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MICHIGAN GENOMICS INITIATIVE (MGI) Uses of resources Developed by: U-MIC University of Michigan IRB Collaborative
UM Precision Health Initiative • MGI integration across large-scale institutional research resources • Michigan Genomics Initiative (MGI) • UMHS surgery patients • • Central Biorepository (CBR) • houses and processes biospecimens collected through • • • blood sample for genetic sequencing consent to link sample to data and specimens stored for future research analysis consent to be contacted by researchers for future studies MGI other research sample collection studies Data. Direct • • self-serve tool access to UMHS clinical data, such as: • • • Developed by: U-MIC diagnoses encounters procedures medications labs 3
IRB requirements • MGI depend on • • identifiability of data/specimens whether patients have already provided consent to be contacted for research purposes Developed by: U-MIC 4
Data. Direct functionalities • MGI assemble cohort from patients within electronic health record system Developed by: U-MIC 5
Data. Direct functionalities • MGI assemble cohort from patients within electronic health record system Developed by: U-MIC 6
Data. Direct functionalities • MGI assemble cohort from patients within electronic health record system • PHI mode • • Developed by: U-MIC identification of potential subjects for a prospective study • including contact information • may only require a HIPAA “limited data set” assembly of dataset for secondary analysis 7
Data. Direct • MGI identifies patients who have consented to • • MGI other studies affiliated with CBR • offers genetic data/biospecimens associated with cohort • Genomic data • may include deidentified genetic data • • • e. g. , SNP data may be transferred to virtual machine environment with tools for custom analysis When genomic and clinical data are combined, Data Office for Clinical and Translational Research (DOCTR) strips direct identifiers. Developed by: U-MIC 8
Recontact • • • MGI Participants may be re-contacted regarding follow-up studies Returning research-level genetic results to MGI participants is not permitted. In addition to IRB approval/exempt determination • MGI committees must approve requests for • • Developed by: U-MIC biospecimens MGI participant re-contact MGI patients 9
MGI Reference MGI study HUM 00071298 in your IRBMED application. Developed by: U-MIC 10
MGI Michigan Genomics Initiative (MGI): Uses of resources Michigan Genomics Initiative (MGI): https: //precisionhealth. umich. edu/michigangenomics/ Data Office for Clinical and Translational Research (DOCTR): https: //research. medicine. umich. edu/our-units/data-office-clinical-translational-research Developed by: U-MIC 11
THANK YOU. Lark Speyer IRBMED Devon Newman DOCTR Developed by: U-MIC 12
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