Adverse event monitoring and reporting
’s injury or illness, ill
ADVERSE EVENTS, EVENTS, EVENT
The DSMC Chair will be notified of all study-related serious adverse events within 48 h of discovery. The Chair will decide if further action beyond what the research team has proposed is warranted. Additionally, participants will be asked to report each adverse health event in person at study visits or during the intervention sessions, or via telephone/email/text message. The principal investigators will consult and determine the severity and appropriate response or action to the reported adverse health event. All serious unanticipated problems or serious adverse health events will be reported to the UIC Institutional Review Board and Office for the Protection of Research Subjects.UIC Office for the Protection of Research Subjects requires that all other problems (non-serious adverse events) be reported within 5 days of discovery and provide sufficient information to gauge severity and to complete reports. UIC Office for the Protection of Research Subjects has procedures in place to review the reports, and the PIs are notified if further review, changes to research protocol or consent form, or other action is required. The PIs will notify NIH should UIC IRB require further action after any unanticipated problem/adverse event is reported.UIC has not set aside money to pay participants if they get ill or injured from being in the study. The only exception to this policy is if it is proven that a participant’s injury or illness is directly caused by the negligence of UIC.