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Category: sops

Research Materials in Participants’ Medical Records

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◀ Back SOP 505: Research Materials in Participants’ Medical Records document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_149’);});Edit Version: E2521 Policy POLICY The IRB allows the placement of research materials—including informed consents; case report forms; laboratory, radiology, or other clinical reports; psychiatric records; surveys or questionnaires; or any other records generated from human subjects research—in research participants’ medical records for research conducted […]

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June 27, 2025

Genetic Research

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◀ Back SOP 503: Genetic Research document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_148’);});Edit Version: C1225 Purpose Scope Policy PURPOSE The University of Utah Institutional Review Board (IRB) requires that special consideration be given during the review of studies involving genetic research and information, given the potential predictive power of some genetic information, the familial nature of some genetic research and information, […]

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June 27, 2025

Clinical Research Involving Investigational Drugs and Devices

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◀ Back SOP 502: Clinical Research Involving Investigational Drugs and Devices document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_147’);});Edit Version: F2625 Purpose Scope Definition Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) requires investigators to submit a plan that ensures the proper use and management of investigational or unlicensed test articles. Humanitarian Use Devices (HUD) must also be reviewed […]

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June 27, 2025

Vulnerable Populations in Research

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◀ Back SOP 501: Vulnerable Populations in Research document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_146’);});Edit Version: C0819 Policy POLICY The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protections. When the IRB reviews research involving vulnerable populations, the IRB applies any additional federal regulations, VA requirements, state and local laws, as […]

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June 27, 2025

Appeal of IRB Decisions

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◀ Back SOP 410: Appeal of IRB Decisions document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_145’);});Edit Version: E1818 Policy Procedures POLICY The University of Utah IRB has the authority to a) approve research activity, b) specify modifications required to secure IRB approval of the research activity or c) disapprove any research activity overseen and/or conducted by the University of Utah. The IRB […]

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June 27, 2025

Alternative IRB Review Arrangements and Agreements

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◀ Back SOP 409: Alternative IRB Review Arrangements and Agreements document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_144’);});Edit Version: F2024 Purpose Scope Definition Policy PURPOSE The University of Utah Institutional Review Board (IRB) may enter into alternative IRB review arrangements and agreements to provide the ethical review of multiple sites. The University of Utah may also rely upon the review of another […]

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June 27, 2025

Medical Case Reports

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◀ Back SOP 408: Medical Case Reports document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_143’);});Edit Version: A3025 Purpose Scope Policy Procedures PURPOSE This policy outlines the position of the University of Utah Institutional Review Board (IRB) regarding medical case reports. SCOPE This policy applies to activities that are considered medical case reports authored by University of Utah faculty or staff. POLICY If […]

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June 27, 2025

IRB Actions to Approve or Disapprove Research

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◀ Back SOP 407: IRB Actions to Approve or Disapprove Research document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_142’);});Edit Version: A3025 Purpose Scope Policy Procedures PURPOSE This SOP outlines the actions to approve or disapprove research by the University of Utah Institutional Review Board (IRB) and the method of communicating those actions. SCOPE This SOP applies to the University of Utah IRB. […]

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June 27, 2025

Final Project Reports

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◀ Back SOP 406: Final Project Reports document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_141’);});Edit Version: B2825 Purpose Scope Policy Procedures PURPOSE The completion or termination of a study is a change in activity and must be reported to the IRB. This SOP outlines the University of Utah IRB policy of reporting the termination or completion of studies. SCOPE This SOP applies […]

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June 27, 2025

Review of Amendments to Research Studies

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◀ Back SOP 405: Review of Amendments to Research Studies document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_140’);});Edit Version: E0825 Purpose Scope Policy PURPOSE The University of Utah Institutional Review Board (IRB) must approve changes in approved research. SCOPE This policy applies to human subject research conducted at the University of Utah. POLICY During the period for which approval has already been […]

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June 27, 2025