data sharing / irb issues data to be shared (raw genotypes? summary data?) timing of data sharing...
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Data Sharing / IRB Issues
• Data to be shared (Raw genotypes? Summary data?)
• Timing of data sharing• Protected time for CARE Consortium? How long?
• Publications Committee?• Data Access Committee?• Is the Data Enclave model a solution?• Ancillary Study Applications
…Staged approach
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Are there funds to address the additional burden at each
Coordinating Center?
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Data to be shared
• Raw genotypes– Analytic advantages– Risks– Protections
• Summary data– Possible formats
• Interacting genes?
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Timing of data sharing?
• Initial phase (current ancillary studies proposal)
• Second phase (all genotypes, phenotypes)
– Protected time for CARE Consortium?• Any scientific reason?• How long?
– Data Enclave– Beyond Data Enclave?
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Data Enclave
• IRB-approved projects only
• Confidentiality agreement (to cover non-identification, etc.)
• For-profit entities (Third party agreements?)
• Access tailored to consent
• Will a data enclave be adequate?
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Publications Committee
• During CARE Consortium “grace period”?
• After any grace period?
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Data Access Committee
• During CARE Consortium “grace period”?
• After any grace period?
• Would a Data Steward be adequate?
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Are there funds to address the additional burden at each
Coordinating Center?
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Additional Issues
• Manuscript-driven data release (CARDIA, CHS) (?)
• Progress reports• Central training documentation (IRB,
HIPAA) (?)
• Results reporting
• Acknowledgements
• Statement of support
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Additional Issues (cont’d)
• Manuscript titles• Cohort publications procedures (reporting, etc.)
• Verification of analyses (CARDIA, MESA, others?)
• Return of data to cohorts– Can cohorts then initiate independent
analyses?
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Ancillary Study Applications
• Phase I– Can we obtain full DNA release for this limited
first stage?
• Phase II– How soon can we start work on this?– What obstacles must be surmounted?