A new IRB assent template is available on the IRB website: Assent form with HIPAA language Assent form for Main Campus This template was designed to better address assent needs for children and cognitively impaired adults. A new section has also been added to the assent template. The section includes a set of options at […]
Read MoreIRB Report Form Changes The report form has been reorganized, allowing the following features beginning 2.06.2010: All report form types (e.g. adverse events, deviations, breaches, information, etc.) can now be selected on the first page of the report form, instead of on multiple pages. The report form now includes a Documents and Attachments page for […]
Read MorePlease note that due to a greater than usual amount of applications submitted in recent weeks, and due to the holiday schedule, we are unable to guarantee that your submission will be reviewed at a particular meeting. Applications will generally be assigned to a meeting date based on date of expiration, expertise available on the […]
Read MoreThe IRB recently lost an important member of the staff. Jeanette Cuthbert has left us. We would like to thank Jeanette for the many years of service she has provided, not only to us, but also to all of you. We hope the future holds many wonderful things for her. In her place, the IRB […]
Read MoreHHS & FDA Institutional Review Board Registration Requirements On July 14, 2009, the new Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations requiring registration of institutional review boards (IRBs) that were published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358) will go […]
Read MoreThe IRB has recently received an increased volume of submissions, with nearly double the amount of reviews for the meetings in May. Due to the number of submissions that require review, some IRB applications will be bumped back 1 – 2 board meetings. The IRB is assigning studies according to the following guidelines and […]
Read MoreThe IRB has updated the Tissue Banking Consent Language Template. The new version can be found on the IRB website. This new template should be used by all investigators when writing consent documents that involve the collection of tissues for storage in a tissue repository, whether the repository is housed at the University of Utah or at […]
Read MoreRGE Application in ERICA Beginning Sunday, March 29th, users who are requesting permission to use the Utah Population Database (UPDB) will be required to submit an application to RGE via the ERICA system. The RGE application has been incorporated into the IRB New Study Application and users will be prompted to complete the RGE application […]
Read MoreProtocol and Research Summary Template Changes The IRB has posted new versions of the Protocol and Research Summary templates. Change 1: The title page of the Protocol and Research Summary templates now requests that contact information for the sponsor and CRO of a study be included. This will need to be revised for all applicable protocol […]
Read MoreJustification for Use of the Short Form When an informed consent process is conducted with an individual who does not speak English, participants should be presented with the consent document written in a language understandable to them. The IRB strongly encourages the use of this procedure whenever possible. However, the Short Form is often used […]
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