and approved by the USAMRMC Human Subjects Research Review Board (HSRRB) in addition to local Institutional Review Boards (IRBs). The HSRRB has different requirements than the local IRBs. The average time to obtain HSRRB approval is approximately 6 months. Therefore, it is strongly suggested that the applicant plan the budget and timeline accordingly. IRB approvals should be in process or completed before proposal submission. Applicants must submit any available internal scientific and local IRB review documents for the clinical protocol and Informed Consent/Assent form(s) that indicate the status of IRB review achieved prior to submission of the Clinical Resource Development Award. Indicate the highest possible level of IRB review within the institution(s) before submission of a proposal. Documentation of local IRB review and approval will be required at the time of the HSRRB regulatory review for all funded proposals. All protocols must be prepared according to the guidelines provided in the document titled "Research Involving Human Subjects and/or Anatomical Substances," which can be found at https://cdmrp.org/Program_Announcements_and_Forms under "Regulatory Document Forms." Separate freestanding protocols should be generated for each site and/or task for all research that involves (a) multiple sites; (b) multiple tasks requiring different study designs, samples, sampling procedures, or methods; and (c) inter-institutional cooperative or collaborative agreements. Please note that each project of a multi-project application will be individually evaluated for compliance with applicable regulatory requirements. Proposals involving human subjects research that do not include a clinical protocol and Informed Consent/Assent forms will be administratively withdrawn and will not be reviewed. Laboratory or animal studies will be considered for funding under this mechanism if the applicability to TSC clinical trials is clear. However, these proposals will face a greater burden to demonstrate clinical relevance. All proposals must include a plan describing the means by which the fully developed tool/resource will be made available to the scientific community for future TSC clinical studies and trials at reasonable or appropriate administrative costs. The Government intends to advertise the tool/resource developed through this award and to provide information on the CDMRP website as to how to obtain access to the product for TSC-relevant clinical research.