Administration and Sample Acquisition

Based on our near 25 years of experience with this P01, we believe the notion of “success” for the program is dependent on the existence of an effective Administrative Core as a central element of fiscal/regulatory coordination, human subject recruitment, and scientific guidance/external evaluation. With this belief, the five goals of Core A are as follows: 1) Manage the budgetary and fiscal aspects of this program. The proposed program involves direct cost disbursements to investigators of Projects 1, 2 & 3 as well as Cores A & B; hence, careful oversight represents an absolute administrative requirement. 2) Coordinate ongoing feedback with regard to the goals and activities of the P01, and facilitate communication among investigators within the program. This aim takes a pragmatic form through implementation of a variety of functions ranging from organizing regularly scheduled meetings to training of Project investigators by the program's Cores. Core A also provides mechanisms for program optimization through meetings of the Internal Program Executive Committee as well as through input provided by the External Advisory Board —for the purposes of maximizing progress and synergy within the program. 3) Organize the collection of human materials through consenting of participants and blood sample collection, assuring compliance with appropriate regulatory bodies and edicts. Our P01 places substantial emphasis on diversity in both the research team and the subjects we study. Our partnerships with units external to UF enable discretion in recruitment of participants with balance for age, sex and diversity in terms of genetic ancestry composition. Through collection of these metadata, data generated by the three Projects and Core B will be robust, generalizable and reflective of population heterogeneity, contributing toward mitigation of disparities. 4) Provide database support for storage of regulatory documents as well as data/metadata in order to facilitate investigator access to appropriate sample sets. We propose upgrades to our existing “Diabase” in order to improve the investigator interface for sample selection (e.g., based on subject genotype at specific loci, polygenic risk score, age, disease status, sex) as well as FAIR Principles-compliant data management and stewardship. 5) Compile appropriate datasets and facilitate communication of program results. Core A will communicate with NIH staff, provide assistance with publications, and presentation of program results.The Internal Program Executive Committee has reviewed changing priorities and advances in the field of type 1 diabetes (T1D) and with this renewal application, organized itself to address the growing needs for: a) identifying processes at the intersection of pancreas biology and anti-β-cell immunity; b) understanding genotype/phenotype interactions that impact immune responsiveness and trafficking; c) developing improved biomarkers (immune, metabolic, genetic) reflective of key pathogenic processes; and d) discovering methods that impart immune modification capable of interrupting T1D progression. We expect that Core A's commitment to facilitating synergy and collaboration across the P01 will continue to prove beneficial for achieving these goals.