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Short Forms Consent Process Instructions For Use

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Short Forms Consent Process Instructions For Use Guidance ⏴back to Guidance Series Short Forms Consent Process Instructions For Use Version: December 13, 2022 Guidance The IRB may approve an oral consent process (see 45 CFR 46.117(b)(2), and 21 CFR 50.27(b)(2), for FDA regulated research). This process requires that the IRB review and approve: A written […]

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New IRB Administrator

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December 1st, 2022 We are pleased to announce that Militza Martinez has accepted our offer to join the Administrator team. Militza has been with the IRB for many years and we are looking forward to adding her experience and expertise to the Administrator team! If you have questions, please Contact Us.

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New IRB Clerk

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November 29nd, 2022 We are pleased to announce that Isabelle Howcroft has joined the IRB as the new IRB Clerk. Please join us in welcoming her to the team! If you have questions, please Contact Us.

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New IRB Operations Manager

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October 17th, 2022 We are pleased to announce that April Edwards has accepted the position as the new IRB Operations Manager. April will have primary responsibilities for reliance activities, as well as leadership of the IRB Coordinator team.  We look forward to having her on the manager team. If you have questions, please Contact Us.

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Safety Monitoring Plans

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Safety Monitoring Plans Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Safety Monitoring Plans Version: September 29, 2022 Definitions Safety Monitoring: The observations required to minimize threats to the safety and welfare of research subjects (White 2007). Federal Research Regulations and University of Utah IRB Policy The Common Rule and FDA […]

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Data Monitoring Plans

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Data Monitoring Plans Definitions Guidance Documents and References Points to Consider Appendices ⏴back to Guidance Topics Data Monitoring Plans Version: September 29, 2022 Definitions Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adherence to the approved investigative plan and the validity of data collected (White 2007). Federal […]

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New IRB Associate Director

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September 22nd, 2022 We are pleased to announce that Annie Risenmay has accepted the position as the new IRB Associate Director. If you have questions, please Contact Us.

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New IRB Coordinator

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August 29th, 2022 Please join us in welcoming Miguel Nieto-Palma’s to the IRB staff team! Miguel will be joining our Coordinator Team. Welcome to the IRB! If you have questions, please Contact Us.

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Employees as Research Participants

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Employees as Research Participants Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Employees as Research Participants Version: August 24, 2022 Introduction Under certain circumstances, employees may not feel free to refuse if asked to participate in research. Employees may feel pressure to participate in research, particularly if the workplace is […]

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Adverse Events/Unanticipated Problems Assessment Flowchart

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Adverse Events/Unanticipated Problems Assessment Flowchart Guidance ⏴back to Guidance Series Adverse Events/Unanticipated Problems Assessment Flowchart Version: August 23, 2022 Guidance Not all adverse events constitute unanticipated problems that need to be reported to the University of Utah IRB. How do you determine whether to submit a report of an adverse event to the IRB? Use […]

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