The IRB is pleased to announce a specific application pathway in the ERICA new study application for physicians intending to treat patients using a humanitarian use device (HUD) or expanded access of an investigational drug or device. A humanitarian use device is intended to benefit patients by treating or diagnosing a disease that affects fewer […]
Read MoreThe following University of Utah Institutional Review Board SOPs were reviewed as part of a scheduled sunset review procedure. As a reminder, all IRB SOPs are also being updated as part of a harmonization project to improve ease of reading and understanding. Please take a moment to review these SOPs as a refresher and part […]
Read MoreWaivers of Consent for Research with Prospective Data Collection Guidance Documents and References Appendices Footnotes ⏴back to Board Member Guidance Series Board Member Guidance Series Version: July 18, 2024 Guidance The University of Utah IRB routinely grants waivers of consent for retrospective chart review and secondary data analysis studies. Investigators occasionally request waivers of consent […]
Read MoreWaiver or Alteration of Consent Guidance Documents and References Points to Consider ⏴back to Guidance Series Waiver or Alteration of Consent Version: July 18, 2024 Guidance The University of Utah IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent or waive the […]
Read MoreThe following University of Utah Institutional Review Board SOPs were reviewed as part of a scheduled sunset review procedure. As a reminder, all IRB SOPs are also being updated as part of a harmonization project to improve ease of reading and understanding. Please take a moment to review these SOPs as a refresher and part […]
Read MoreDear IRB members, After more than 18 years with the University of Utah IRB, I am excited to let you know that I have accepted the position of Associate Vice Provost for Research Compliance at Stanford University, starting August 15th. This excitement also comes with heartfelt sadness to be leaving such a wonderful place as […]
Read MoreUpdated Research-Related Injury Language Required by August 1, 2024 For research involving greater than minimal risk, participants must be informed about options available in case they get injured. The University of Utah IRB mandates specific language for addressing research-related injuries. To make it easier to understand (aiming at an 8-9th grade reading level instead of […]
Read MorePregnant Women & Fetuses Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Pregnant Women & Fetuses Version: April 26, 2024 Definitions Subpart B: This term refers to the regulations which apply to research involving pregnant women and fetuses as subjects. Subpart B is found in 45 CFR 46 (DHHS). Pregnancy: Encompasses […]
Read MoreCertificates of Confidentiality Guidance Documents and References Points to Consider Footnotes ⏴back to Guidance Series Certificates of Confidentiality Version: April 26, 2024 Guidance Certificates of Confidentiality (CoCs) are intended to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive information to anyone not connected to the research except when the subject consents, […]
Read MoreThe following University of Utah Institutional Review Board SOPs were reviewed as part of a scheduled sunset review procedure. As a reminder, all IRB SOPs are also being updated as part of a harmonization project to improve ease of reading and understanding. Please take a moment to review these SOPs as a refresher and part […]
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