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            "text": "or recognized? It the answer to all three questions is yes, then the adverse event is an unanticipated problem and must be reported to appropriate entities."
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            "text": "For further clarifications as to whether or not a particular adverse event is an unanticipated problem that requires reporting, researchers should consult the OHRP guidance."
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            "text": "12.2 Types of Unanticipated Problems",
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            "text": "The following are situations that may meet OHRP's definition of unanticipated problems involving risks to subjects or others and should be reported:"
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                    "text": "Any serious accidental or unintentional change to the IRB-approved protocol that involves risk or has the potential to recur.",
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                    "text": "Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research subject.",
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                    "text": "Any publication, safety monitoring report, interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research.",
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                    "text": "Any breach in confidentiality that may involve risk to the subject or others.",
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                    "text": "Any complaint of a subject that indicates an unanticipated risk.",
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            "text": "12.3 Procedures for Reporting and Responding to Reports",
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            "text": "According to OHRP guidance, an investigator should include the following information when reporting an adverse event or any other incident, experience, or outcome as an unanticipated problem to the IRB:"
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                    "text": "appropriate identifying information for the research protocol, such as the title, investigator's name, and the IRB project number.",
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                    "text": "a detailed description of the adverse event, incident, experience, or outcome.",
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                    "text": "an explanation of the basis for determining that the adverse event, incident, experience, or outcome represents an unanticipated problem.",
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                    "text": "a description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem.",
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            "text": "Once the report is ready, the investigator should submit it to the OSP, and OSP staff will in turn immediately provide the report to IRB members. After the IRB receives a report of an unanticipated problem involving risk to subjects or others, the IRB Chair in consultation with other IRB members and OSP staff will evaluate and make a decision on the reported event as quickly as possible. The IRB Chair may recommend that the problem be"
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