Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 4. |
Subtitle 25. MARYLAND HEALTH CARE COMMISSION |
Chapter 10.25.11. Institutional Review Board |
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.