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Unanticipated problems involving risk to subjects or others need to be reported to the Human Subjects Protection Program office within10 business days of the occurrence. An unanticipated problem that requires reporting is unanticipated in nature, frequency or severity; related or possibly related to participation in the research; and suggests that the research places subjects or others at a greater risk of harm. Unanticipated problems also need be reported to the College of Nursing Associate Dean for Research.
- Complete the Unanticipated Problem Report Form. This can be found at http://www.irb.arizona.edu/.
- Submit the completed form via e-mail to Alice Pasvogel (Office of Nursing Research) at pasvogel@nursing.arizona.edu.
The Principal Investigator will be notified if additional information is needed.
- The Office of Nursing Research will send the documents to the University of Arizona Human Subjects Protection Program.
Deviations /Violation/Non-Compliance
Failure to comply with Federal regulations, IRB policy, the determination or requirements of the IRB or the requirements of VA guidance is considered to be non-compliance. This includes protocol deviations, protocol violations, use of unapproved consent instruments, incomplete documentation of informed consent, use of unapproved translations of previously approved consent documents or study materials, use of unapproved recruitment, etc. Non-compliance must be reported to the Human Subjects Protection Program within 10 business days of knowledge of the occurrence. Non-compliance also needs be reported to the College of Nursing Associate Dean for Research.
- Complete the Deviation/Violation/Non-Compliance Report Form. This can be found at http://www.irb.arizona.edu/.
- Submit the completed form via e-mail to Alice Pasvogel (Office of Nursing Research) at pasvogel@nursing.arizona.edu.
Include a copy of all revised/new documents (consent documents, etc). Highlight the changes to the revised forms and include a clean copy of consenting documents for approval stamp.
The Principal Investigator will be notified if additional information is needed.
- The Office of Nursing Research will send the documents to the University of Arizona Human Subjects Protection Program.
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