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Institutional Reporting Procedures

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◀ Back SOP 905: Institutional Reporting Procedures document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_262’);});Edit Version: I1619 Policy Procedures POLICY It is the policy of the University of Utah IRB to comply with all applicable local, state, and federal regulations in the conduct of research studies and to communicate certain actions to entities that may have an interest in the status of […]

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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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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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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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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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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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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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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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Unanticipated Problems Involving Risks to Participants and Others

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◀ Back SOP 901: Unanticipated Problems Involving Risks to Participants and Others document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_161’);});Edit Version: G1224 Purpose Scope Definition Policy Procedures PURPOSE This SOP outlines the requirements for reporting of events at the University of Utah. SCOPE This policy applies to human subject research conducted at the University of Utah. DEFINITIONS A related adverse event is […]

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Research Related Injury

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◀ Back SOP 803: Research Related Injury document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_160’);});Edit Version: E2125 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) ensures research participants are informed about compensation and treatment for any research-related injuries. SCOPE This policy applies to human subject research conducted at the University of Utah. This policy does not apply […]

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