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IRB Update: Guidance Document Changes, January-April 2018

May 10th, 2018

The University of Utah IRB continually strives to provide information and training to the research community. Additionally, we regularly review our guidance documents to make updates as necessary. This e-mail is intended to give a summary of updates that were made and posted during January-April of 2018.  It may also be helpful to the research community to have a better understanding of research topics. Below, you will find a brief description of the updates. You can find the revised documents by clicking on the link or on this page: https://irb.utah.edu/guidelines/investigator.php. You can also find tracked versions of updated documents.

Investigator Guidance Series: Compensation of Research Subjects (version 2/16/18)

This document describes the guidelines for participant compensation. A section was added to describe considerations for compensation to participants in FDA regulated clinical trials. Additionally, this guidance was updated to align with current VA policy regarding compensation to participants in VA research. Finally, additional description was added regarding Accounts Payable policy for research participant compensation.

Investigator Guidance Series: Pregnancy During Research Participation (version 3/5/18)

This document describes follow-up guidelines for participant, pregnant partner, and newborn; monitoring pregnancy occurrences; and reporting guidelines should pregnancy occur during research participation. This document made minor updates to more clearly describe the process for investigators to outline the monitoring of pregnancy during research participation.

Investigator Guidance Series: Research Involving Pregnant Women and Fetuses (version 3/5/18)

This IGS focuses on Subpart B and the additional protections for the inclusion of pregnant women and fetuses in research (approvable categories of research and additional considerations); a section about incidental partner pregnancy; research on dead fetuses or fetal material; and additional VA considerations for research on pregnant women. This document was updated to include a reference to the IGS: Pregnancy During Research Participation.

Board Member Guidance Series: Biopsies for Research Purposes (version 05/01/18)

This document is useful guidance for board members in making determinations. The document was updated to include clarifications such as research biopsies must only be obtained after clinical biopsies have been obtained.

All of the IRB's guidance documents can be found on the Investigator Guidance Series (IGS) page (https://irb.utah.edu/guidelines/investigator.php) and the A-Z Index (https://irb.utah.edu/a-z.php). 

  • GCP Training Requirements

    Effective January 1, 2017, the University of Utah IRB requires clinical investigators and staff listed on an IRB application funded by the NIH to have both human subjects training and GCP training before an IRB application will be approved.

  • IRB Staff Telephone Availability Interruption

    The IRB office is currently undergoing construction. Several of our staff members have moved to temporary accommodations away from their desks and usual telephones while the remodel is under way.

  • IRB Staff Changes

    Please join us in welcoming our new Panel 4 Coordinator.

  • Delayed Pre-Review Timelines

    Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.

  • IRB Staff Changes

    We are excited to welcome a new Administrator to the IRB.

  • IRB Staff Changes

    We are happy to welcome a new IRB Coordinator. We are also pleased to announce that Jessica Loayza has joined the Administrator team.

  • Delayed Pre-Review Timelines

    Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.

  • IRB Staff Changes

    We have added two new positions to the IRB.

  • IRB Staff Changes

    We are pleased to welcome a new Coordinator to the IRB.

  • IRB Staff Changes

    We are happy to welcome a new IRB Administrator to the New Study pre-review team.

  • IRB Updates

    Due to F&A increase to 36.5%, the IRB fee schedule is changing for industry-sponsored new studies, continuing reviews, and amendments. The new IRB fee schedule will be effective on July 1, 2016.

  • IRB Staff Changes

    Please join us in welcoming our new IRB Clerk.

  • RDRC-HUS Workflow for Amendments

    Effective 5/1/2016, the RDRC-HUS will now review all amendments related to radiation use within the ERICA system.

  • IRB Staff Changes

    Please join us in welcoming our newest IRB Administrator.

  • IRB Updates

    All studies conducted at Shriners Hospitals for Children in Salt Lake City are now required to obtain approval from Shriners Hospital leadership before the IRB will issue final approval of the study.

  • Institutional Conflict of Interest Policy

    Beginning January 15, 2016, the conflict of interest review process for all New Study applications will include a review for Institutional Conflicts of Interest (ICoI).

Last Updated: 5/10/18