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 an organization's policies and procedures.
The policies and procedure stated or written by a company determines how risk to subject problems are reported to the IRB. The harm could range from economic to physical to psychological, etc. These problems must be reported within 14days of learning about the problem by the investigator.
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