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Tag: SOPs

Expanded Access

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◀ Back SOP 507: Expanded Access document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_151’);});Edit Version: F2425 Purpose Scope Policy Procedures Content PURPOSE The Food and Drug Administration (FDA) Expanded Access Program allows the use of an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies. This policy describes the […]

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June 27, 2025

Emergency Use of a Test Article

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◀ Back SOP 506: Emergency Use of a Test Article document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_150’);});Edit Version: F2625 Purpose Scope Definition Policy Procedures PURPOSE The emergency use of a test article at the University of Utah must be reported to the University of Utah Institutional Review Board (IRB). SCOPE This policy applies to the emergency use of a test article […]

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June 27, 2025

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: I0525 Purpose Scope Policy PURPOSE This policy addresses the inclusion of research materials in participants’ medical records and the process for requesting and documenting exceptions. SCOPE This policy applies to human subject research conducted under the University of Utah covered entity. POLICY The University […]

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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: H1925 Purpose Scope Policy PURPOSE The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protection. When the University of Utah Institutional Review Board (IRB) reviews research involving vulnerable populations, the IRB applies any additional federal regulations, […]

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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: H2125 Purpose Scope Policy Procedures PURPOSE This policy describes how investigators may appeal decisions made by the University of Utah Institutional Review Board (IRB). SCOPE This policy applies to human subject research conducted at the University of Utah. POLICY The University of Utah IRB has […]

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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