The procedures for reporting potential unanticipated problems involving risk to subjects or others to the irb are: stated in the human subject protection regulations, but not in the drug or device regulationsincluded in the consent processdetermined by research staffdetermined by the institution in its written policies and procedures

Determined by the institution in its written policies and procedures

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Unanticipated problems including dangers to subjects or others. In the event that the occasion speaks to a UPIRSO, answering to the IRB must happen within 7 days if in light of interior data and 14 days if in view of outer data. OHRP considers unfriendly occasions that are startling, related or perhaps identified with investment in research, and genuine to be the most critical subset of antagonistic occasions speaking to unforeseen issues