Completing the Sponsor Section in ERICA
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 firstname.lastname@example.org.
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.
The VA administrative review has been incorporated into ERICA's new study review process.
The IRB has updated a number of consent and parental permission document templates.
Due to changes in HIPAA regulation released in March 2013, participation in the tissue bank must be optional for treatment/intervention trials.
The IRB has reviewed studies where the sponsor section of the application is blank, even when the study has a sponsor.
This policy change proposes one additional non-federal exemption category, and outlines the new Exemption Umbrella Protocol procedures.
Effective Monday, April 29, 2013, the ERICA system will be updated.
The IRB is pleased to announce two new Coordinators have been selected!
There will be several IRB staff changes in the coming weeks.