Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 108
- UIC OPRS is required to prepare and maintain adequate documentation of IRB activities, including the following:
- 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.
- 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 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).
- 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).
- Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5) and 21 CFR 50.25(b)(5).
- IRB and OPRS records are subject to regulation and inspection by governmental agencies [e.g., FDA, OHRP].
- Upon Initial Notification of Inspection.
- When the IRB or OPRS receives notification that the IRB or IRB records will be audited by an official from a Federal regulatory agency, the OPRS Director, HPA and IO should be immediately notified. When possible, the initial notification should be referred to the OPRS Director for finalization of the inspection plans.
- In instances when the OPRS Director is not available, OPRS staff should inform the inspector that the supervisor is not present in the office. The OPRS staff should gather the contact information from the inspector and suggest that the OPRS Director recontact the inspector to finalize the inspection plans.
- In addition to gathering information related to the Agency performing and the proposed timing of the inspection, the reason for the inspection should also be requested upon initial contact.
- Upon Arrival of the Inspector.
- Upon arrival of an inspector, OPRS staff will ask all inspectors to identify themselves by name, title, Agency, and show appropriate identification. Inspectors must also state the reason for the inspection. If an inspector is unable to provide identification, the individual will not be permitted to initiate the inspection, but will be asked to return with the appropriate identification.
- After the inspector has identified her/himself, the OPRS Director will be immediately notified of the inspector’s arrival. In instances when the inspection is unannounced and the OPRS Director is not available, OPRS staff should offer to assist, but inform the inspector that the supervisor is not present in the office. OPRS staff should suggest that although they will do their best to help, the inspection should be rescheduled for a time when the OPRS Director is available, as the OPRS Director might be better equipped to answer questions. If the OPRS Director is not present and the federal inspector decides to stay and conduct the inspection, OPRS staff must contact the HPA, Associate Director for Research Compliance, Associate Director of Operations, and the Associate Director of External Relations and Quality Assurance immediately.
- Inspectors with the FDA must also present a Form 482 upon arrival.
- During the Inspection.
- The OPRS Director or designee and designated OPRS staff will be available to the inspector throughout the inspection.
- The OPRS Director or designee, the designated OPRS staff, the Chair of the appropriate IRB, if available, and the HPA and IO, if available, may meet with the inspector at the beginning of the inspection.
- OPRS staff and the IRB Chair will answer all inspector questions or concerns accurately, honestly, and succinctly and answer only the questions asked.
- The federal inspector has the right to visually observe and inspect all facilities and original, unredacted records of the IRB. A list should be kept of all the materials the inspector reviews.
- If the inspector requests duplicate copies of IRB records, OPRS staff must comply with the request. The inspector may ask to duplicate these records or ask office personnel to duplicate the records. If the inspector decides to use duplicating equipment outside of the OPRS office space, an OPRS staff must travel with the inspector to the duplication facility to verify the documents copied. A second copy of all materials duplicated for the inspector should be kept by OPRS staff and used to construct a separate list of the records duplicated.
- At the conclusion of the inspection, the OPRS Director or designee, designated OPRS staff member, the appropriate IRB Chair, if available, and the HPA and IO, if available, may attend the exit interview. If an inspector identifies deficiencies, he/she may leave a copy of the findings with OPRS staff, documenting the results of the inspection. If the inspector does not identify any problems during the inspection, the OPRS Director/IRB Chair should receive a letter following the inspection from agency headquarters confirming the outcome. At the exit interview, inspectors from the FDA will document deficiencies on Form 483.
- Following the Inspection.
- The OPRS Assistant to the Director or designee will maintain a record of everything reviewed by the inspector following the inspection, along with copies of any correspondence provided at the conclusion of the inspection or received after the inspection.
- The OPRS Assistant to the Director or designee will forwards copies of correspondence received from the inspector to the OPRS Director, IRB Chair, HPA, and IO. The IO, HPA, OPRS Director, IRB Chair, and other OPRS staff will discuss the findings and prepare and implement a corrective action plan as appropriate.
- The OPRS will submit a written response regarding the inspection to the appropriate authority, if required and/or as deemed appropriate. The IO, HPA, OPRS Director, and, if appropriate, the IRB Chair will approve any written response. OPRS will send copies to the IRB Chair, HPA, IO, and the Associate Director for Research Compliance, Associate Director of Operations, and the Associate Director of External Relations and Quality Assurance.
- Research reviewed by CHAIRb.
- When research reviewed by CHAIRb is involved in an inspection by a regulatory agency the above stated policy and procedures will be followed. In addition, the Site Liaisons and IOs from each participating site will be informed of the inspection.
- The OPRS Assistant to the Director or CHAIRb Staff will forward copies of the correspondence received from the inspector to the Site Liaisons and IOs from the participating institutions. The Site Liaisons and IOs from the participating institutions may be asked to assist in preparing a corrective action plan as appropriate.
- The OPRS will submit a written response regarding the inspection to the appropriate authority, if required and/or as deemed appropriate. If appropriate, Site Liaisons and IOs from the participating institutions may be asked to approve any written response. OPRS will send copies of the response to the Site Liaisons and IOs from the participating institutions.
21 CFR 56.108(a) and (b), 21 CFR 56.108(a) and (b)
45 CFR 46.103(b)(3), (4) and (5), 45 CFR 46.116(b)(5)
Version (#, date)
Replaces (#, date)
Summary of changes
Creation of policy.
Removal of references to JBVAMC and IRB #4. Addition of CHAIRb.