OpportunityTitle: An Intergenerational Precision Medicine Research Program for the Study of Factor VIII Immunogenicity in Severe Hemophilia A: Hemophilia A Analytical Cohort Research Program (UG3/UH3 Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: The purpose of this FOA is to support applications that propose the establishment of a Hemophilia A Analytical Cohort Research Program (HARP) that will: 1) collaborate with an established consortium of clinical centers to support the recruitment, enrollment, and follow-up of an antenatal/ neonatal/ pediatric cohort in severe hemophilia A; 2) provide data management, laboratory, and biospecimen support necessary for the establishment of a unique and sharable biospecimen resource annotated with robust intergenerational clinical and demographic data to enable future studies of FVIII immunogenicity; and 3) develop and implement protocols and procedures to conduct hypothesis-driven research studies utilizing data and biospecimens from the antenatal/neonatal/pediatric cohort. The role of HARP is to provide overall project coordination, administration, data and biospecimen management, research protocols and procedures development and implementation, biostatistics/data analytics support; as well as laboratory (including multi-omics) and biorepository expertise for development of this unique intergenerational cohort and resource. HARP, in collaboration with the consortium of clinical centers, will lead the scientific development, pragmatic implementation, and expert conduct of the hypothesis-driven protocols that will permit the establishment of the severe Hemophilia A intergenerational cohort, utilization of some of the cohort longitudinal data and biospecimens, and establishment of a shareable resource for the scientific community.
GrantorContactEmailDescription: See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
GrantorContactText: NIH OER Webmaster&lt;br/&gt;OERWebmaster03@od.nih.gov