u6063341 – Page 4 – Institutional Review Board

Training and Education

Categories: sops

Back SOP 102: Training and Education document.addEventListener(‘DOMContentLoaded’,function(){frmFrontForm.scrollToID(‘frm_container_3’);});Edit Version: I0525 Purpose Scope Definition Policy Procedures PURPOSE Training of Institutional Review Board (IRB) staff and IRB members is critical to fulfilling its mandate to protect the rights and welfare of research subjects consistently throughout the University of Utah research community. The training and education of those who […]

June 27, 2025

Policies and Procedures Management

Categories: sops

◀ Back SOP 101: Policies and Procedures Management Edit Version: D2122 Purpose Scope Policy Procedures PURPOSE University of Utah Institutional Review Board (IRB) standard operating procedures (SOPs) provide a framework for the ethical and scientifically sound conduct of human research. This SOP outlines the University of Utah IRB practice for creating, publishing, and routine review […]

June 27, 2025

Multimedia Recordings

Categories: guidance-series

Multimedia Recordings Guidance Documents and References ⏴back to Guidance Series Multimedia Recordings Version: April 25, 2025 Guidance Using multimedia tools to record the image and/or voice of an individual creates a record that requires careful handling and storage, particularly if the content of media or the purpose of the research may be considered sensitive. These […]

April 25, 2025

Deception & Debriefing

Categories: guidance-series

Deception & Debriefing Guidance Documents and References Points to Consider ⏴back to Guidance Topics Deception & Debriefing Version: April 20, 2025 Guidance Deception is the intentional misleading of participants or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, […]

April 20, 2025

Basic Physiological Research

Categories: guidance-series

Basic Physiological Research Guidance Documents and References Points to Consider ⏴back to Guidance Series Basic Physiological Research Version: April 14, 2025 Guidance The Food and Drug Administration (FDA) is responsible for regulating devices for human use including Investigational Device Exemptions (IDE). An IDE allows an investigational device (i.e., a device that is the subject of […]

April 14, 2025

Sponsor-Investigator Guidelines and Responsibilities

Categories: guidance-series

Sponsor-Investigator Guidelines and Responsibilities Guidance Documents and References ⏴back to Guidance Series Sponsor-Investigator Guidelines and Responsibilities Version: April 9, 2025 Guidance A sponsor-investigator is an individual who both initiates and conducts a clinical investigation. The sponsor-investigator may conduct the research alone or with others. Investigators who conduct studies involving an FDA test article and for […]

April 9, 2025

Expedited Category 8(a) Decision Chart

Categories: Board Members Guidance Series

Expedited Category 8(a) Decision Chart Guidance Documents and References Footnotes ⏴back to Board Member Guidance Series Board Member Guidance Series Version: April 3, 2025 Guidance Allowing the research to be reviewed using expedited review procedures under category 8(a)1 requires a clear understanding of the status of the study. If in doubt, ask for more details […]

April 3, 2025

Pregnancy Testing Prior to Radiation Exposure for Research Purposes

Categories: Board Members Guidance Series

Pregnancy Testing Prior to Radiation Exposure for Research Purposes Guidance Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 27, 2025 Guidance The IRB is responsible for considering the risks of radiation exposure for women who are pregnant and participate in research. The IRB may choose to allow a […]

February 27, 2025

Equitable Selection of Participants

Categories: Board Members Guidance Series

Equitable Selection of Participants Guidance Documents and References Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 26, 2025 Guidance The concept of justice is one of the fundamental ethical principles in the Belmont Report. It is described as the idea that “equals ought to be treated equally,” with […]

February 26, 2025

Transplantation of Fetal Tissue

Categories: guidance-series

Transplantation of Fetal Tissue Definitions Guidance Documents and References Points to Consider ⏴back to Guidance Series Transplantation of Fetal Tissue Version: February 26, 2025 Definitions For the purposes of this law, the term “human fetal tissue” means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or […]

February 26, 2025