with KSU on the study.

XV. RECORDS AND DOCUMENTATION

15.1 General Requirements

The OSP will be responsible for IRB records in accordance with 45 CFR § 46.115, which states that the University is required to prepare and maintain documentation of IRB activities including the following:

  1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, 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, including the rationale for conducting continuing review of research that otherwise would not require continuing review.
  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 § 46.108(a)(2).
  6. Written procedures for the IRB in the same detail as described in 45 CFR § 46.108(a)(3) and (4).
  7. Statements of significant new findings provided to subjects, as required by 45 CFR § 46.116(c)(5).
  8. The rationale for an expedited reviewer's determination under 45 CFR § 46.110(b)(1)(i) that research appearing on the expedited review list described in 45 CFR § 46.110(a) is more than minimal risk.
  9. Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in 45 CFR § 46.103(e).

15.2 Minutes of IRB Meetings

The minutes of IRB meetings should document, among other things: separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB; the vote on all IRB actions including the number of members voting