May 24th, 2015
The ERICA system has been updated.
Please find a summary of the changes below. For questions regarding these changes, contact the IRB at 801-581-3655 or firstname.lastname@example.org.
Changes to Ancillary Review Components
- VA Review and Primary Children’s Hospital (PCH) Review of applicable amendment and continuing review applications will now be completed via the ERICA system. All continuing reviews for VA research will require VA review prior to IRB review. All amendments affecting VA and PCH research will also require review from their respective institutions prior to IRB review. A new question has been added to the Amendment Application to determine which research sites are affected by the proposed changes, which will subsequently initiate VA and PCH reviews.
- The VA pages in the New Study Application have received minor modifications for consistency with the most recent VHA Handbook 1200.05.
- The VA Enrollment Status page of the Continuing Review Application has been updated to record exact enrollment numbers at the VA. Additionally, this page was updated for consistency with the VHA Handbook 1200.05.
- The VA Real SSN Access Request Form is no longer required, as the IRB approval letter for VA studies will now provide acceptable determination information for use of real SSNs at the VA.
- Modifications to the CCTS Clinical Services Core page in the New Study Application have been made to gather more effective information for the CCTS Review process.
- The name of the Clinical Cancer Investigations Committee (CCIC) has been changed to the Huntsman Cancer Institute Protocol Review and Monitoring Committee (HCI PRMC).
New "Edit Personnel" Activity
The Edit Personnel activity is a mechanism for changing the study contacts, internal staff and sub-‐investigators, and guests without an amendment application. Changes that can be made include adding personnel, removing personnel, and indicating which internal staff and sub-‐investigators are responsible for obtaining informed consent.
The ERICA system automatically evaluates the profile of any person being added to ensure that appropriate human subjects training has been completed and that Conflict of Interest requirements have been met.
Because the Edit Personnel activity allows for changes to internal staff and sub-investigators, only PI has access to use the activity. To use the Edit Personnel activity, the PI clicks the Edit Personnel link on the left side of the main study workspace, enters the changes, and clicks OK. If an error message displays at the top of the window, the personnel listed in the error message cannot be added because profile components could not be verified. You may remove these personnel and click OK again to finish processing the other changes.
The Edit Personnel activity cannot be used for the following:
- Changing the Principal Investigator; this can only be done via an amendment.
- Adding internal staff and sub-‐investigators who have potential financial conflicts of interest; adding these personnel can only be done via an amendment or continuing review.
- When a study has an amendment or continuing review application in process; changes to personnel can be made via the existing amendment or continuing review.
- When a study involves the use of the Utah Population Database; changes to personnel can only be made via an amendment or continuing review.
For more information about the Edit Personnel activity, visit the IRB website at http://irb.utah.edu/guidelines/erica-‐assistance/contact-‐person.php.
Researchers conducting procedures at the Salt Lake City VA need to be aware of the additional administrative forms that may be required in addition to the IRB application.
The IRB has received several requests to allow the use of external research nurses who have contracted with a study sponsor to conduct research procedures with participants in their homes.
We are pleased to welcome a new Coordinator to the IRB.
Yan "Kiki" Wai, IRB Coordinator for Panel 2, has left the IRB. We are pleased to announce that Chantyl Staheli has been selected as the new IRB Coordinator for Panel 2.
The IRB is introducing Exemption Categories 8-11 as additional non-federal categories.