The procedures for reporting potential unanticipated problems involving risk to subjects or others to the irb are

Determined by the institution in its written policies and procedures

Hope this helps.

Iam a german monk and professor of theology. i believe that the catholic church's practice of buying forgiveness of sins through indulgences is wrong. i have translated the bible into german to make it easier for more people to be able to study it. i am here to stand by my writings and i refuse your demand that i recant them