Transitioning to the Final Common Rule Introduction Guidance Documents and References ⏴back to Guidance Topics Transitioning to the Final Common Rule Version: April 6, 2022 Introduction The federal government changed the Common Rule (45 CFR 46) that governs human subjects research, with an effective date of January 21, 2019. Studies initiated before January 21, 2019, […]
Read MoreFebruary 16th, 2022 Please join us in welcoming Shaina Jasenof and Elias Rios to the IRB staff team! Shaina and Elias will be joining our Coordinator Team. Welcome to the IRB! If you have questions, please Contact Us.
Read MoreConcise Summary Guidance Documents and References ⏴back to Guidance Series Concise Summary Version: February 3, 2022 Guidance The revised “common rule” (effective January 21, 2019) requires that key information be included in the beginning of the informed consent in a concise and focused presentation. The University of Utah IRB refers to this as a “concise […]
Read MoreChildren Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Children Version: February 2, 2022 Definitions Subpart D: This term refers to the regulations which apply to research involving children as subjects. Subpart D is found in both 45 CFR 46 (DHHS) and 21 CFR 50 (FDA). Children: By regulatory definition, “children” […]
Read MoreJanuary 25th, 2022 Please join us in welcoming Katherine Frederickson to the IRB staff team! Katherine will be joining our Administrative Support Team and will be helping with our front desk phones, and managing CITI trainings and fee invoices. If you have questions, please Contact Us.
Read MoreDecember 13th, 2021 Please join us in congratulating Hannah Baley and Anthon Wood on their promotions to IRB Administrator! Hannah and Anthon will be joining our New Study Administrators Team. Congrats! Questions? If you have questions, please Contact Us.
Read MoreAugust 30th, 2021 Please join us in welcoming Heather Brown to the IRB staff team! Heather will be joining our Quality & Compliance Team. Welcome, Heather! If you have questions, please Contact Us.
Read MoreAnnual HRPP Progress Updates The IRB and Human Research Protection Program (HRPP) have initiated a new requirement for Annual HRPP Progress Updates in the ERICA system. The purpose of the Annual HRPP Progress Update is to receive study status information for studies that do not require the traditional continuing review. This means that all active,open studies […]
Read MoreRegulatory References – Consent Language for Future Use of Information or Biospecimens Introduction Definitions Guidance ⏴back to Guidance Series Regulatory References – Consent Language for Future Use of Information or Biospecimens Version: July 16, 2021 Introduction Prior to the implementation of the revised Common Rule (effective date January 21, 2019), the University of Utah policy […]
Read MoreJune 17th, 2021 We are excited to announce that beginning July 1st, Dr. Mark Eliason, Dr. Dick Lemons, and Dr. Ruth Gerritsen-McKane will begin their service as Chairs of the IRB. Together with our Vice Chairs and IRB management staff, the IRB Executive Committee will be exploring several exciting initiatives as we move into FY […]
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