PROJECT SUMMARY/ABSTRACT Many people hesitate to contribute their biospecimens and data, including genomic data, for research because they believe that misuse is likely. Biobanks have a tricky problem – that they must engender trust with specimen contributors that they will protect biospecimens and data while simultaneously aiming to get biospecimens and data to the investigators who can most use them. Most biobanks report underutilization of their stored biospecimens and data (including genomic information) for reasons including underdeveloped, unharmonized data management technologies. Without metadata to link permitted conditions for sharing and reuse, biorepositories risk sharing resources which were impermissible to share or contributing to resource inefficiencies by not sharing. The long-term goal of this research program is to respect and protect biospecimen contributors’ autonomous choices and to promote transparency in how those choices are made knowable across biorepositories’ information systems and expressed to individual investigators. The overall objective of the proposed research is to empirically validate one or more standards-based models which make permissions for biospecimen sharing and reuse understandable to machines. This study will include examination of four information models and will be achieved through a single specific aim: to evaluate four established machine-interpretable models for expressing permissions, restrictions, and obligations for biospecimen and information sharing and reuse. Our rationale is: before biospecimen management applications implement a model for labeling biospecimens and information resources according to permissions, restrictions, and obligations which govern their reuse, that model must be vetted for accurate representation of real-world consent forms and policy documents. This aim will be achieved through identifying and annotating sentences from at least 20 consent forms which express permission or constraint regarding biospecimen and data sharing and reuse, those sentences will be deconstructed according to the entities and processes within each model, and the models will be evaluated in terms of their consistency, completeness, conciseness, and interoperability. Additionally, the deconstructed sentences will be applied to each model’s response lists (or value sets) and evaluated in terms of their integration with the model and coverage of the concepts. The proposed research is innovative because it will be the first empirical validation of existing, potentially in-use models using real-world consent forms. The proposed research is significant because more robust models have the potential to enhance responsible stewardship of biospecimens and information, protect specimen contributors’ autonomous choices, and engender trust between those contributors who gave consent and the individual investigators who require permission to use biospecimens in research.