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6. Regulatory and privacy essentials

Draft — summary layer over Operations › Regulatory and Consenting; needs the regulatory coordinator's pass.

The protocols

The lab's work runs under several IRB protocols (R01, R61/R33 and collaborative protocols among them) and each collaborating site is either covered by one or explicitly does not need one. You must be added to a protocol before touching its data — Adding Personnel to an IRB Study. Annual continuing reviews and study closure are in Operations › Regulatory, IRB & Reporting.

Where PHI may and may not live

Danger

May: cnt1, cnt-fs and BSC (PMACS systems permitted for identifiable data), REDCap, Penn+Box, PennChart, the CRC scheduling trackers. BSC permission confirmed by Nishant Sinha on 2026-09-20.
May not: this wiki, GitHub, Slack, Borel/Leif/Pioneer, Pennsieve, ieeg.org, personal devices, email attachments. If in doubt, it is PHI until de-identified.

Documentation you maintain

Read Consent Signing Checklist and How the e-Consent Form Works first; use the study's script and the Consent Note Templates. Current forms are linked from All Consent Forms (Box links).