As of July 1, 2008, the IRB will increase the fees charged to review for-profit sponsored research. This is the first increase since the fees were instituted in 2004 and is due in large part to the increase in F&A to 32.7%. IRB fees support a number of Research Administration operations including the ERICA system. […]
Read MoreThis announcement is in regards to the IRB policy regarding sponsor-investigators. A sponsor-investigator is someone who both initiates and actually conducts a clinical investigation. According to IRB policy, sponsor-investigators must provide documentation of an audit performed by a CRO or an ad-hoc qualified auditor before the initiation of the study to verify the sponsor-investigator meets […]
Read MoreThe ERICA renewal and amendment applications have been revised. Please read below for the updates: Amendment Application New questions have been added to this application and all amendments submitted after September 29th will be required to complete these questions. Amendments that are currently in process that have not been pre-reviewed by the IRB staff before […]
Read MoreDue to a large number of submissions and the July 4 holiday (Independence Day), there may be some delay in IRB review. We apologize for any inconvenience and hope to return to the regular review schedule as soon as possible.
Read MoreThe IRB review process is changing as of April 30, 2007. Pre-Review FAQ’s Tips to Submit a Complete Application New Pre-Review Deadlines New Study, Renewal, and Amendment applications will be assigned to the IRB staff for a pre-review. However, a board date will not be assigned to the study until any necessary pre-board revisions have […]
Read MoreThe University of Utah IRB has worked to improve the review process over the last 18-months in an effort to gain accreditation from the Association for Accreditation of Human Research Protection Programs (AAHRPP) and to address regulatory issues identified by the Office for Human Research Protection (OHRP). As the next step in this process, the […]
Read MoreThe 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 More