118 Non-Human Subjects Research Determinations: What You Need to Know

Non-human subjects research is research that does not involve obtaining information about living individuals.  

You may submit a Form 118 to request a non-human subjects research determination if you are planning any of the following types of research: 

• Research involving deceased individuals or their information. 
• Course-related activities designated specifically for educational or teaching purposes, where data is collected from and about human subjects as part of a class but not intended for use outside the classroom.  
• Case reports of an individual patients. 
• Quality improvement (QI) and quality assurance (QA) research intended for internal use. 

Rush considers human subject research to be any of the following: 

• Prospective or retrospective research of investigational devices, drugs, products or materials involving one or more individuals. 
• Research activities that collect data through intervention or interaction with individuals. 
• Research activities that use private information that can be associated with individuals. 
• Research activities that use biospecimens such as cells, blood, hair, urine, tissues or organs from individuals. 

Complete this form via REDCap. If you’re a student or trainee, include your faculty sponsor’s name and contact information. 

• Within roughly 3-5 business days, you will receive an official determination that your project does not require IRB review, 
• You may also be notified your project is human subjects research and requires review via the Rush research portal.  
• In some instances, IRB administration will request more information prior to determination.