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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 reviewed by a convened meeting, depending on the nature of the problem."
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            "text": "OHRP guidance indicates that when reviewing a report of an unanticipated problem, the IRB should consider whether the affected research protocol still satisfies the requirements for IRB approval. In particular, the IRB should consider whether risks to subjects are still minimized and reasonable in relation to the anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. At the conclusion of its review, the IRB may require that corrective actions be taken or that substantive changes be made to a protocol."
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            "text": "Examples of corrective actions or substantive changes that the IRB may consider in response to an unanticipated problem include: changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects; modification of inclusion or exclusion criteria; implementation of additional procedures for monitoring subjects; suspension of enrollment of new subjects; suspension of research procedures in currently enrolled subjects; modification of informed consent documents to include a description of newly recognized risks; and"
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            "text": "45",
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