Section 11: IRB Documentation

IRB records [ 45 CFR 46.115 ]

The Trinity College IRB shall prepare and maintain adequate documentation of IRB activities, including the following (records may be maintained electronically and/or in hard copy):

  1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
  2. Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; 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 written summary of the discussion of controverted issues and their resolution.
  3. Records of continuing review activities.
  4. Copies of all correspondence between the IRB and the investigators.
  5. A list of IRB members in the same detail as described in [45 CFR 46.115 46.103(b) (3)].
  6. Written procedures for the IRB in the same detail as described in [45 CFR 46.115 46.103(b) (4)] and [45 CFR 46.115 46.103(b) (5)].
  7. Statements of significant new findings provided to subjects, as required by [45 CFR 46.115 46.116(b) (5)].
  8. The records shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the applicable federal department or agency at reasonable times and in a reasonable manner.