The IRB has reviewed some studies where the sponsor section of the IRB application is mistakenly blank, even when the study has a sponsor.  It is very important to add each sponsor to the IRB application on the Study Location and Sponsors page, question 5.  The type of sponsor helps the IRB to determine which rules and regulations must be applied to the study.

If you have questions about the sponsor section of the IRB application, please contact the IRB office at 801-581-3655 or irb@hsc.utah.edu.

Please note the following for federal funding:

• Many federal agencies use the Common Rule (45 CFR 46); however, many also have other research regulations specific to the agency.  If the sponsor section of the IRB application is not completed appropriately and this results in the incorrect regulations being applied, the IRB will review the study for non-compliance.
• The IRB uses different standards to review federally funded and non-federally funded research.  If the application erroneously indicates that the study is not federally funded, the IRB will review the study for non-compliance if incorrect standards were applied.

Please note the following for industry funding:

• If an industry sponsor is mistakenly not provided in the new study application, the study may be unnecessarily delayed during consent and contract review.
• If an industry sponsor is mistakenly not provided in the new study application and is later added via an amendment, the IRB will charge the new study fee for the amendment.  The IRB will also retroactively charge for any other amendments or continuing reviews that were not previously invoiced.