Monitoring/Reporting Requirements in On-Going Research

The Principal Investigator is responsible for reporting promptly to the IRB on the following situations:

• Adverse Events. A report, in writing, should be made as soon as possible regarding any unanticipated injuries or other problems involving risks to subjects and others.
• Changes in Protocol. Any changes in the approved research protocol with respect to human subjects should be communicated in writing. Proposed changes should not be initiated without IRB review and approval.

Reports should submitted through Mentor IRB. You may access Mentor IRB from your my.fordham.edu account by clicking on the Institutional Review Board button located on the bottom of the Employee tab or the lower-right hand side of the Student tab.