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 […]
Read MoreThe 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 […]
Read MoreThe 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” […]
Read MoreTo 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 […]
Read MoreWe 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 […]
Read MoreThe 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 […]
Read MoreFebruary 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 […]
Read MoreNew 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.
Read MoreUpdate on Federal Funding: Supporting Our Research Community We recognize the concerns stemming from the recent Office of Management and Budget (OMB) memorandum (M-25-13), which calls for a temporary pause on federal financial assistance programs, including grant disbursements and new awards, effective January 28th, 2025 at 5:00pm EST. This directive applies to all federal agencies […]
Read MoreThe platform for the University of Utah’s Business Relationship Reporting (“BRR”) financial disclosure system was upgraded on January 22, 2025, to a revised system supported by the U Research. This upgraded system will have increased data security and offer enhanced functionality over time. The site will look different, but questions and training in the disclosure […]
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