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Standard Operating Procedures
On January 1, 2012, the IRB fully implemented Protis - Protocol Information System - for on line submission [and tracking] of applications. For an introduction to the system and user instructions click here: http://help.protis.usu.edu
The purpose of the Institutional Review Board (IRB) Standard Operating Procedure (SOP) is to provide direction to members of the IRB and the IRB staff in carrying out duties assigned to the IRB, and to provide a “best practices” reference guide. This SOP comprehensively summarizes existing policy as well as the regulatory expectations found in the Common Rule (45 CFR 46). At the time of the release of Version 2.0, USU is not carrying out research on new investigational drugs or biomedical devices. Therefore, these SOPs do not include extensive information concerning the requirements of the Food and Drug Administration (FDA) regulations, found at 21 CRF 56.
Utah State University's (USU) IRB periodically reviews its local practices and SOPs to maintain procedures tailored to the practices and research programs at USU. The procedures described are also reviewed to ensure compliance with applicable regulations and guidance.
Another purpose of these SOPs is to ensure conformity between written university policies and procedures and operational practices within USU. The SOPs reflect the practices and procedures expected by USU’s IRB at multi-site studies as well, when those studies involve research programs supported by USU. If defined procedures are not found in these SOPs, then research must be suspended in accordance with the provisions set forth in 45 CFR 46 and all its subparts (A, B, C, & D), and to comply with USU's Federal Wide Assurance (FWA) on file with the Office of Human Resource Protection (OHRP) until the SOPs adequately address all regulatory requirements. USU and its IRB have made important procedural decisions that are documented in these SOPs.
Download the complete IRB Standard Operating Procedures manual (SOP) updated 12/20/2011