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Tag: SOPs

Administrative Review and Distribution of Materials

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Back 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 […]

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September 17, 2025

Exception from Informed Consent for Planned Research in Emergency Settings

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◀ 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, […]

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July 18, 2025

Institutional Reporting Procedures

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◀ 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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June 27, 2025

HRPP and Non-Compliance

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◀ Back SOP 903: HRPP and Non-Compliance document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_168’);});Edit Version: A2725 Purpose Scope Definition Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) addresses both allegations and confirmed reports of non-compliance as outlined in this policy. For VA research, the VHA Handbook 1058.01: Research Compliance Reporting Requirements is followed. SCOPE This policy applies to […]

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June 27, 2025

Institutional Review Board (IRB) Community Outreach

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◀ Back SOP 909: Institutional Review Board (IRB) Community Outreach document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_167’);});Edit Version: G1724 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) may conduct community outreach activities with the goal of enhancing the understanding of research involving participants in the community. SCOPE This policy applies to the University of Utah IRB. […]

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June 27, 2025

Routine and For-Cause Audits

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◀ Back SOP 908: Routine and For-Cause Audits document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_166’);});Edit Version: F0925 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) conducts routine and for-cause audits using systematic methods to evaluate compliance with federal regulations, state and local laws, and University of Utah policies and procedures, and to verify that research is […]

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June 27, 2025

Research Complaints and Concerns

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◀ Back SOP 907: Research Complaints and Concerns document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_165’);});Edit Version: K1123 Purpose Scope Policy Procedures PURPOSE The University of Utah IRB is committed to the protection of research participants. Research participants are encouraged to express any concerns or complaints regarding the involvement in a research study. SCOPE This policy applies to human subject research conducted […]

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June 27, 2025

Protection of Research Participants

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◀ Back SOP 906: Protection of Research Participants document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_164’);});Edit Version: G1724 Purpose Scope Policy Procedures PURPOSE This SOP outlines the steps taken by the University of Utah Institutional Review Board (IRB) to protect the rights and welfare of participants in research following the implementation of an administrative hold, suspension, or termination of that research. SCOPE […]

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June 27, 2025

Administrative Hold, Suspension and Termination of Approved Research

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◀ Back SOP 904: Administrative Hold, Suspension and Termination of Approved Research document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_163’);});Edit Version: A3124 Purpose Scope Definition Policy Procedures PURPOSE This policy outlines the procedures for the University of Utah Institutional Review Board (IRB) to suspend or terminate research. SCOPE This policy applies to research reviewed and approved by the University of Utah IRB […]

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June 27, 2025

Deviations

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◀ Back SOP 902: Deviations document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_162’);});Edit Version: G1724 Purpose Scope Definition Policy Procedures PURPOSE This SOP outlines the requirement for reporting of deviations at the University of Utah. SCOPE This policy applies to human subject research conducted at the University of Utah. DEFINITIONS Responsible Investigator (RI) is the individual who is the principal investigator and […]

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June 27, 2025