Unanticipated Problems
An Unanticipated problem is any event, experience, issue, instance, problem, or outcome that meets all 3 of the following criteria:
- Unexpected
In terms of the nature, severity, or frequency given the research procedures that are described in the protocol-related documents AND in the characteristics of the population under study. - Related or Possibly Related
This means that there is a reasonable possibility that the incident may have been caused by the procedures involved in the research study. - Greater Risk of Harm
The incident suggests that the research places the subject or others at greater risk of harm (physical, psychological, economic or social) than was previously known or recognized OR results in actual harm of the subject or others.
An unanticipated problem generally required a change in policy or procedure and warrants consideration of substantive changes to the protocol/consent or other immediate corrective actions in order to reduce the risk or eliminate immediate hazard.
For more information see Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007).
Examples of Unanticipated Events
- Serious Adverse Event
- Unintentional or intentional change to the IRB-approved protocol (Protocol Deviation)
- Breach of privacy or confidentiality
- Receipt of wrong dose or contaminated study medication
- Complaint from a subject or family member
- Lab or medication errors (that may involve risk to subjects)
- Disqualification or suspension of a study investigator
- Change in the status of a subject that might affect their eligibility to remain in a study
- New information that suggests an unexpected change to the risk-benefit assessment or results in sponsor-imposed suspension of study or enrollment due to newly recognized risk
IRB Actions
The IRB will review the Unanticipated Event in a timely manner and confirm whether the submission constitutes an unanticipated problem involving risk to participants or others.
The IRB will consider a range of possible corrective actions such as:
- Requiring modifications to the research plan
- Modifying the consent document or consent process
- Providing additional information to current and/or past subjects
- Requiring additional training of the researcher or study staff
- Reporting the unanticipated problem to federal agencies
- Suspension or termination of the research