Investigators must notify the IRB Committee of any event that does or could possibly pose a risk to the study participants or others. These events can present themselves in a variety of ways, such as a compliant from a study participant to flooding of the study site. A reportable event may include various harms, including psychological, physical, legal, social, or economic.
Adverse events must be promptly reported to the IRB using the Adverse Event Report Form through Cayuse Human Ethics.
When considering whether the event is worth reporting, ask yourself these key questions: Is this unexpected? Is it possibly, probably, or definitely related to the study? Does this pose a potential risk of any kind? If the answer is yes, then an Adverse Event Report Form should be submitted to YSUIRB@ysu.edu as soon as possible.
YSU no longer uses the previous IRB Forms. Previously approved protocols will continue to use the paper forms until their protocol expires. If an investigator has any question, feel free to contact the YSU IRB.