Version
1.0
Date Updated
Wednesday, October 15, 2008
Descripton

Approved by: Interim Vice Chancellor for Research
AAHRPP REF#: 108
AAHRPP Elements: II.3.B


POLICY


  1. UIC OPRS is required to prepare and maintain adequate documentation of IRB activities, including the following:
    1. Copies of all required IRB records (refer to UIC HSPP policy IRB Record Retention) 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.
    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.
    4. Copies of all correspondence between the IRB and the investigators.
    5. A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc. sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution as in the same detail as described in 45 CFR 46.103(b)(3).
    6. Written procedures for the IRB in the same detail as described in 45 CFR 56.103(b)(4) and (5) and 21 CFR 56.108(a) and (b).
    7. Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5) and 21 CFR 50.25(b)(5).
  2. IRB and OPRS records are subject to regulation and inspection by governmental agencies [e.g., FDA, OHRP].