Prisoners Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Prisoners Version: August 22, 2022 Definitions Subpart C: This term refers to the regulations which apply to research involving prisoners as subjects. Subpart C is found in 45 CFR 46 (DHHS). Prisoner: A prisoner means any individual involuntarily confined or detained in […]
Read MoreInternational Research Guidance Documents and References Points to Consider ⏴back to Guidance Series International Research Version: August 22, 2022 Guidance Investigators conducting international research must be qualified by training and experience to conduct such research. Investigators must design scientifically sound and culturally appropriate research that is relevant to the needs and conditions of the population […]
Read MoreEconomically or Educationally Disadvantaged Individuals Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Economically or Educationally Disadvantaged Individuals Version: August 11, 2022 Definitions Common Rule: The Federal Policy for Protection of Human Subjects found in HHS regulations in 45 CFR 46 includes four subparts. Subpart A is also known as the […]
Read MoreHuman 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 Series 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 MoreJune 16th, 2022 Please join us in welcoming Ryane Sorenson to the IRB staff team! Ryane will be joining our Administrator Team. Welcome to the IRB! If you have questions, please Contact Us.
Read MoreApril 19th, 2022 Please join us in welcoming Kali Persons to the IRB staff team! Kali will be joining our Coordinator Team. Welcome to the IRB! If you have questions, please Contact Us.
Read MoreThe 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 without an expiration date […]
Read MoreApril 18th, 2022 ERICA will be offline to support the U of U Health implementation of Oncore and Epic Research: Thursday, April 21 at 5:00 PM through Sunday, April 24th, 2022 Please plan your IRB submissions accordingly, and note that the ERICA system will also be unavailable to IRB staff and board members during this […]
Read MoreTransitioning to the Final Common Rule Introduction Guidance Documents and References ⏴back to Guidance Series 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, […]
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