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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.

An Unanticipated Problem Report may be submitted to the Human Studies Program by email at uhirb@hawaii.edu 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.

Submit the Protocol Violation Report to the Human Studies Program via email at uhirb@hawaii.edu 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