Regulation .10 IRB Records.
Regulation .10 IRB Records.LinkCopy Citation
A.
The IRB shall maintain the following records:
(1)
Minutes of all IRB meetings describing:
(a)
Time and date of the meetings;
(b)
Members present;
(c)
Actions taken;
(d)
Votes on the actions including the number:
(i)
Voting for;
(ii)
Voting against; and
(iii)
Abstaining;
(e)
The basis for requiring changes in or disapproving research; and
(f)
A discussion of controverted issues and their resolution;
(2)
Minutes which shall include:
(a)
Copies of all applications, supporting documentation, related correspondence, and progress reports;
(b)
Records of continuing review activities;
(c)
A list of IRB members and current curriculum vitae sufficient to demonstrate the IRB members' areas of expertise and current employment or consultant relationships and board memberships; and
(d)
Any written procedures or bylaws adopted by the IRB.
B.
The IRB shall adhere to the record retention guidelines applicable to the Commission.