Exempt 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 […]
Read MoreThe NIH and HIPAA have guidance and regulations regarding mandatory future use of biospecimens and/or data collected in research that offers treatment/intervention to participants. NIH guidance focuses on ethical considerations, voluntariness, undue influence, and coercion of mandatory contribution of data/biospecimens for future use. HIPAA regulation defines access to and use of PHI in “conditional” […]
Read MoreTo support thorough risk assessment, the IRB is now asking study teams to upload any questionnaires or surveys (including validated surveys) used in studies under the Surveys, Questionnaires, Etc. section of the Documents & Attachments page in their IRB application. This helps the IRB evaluate the nature of questions participants are asked, especially when these […]
Read More◀ Back SOP 508: Exception from Informed Consent for Planned Research in Emergency Settings document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_1822’);});Edit Version: F2625 Purpose Scope Policy Procedures Notes PURPOSE The exception from informed consent for planned research in emergency settings SCOPE This policy applies to planned research in emergency settings. This policy does not cover emergency use of a test article, […]
Read MoreWe are thrilled to announce the promotion of Hannah Owen to the role of IRB Associate Director. Hannah demonstrates exceptional leadership, deep expertise in research ethics, and a steadfast commitment to protecting the rights and welfare of research participants. We are excited for her collaborative spirit, strategic thinking, and dedication to excellence to continue making […]
Read More◀ Back SOP 905: Institutional Reporting Procedures document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_262’);});Edit Version: G0925 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) is committed to complying with all applicable local, state, and federal regulations in the conduct of research studies. The IRB will communicate specific actions to relevant entities that may have an interest […]
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