Non-Compliance, Problems, and Adverse Events
Noncompliance is defined as a failure to comply with any of the regulations, laws, or organizational policies as well as not complying with any determinations of the IRB. Noncompliance may be serious or non-serious (minor), a one-time incident or continual. Serious, increases risk of harms to subjects, decreases potential benefits, or compromises the integrity of the research. Research conducted without prior IRB approval, or research conducted where subjects have not provided their informed consent (unless this requirement was formally waived by the IRB), always constitutes serious noncompliance. Noncompliance policies are outlined on the OSP website and noncompliance should be reported to the IRB as soon as it occurs..
Investigators must report all potential unanticipated problems to the IRB. Unanticipated problems are defined as any incident, experience or outcome that meets all of the following criteria:
- Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied;
- Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants;
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
Investigators must report all adverse events to the IRB. Adverse Events are defined as any unexpected or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. An adverse event would not be considered an adverse event if either of the following applied:
- the known or foreseeable risk of adverse events associated with the procedures involved in the research are described in the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document
- the event is part of the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event
How to Report a Potential Unanticipated Problem or Adverse Consequence
Investigators who experience any complaints, unanticipated problems, or adverse events must report this information promptly (typically, within 48 hours) to the IRB for evaluation. Please report this by either using the below form or by accessing TOPAZ and Choosing Create Interim Review Protocol under the Protocols Tab. The IRB Chair will review this report and will contact the investigator if more information is needed.
IRB Unanticipated Problems Report
For more information on Unanticipated Problems or Adverse Events you can go to https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html#Q1