Who determines the procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB?

Who determines the procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB?

• A. The IRB
• B. The institution in its written policies and procedures
• C. The individual investigator
• D. Federal guidelines

Answer: (B)

The procedures for reporting potential unanticipated problems to the IRB are set by the institution through its written policies and procedures. Institutions develop standard operating procedures that specify what must be reported, who reports it, to whom, the format and content of the report, and the timelines for notification. These policies ensure consistency across studies and align with federal requirements. Federal guidelines require that researchers report unanticipated problems to the IRB and outline general expectations, but they do not dictate the exact internal process a given institution must use. The investigator follows the institution’s procedures rather than determining them. The IRB reviews and acts on reports in accordance with those established procedures, not by creating them anew for each study.

The procedures for reporting potential unanticipated problems to the IRB are set by the institution through its written policies and procedures. Institutions develop standard operating procedures that specify what must be reported, who reports it, to whom, the format and content of the report, and the timelines for notification. These policies ensure consistency across studies and align with federal requirements.

Federal guidelines require that researchers report unanticipated problems to the IRB and outline general expectations, but they do not dictate the exact internal process a given institution must use. The investigator follows the institution’s procedures rather than determining them. The IRB reviews and acts on reports in accordance with those established procedures, not by creating them anew for each study.