Standards and Procedures

OPRS SOP 305: Documentation of IRB Discussions, Decisions and Findings

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  3. OPRS SOP 305: Documentation of IRB Discussions, Decisions and Findings

Approved Date

Revised Date

Full Details

PURPOSE
This SOP outlines the procedure for documenting University of Illinois Urbana-Champaign Institutional Review Board (IRB) review of research applications, and the related discussion, decisions or actions, and findings.

SCOPE

This SOP applies to the University of Illinois Urbana-Champaign IRB.

POLICY

The University of Illinois Urbana-Champaign IRB documents discussions, decisions or actions, and findings through minutes of convened meetings. Copies of the minutes and pertinent materials are maintained within the OPRS Shared OVCRI drive.

When the expedited procedure for review is used, documentation of decisions or actions, and findings are made in the IRB reviewer checklist. Reviewer checklists and pertinent materials are maintained within the OPRS Shared OVCRI drive.

Investigators are notified of IRB decisions and findings by email. Emails are saved to the OPRS Shared OVCRI drive.

PROCEDURES

  1. Recording Minutes
    • Minutes document discussions, decisions, and findings made during convened IRB meetings. Meeting facilitators prepare minutes and are responsible to record the following:
      • Meeting attendance.
      • When an alternate member replaces a regular member.
      • Attendance of members or alternate members who participate through teleconference or videoconference. It should be noted whether the meeting was conducted in-person or virtually.
      • The presentation and discussion of each agenda item (new studies, continuing review, and review of amendments, etc.). Each item will be discussed and voted individually, including a description for the basis of requiring changes in or disapproving the research.
      • Summary of the discussion of controverted issues and resolution.
      • Recommendations documented in the IRB reviewer checklists submitted prior to the meeting may deviate from board decisions after a discussion at a convened meeting. In the event that recommendations in the IRB checklist are not consistent with the conclusions resulting from the board discussion, the minutes will document the final decisions and determinations.
      • Voting results include number for, opposed, and abstaining. This will include only voting members present at the meeting when the vote is called. The names of the members absent for the vote will be documented. Members who recused themselves for a conflicting interest will be recorded in the minutes.
      • Determination of the level of risk (minimal, greater than minimal).
      • For initial and continuing review, the approval period.
      • If applicable, determinations required by regulation and protocol specific findings justifying those determinations for: waiver or alteration of informed consent and/or authorization; waiver of documentation of consent; research involving pregnant women, human fetuses, and neonates; research involving children; research involving prisoners; research involving participants with diminished capacity to consent.
      • If applicable, the rationale for significant risk/non-significant risk device determinations.
      • If applicable, the rationale for conducting continuing review on research that otherwise would not require continuing review.
      • If applicable, the rationale for an expedited reviewer’s determination that research appearing on the expedited review list is more than minimal risk.
  1. Distribution of Minutes
    • Meeting facilitators are responsible for preparing the meeting minutes. Finalized meeting minutes are made available at the subsequent meeting of that panel via email. Meeting minutes are retained in OPRS Shared OVCRI drive.
  2. Results of Reviews, Actions, and Decisions
    • The results of reviews and actions taken by the convened IRB that grant or may appear to grant investigators with initial or continuing approval of research involving human subjects, are signed off by the IRB Chair or IRB Vice Chair except when the convened IRB votes to approve research as submitted.
    • If the convened IRB approves research as submitted, documentation of the board’s determination in the minutes is sufficient and subsequent electronic approval by an IRB Chair or IRB Vice Chair is not required.
    • The results of reviews and actions taken by the IRB via expedited review that grant or may appear to grant investigators with initial or continuing approval of research projects involving human subjects, must be signed off by the IRB Chair, IRB Vice Chair, or IRB member designated by the IRB Chair (i.e., designated expedited reviewer).
    • Projects which are classified as exempt from IRB review must be determined by the IRB Chair, IRB Vice Chair, or IRB member designated by the IRB Chair.
  3. Notification of IRB Decisions and Findings
    • Meeting facilitators are responsible for notifying the investigator of the IRB’s decision within seven business days after the convened meeting or expedited review. Notifications are sent via email. As required, notifications will be sent to other offices according to IRB SOP 905: Institutional Reporting Procedures.
    • If the IRB approves the application, the approval notification includes the date of approval, the expiration of approval (as applicable), and the effective date. The date of approval is the date the board voted to approve the application or the expedited reviewer electronically approved the application. The date of the expiration is explained in IRB SOP 307: Approval Period and Determination of Expiration. The approval is effective as of the day the approval notification is issued.
    • If the IRB disapproves the application, the notification includes the reason(s) for disapproval and instructions to the investigator for appeal of the decision.
    • If the IRB requires additional materials or a response from the investigator or sponsor, the notification describes the request(s) of the IRB in detail. The notification also states the IRB must receive the response within 30 days of the date of notification; however, this period may be extended if the investigator or sponsor communicates a need for an extension.