717. Notification Requirements for IRB Findings of Serious or Continuing Noncompliance

For all incidents determined by the fully convened IRB to be serious or continuing noncompliance or both, the IRB will notify the following individuals within seven business days of the IRB's decision:

·        Principal investigator

·        Faculty Advisor, as applicable,

·        Responsible Official (e.g., chair, dean or director) for the research, and

·        Institutional Official (i.e., the Vice President for Research).

Within 30 days of its decision, the IRB will notify as applicable:

·        University Office of Sponsored Projects,

·        DHHS OHRP,

·        FDA,

·        the funding agency, and

·        for research in which other institutions are engaged in the research, the HRPP Administrator and IRB Chairs of those institutions.

PI Notification of IRB Determination and Confirmation of Completion of IRB Required Actions

The report to the principal investigator will include the IRB's determination and required actions.

Within 30 days of receiving the notification from the IRB, the investigator must provide the QI Officer with confirmation that all actions required by the IRB have been implemented.

The QI Officer will send the principal investigator an acknowledgement that the implementation confirmation has been received.

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