Subject: IRB Records

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to prepare and maintain adequate documentation of IRB activities as defined by Federal regulations.

1. The IRB will prepare and/or maintain all of the following documents:
   1. Copies of all research proposals reviewed, including scientific and scholarly evaluations, if any that accompany the proposals, approved sample consent documents, continuing review reports submitted by the Investigators and reports of injuries to subjects.
   2. Minutes of IRB meetings that will be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
   3. Records of continuing review activities.
   4. Copies of all correspondence between the IRB and the Investigators.
   5. A list of IRB members in the same detail as described in IRB Policy VI.A. ^[1]
   6. Written procedures for the IRB in the same detail as required in the IRB Policy manual.
   7. Statements of significant new findings provided to subjects, as required by IRB Policy IV.A. ^[2]
2. The IRB records required by this policy shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of FDA, OHRP or any authorized department or agency at reasonable times and in a reasonable manner. ^[3], ^[4]

^[1] IRB Policy VI.A

^[2] IRB Policy IV.A

^[3] 45 CFR 46.115

^[4] 21 CFR 56.115