The University of Utah IRB has worked very hard over the past 18 months to improve the review process. Many of you have received feedback from the staff prior to review by the board. Such a process has enabled more complete information to be presented to the board and resulted in a shorter turn-around after […]
Read MoreNew HIPPA Consent and Authorization Templates The IRB released new consent and authorization templates March 14, 2007. New study applications submitted after March 19, 2007, must follow the template requirements. For studies with approved consent documents, these updates should be made at the time of continuing review. Please review the updates as outlined below and […]
Read MoreResume/CV: As you may know, the IRB requires the CV (or resume) of the principal investigator and faculty sponsor (if applicable) as part of the application. Instead of requiring this for each submission, ERICA will now keep the CV with the investigator’s profile. For investigators who already attached a CV in the system, it will now […]
Read MoreInvestigators, past or prospective participants or their designated representatives, and others who wish to obtain answers to questions, express concerns, and convey suggestions, or provide input regarding the Human Research Protection Program may contact the Research Integrity and Compliance Office by calling (801) 581-7170. This office is independent of the IRB and unaffiliated with any […]
Read MoreThe IRB will no longer electronically stamp the protocol/research summary or advertisements. These materials will still be ‘approved’ by the IRB but the electronic stamp will not be used. Consent forms and Questionnaire Cover Letters will still be stamped, although the look will be different. Please review the Frequently Asked Questions document regarding electronic stamps […]
Read MoreThe Clinical Cancer Investigations Committee (CCIC) November and December meeting dates and deadlines have changed: New November Deadline: November 10th at noon New December Deadline: December 15th at noon
Read MoreA number of revised templates and resources have been posted on the IRB web site. Protocol Summary Template New Protocol Summary. Instructions have been updated. (NOTE: As of 1/16/2012, protocol summary now writes itself. Information pertaining to the link no longer applies.) Study Procedures Section: Standard of care vs. research related procedures should be described if applicable. […]
Read MoreThe Tissue/Specimen Banking guidelines and checkboxes have been revised to make it clear that participants who elect to de-identify their samples waive the right to withdraw consent for future research because the samples can longer be linked to them. Consent forms with tissue banking language must be updated at the time of continuing review / […]
Read MoreNovember and December IRB deadlines/meeting dates have changed. Please review the new deadlines and meeting dates. Laurel Hermanson, IRB Coordinator for Panel Two, has transitioned to a part-time role. Lisa Rigtrup, IRB Coordinator, will join the office September 14.
Read MoreWhen submitting amendments (or applications for continuing review that include an amendment) that update the Investigator’s Brochure (IB) to include new risks, please remember to update the Investigational Drug Data Form (IDDF). This can be done using the ‘Update Study’ ERICA process after completing the amendment application. The IDDF is an important tool used as […]
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