1. A. The IRB shall maintain the following records:

   1. (1) Minutes of all IRB meetings describing:

      1. (a) Time and date of the meetings;
      2. (b) Members present;
      3. (c) Actions taken;

      4. (d) Votes on the actions including the number:

         1. (i) Voting for;
         2. (ii) Voting against; and
         3. (iii) Abstaining;
      5. (e) The basis for requiring changes in or disapproving research; and
      6. (f) A discussion of controverted issues and their resolution;

   2. (2) Minutes which shall include:

      1. (a) Copies of all applications, supporting documentation, related correspondence, and progress reports;
      2. (b) Records of continuing review activities;
      3. (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
      4. (d) Any written procedures or bylaws adopted by the IRB.
2. B. The IRB shall adhere to the record retention guidelines applicable to the Commission.

Authority: Health-General Article, §§19-109(a)(1) and (7) and (b)(5), 19-103(c)(3), and 19-133(d), Annotated Code of Maryland

Effective date: March 8, 1999 (26:5 Md. R. 391)

Regulation .01 amended effective October 14, 2002 (29:20 Md. R. 1589)

Regulation .01A amended effective August 22, 2011 (38:17 Md. R. 1013)