Human Tissue Transfer Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Human Tissue Transfer Version: August 9, 2022 Definitions Human Tissues means any biological product or byproduct obtained from a living or deceased individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties. […]
Read MoreInvestigators and Key Study Personnel Guidance Documents and References Points to Consider ⏴back to Guidance Topics Investigators and Key Study Personnel Version: July 8, 2022 Guidance Investigators and key study personnel conducting research at the University of Utah should be listed on the ERICA application and must complete required human subject research training. This guidance […]
Read MoreTransitioning 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 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 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 MoreBiopsies For Research Purposes Guidance Documents and References ⏴back to Board Member Guidance Series Board Member Guidance Series Version: May 27, 2021 Guidance Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during […]
Read MorePregnancy During Research Participation Guidance Documents and References Points to Consider ⏴back to Guidance Series Pregnancy During Research Participation Version: April 28, 2021 Guidance For some research protocols, women of childbearing age are advised to avoid pregnancy or nursing for a time during or following the research to protect the health and safety of the […]
Read MoreGenetic Research Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Genetic Research Version: February 2, 2021 Introduction Information developed during genetic studies may vary considerably with respect to its impact and value to subjects. When using the following guidance, it is acknowledged that there are many ways of responding to […]
Read MoreSIRB Site-Control Review Instructions Guidance ⏴back to Board Member Guidance Board Member Guidance Series SIRB Site-Control Review Instructions Version: November 17, 2020 Guidance As a board reviewer, you may be asked to review an application for a Single IRB (SIRB) study that the site-control model. These instructions are intended to help board members navigate ERICA […]
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