Md. Code Regs. 10.25.11.10

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.25.11.10 - IRB Records

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.

Md. Code Regs. 10.25.11.10