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

Are there funds to address the additional burden at each

Coordinating Center?

Data to be shared

• Raw genotypes– Analytic advantages– Risks– Protections

• Summary data– Possible formats

• Interacting genes?

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?

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?

Publications Committee

• During CARE Consortium “grace period”?

• After any grace period?

Data Access Committee

• During CARE Consortium “grace period”?

• After any grace period?

• Would a Data Steward be adequate?

Are there funds to address the additional burden at each

Coordinating Center?

Additional Issues

• Manuscript-driven data release (CARDIA, CHS) (?)

• Progress reports• Central training documentation (IRB,

HIPAA) (?)

• Results reporting

• Acknowledgements

• Statement of support

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?

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?