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Records

  1. The IRB shall prepare and maintain adequate documentation of activities, including the following:

    • 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 detail.

    • Written procedures for the IRB in detail.

    • Statements of significant new findings provided to subjects.

  2. The records required by this policy shall be retained for at least (3) three years.

  3. Records relating to the approved research (e.g., consent forms), must be retained by the investigator for at least (3) three years after completion of the research. An investigator who leaves the university prior to the end of the 3-year retention period must notify the IRB, specifying the new location of the records. If records are maintained by a student or research assistant, the records must be turned over to the faculty member after the research has been conducted.