Unanticipated Problem and Protocol Violation Report Forms
An UNANTICIPATED PROBLEM is any unfavorable incident, experience, or outcome that is unexpected, related or possibly related, and suggests that the research places participants or others at greater risk of harm than expected for this research.
- Reporting Form for Unanticipated Problems (Word Document)
An Unanticipated Problem Report may be submitted to the Human Studies Program by email at email@example.com OR by hard-copy delivery to Human Studies Program, University of Hawaii at Manoa, 2425 Campus Road, Sinclair 10, Honolulu, HI 96822
A PROTOCOL VIOLATION is any deviation or departure from the IRB-approved protocol that does not have prior approval by the IRB.
- Reporting Form for Protocol Violations (Word Document, rev. 12-28-2014)
Submit the Protocol Violation Report to the Human Studies Program via email at firstname.lastname@example.org AND delivery of a hard-copy with original signature to Human Studies Program, University of Hawaii at Manoa, 2425 Campus Road, Sinclair 10, Honolulu, HI 96822
Further guidance on completing these forms can be found under SOPs 101 and 104 HERE