ABSTRACT
IRB records will be made available for inspection and copying by authorized representatives of DHHS, FDA, and other regulatory authorities after receiving the request in writing.
D. IRB Minutes
1. The minutes of the IRE3 meetings will be in sufficient detail to show the following for each research protocol: a. Attendance at the meeting b. A summary of the discussion and the resolution of controversial issues c. Actions taken by the board
d. Vote on the actions e. The basis for requiring changes or disapproving the research f. IRE3's determination of risk
g. IRB review date (date of progress report)
2. The format of the IRB Meeting minutes will follow that outlined in Attachment A.
