Spanish is the second-most common language spoken in the state of Utah. Approximately 10 percent of people in the state of Utah and 14 percent of people in Salt Lake County speak Spanish at home. Currently, the University of Utah IRB requires the inclusion of Spanish-speaking individuals in research on a case-by-case basis. At the […]
Read MoreDrug Studies – Investigator Responsibilities Introduction Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Drug Studies – Investigator Responsibilities Version: February 22, 2023 Introduction Federal Research Regulations The FDA is responsible for regulating drugs for human use. Investigators conducting clinical trials involving drugs have specific responsibilities outlined in 21 CFR 312, […]
Read MoreDevice Studies – Investigator Responsibilities Introduction Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Device Studies – Investigator Responsibilities Version: February 22, 2023 Introduction Federal Research Regulations The FDA is responsible for regulating devices for human use. Investigators conducting clinical trials involving devices have specific responsibilities outlined in 21 CFR 812. […]
Read MoreExpedited Review of Research Guidance Appendices Footnotes ⏴back to Guidance Topics Expedited Review of Research Version: February 21, 2023 Guidance Research activities may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. All the following must be true in order for the application to be […]
Read MoreIn October 2022, the University of Utah IRB approved a policy change which allowed the IRB to grant general approval of a standard short form document. This change was intended to streamline the procedure for approval of short form documents and relieve administrative burden. When is a short form used? The short form consent process is a […]
Read MoreJanuary 3rd, 2023 Please join us in welcoming Lindsey Martineau, Shellie Cunningham, and Meg Rasmussen to the IRB staff! Lindsey will be joining our Administrator Team, and Shellie and Meg are joining our Coordinator Team. Welcome to the IRB, Lindsey, Shellie, and Meg! If you have questions, please Contact Us.
Read MoreDecember 21st, 2022 Beginning in August of 2021, studies without an expiration date were required to submit a Human Research Protection Program (HRPP) Progress Update in the ERICA system. HRPP Progress Updates are due before the annual anniversary date of the study’s initial approval or exemption determination from the ERICA system. An HRPP Progress Update submission is […]
Read MoreShort Forms Consent Process Instructions For Use Guidance ⏴back to Guidance Series Short Forms Consent Process Instructions For Use Version: December 13, 2022 Guidance The IRB may approve an oral consent process (see 45 CFR 46.117(b)(2), and 21 CFR 50.27(b)(2), for FDA regulated research). This process requires that the IRB review and approve: A written […]
Read MoreDecember 1st, 2022 We are pleased to announce that Militza Martinez has accepted our offer to join the Administrator team. Militza has been with the IRB for many years and we are looking forward to adding her experience and expertise to the Administrator team! If you have questions, please Contact Us.
Read MoreNovember 29nd, 2022 We are pleased to announce that Isabelle Howcroft has joined the IRB as the new IRB Clerk. Please join us in welcoming her to the team! If you have questions, please Contact Us.
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