Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
HUS
COMPLICATIONS, PATHOPHYSIOLOGY
With informed consent, and as approved by local IRBs/REBs, de-identified biological samples will be stored to be used to explore the pathophysiology of HUS in STEC-infected patients and its complications. During, and after the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. A code-link will be created to link biological specimens with clinical data, thereby enabling analyses while maintaining blinding to participant identity. Following study completion, access to study data and/or biospecimens will be determined by the study’s leadership team. IRB/REB approval will be required for all studies involving biospecimens. Genetic testing of blood samples will not be performed.