IRB Updates The Utah Population Database was recently determined to be outside of the University of Utah Covered Entity. This means that for studies using the UPDB, new HIPAA requirements and privacy and confidentiality protections may be applicable, depending on (a) the location of the study (i.e. Inside or outside the covered entity), as well […]
Read MoreInternet Recruitment and Advertising The IRB has revised the Recruitment Methods and Advertisements document in the Investigator Guidance Series to include guidance on internet advertising. This document may be accessed using the following link: (www.research.utah.edu/irb/guidelines/pdf/IGS/IGS-Advertisements.pdf) The following information has been added to the guidance: Internet Advertising Advertisements posted on the internet must adhere to the […]
Read MoreNational AWARE for ALL Program Event This is an announcement for the National AWARE for All: Clinical Research Education Day for the Public. Registration for this program is free and open to the public. We do ask however, that you register as soon as possible, so that we may plan for the right number of […]
Read MoreIRB Updates The IRB has received record submissions in 2009 and 2010 due to the increase in human subject research being conducted at the University of Utah. As a result, the IRB has worked diligently to improve our processes to ensure that the review and approval of research is thorough as well as efficient. The […]
Read MoreA 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 […]
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