Institutional Review Board

Administrative Review and Distribution of Materials

Categories: sops

Back SOP 302: Administrative Review and Distribution of Materials document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_128’);});Edit Version: B1624 Purpose Scope Policy Procedures PURPOSE The efficiency and effectiveness of the University of Utah Institutional Review Board (IRB) must be supported by administrative procedures that ensure that University of Utah IRB members have adequate time for thorough assessment of each proposed study, and […]

September 17, 2025

Privacy and Confidentiality

Categories: guidance-series

Privacy and Confidentiality Guidance Points to Consider ⏴back to Guidance Topics Privacy and Confidentiality Version: September 16, 2025 Guidance When thinking about privacy and confidentiality in the research context, distinctions should be made between the two issues. Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy can be […]

September 16, 2025

HIPAA Privacy Rule & Authorization

Categories: guidance-series

HIPAA Privacy Rule & Authorization Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics HIPAA Privacy Rule & Authorization Version: September 16, 2025 Definitions Breach: The term breach means the unauthorized acquisition, access, use, or disclosure of protected health information (PHI) which compromises the security or privacy of such information, […]

September 16, 2025

Exempt Research: Guided Exemption

Categories: guidance-series

Exempt Research: Guided Exemption Introduction Guidance Documents and References Points to Consider ⏴back to Guidance Topics Exempt Research: Guided Exemption Version: September 3, 2025 Introduction Exempt research is no greater than minimal risk and fits within an exemption category. Exemption determinations are made by a designated IRB reviewer. In limited circumstances, investigators may obtain an […]

September 3, 2025

Neonates

Categories: guidance-series

Neonates Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Neonates Version: September 3, 2025 Definitions Subpart B: Subpart B is found in 45 CFR 46 (DHHS) and includes additional protections for neonates involved in research (45 CFR 46.205). Neonate: Newborns from the time of delivery up until 28 days old. Nonviable […]

September 3, 2025

Spanish-Speaking Individuals in Research

Categories: guidance-series

Spanish-Speaking Individuals in Research Definitions Guidance Documents and References Points to Consider Appendices Footnotes ⏴back to Guidance Topics Spanish-Speaking Individuals in Research Version: September 2, 2025 Definitions Interpretation is the spoken exchange of communication between two languages. A certified interpreter is an individual who has passed a certification exam given by an accredited entity to […]

September 2, 2025

Wards of State

Categories: guidance-series

Wards of State Introduction Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Topics Wards of State Version: August 6, 2025 Introduction Federal regulations require additional safeguards for certain categories of research involving wards of the state. These protections are outlined in Subpart D of 45 CFR 46 (Additional Safeguards for Children Involved […]

August 6, 2025

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

Categories: Article, News Archive

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 […]

July 31, 2025

Regulatory Guidance on Optional Data and Biospecimen Use

Categories: Article, News Archive

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” […]

July 30, 2025

Submitting Validated Surveys

Categories: Article, News Archive

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 […]

July 30, 2025