Single IRB Institutional Review Board

Single IRB (SIRB) at the University of Utah. The University of Utah IRB has agreed to provide SIRB services for this project. It is the mission of the University of Utah Human Research Protection Program (HRPP) and the Institutional Review Board (IRB) to protect the rights and welfare of human participants in research at the University of Utah and its research affiliates. The University of Utah has an active Federal-wide Assurance (FWA) with the Office for Human Research Protections (FWA00003745). The University of Utah IRB adheres to 45 CFR Part 46 (Common Rule); 21 CFR Parts 50 and 56 as well as other parts of 21 CFR as appropriate for clinical investigations regulated by the Food and Drug Administration (FDA); the principles of the International Conference on Harmonization’s Good Clinical Practice (ICH-GCP) to clinical investigations, as adopted by the FDA; and the HIPAA Privacy Rule. The IRB also has vast experience applying the regulations and policies of Veterans Affairs and the Department of Defense. The IRB oversees more than 7,000 active human research projects, including clinical trials and related biomedical research, social and behavioral sciences research, and research involving all vulnerable populations described in the Common Rule and related regulatory guidance. The IRB has particular expertise for reviewing molecular and genetic research using biospecimens and data.

The University of Utah has been at the forefront of designing and evaluating SIRB methodology through empirical evidence and experience. The University of Utah IRB serves as the SIRB for many multi-site trials, some with more than 40 participating sites per trial. The IRB has also served as a SIRB for several research networks, including the Trial Innovation Network designated by the National Center for Advancing Translational Sciences (NCATS). The University of Utah has joined the SMART IRB Master Authorization Agreement, allowing for a streamlined SIRB reliance process with more than 1100 institutions who have also joined. The IRB has an established process for engaging with site investigators and HRPP representatives to secure IRB reliance and approval for each participating site. Use of the University of Utah IRB as a SIRB provides investigators with access to the ERICA Online System, an electronic system that streamlines submission, review, communication, and documentation for studies. Additionally, investigators have access to a comprehensive SIRB consultation process for navigating issues related to study design, methods, and consent documentation for multi-site studies.