Section 100. Committee records

A. Documentation of all committee activities shall be prepared and maintained and shall include the following:

1. Copies of all research documents, including proposals reviewed, evaluations that may accompany the proposals, approved sample consent documents, progress reports submitted by researchers, reports of injuries to participants, and correspondence related to the research project;

2. Minutes of committee meetings which shall be in sufficient detail to show attendance; actions taken by the committee; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research and a summary of the discussion of controversial issues and their resolution;

3. Records of continuing review activities;

4. A list of committee members; and

5. Written procedures for the committee.

Historical Notes

Derived from VR615-80-01 § 10, eff. August 11, 1993.

Statutory Authority

§§ 63.2-217 and 63.2-218 of the Code of Virginia.