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Reporting

The IRB chairperson shall ensure prompt reporting, within 30 days, to the IRB, appropriate College officials, the Office for Human Research Protections of the U.S. Department of Health and Human Services and any other appropriate entities of any unanticipated problems involving  risk to subjects or others, or any serious or continuing noncompliance with 45 CFR, Part 46, or the requirements or determinations of the IRB, or any suspension or termination of IRB approval.