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700-2- IRB Authority and Signatory Authority

Title: IRB Authority and Signatory Authority
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: The Provost has been designated to serve as the Institutional Official on USU’s Federalwide Assurance (FWA) with the Office of Human Research Protection (OHRP). The Institutional Official is ultimately responsible for the oversight and conduct of the IRB.

The USU Administration through the Institutional Official, grants the USU IRB authority to:

  • operate independently,
  • make determinations of projects that are not human subject research,
  • make determinations of exempt research,
  • approve proposed research activity,
  • specify modifications required to secure IRB approval for proposed research activity,
  • disapprove proposed research activity,
  • suspend or terminate approval of research that is not being conducted in accordance with the IRB’s policies, is not in compliance with federal regulations, and/or is associated with unexpected, serious harm to participants, and
  • name another party as the IRB of record for research by a USU community member(s) but that is executed at another location (e.g., a hospital, clinic, or another university).

Research that has been approved by the USU IRB may be subject to further review and approval or disapproval by officials of the USU, specifically the Provost or designee. However, USU officials may not approve research if it has not been approved by the USU IRB.

The IRB Chair is authorized to sign any documents concerning any proposed project/research activity that has been reviewed pursuant to USU IRB policies and procedures. The IRB Chair may designate signatory authority to qualified IRB staff members, as appropriate. In all cases, individuals must sign their own name and indicate their title.

Electronic signatures are considered valid.

Any letters or memos sent to agencies of the federal government and/or funding agencies (private or public) or their agents on behalf of the USU IRB are signed by the Institutional Official, IRB Chair, or designee, as appropriate.

Purpose: This policy outlines the specific authority granted to the USU IRB to review, approve, and monitor proposed projects/research involving human subjects at USU. The policy also designates USU’s Institutional Official.

Scope: This policy applies to the USU IRB and those with signatory authority for the IRB.

Documents and Forms:
None