What does the IRB do with Report Forms after they are submitted?
Question
What does the IRB do with Report Forms after they are submitted?
Answer
The OPRS director or designated reviewer will conduct an initial review of all reports that are submitted. If it is determined in the initial review that this report may represent an unanticipated problem involving risk to participants or others or may represent serious or continuing non-compliance, then the convened IRB will review the report to make a final determination.
All reports requiring the convened IRB for review will be assigned to the next available meeting.