HIPAA 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 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 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 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 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 More◀ Back SOP 104: IRB Authority and Signatory Authority document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_124’);});Edit Version: C0323 Purpose Scope Definition Policy PURPOSE This SOP outlines the specific authority granted to the University of Utah Institutional Review Board (IRB) to review, approve, and monitor research involving human subjects as a component of the Human Research Protection Program at the University of […]
Read More◀ Back SOP 106: Implementation of the Final Rule document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_6’);});Edit Version: G1024 Purpose Scope Definition Policy Procedures PURPOSE This policy describes the implementation of the Final Rule, or 2018 Common Rule, at the University of Utah. SCOPE This policy applies to the University of Utah Institutional Review Board (IRB) and human subject research conducted at […]
Read More◀ Back SOP 105: Non-Federally Funded Research document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_5’);});Edit Version: C0124 Purpose Scope Definition Policy PURPOSE The University of Utah Institutional Review Board (IRB) applies applicable U.S. federal regulations for protecting research participants when research is sponsored or supported by a federal agency. Generally, those same regulations are followed by the University of Utah IRB for […]
Read More◀ Back SOP 103: Management of IRB Personnel document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_4’);});Edit Version: D2922 Purpose Scope Definition Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) staff provides expertise, and administrative support to IRB panels. IRB staff is a link between the board members and the research community. The University of Utah IRB staff is a […]
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