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Tag: SOPs

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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June 27, 2025

Privacy and Confidentiality

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◀ Back SOP 802: Privacy and Confidentiality document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_159’);});Edit Version: E0825 Purpose Scope Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) ensures that all research participants receive adequate privacy and confidentiality protections. SCOPE This policy applies to human subject research conducted at the University of Utah. POLICY The University of Utah IRB provides […]

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June 27, 2025

Conflict of Interest

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◀ Back SOP 801: Conflict of Interest document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_158’);});Edit Version: E1821 Policy POLICY The University of Utah IRB will follow and adhere to the University’s Conflict of Interest policy. The full policy (1-006) is posted on the University Regulations website. All investigators engaged in research are required to comply with the policy. The IRB requires financial […]

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June 27, 2025

Assent

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◀ Back SOP 704: Assent document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_157’);});Edit Version: E2523 Purpose Scope Definition Policy Procedures PURPOSE The University of Utah Institutional Review Board (IRB) follows the regulatory requirements for making adequate provisions to obtain the assent of children in research as outlined in this policy. Additionally, the University of Utah IRB requires adequate provisions be made to […]

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June 27, 2025

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