During the conduct of human subjects research, unanticipated events may occur. These events must be reported to the IRB using the “Reportable Events” mechanism in OSIRIS. While the smart form questions within the OSIRIS application will assist investigators in determining the type of report required, a general summary is provided in the paragraphs below and in figure 1.
Events involving risk to human subjects or others must be reported as an “Unanticipated Problem Involving Risk to Human Subjects or Others”. This category includes some types of adverse events meeting the definition of an unanticipated problem involving risk to human subjects or others. This category can also include protocol deviations, non-compliance, or other unanticipated problems that place subjects at risk of harm. Examples include but are not limited to: missed safety labs, medication or dosing errors, potential breaches of confidentiality, etc.
Protocol deviations and incidents of non-compliance, which do NOT involve risk to human subjects or others must be reported as “Non-compliance”. Examples include but are not limited to performing research procedures outside the protocol specified window, deviating from the protocol without risk to the subject, obtaining consent using an outdated consent form with no other substantive differences other that the date, etc.
Figure 1. Reportable Events summary
Figure 2. Venn Diagram summarizing the general relationship between adverse events, unanticipated problems, and non-compliance
Figure 2 illustrates several key points:
- The vast majority of adverse events occurring in human subjects are not unanticipated problems (area A) and do not need to be reported to the IRB.
- Only a small proportion of adverse events are unanticipated problems (area B).
- Unanticipated problems include other incidents, experiences, and outcomes that are not adverse events (area C).
- Deviations or non-compliance can also be unanticipated problems involving risk to subjects or others.
- Events meeting criteria for an Unanticipated Problem Involving Risk to Subjects or Others, or Non-compliance (Areas B, C D and E) must be reported to the IRB.
Management and Reporting of Unanticipated Problems Involving Risks to Human Subjects and Others and Non-compliance
It is the policy of the University of Pittsburgh Institutional Review Board (University IRB) to:
- Require the reporting of adverse events and other unanticipated events which meet the definition of an “unanticipated problem involving risks to human subjects or others” and/or Non-compliance
- Review reports of adverse events, unanticipated problems and ECO-HSR compliance activity reports that have been designated for review by the IRB as outlined in the ECO-HSR policy (SOP-I-A-15) , and determine which meet the OHRP criteria for “unanticipated problems involving risks to human subjects or others”
- Review reports of non-compliance and determine which constitute serious or continuing non-compliance and/or an unanticipated problem involving risk to human subjects or others
- Fulfill reporting requirements to the appropriate entities (institutional officials, federal departments or agencies)