Unanticipated Problem Involving Risks to Human Subjects and Others
Per 
OHRP and FDA guidances, Schulman requires that any unanticipated problem involving risks to human subjects or others (“unanticipated problem”) must be submitted for review. Each report will be reviewed and follow-up information may be required. Unanticipated problems are events that are:
Examples of such unanticipated problems include, but are not limited to:
Breaches of subject confidentiality
Unanticipated additional cost to study subjects
Unanticipated legal risk to a subject
Adverse events of greater frequency or severity than originally anticipated.
Unanticipated problems must be reported to the Board within ten (10) business days of the site becoming aware of the problem. The unanticipated problem(s) must be reported in writing using the 
Unanticipated Problems Involving Risks to Human Subjects and Others Report Form (Unanticipated Problem Form).
The Principal Investigator (PI)/Qualified Investigator (QI) must use his/her clinical judgment in determining whether an unanticipated problem is an event that is both unexpected/unforeseen, whether it is related or possibly related to participation in the research and if the event suggests that the research places the subject(s) or others at greater risk of harm than was previously known or recognized.
Unanticipated Problem Forms that are submitted electronically will receive an acknowledgment of receipt via e-mail.