1. 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

2. Are there funds to address the additional burden at each Coordinating Center?

3. Data to be shared Raw genotypes –Analytic advantages –Risks –Protections Summary data –Possible formats Interacting genes?

4. 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?

5. 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?

6. Publications Committee During CARE Consortium “grace period”? After any grace period?

7. Data Access Committee During CARE Consortium “grace period”? After any grace period? Would a Data Steward be adequate?

8. Are there funds to address the additional burden at each Coordinating Center?

9. Additional Issues Manuscript-driven data release (CARDIA, CHS) (?) Progress reports Central training documentation (IRB, HIPAA) (?) Results reporting Acknowledgements Statement of support

10. 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?

11. 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?