Access to IRB minutes and records

Applies to: Agreement V3.0 · SMART IRB SOPs

Minutes (§5.5). The Reviewing IRB must maintain, and on reasonable request make available to designated officials of a Relying Institution, the portions of its meeting minutes on its review of the research for that institution — at least enough to show compliance with federal requirements for IRB minutes, and to the extent applicable law allows. Other review records, including HIPAA waivers the Reviewing IRB approved, are covered by the same provision. A Participating Institution's own policy against sharing minutes cannot override it.

Records. Under the SMART IRB SOPs, records of the ceded review are retained for seven years after the Reviewing IRB closes or terminates the study, and each institution keeps its locally stored records accessible for audits and investigations. Recordkeeping obligations survive termination of participation.

See also - Noncompliance, investigations, and audits - What survives termination