Question

After the start of the study, the PI reports to the IRB that, as expected, one of the children became upset. The incident was handled according to the protocol and the child is fine. What should the IRB do with regard to this report?

Answer 1

Since the incident was handled according to protocol, The IRB should let the PI know it is okay to continue the study. The IRB will keep a close eye on the study to make sure another similar situation does not happen again.