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Waiver or Alteration of Consent

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◀ Back SOP 703: Waiver or Alteration of Consent document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_156’);});Edit Version: E2523 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) may waive the regulatory requirement to obtain consent or may approve a consent procedure that alters elements of informed consent. This SOP outlines how the University of Utah IRB determines […]

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June 27, 2025

General Requirements of Documentation of Consent

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◀ Back SOP 702: General Requirements of Documentation of Consent document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_155’);});Edit Version: J0722 Purpose Scope Definition Policy Procedures PURPOSE This SOP outlines the requirements and acceptable methods for documentation of informed consent. The University of Utah Institutional Review Board (IRB) may also approve a waiver of documentation of consent under limited circumstances as outlined in […]

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June 27, 2025

General Requirements of Informed Consent

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◀ Back SOP 701: General Requirements of Informed Consent document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_154’);});Edit Version: E2523 Purpose Scope Definition Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) adheres to the regulatory requirements for informed consent. This SOP outlines how the University of Utah IRB determines that the applicable requirements for informed consent are met. SCOPE This […]

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June 27, 2025

Payment for Participation in Research Studies

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◀ Back SOP 602: Payment for Participation in Research Studies document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_153’);});Edit Version: D2825 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) ensures research participants are informed of payments. The University of Utah IRB reviews payment arrangements to research participants to ensure an equitable selection of subjects by only approving payment […]

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June 27, 2025

Screening, Recruiting, and Advertising for Participant Enrollment

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◀ Back SOP 601: Screening, Recruiting, and Advertising for Participant Enrollment document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_152’);});Edit Version: F2421 Policy Procedures POLICY The University of Utah IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective subjects without the informed consent of the subject […]

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June 27, 2025

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: 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