u0028378 – Page 17 – Institutional Review Board

Revised Consent and Parental Permission Templates

The IRB has updated the following consent and parental permission templates; clean and tracked copies are available at IRB Forms: Consent Document Consent and Authorization Document Consent and Authorization Document for Minimal Risk Research Consent and Authorization Cover Letter Consent and Release of Information Authorization Document – Pregnancy Follow-up Parental Permission Document Parental Permission and Authorization Document Parental Permission and Authorization Document for […]

October 28, 2013

Changes to Tissue Banking Policy

Categories: News Archive

The IRB requires investigators to indicate in the consent document whether or not it is mandatory to participate in a tissue bank if the participant wants to be in another larger or primary study. Some studies require participation in the tissue bank as a condition of participation and this must be stated in the consent […]

September 13, 2013

Completing the Sponsor Section in ERICA

Categories: News Archive

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 […]

September 9, 2013

Policy Changes for Exempt Research

Categories: News Archive

September 4th, 2013 The Department of Health and Human Services has identified categories of research involving human subjects that qualify for exemption from certain federal regulations applicable to research. At the University of Utah, the IRB makes federal exemption determinations according to 45 CFR 46.101. This policy change proposes one additional non-federal exemption category, which may be […]

September 4, 2013

IRB Updates

Categories: News Archive

April 25th, 2013 Effective Monday, April 29, 2013, the ERICA system will be updated. For a full summary of these changes, please see the attached document. IRB Updates Summary – April 29 2013

April 25, 2013

New IRB Coordinators

Categories: News Archive

February 19th, 2013 The IRB is pleased to announce that Hannah Owen has been selected as the new IRB Coordinator for Panel 1, and Beth Mauchley has been selected as the new IRB Coordinator for Panel 6. Hannah’s first day is today, and Beth begins on February 25th. Please join us in welcoming them to the […]

February 19, 2013

IRB Staff Changes

Categories: News Archive

February 11th, 2013 Blair Murdock, IRB Coordinator for Panel 1, will be leaving the IRB for an opportunity out of state. His last day will be February 13th. The IRB is grateful for his long-time service and wishes him and his family the best. Annie Risenmay is also moving out of state at the end […]

February 11, 2013

Increasing Fees for Industry-Sponsored Studies

Categories: News Archive

September 11, 2012 The IRB fee schedule for industry sponsored studies is changing. Fee increases for all types of applications will go into effect on November 1, 2012. All industry sponsored studies originally submitted to the IRB prior to November 1, 2012 will be charged according to the previous fee schedule for the duration of […]

September 11, 2012

IRB Updates

Categories: News Archive

June 18, 2012 Effective Monday, June 18, 2012, the ERICA system was updated. This update includes changes to the IRB amendment application, IRB letters, IRB new study application, and other minor changes. For a full summary of these changes, please see the attached document. Thank you.

June 18, 2012

FDA Inspection of the IRB

Categories: News Archive

May 30, 2012 Dear Researchers, The IRB was inspected by the FDA May 14 through May 18. The inspector informed us that she discovered no actionable items. This is our third FDA inspection in the last decade with no findings. We feel this demonstrates the University’s strong commitment to protect the rights and welfare of […]

May 30, 2012