The regulations for the protection of human subjects (the Common Rule) were revised in 2019. One of the major revisions was the expansion of the exempt research categories and the creation of Limited IRB Review for exempt categories 2(iii) and 3(i)(C). These expanded provisions allow
What is the difference between “quality improvement” and “research,” under the human subjects research regulations? Does quality improvement ever overlap with research? Is IRB review ever required for quality improvement projects? In the “Excluded vs. Exempt” education article, we delved into the topic of excluded
When a project is complete, or when an investigator leaves UNLV, it is important for IRB records to be closed or transferred to a new PI as appropriate. Learn more about when closure is appropriate for a study, and how to complete a closure submission,
When is IRB review required for a project? What is the difference between research which is deemed “excluded” from the requirement for IRB review, versus research that is considered “exempt”? The former does not require IRB review, but the latter does require submission to the