changes in or disapproving research; and a written summary of the discussion of
controverted issues and their resolution.
Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review.
Copies of all correspondence between the IRB and the investigators.
A list of IRB members in the same detail as described in 45 CFR § 46.108(a)(2).
Written procedures for the IRB in the same detail as described in 45 CFR § 46.108(a)(3) and (4).
Statements of significant new findings provided to subjects, as required by 45 CFR § 46.116(c)(5).
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.
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).
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 for, against, and abstaining; the basis for requiring changes in or disapproving the research; and a summary of the discussion of controverted issues and their resolution. OHRP recommends that the recusal of IRB members because of a conflicting interest also be documented when recording votes on IRB actions.
In order to document the continued existence of a quorum, the following examples demonstrate one acceptable format for documenting in the minutes the votes on actions taken by the IRB on research projects undergoing initial or continuing review:
Total = 6; Vote: For - 5, Opposed - 0, Abstained - 1.
Total = 5 (1 member recused and did not vote); Vote: For – 4, Opposed – 1, Abstained – 0.
OSP staff will develop IRB meeting minutes in draft form within three working days following an IRB meeting. Draft minutes will be sent to the IRB Chair for initial review. After initial review, the minutes will be distributed via email to all IRB members for