Post-Approval Reporting
Researchers must comply with policies and procedures of the University of Minnesota and IRB when implementing reporting mechanisms to monitor the rights and welfare of participants enrolled in research.
Continuing Review
Researchers must report information concerning the progress and monitoring of their research study at the time of continuing review. Refer to the following link for additional guidance concerning the continuing review process:
Changes in Protocol
Researchers must report and seek prior approval for changes or modifications to their research study. Changes should not be implemented without IRB approval unless they are needed in order to eliminate an immediate hazard.
Unanticiapted Problems
Researchers must report information concerning unanticipated problems involving risk to subjects or others (UPIRTSO) within 10 business days. The following link provides detail concerning submission of UPIRTSO reports to the IRB:
Other
When appropriate, researchers should include additional reporting mechanisms in the research protocol beyond those described by local policies and procedures. Refer to the following websites for additional information regarding regulations and policies:
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