Chapter 17 - Reportable New Information
During the conduct of human subject research, unanticipated events may occur. These events must be reported to the IRB using the electronic submission process. While the smart form questions within the electronic submission application will assist investigators in determining the type of report required, a general summary is provided below.
Events involving risk to human subjects or others must be reported as “Unanticipated Problems Involving Risk to Human Subjects or Others”. This category includes adverse events (medical occurrences) which meet the definition of an unanticipated problem involving risk to human subjects or others. This category can also include protocol deviations/non-compliance (which will now be referred to as “non-compliance”) or other unanticipated problems that place subjects at risk of harm.
Non-compliance, which does NOT involve risk to human subjects or others may also need to be reported to the IRB. Incidents of non-compliance that adversely affect the rights and welfare of human subjects or significantly compromise the quality of the research data must be reported as “Non-Compliance”. Incidents of non-compliance that do not meet this definition will not need to be reported to the IRB. However, logs can be maintained in the subject’s research record or in a log maintained for the study and managed as part of the Data and Safety Monitoring Plan, as applicable. This documentation will be mandatory for research studies that are greater than minimal risk, meet the federal definition of a “clinical trial”, and if required by the funding agency. It is strongly recommended that a log (or similar documentation) be kept for all other studies. This documentation should be made available upon request.
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 unanticipated events which meet the definition of an “unanticipated problem involving risks to human subjects or others”
- Require reporting of non-compliance which:
- Significantly adversely effects the rights or welfare of participants or
- Significantly compromises the quality of the research data or
- may represent serious and/or continuing non-compliance or is otherwise deemed reportable to the IRB
- 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)
An adverse event that occurs at a site that falls directly under the authority of the University IRB compliance need not be reported to the IRB.