What are the researchers responsibilities if an adverse or unexpected event occurs on an approved protocol?
An Adverse/Unexpected Event is defined as: (1) any medical, psychological or behavioral event that is undesirable and unintended, although not necessarily unexpected; (2) an event in which the outcome is fatal or life threatening, causes permanent disability, causes hospitalization or prolongation of hospitalization; (3) an overdose; or (4) a complaint by a research subject or family member of a research subject concerning the research or the protocol. If an adverse or unexpected event occurs on an approved protocol, the investigator is required to submit an Adverse/Unexpected Event Report to the IRB. The form and specific instructions may be downloaded from the ORSP website at: http://orsp.rutgers.edu/Humans/default.php . The investigators must notify the IRB in a timely manner (typically within 48 hours of the event). [Return to top of document] D.
