The investigator has the responsibility to perform ongoing assessments of subjects and to identify and report adverse events. The occurrence of serious or unexpected adverse events in subjects should cause the investigator to reassess the risk-benefit relationship of the research. New information that may change the risk-benefit ratio needs to be disclosed to subjects, as part of the promise made to share any new information with them. This reassessment may result in a modification of the informed-consent form, negotiation of continuing consent with current subjects, or modification of the protocol to reduce the risk. In some cases, termination of the study may be warranted. Individual subjects may develop a condition or attribute while participating in the study that could place them at higher risk if they continue to participate. This condition or attribute may have been anticipated and identified as an exclusion criterion. But if it was not anticipated, and therefore is not addressed in the protocol, it may be necessary to remove the subject from the study. The IRB should be contacted to review whether the subject may remain in the study (with or without modifications to the protocol) and if the protocol needs revision to address this issue as the study proceeds. Module 6 contains additional information on monitoring research data and reporting adverse events.