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 […]
Read MoreExpanded 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 […]
Read MoreAt-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 […]
Read MoreSecondary 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 […]
Read MoreEmergency 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 […]
Read MoreNon-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 […]
Read MoreHumanitarian 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 […]
Read MoreHIPAA Privacy Rule & Authorization Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics HIPAA Privacy Rule & Authorization Version: September 16, 2025 Definitions Breach: The term breach means the unauthorized acquisition, access, use, or disclosure of protected health information (PHI) which compromises the security or privacy of such information, […]
Read MorePrivacy and Confidentiality Guidance Points to Consider ⏴back to Guidance Topics Privacy and Confidentiality Version: September 16, 2025 Guidance When thinking about privacy and confidentiality in the research context, distinctions should be made between the two issues. Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy can be […]
Read MoreExempt Research: Guided Exemption Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Exempt Research: Guided Exemption Version: September 3, 2025 Introduction Exempt research is no greater than minimal risk and fits within an exemption category. Exemption determinations are made by a designated IRB reviewer. In limited circumstances, investigators may obtain an […]
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