HHS & 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 […]
Read MoreWitness Signature Page The IRB has recently created a witness signature page. The witness signature page is intended to be used in unanticipated situations when a participant is able to give full consent for participation in a research study, however, a witness to the consent process is necessary. Such situations may include: The participant is […]
Read MoreDue to the increased number of study submissions and the Thanksgiving, Christmas, and New Year’s holidays, please expect delays in the IRB review process during the months of November, December, and January. Some IRB applications will be bumped back one board meeting, including continuing reviews, amendments, and new studies. Because of the holidays, changes have […]
Read MoreChanges have been made to the liability statement using the consent and parental permission forms for research conducted at Shriners Hospital for Children. The new statement is displayed below. Updated consent and parental permission templates are available on the IRB website. This statement must be updated in consent and parental permission forms at the time […]
Read MoreERICA will be offline all day on Saturday, August 30th and Sunday, August 31st for maintenance and the following updates to the IRB Report Form: In the opinion of the local Principal Investigator, was the event unexpected? In the opinion of the local Principal Investigator, was the event related to research? In the opinion of the local […]
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