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):
- 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.
- 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.
- Records of continuing review activities.
- Copies of all correspondence between the IRB and the investigators.
- A list of IRB members in the same detail as described in [45 CFR 46.115 46.103(b) (3)].
- 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)].
- Statements of significant new findings provided to subjects, as required by [45 CFR 46.115 46.116(b) (5)].
- 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.