UAB policy requires that "unanticipated problems involving risks to research subjects or others" be promptly reported to the IRB, the Institutional Official, the sponsor, and appropriate federal agencies. Others, in "research subjects or others," includes investigators, research staff, or other individuals affected by the research project.
In accord with that policy, the IRB has published a list of problems (below) that investigators must report to the IRB. The Principal Investigator must report the problems listed to the IRB within the timeframes indicated. The IRB may request further information as necessary and will determine whether any research project that has been associated with unexpected serious harm to the participants must be terminated.
Investigators are responsible for meeting all reporting requirements that apply to their projects. For example, investigators have reporting responsibilities to sponsors of FDA-regulated research. Investigators serving as sponsors of FDA-regulated research have additional reporting responsibilities (see FDA-Regulated Research).
Adverse events and safety reports that require prompt reporting should be submitted to the IRB using the Problem Report form. If the event being reported leads to a change in the informed consent document, see "Changes in the Informed Consent Document" in Revisions & Amendments.
Along with the Investigator's Progress Report and other materials described in the section on Continuing Review & Approval, the investigator must report to the IRB:
If the IRB determines that a reported event constitutes an unanticipated problem that alters the risk of the research, it promptly reports its determination and actions to the investigator and the Institutional Official. The Institutional Official, in turn, is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies.
Adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory findings), symptom, or disease, temporally associated with the subject´s participation in the research, whether or not considered related to the subjects´ participation in research.
Adverse events encompass both physical and psychological harms.
Serious adverse event (includes serious adverse drug or biological experience and unanticipated adverse device experiences under FDA regulations) is any adverse event temporally associated with the subject's participation in research that meets any of the following criteria:
Page updated: May 8, 2013