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Category: News Archive

Modernizing Biosafety (IBC) Regulations

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Modernizing Biosafety (IBC) Regulations On September 9, the NIH announced plans to modernize their biosafety regulatory framework. You can see details here: https://www.nih.gov/about-nih/nih-director/statements/nih-launches-initiative-modernize-strengthen-biosafety-oversight and here: https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy/#tab2/ The NIH has indicated the new regulations will align with risk, lower regulatory burden for low-risk research, expand oversight beyond work with recombinant and synthetic nucleic acids, and empower IBCs. […]

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October 30, 2025

Upcoming Holidays and the IRB

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Please plan for a little extra time during the upcoming holiday season for application approvals, as some of our meetings will be canceled; see schedule below. November 26, 2025 (day before Thanksgiving): Regular IRB board meeting December 24, 2025 (Christmas Eve): Canceled board meeting December 31, 2025 (New Year’s Eve): Canceled board meeting January 7, […]

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October 30, 2025

New IRB Guidance, MRI Risk Language

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New IRB Guidance We are excited to share two new guidance pages designed to help you understand when IRB review is required and when a project may be Non-Human Subjects Research (NHSR). These resources provide more information about projects that may not need to be reviewed by the IRB. These resources intended to provide you […]

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October 30, 2025

Urgent Update: Temporary Halt on Debit Card Distribution for Human Research Participant Payments

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The Clinical Research Support Office is aware of escalating fraudulent activity impacting participant debit cards and the significant burden this could place on your participants to submit fraud claims to the Hyperwallet Visa team. It is unacceptable that some participants are receiving cards with depleted funds due to this activity. We understand that replacement cards […]

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July 31, 2025

Regulatory Guidance on Optional Data and Biospecimen Use

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The NIH and HIPAA have guidance and regulations regarding mandatory future use of biospecimens and/or data collected in research that offers treatment/intervention to participants. NIH guidance focuses on ethical considerations, voluntariness, undue influence, and coercion of mandatory contribution of data/biospecimens for future use.   HIPAA regulation defines access to and use of PHI in “conditional” […]

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July 30, 2025

Submitting Validated Surveys

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To support thorough risk assessment, the IRB is now asking study teams to upload any questionnaires or surveys (including validated surveys) used in studies under the Surveys, Questionnaires, Etc. section of the Documents & Attachments page in their IRB application. This helps the IRB evaluate the nature of questions participants are asked, especially when these […]

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July 30, 2025

New IRB Associate Director

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We are thrilled to announce the promotion of Hannah Owen to the role of IRB Associate Director. Hannah demonstrates exceptional leadership, deep expertise in research ethics, and a steadfast commitment to protecting the rights and welfare of research participants. We are excited for her collaborative spirit, strategic thinking, and dedication to excellence to continue making […]

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July 15, 2025

OQC Tip of the Month: Documenting the Consent Process

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The Office of Quality Compliance sends a “Tip of the Month” directly to your email! Learn more and subscribe by going to their website at: https://qualitycompliance.research.utah.edu/tip-of-the-month.php. This month’s tip: The informed consent process must be documented in the research record. The note should include the following details: Informed Consent Form (ICF) obtained voluntarily Participant consented […]

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April 8, 2025

Notification for ERICA Users on MacOS

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February 11st, 2025 Notification for ERICA Users on MacOS The IRB has been notified that that there is an urgent usability issue related to ERICA for individuals using Mac computers. ORIS has received multiple reports from ERICA users who use Mac computers and who have updated their machines to the most recent version of Mac OS Sequoia […]

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February 11, 2025

New IRB Staff Member

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New IRB Staff Member Please join us to welcome a new member to the IRB staff! They will be joining our Convened Board Team. Welcome to the IRB! If you have questions, please Contact Us.

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February 6, 2025