Partner with the University of Utah Institutional Review Board (IRB) to elevate your research. We conduct ethics reviews for research that includes humans as participants. This includes biomedical research and social and behavioral sciences research. We offer single IRB (SIRB) review services for multi-site human subject research. You do not need to be affiliated with the University of Utah to request our services.
We are willing to consider serving as the single IRB (SIRB) for multi-site research or rely on an external SIRB on a case-by-case basis. The University of Utah has long been supportive of the single IRB (SIRB) effort and has successfully worked with many SIRBs around the country for more than ten years.
Our Mission
To protect the rights and welfare of human research participants by ensuring compliance with state and federal laws, as well as the high ethical standards set forth in University policy.
Our Vision
To provide the University and national research communities with the support and resources they need to conduct high quality research, using innovative and efficient operational practices.
Contact Us
The University of Utah has a dedicated team of experts ready to help you navigate the single IRB review process.
Our Institutional Profile and Local Context Information
If you are a reviewing SIRB or member of a study team and need information about the University of Utah for your local context database, please refer to our Institutional Profile.
Experience
The University of Utah (UU) 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, with up to 40 participating sites per trial. We were an early adopter of the SMART IRB Authorization Agreement, allowing for a streamlined SIRB reliance process with the other 1100+ institutions who have also joined.
We have also served as a SIRB for several research networks, including the Trial Innovation Network designated by the National Center for Advancing Translational Sciences (NCATS). We have been engaging with various central IRB (CIRB) models for multi-site research for almost a decade.
The IRB has an established process for engaging with site investigators and HRPP representatives to secure IRB reliance and approval for each participating site.
Expertise
We are one of the leading developers of the SIRB process for academic and local institutions. We provide SIRB review services for multi-site research across the United States, with as many as 40 participating sites per study.
The University of Utah IRB has extensive experience applying the regulations and policies of:
- FDA
- Common Rule
- HIPAA
- Veterans Affairs
- Department of Defense
We oversee 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. We have particular expertise for reviewing molecular and genetic research using biospecimens and data.
Scientific members of the University of Utah Board are currently practicing physicians, nurses, scientists, and faculty members. Non-scientific members include University students, staff, and community members.
The University of Utah IRB has been fully AAHRPP accredited since 2007. The FDA has conducted multiple site visits at our institution going back to 2004, with no findings.
Education
We are amongst the leaders in the nation in educating the public about the SIRB process. We offer training resources and materials to educate investigators and staff, and we strive to provide study teams with support and resources to conduct high quality research that protects participants.
Our Human Research Protection Program (HRPP) has numerous publications available. We invite you to review our Publications Library.
Resources
Use of the University of Utah IRB as a SIRB provides investigators with access to ERICA Online, an electronic system that streamlines submission, review, communication, and documentation for studies.
Our online application system allows access for users who are not affiliated with our institution. We have specially designed workflows in place to allow participating sites in multi-site research to manage their own submissions to the IRB.
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.
Credentials
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 a 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 joined the SMART IRB Master Authorization Agreement, allowing for a streamlined SIRB reliance process with the more than 700 institutions who have also joined. The IRB has an established process for engaging with site investigators and HRPP representatives in order 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.
The University of Utah Institutional Review Board has Full Accreditation by the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP). The University of Utah IRB achieved initial full accreditation by AAHRPP on June 15, 2007.