UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB
Unanticipated problems involving risks to subjects or others includes any incident, experience, or outcome that is involving risks to subjects or others
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 is any adverse event temporally associated with the subject's participation in research that meets any of the following criteria:
This definition includes serious adverse drug or biological experience and unanticipated adverse device experiences under FDA regulations.
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. The term "others" includes investigators, research staff, or other individuals affected by the research project. Some adverse events will qualify as "unanticipated problems." Only the IRB can determine whether a problem including an adverse event will qualify as an unanticipated problem. Therefore, the Principal Investigator will report to the IRB any problems listed in Attachment A to this policy as soon as possible but in all cases within the time frame listed in Attachment A.
The IRB and OIRB will develop procedures to receive and evaluate the information it requires in a timely fashion. Whenever the IRB determines an unanticipated problem alters the risk of the research, it shall report promptly its determination and actions to the principal investigator and the Institutional Official. The Institutional Official is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies. (See also: PRO106 Procedure to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB).
Approved on March 1, 2010, by:
Richard B. Marchase, PhD
Vice President for Research and Economic Development
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP
ATTACHMENT TO POL006: LIST OF PROBLEMS INVESTIGATORS MUST REPORT TO THE IRB AND ENSURE RESEARCH STAFF ARE FOLLOWING THE REPORTING REQUIREMENTS
As soon as possible but in all cases within 5 working days, the Principal Investigator must report to the IRB:
As soon as possible but in all cases within 10 working days the Principal Investigator must report to the IRB:
At the time of continuing review the Principal Investigator must report to the IRB the following: