Document the review of research proposals that involve any use of human subjects (research subjects) by the Institutional Review Board.

These records found in all media (paper, digital, or other) must include but are not limited to:

• copies of all research proposals reviewed, including scientific evaluations, if any, that accompany the proposals;
• approved sample consent documents; progress reports submitted by investigators;
• reports of injuries to subjects; minutes of IRB meetings with 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;
• a written summary of the discussion of controverted issues and their resolution;
• continuing review activities;
• a list of IRB members;
• written procedures for the IRB;
• statements of significant new findings provided to subjects;
• related correspondence, including e-mail, between the IRB and the investigators.