Federal Regulations

Non Compliance

Your IRB materials, once approved by the IRB, are the blueprint of your study. You are expected to follow the IRB approved research protocol, and use only IRB approved materials when conducting your research.  Any unapproved departure from your approved IRB protocol or implementation of research with human subjects without appropriate IRB approval is non-compliance. Non-compliance has many different consequences, but can result in your being prevented from using data that were collected outside of IRB approval, or require reporting to the federal government. Most importantly, any departure from your approved IRB protocol that INCREASES RISK TO PARTICIPANTS, without IRB approval, is very serious and must be dealt with immediately. Please see our guiding information regarding Non-Compliance.