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700-26-Documentation and Notification of IRB Discussions, Decisions, Actions, and Findings

Title: Documentation and Notification of IRB Discussions, Decisions, Actions, and Findings
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: The USU IRB documents discussions, decisions, and actions through minutes of convened meetings. Copies of the minutes and pertinent materials are maintained within the IRB Google Drive.

When the submission qualifies for the determination of not human subject research or exempt research, or the expedited procedure for review is used, documentation of decisions is made in the appropriate IRB Reviewer Checklist. Reviewer checklists and relevant materials are maintained in the IRB Google Drive.

All other actions related to continuing review, amendment forms, event reporting forms, final reports, etc. are maintained on the IRB Google Drive.

Investigators (and chairs of doctoral students) are notified of IRB decisions and findings within 5 business days by email via IRB@usuniversity.edu.

Purpose: This policy outlines the procedure for documenting the USU IRB review of submissions, related discussions, decisions, actions, and findings.

Procedures:

  1. Documentation Location
    1. All documents related to IRB discussions, decisions, actions, and findings are stored on the IRB Google Drive.
  2. Notification of IRB Decisions, Actions, and Findings
    1. The IRB Chair or designee is responsible for notifying the investigator (and chairs of doctoral students) via IRB@usuniversity.edu within 5 business days of receipt of a submission as follows:
      • If the submission is incomplete, a detailed request for missing documents/items will be sent.
      • If a determination of not human subjects research or exempt research was made along with the appropriate determination letter.
      • If the submission is eligible for expedited review with an expected review completion date.
      • If the submission will require a full board review the date the IRB will convene to deliberate. 
    2. The IRB Chair or designee is responsible for notifying the investigator (and chair of a doctoral student) of the IRB’s decision within 5 business days after the convened meeting or completion of an expedited review. Notifications are sent via IRB@usuniversity.edu.
    3.  The institutional official, appropriate leadership, and IRB committee receive quarterly reports as detailed in (700-4: IRB Management and Composition of the IRB).
    4. The Institutional official and relevant leadership (e.g. College Deans) will receive communication regarding relevant actions such as reports of adverse events as they occur.

Scope: This policy applies to the USU IRB.

Documents and Forms: None