Subject: Documentation of IRB Determinations

Policy:

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

1. The IRB will prepare and maintain adequate documentation of IRB activities, including the following:
   1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, continuing review reports submitted by Investigators, and reports of injuries to subjects.
   2. Minutes of IRB meetings which 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 described in IRB Policy III.F. ^[2]
   7. Statements of significant new findings provided to subjects, as required in Section III.E of IRB Policy IV.A. ^[3], ^[4], ^[5]
2. The records required by this policy will be retained for at least 3 years, and records relating to research which is conducted will be retained for at least 3 years after completion of the research. All records will be accessible for inspection and copying by authorized representatives of any Federal department or agency with responsibility for oversight of the research at reasonable times and in a reasonable manner. ^[6], ^[7]
3. The IRB will notify Investigators and the institution in writing of its decision to approve, defer, or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the Investigator an opportunity to respond in person or in writing. ^[8], ^[9]

^[1] IRB Policy VI.A

^[2] IRB Policy III.F

^[3] 45 CRF 46.115(a)

^[4] 21 CFR 56.115(a)

^[5] Section III.E of IRB Policy IV.A

^[6] 45 CFR 46.115(b)

^[7] 21 CFR 56.115(b)

^[8] 45 CFR 46.109(d)

^[9] 21 CFR 56.109(e)