Adverse Events, Unanticipated Problems and Protocol Deviations
Faculty, staff and students who conduct human subject research on behalf of the University assume responsibility for conducting their duties within the law and in keeping with Princeton’s highest ethical standards. In keeping with this responsibility, each individual who works on human research studies must:
- Understand and follow principles of conduct in the comportment of their University obligations,
- Ensure that they and the staff who report to them are aware of and operate in compliance with applicable laws and policies, and
- Report incidents of non-compliance or concerns.
The most common event that occur are considered unanticipated problems or protocol deviations that take place during the course of a research project involving human research should be reported to the IRB promptly. In addition to consultation with the IRB administrators, a form recording the pertinent information about the unanticipated event or deviation should be submitted to the IRB within 10 days of the event.
Unanticipated problem involving risks to subjects or others (including, researchers, technicians, bystanders, the public, etc.) include any incident, experience, or outcome that meets all of the following criteria:
Events Requiring Prompt Reporting to the IRB
The following events may represent unanticipated problems involving risks to subjects or others and thus should be promptly reported:
These events may be reviewed using expedited review procedures or at a fully convened IRB meeting. A determination will be made by the full committee regarding whether the event is an unanticipated problem involving risks to subjects or others and if further action is necessary.
Possible IRB Actions may include the following: