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Standard Operating Procedures

SOP 403: Initial Review – Criteria for IRB Approval

Version: K1015

POLICY

All research proposals that intend to enroll human subjects must meet certain criteria before study related procedures can be initiated. Three core principles: respect for persons, beneficence and justice, as discussed in the Belmont Report are the basis of the criteria for IRB approval. All regulatory criteria must be met and any applicable state or local laws apply. In addition, certain other criteria that are unique to the University of Utah and the VASLCHCS may apply and must be met as well. In order to assure that all regulatory criteria and any other applicable requirements are met, the IRB uses a checklist system.

The criteria for approval and other applicable requirements are included in the board member checklist. Assigned IRB reviewers must complete the board member checklist to ensure that the criteria for approval and other applicable requirements are met.

More detailed information about the criteria for approval and other applicable requirements is provided according to specific topics. Board members may access supplemental guidance on the IRB website or in the ERICA system.

 

Please contact the IRB Office at (801) 581-3655 or irb@hsc.utah.edu for additional guidance.