Any proposed change to the IRB protocol or consent form(s), including a change in investigator(s) or key personnel, must be reviewed and approved by the IRB prior to implementation, except where an immediate change is necessary to eliminate hazard to the participant
Investigators are encouraged to use their best judgment regarding the nature and degree of a reportable injury or unanticipated problem. In general, anything serious enough to warrant medical or psychiatric intervention is reportable, as are verbal or written complaints of participants in which they proclaim that participation presents substantial discomfort, risk, and/or endangerment beyond that explained to them, or as otherwise stated in the consent form. Investigators are also strongly encouraged to share such information with their Department Chair and College Dean.
