January 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.
Read MoreOctober 17th, 2022 We are pleased to announce that April Edwards has accepted the position as the new IRB Operations Manager. April will have primary responsibilities for reliance activities, as well as leadership of the IRB Coordinator team. We look forward to having her on the manager team. If you have questions, please Contact Us.
Read MoreSafety Monitoring Plans Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Safety Monitoring Plans Version: September 29, 2022 Definitions Safety Monitoring: The observations required to minimize threats to the safety and welfare of research subjects (White 2007). Federal Research Regulations and University of Utah IRB Policy The Common Rule and FDA […]
Read MoreData Monitoring Plans Definitions Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Data Monitoring Plans Version: September 29, 2022 Definitions Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adherence to the approved investigative plan and the validity of data collected (White 2007). Federal […]
Read MoreSeptember 22nd, 2022 We are pleased to announce that Annie Risenmay has accepted the position as the new IRB Associate Director. If you have questions, please Contact Us.
Read MoreAugust 29th, 2022 Please join us in welcoming Miguel Nieto-Palma’s to the IRB staff team! Miguel will be joining our Coordinator Team. Welcome to the IRB! If you have questions, please Contact Us.
Read More