Even after you receive IRB approval, there are a couple of reasons you may need to contact the IRB: you may need to make an amendment (see the “I need to change something about my study” section), report an adverse event or serious adverse event occurs, or notify the IRB of significant new findings. An Adverse Event (AE) is any untoward medical occurrence in a research participant receiving an investigational pharmaceutical product or device-regardless of causal relationship. Examples include any abnormal lab finding, symptom, or disease associated with the intervention. If in doubt about whether or not something is an AE, call the IRB to discuss your situation. AEs must be reported in writing to the IRB for Full Board review to determine next steps.  If a deviation from the IRB-approved protocol results in a reportable AE, you must report the AE,  the mechanism, and a Plan of Correction. It is worth noting that the IRB has the authority to suspend or terminate a study that is not being conducted according to the approved protocol or established policies. You are expected to complete the Continuing Review Annually  – a general check in on how your study is going and if any changes need to be made to your protocol. The IRB will send you a notification when the updates are due. If, in the course of your study, significant new findings arise (either within your study or the published literature) that may make the study more risky for participants or affect their willingness to participate, you will need to notify participants and contact the IRB with a proposal for how you would inform participants plus any new consent forms and/or contact letters for participants.