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Modernizing Biosafety (IBC) Regulations

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Modernizing Biosafety (IBC) Regulations On September 9, the NIH announced plans to modernize their biosafety regulatory framework. You can see details here: https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight and here: https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy/#tab2/ The NIH has indicated the new regulations will align with risk, lower regulatory burden for low-risk research, expand oversight beyond work with recombinant and synthetic nucleic acids, and empower IBCs. […]

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October 30, 2025

Upcoming Holidays and the IRB

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Please plan for a little extra time during the upcoming holiday season for application approvals, as some of our meetings will be canceled; see schedule below. November 26, 2025 (day before Thanksgiving): Regular IRB board meeting December 24, 2025 (Christmas Eve): Canceled board meeting December 31, 2025 (New Year’s Eve): Canceled board meeting January 7, […]

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October 30, 2025

New IRB Guidance, MRI Risk Language

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New IRB Guidance We are excited to share two new guidance pages designed to help you understand when IRB review is required and when a project may be Non-Human Subjects Research (NHSR). These resources provide more information about projects that may not need to be reviewed by the IRB. These resources intended to provide you […]

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October 30, 2025

Legally Authorized Representative (LAR) and Surrogate Consent

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Legally Authorized Representative (LAR) and Surrogate Consent Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics Legally Authorized Representative (LAR) and Surrogate Consent Version: October 30, 2025 Definitions Assent: Assent is a term used to express willingness to participate in research who are too young to give informed consent or […]

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October 30, 2025

At-a-Glance: Is IRB Review Required?

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At-a-Glance: Is IRB Review Required? Guidance ⏴back to Guidance Topics At-a-Glance: Is IRB Review Required? Version: October 14, 2025 Guidance This guidance is an at-a-glance guide to assist researchers in understanding submission requirements for research or non-research activities. Activity Description IRB Submission? Case Reports (Medical) The University of Utah IRB does not require review of […]

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October 14, 2025

Expanded Access of Drugs and Devices

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Expanded Access of Drugs and Devices Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Expanded Access of Drugs and Devices Version: October 14, 2025 Introduction The Food and Drug Administration’s (FDA) Expanded Access Program offers a potential pathway for patients with serious or immediately life-threatening diseases or conditions to gain access […]

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October 14, 2025

Secondary Analysis of Public Use Datasets

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Secondary Analysis of Public Use Datasets Introduction Guidance ⏴back to Guidance Topics Secondary Analysis of Public Use Datasets Version: October 10, 2025 Introduction Secondary analysis of publicly available data is a common method of research. One of the main sources of such data is the federal government (e.g., Bureau of Labor Statistics). Increasingly, federal agencies […]

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October 10, 2025

Emergency Use of a Test Article

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Emergency Use of a Test Article Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Emergency Use of a Test Article Version: October 8, 2025 Introduction The Food and Drug Association (FDA) regulates use of all investigational drugs and devices, including emergency use. The IRB must be notified of all emergency […]

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October 8, 2025

Non-Human Subject Research (NHSR)

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Non-Human Subject Research (NHSR) Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Non-Human Subject Research (NHSR) Version: September 25, 2025 Definitions Clinical Investigation: The Food and Drug Administration (FDA) defines clinical investigations as: a) use of a drug other than the use of an approved drug in the course of medical […]

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September 25, 2025

Humanitarian Use Devices (HUD)

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Humanitarian Use Devices (HUD) Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Humanitarian Use Devices (HUD) Version: September 23, 2025 Introduction A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 8,000 individuals in the United States […]

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September 23, 2025