Suspension or Termination of Approval of Research Activities:
The IRB Chairperson may suspend a study at any point after receiving information regarding unacceptable and uncorrectable levels of risk or harm to the participants or others or serious disregard on the part of the researcher to the policiy and requirements of the IRB. The Chairperson will promptly notify the PI(s), as well as the OSRP, in writing of this decision and the reason(s) for suspension of approval. The OSRP will notify OHRP and funding agency (if applicable) of the suspension or termination of approval.
Furthermore, the IRB Chairperson will convene a meeting of the IRB to discuss the suspension of IRB approval and the IRB will decide whether (1) IRB approval should be reinstated with or without modifications, (2) suspension of IRB approval should be continued, or (3) IRB approval should be terminated. The PI will be informed, in writing, of the outcome of the IRB meeting.
Reporting of Problems or Noncompliance:
The IRB Chairperson will keep the OSRP informed of reports by PIs or others of unanticipated problems involving risk to participants or others, adverse effects, serious or continuing noncompliance, and suspension or termination of IRB approval. The OSRP will notify appropriate PIs Department Head, University Administrative officials, OHRP, and funding agency (if applicable) of unanticipated problems involving risk to participants or others, unanticipated adverse effects, serious adverse effects that may have been expected, serious or continuing noncompliance, and the IRB suspension or termination of approval for research activities.