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700-40-Revisions to Policies, Procedures, and Documents

Title: Revisions to Policies, Procedures, and Documents
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: Policies, procedures, and documents related to the IRB are managed through specific procedures that include the review, approval, revision, and dissemination as described below.

Purpose: This policy documents how all practices related to creating and reviewing policies, procedures, and documents related to the IRB are handled.

Procedures:

  1. Review, Approval, and Revision of IRB Policies, Procedures, and Documents
    1. If the creation of an IRB policy or procedure is necessary, it will be sent to the full IRB for review and approval.
    2. Documents in the form of checklists, review forms, and handbooks are managed and approved by the IRB Chair, with review from the IRB members and college leadership, as appropriate.
    3. If a Dean or Dean’s designee creates training materials or work guides for their students or faculty, these documents must be approved by the IRB Chair or designee.
    4. The IRB Standard Operating Procedures (SOP) Manual will be reviewed no less than every year from the initial IRB origination date of January 2024. The IRB Chair may extend the review date as deemed necessary.
    5. For the review of the SOP Manual, the IRB Chair will initially review the document for consistency with federal guidelines, current practices, and institutional policies.
      1. If no changes are necessary, the IRB Chair will email all IRB members that no changes are required.
      2. If clarifications/changes are necessary, the IRB Chair will provide the revised SOP, with track changes and comments to designated members of the IRB for review. When ready for formal approval, the IRB Chair will send the revised SOP to the full IRB for approval.
  2. Dissemination
    1. Any new or revised SOP is disseminated via the regular publication of the USU Policy and Procedure Manual.
    2. If appropriate, the IRB Chair will notify stakeholders of additions/changes via email.
    3. New documents are sent to appropriate leadership and will appear on the USU website or in the learning platform, as appropriate. 

Scope: This policy applies to the policies, procedures, and documents related to the IRB.

Documents and Forms:

None