Symposium: The Future of Clinical Research at the University of Utah, CHALLENGES AND OPPORTUNITIESPlease join fellow researchers, leaders and administrators as we prepare for future challenges and opportunities in clinical research.
Updated IRB Fee ScheduleThe IRB Review Fees for an Individual Site, which are typically only charged to industry-sponsored studies, have increased. Additionally, fee information for Single IRB (sIRB) Review Services for Multi-Site Studies is now available on the IRB website.
January 21st is the Go-Live Date for the New Version of the Common RuleThe Common Rule regulations have been revised, with a general compliance date of January 21st, 2019.
IRB CoordinatorPlease welcome Rachel Snow as our newest IRB Coordinator.
New Consent Guidance and Revised Common RuleIn anticipation of the revisions to the Common Rule that go into effect on January 21, 2019, the IRB is excited to announce changes to the informed consent guidance we offer the research community.
- IRB Administrator
Please welcome Lindsey Byrd as our newest IRB Administrator.
- IRB Coordinator
Please welcome Emma Tkachuck as our newest IRB Coordinator.
Short Form Consent Documents and Interpreter Signatures
In order to clarify the exact role that the interpreter plays as a witness to the Short Form consent process, the University of Utah IRB has updated the Short Forms to include a statement with the interpreter signature lines.
Access to Training Reports in ERICA
ERICA users can now access training reports in ERICA for any individual with an ERICA account.
Changes to Screening & Recruiting Policies
Effective June 2018, the University of Utah IRB (UUIRB) updated its screening and recruiting policies and procedures.
Transition from Campus Orders to UShop for IRB Fees
Beginning June 29, 2018, the IRB will no longer accept payment for fees using a Campus Order.
Manager, Administrator
Please join us in welcoming our newest IRB Manager and Administrator.
IRB Guidance Updates
The IRB regularly reviews our guidance documents to make updates as necessary. Several updates have been made this year.
Associate Director
Please join us in welcoming our new IRB Associate Director.
ERICA Update: Edit Personnel Activity
The Edit Personnel activity has now been restored in ERICA. It has been modified to align with the new model for study personnel roles in the ERICA application.
Delay on Changes to the Common Rule
The Department of Health and Human Services (DHHS) has announced a delay on implementation of the proposed changes to the Common Rule.
ERICA Update: New Model for Study Personnel Roles in the ERICA Application
Effective January 13, 2018, the ERICA application changes the way it asks for study personnel to be listed. The new model is described on the IRB website, with an FAQ for new and existing studies.
IRB Staff Changes
Please join us in welcoming our new Panel 2 Coordinator.
IRB Director, Dr. Ann Johnson
We are pleased to announce that Ann Johnson will formally assume the IRB Director position as of October 15, 2017.
Recent Problem with IRB Expiration Notices
The ERICA system recently experienced a problem with the automated IRB Expiration Notices. We discovered that some studies were not receiving these automatically during the month of September, even though a study may have expired.
IRB Staff Changes
Please join us in welcoming our two newest IRB Coordinators.
IRB Staff Changes
Margaret McFarland and Annie Huff have accepted positions on the IRB Administrator team.
IRB Staff Changes
We have added two additional Operations Managers to the IRB.
Two-Factor Authentication Required for ERICA
Starting on June 1st University employees, students, and committee members are required to use two-factor authentication (2FA) to login to the ERICA system.
SIRB Training Now Available Online
The online version of the Single IRB (SIRB) training module is now available.
ERICA Updates
Several changes have been made in the ERICA system.
Revised Requirements for Human Subjects Training
The IRB’s training policy for Human Subject Research training and Good Clinical Practice (GCP) training has been revised
IRB Staff Changes
We are pleased to announce that Hannah Owen has accepted the position of IRB Administrator.
SIRB Training Requirements
Effective February 1, 2017, the University of Utah Human Research Protection Program requires investigators and staff performing research under a SIRB model to complete SIRB training before the research can be activated at the University of Utah.
GCP Training Requirements
Effective January 1, 2017, the University of Utah IRB requires clinical investigators and staff listed on an IRB application funded by the NIH to have both human subjects training and GCP training before an IRB application will be approved.
IRB Staff Telephone Availability Interruption
The IRB office is currently undergoing construction. Several of our staff members have moved to temporary accommodations away from their desks and usual telephones while the remodel is under way.
Delayed Pre-Review Timelines
Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.
IRB Staff Changes
Please join us in welcoming our new Panel 4 Coordinator.
IRB Staff Changes
We are excited to welcome a new Administrator to the IRB.
IRB Staff Changes
We are happy to welcome a new IRB Coordinator. We are also pleased to announce that Jessica Loayza has joined the Administrator team.
Delayed Pre-Review Timelines
Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.
IRB Staff Changes
We have added two new positions to the IRB.
IRB Staff Changes
We are pleased to welcome a new Coordinator to the IRB.
IRB Staff Changes
We are happy to welcome a new IRB Administrator to the New Study pre-review team.
IRB Staff Changes
Please join us in welcoming our new IRB Clerk.
IRB Updates
Due to F&A increase to 36.5%, the IRB fee schedule is changing for industry-sponsored new studies, continuing reviews, and amendments. The new IRB fee schedule will be effective on July 1, 2016.
RDRC-HUS Workflow for Amendments
Effective 5/1/2016, the RDRC-HUS will now review all amendments related to radiation use within the ERICA system.
IRB Staff Changes
Please join us in welcoming our newest IRB Administrator.
IRB Updates
All studies conducted at Shriners Hospitals for Children in Salt Lake City are now required to obtain approval from Shriners Hospital leadership before the IRB will issue final approval of the study.
Institutional Conflict of Interest Policy
Beginning January 15, 2016, the conflict of interest review process for all New Study applications will include a review for Institutional Conflicts of Interest (ICoI).
IRB Staff Changes
We are pleased to announce a new Coordinator for Panel 2.
ERICA Updates
Effective Sunday, October 26, 2015, the ERICA system has been updated.
Updated Guidance for Genetic Research
The IRB has updated the guidance on Genetic Research to add information on the topic of disclosure of incidental findings.
University of Utah HRPP Receives Reaccreditation from AAHRPP
We are pleased to announce that the University of Utah Human Research Protection Program (HRPP) was awarded full reaccreditation by AAHRPP.
IRB Updates
The IRB will no longer require that the FDA Form 1572 be provided with submissions for investigational drug studies and the IRB will no longer consider new risks reported in updated IBs as possible unanticipated problems according to the IRB’s reporting policy.
ERICA Updates
Effective Sunday, May 24, 2015, the ERICA system has been updated.
Interim Policy on Institutional Conflicts of Interest (ICOI) Rule
The University of Utah has implemented an interim rule for addressing institutional conflicts of interest, effective May 1, 2015.
Revised VA Consent and Authorization Templates
The VA Consent and Authorization Templates have been updated in accordance with the November 12, 2014 version of VHA Handbook 1200.05.
IRB Staff Changes
We are pleased to welcome a new Coordinator to the IRB.
Forms for Conducting Research at the VA
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.
Use of External Research Nurses
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.
IRB Staff Changes
We are pleased to welcome a new Coordinator to the IRB.
IRB Staff Changes
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.
Additional Exemption Categories
The IRB is introducing Exemption Categories 8-11 as additional non-federal categories.
VA Application and Administrative Review in ERICA
The VA administrative review has been incorporated into ERICA's new study review process.
Revised Consent and Parental Permission Templates
The IRB has updated a number of consent and parental permission document templates.
Changes to Tissue Banking Policy
Due to changes in HIPAA regulation released in March 2013, participation in the tissue bank must be optional for treatment/intervention trials.
Completing the Sponsor Section in ERICA
The IRB has reviewed studies where the sponsor section of the application is blank, even when the study has a sponsor.
Changes to Exempt Research Policy
This policy change proposes one additional non-federal exemption category, and outlines the new Exemption
IRB Updates
Effective Monday, April 29, 2013, the ERICA system will be updated.
New IRB Coordinators
The IRB is pleased to announce two new Coordinators have been selected!
IRB Staff Changes
There will be several IRB staff changes in the coming weeks.
Increasing Fees for Industry-Sponsored Studies
The IRB fee schedule for industry sponsored studies is changing.
IRB Updates
Effective Monday, June 18, 2012, the ERICA system was updated.
FDA Inspection of the IRB
The IRB was inspected by the FDA May 14 through May 18.
Protocol Summary Integration: FAQ
The IRB is continually monitoring the progress of the recent protocol summary integration update in ERICA as study teams complete new studies, amendments, and continuing reviews. We feel that the process is working smoothly as we address questions and concerns.
IRB Website Updates
The University of Utah Institutional Review Board is excited to announce that the IRB website has been updated.
ERICA System Offline
The ERICA system will be offline starting Friday, 1/20 at 12:00 PM until Monday, 1/23. Beginning 1/23/2012.
Protocol/Research Summary Forms
The IRB recently announced that the information collected in the Protocol/Research Summary forms is being integrated into the ERICA new study application.
