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 MoreSpanish is the second-most common language spoken in the state of Utah. Approximately 10 percent of people in the state of Utah and 14 percent of people in Salt Lake County speak Spanish at home. Currently, the University of Utah IRB requires the inclusion of Spanish-speaking individuals in research on a case-by-case basis. At the […]
Read MoreIn October 2022, the University of Utah IRB approved a policy change which allowed the IRB to grant general approval of a standard short form document. This change was intended to streamline the procedure for approval of short form documents and relieve administrative burden. When is a short form used? The short form consent process is a […]
Read MoreThe IRB and Human Research Protection Program (HRPP) have initiated a new requirement for Annual HRPP Progress Updates in the ERICA system. The purpose of the Annual HRPP Progress Update is to receive study status information for studies that do not require the traditional continuing review. This means that all active,open studies without an expiration date […]
Read MoreAnn Johnson’s STEM Ambassador project centers around her love of sewing. Ann will be teaching a sewing class through the University’s Lifelong Learning program called “Wear Your Heart on Your Sleeve: Sewing Textiles to Express Your Values”. Ann’s goal with her project is to help learners make an item of clothing that helps to express […]
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