- An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation
or IRB 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 the same detail as described in §46.103(b)(3).
- Written procedures for the IRB in the same detail as described in §46.103(b)(4) and §46.103(b)(5).
- Statements of significant new findings provided to subjects, as required by §46.116(b)(5).
- The records required by this policy 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 department or agency at reasonable times and in a reasonable manner.
(Approved by the Office of Management and Budget under control number 0990-0260.)