Sec. 10.25.11.10. IRB Records  


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  • 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.