Expedited Category 8(a) Decision Chart Guidance Documents and References Footnotes ⏴back to Board Member Guidance Series Board Member Guidance Series Version: April 3, 2025 Guidance Allowing the research to be reviewed using expedited review procedures under category 8(a)1 requires a clear understanding of the status of the study. If in doubt, ask for more details […]
Read MorePregnancy Testing Prior to Radiation Exposure for Research Purposes Guidance Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 27, 2025 Guidance The IRB is responsible for considering the risks of radiation exposure for women who are pregnant and participate in research. The IRB may choose to allow a […]
Read MoreEquitable Selection of Participants Guidance Documents and References Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 26, 2025 Guidance The concept of justice is one of the fundamental ethical principles in the Belmont Report. It is described as the idea that “equals ought to be treated equally,” with […]
Read MoreWriting a Review Summary Introduction Guidance Documents and References ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 19, 2025 Introduction The board reviewer checklist asks specific questions about the requirements that need to be satisfied for approval. Addressing the criteria for approval is particularly important in both the written review and […]
Read MoreWaivers of Consent for Research with Prospective Data Collection Guidance Documents and References Appendices Footnotes ⏴back to Board Member Guidance Series Board Member Guidance Series Version: July 18, 2024 Guidance The University of Utah IRB routinely grants waivers of consent for retrospective chart review and secondary data analysis studies. Investigators occasionally request waivers of consent […]
Read MoreGuidance Footnotes ⏴back to Board Member Guidance Series Version: February 16, 2024 Guidance The University of Utah IRB seeks assistance from the University’s Office of General Counsel when assessing the applicability and requirements of federal and state law. Additionally, the Office of General Counsel helps resolve conflicts between federal, state, and other applicable laws. Assistance […]
Read MoreEthical Considerations for Surrogate Consent Definitions Guidance Documents and References Footnotes ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 16, 2024 Definitions Assent: Assent is a term used to express willingness to participate in research who are too young to give informed consent or do not have the decision-making capacity to […]
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 MoreSIRB Site-Control Review Instructions Guidance ⏴back to Board Member Guidance Series Board Member Guidance Series 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 in order to […]
Read MoreWriting a Review Summary – Facilitated Review of Community Consultation Plans for Studies Using an Exception from Informed Consent (EFIC) Introduction Guidance Documents and References ⏴back to Board Member Guidance Board Member Guidance Series Version: October 8, 2020 Introduction When the University of Utah defers to an external single IRB (SIRB) for the review and […]
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