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 […]
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 MoreBack SOP 302: Administrative Review and Distribution of Materials document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_128’);});Edit Version: B1624 Purpose Scope Policy Procedures PURPOSE The efficiency and effectiveness of the University of Utah Institutional Review Board (IRB) must be supported by administrative procedures that ensure that University of Utah IRB members have adequate time for thorough assessment of each proposed study, and […]
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 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 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 […]
Read MoreNeonates Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Neonates Version: September 3, 2025 Definitions Subpart B: Subpart B is found in 45 CFR 46 (DHHS) and includes additional protections for neonates involved in research (45 CFR 46.205). Neonate: Newborns from the time of delivery up until 28 days old. Nonviable […]
Read MoreSpanish-Speaking Individuals in Research Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics Spanish-Speaking Individuals in Research Version: September 2, 2025 Definitions Interpretation is the spoken exchange of communication between two languages. A certified interpreter is an individual who has passed a certification exam given by an accredited entity to […]
Read MoreWards of State Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Wards of State Version: August 6, 2025 Introduction Federal regulations require additional safeguards for certain categories of research involving wards of the state. These protections are outlined in Subpart D of 45 CFR 46 (Additional Safeguards for Children Involved […]
Read MoreThe Clinical Research Support Office is aware of escalating fraudulent activity impacting participant debit cards and the significant burden this could place on your participants to submit fraud claims to the Hyperwallet Visa team. It is unacceptable that some participants are receiving cards with depleted funds due to this activity. We understand that replacement cards […]
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