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Implementation of the Final Rule

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◀ 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 […]

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Non-Federally Funded Research

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◀ 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 […]

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Management of IRB Personnel

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◀ 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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Training and Education

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◀ Back SOP 102: Training and Education document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_3’);});Edit Version: D2822 Purpose Scope Definition Policy Procedures PURPOSE Training of Institutional Review Board (IRB) staff and IRB members is critical to fulfilling its mandate to protect the rights and welfare of research subjects consistently throughout the University of Utah research community. The training and education of those […]

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Policies and Procedures Management

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◀ Back SOP 101: Policies and Procedures Management Edit Version: D2122 Purpose Scope Policy Procedures PURPOSE University of Utah Institutional Review Board (IRB) standard operating procedures (SOPs) provide a framework for the ethical and scientifically sound conduct of human research. This SOP outlines the University of Utah IRB practice for creating, publishing, and routine review […]

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Multimedia Recordings

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Multimedia Recordings Guidance Documents and References ⏴back to Guidance Series Multimedia Recordings Version: April 25, 2025 Guidance Using multimedia tools to record the image and/or voice of an individual creates a record that requires careful handling and storage, particularly if the content of media or the purpose of the research may be considered sensitive. These […]

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Deception & Debriefing

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Deception & Debriefing Guidance Documents and References Points to Consider ⏴back to Guidance Topics Deception & Debriefing Version: April 20, 2025 Guidance Deception is the intentional misleading of participants or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, […]

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Basic Physiological Research

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Basic Physiological Research Guidance Documents and References Points to Consider ⏴back to Guidance Series Basic Physiological Research Version: April 14, 2025 Guidance The Food and Drug Administration (FDA) is responsible for regulating devices for human use including Investigational Device Exemptions (IDE). An IDE allows an investigational device (i.e., a device that is the subject of […]

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Sponsor-Investigator Guidelines and Responsibilities

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Sponsor-Investigator Guidelines and Responsibilities Guidance Documents and References ⏴back to Guidance Series Sponsor-Investigator Guidelines and Responsibilities Version: April 9, 2025 Guidance A sponsor-investigator is an individual who both initiates and conducts a clinical investigation. The sponsor-investigator may conduct the research alone or with others. Investigators who conduct studies involving an FDA test article and for […]

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OQC Tip of the Month: Documenting the Consent Process

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The Office of Quality Compliance sends a “Tip of the Month” directly to your email! Learn more and subscribe by going to their website at: https://qualitycompliance.research.utah.edu/tip-of-the-month.php. This month’s tip: The informed consent process must be documented in the research record. The note should include the following details: Informed Consent Form (ICF) obtained voluntarily Participant consented […]

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