Under federal regulations for the protection of human subjects in research, investigators have an obligation to report certain AEs occurring to research subjects. The AE is life-threatening, meaning that the subject was at immediate risk of death. The AE results in cancer, a congenital anomaly, disability, medical or surgical intervention, admission to the hospital, or prolongation of a hospital stay.
Disability means a substantial disruption of one's ability to carry out normal life functions.
The AE changes the risk benefit ratio of the study. The AE requires that the study consent form be changed. The AE is medically unexpected, regardless of severity. AEs do not need to be reported to the CHR if the event is considered by the investigator to be unrelated to the procedures involved in the research. An AE is not reportable if it is expected and due to the natural progression of the patient's underlying disease.