UI IRB Standard Operating Procedures (SOP) and Researcher Guide

This document provides information on human subjects research policies, regulations, and guidance. It is written for investigators, research team members, Institutional Review Board members, members of other UI committees, UI administrators, and others involved with reviewing or conducting human subjects research. 

UI IRB-03 Researcher Guide (For VA PIs)

The University of Iowa and the VA Health Care System (VAHCS) have established collaborations under several Institutional Agreements allowing maximization of resources available at their respective Institutions. This document describes policies and procedures for VAHCS investigators to submit research applications to IRB-03.

Standard Operating Procedures (SOP) for Use of a Single or External IRB

The University of Iowa Human Subjects Office has established policies and procedures when relying on an external IRB or serving as the lead IRB of record.  The External IRB SOP addresses requirements when serving as a lead IRB of record for a single IRB of record study or when relying on an external IRB for a multi site research project.

Department of Defense (DoD) Researcher Guide

Researchers with Department of Defense (DoD) funding are required to follow all Health and Human Services and/or FDA regulations as applicable to the research.  The Department of Defense also has established human subjects research regulations that also apply.  The UI Department of Defense (DoD) researcher guide addresses those regulations.  

Emergency Use or Expanded Access to an Investigational Drug, Biologic or Device

Expanded Access (sometimes referred to as “compassionate use”) provides a potential pathway for access to an investigational drug, biologic or medical device that is not currently approved by the Food and Drug Administration (FDA). Expanded Access is an option for a patient with serious or immediately life-threatening disease or condition for which there is no alternative for therapy to diagnose, monitor or treatment; it is not possible to enroll in a clinical trial; the potential benefits outweigh the risks of treatment; and providing that treatment will not interfere with ongoing clinical trials.

According to the Emergency Use Authorization (Section 564 of the Federal Food, Drug and Cosmetic Act) the Secretary of Health and Human Services can authorize emergency use of unapproved medical products or unapproved uses of a medical product. This can be done to protect against chemical, biological, radiological and nuclear threats, including infectious disease during a public health emergency.

FDA Site Inspection Guide 

The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations. The UI IRB Compliance and Education Program attends the initial and closing meetings of an FDA site inspection. Contact us at irb-monitors@uiowa.edu or 319-335-6564 as soon as you learn of an FDA site inspection.

The UI FDA Site Inspection Guide provides practical advice for Principal Investigators (PI) and research staff undergoing an FDA site inspection. 

Glossary and Acronyms

The glossary contains words commonly used in human subjects research. Portions of this glossary were adapted from the Clinical Research Glossary developed by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT) and the Clinical Data Interchange Standards Consortium (CDISC).

The acronym guide provides frequently referenced acronyms that are utilized in human subjects research.

Medical Terms in Lay Language 

Use these terms in place of medical jargon in recruitment messages, consent documents and other study materials. These terms are not the only acceptable plain language alternatives for these vocabulary words.

Use of Gadolinium in Research

In accordance with FDA guidance, the Human Subjects Office has a memo to researchers regarding safety risks associated with the use of gadolinium-based contrast agents to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). UI research proposals involving the use of gadolinium-based contrast must provide information to subjects and comply with screening requirements for kidney function and  possible brain deposits of gadolinium following repeated use.