November 5th, 2014 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. VA IRB Documentation of Waiver of HIPAA Authorization for Research: Required at new study review for studies requesting a waiver of authorization. Also required at amendment review if the amendment […]
Read MoreAugust 13th, 2014 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. The external research nurses would report to the local site PI in order to conduct procedures with locally enrolled participants. In these […]
Read MoreAugust 11th, 2014 We are delighted to announce that Lacy Clegg has been selected as our newest IRB Administrator. Jessica Pilling will be taking her place as IRB Senior Coordinator, and we will be welcoming Heather Jewett as the new IRB Coordinator for Panel 3 on August 18th. Please see the Contact Us page for […]
Read MoreFebruary 26th, 2014 Yan “Kiki” Wai, IRB Coordinator for Panel 2, has left the IRB for an opportunity out of state. The IRB is grateful for her diligent service and we wish her the best of luck. Yan will be helping the IRB remotely with Continuing Review and Amendment pre-reviews as we train her replacement, […]
Read MoreIn September 2013, the IRB released Exemption Category 7 as a non-federal exemption category. As of February 3, 2014, the IRB is introducing Exemption Categories 8-11 as additional non-federal categories. These five categories were created based upon commonly accepted, minimal risk research practices All five non-federal exemption categories are available on the IRB website at: IGS Exempt Research In order […]
Read MoreThe VA administrative review has been incorporated into ERICA’s new study review process.
Read MoreThe 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 […]
Read MoreThe 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 […]
Read MoreThe 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 […]
Read MoreSeptember 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 […]
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