Adverse Event

 

Federal policy (45 CFR 46.103(b) (5)) requires IRBs to have and follow written procedures for "prompt reporting to the IRB of any unanticipated problems involving risks to human subjects or others." Investigators have the responsibility for timely reporting of adverse events to the IRB, to ensure that the IRB is cognizant of any new information that might affect its assessment of the benefit-to-risk ratio of research study participation and/or the adequacy of research protocol provisions for protecting the welfare of research subjects.

To report an adverse event, the IRB investigator should complete the Adverse Event form (available on the OSU IRB website) and submit it to the Human Protections Administrator within three calendar days of identifying the adverse event. The Human Protections Administrator will immediately share the information with the IRB Chair for review and consideration of next steps. A copy of the Adverse Event Report will be sent to the Vice President for Research and the OSU General Counsel.