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            "text": "on the IRB-approved protocol, this would represent a violation of the requirement that all changes in research not be initiated without IRB review and approval except when necessary to eliminate immediate risks or hazards to the subjects. If over enrollment occurs, the research must address why additional subjects were enrolled. The IRB will offer guidance on how data obtained from over enrollment may be used."
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            "text": "In addition, if relevant to the project, the IRB should receive and review information regarding the number of subjects who discontinued their participation and a summary of the reasons for the withdrawals, if known. IRB review of this information may shed light on problems related to the conduct of the research. For example, a high rate of subject withdrawal may indicate that the risks of the research are greater than expected and may lead the IRB to conclude that the research should not be approved for continuation. In addition, as with a lower-than-expected enrollment rate, if there is a higher-than-expected rate of subject withdrawal, it may not be ethical to continue exposing subjects to the risks of the research because the project may not provide sufficient data to answer the scientific question. An IRB may recommend that the reasons behind the high withdrawal rate be explored by the investigator and appropriate steps taken to remedy the situation. In the absence of an adequate plan to remediate a high withdrawal rate, the IRB may determine that the research should not be approved for continuation."
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            "text": "Verifications from Outside Sources",
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            "text": "Investigators are expected to provide the IRB with all relevant information regarding the conduct of the research. In order to ensure that no material changes occurred during the IRB designated approval period, the IRB may require verification of information from sources other than the investigator. Such independent verification may be considered in the following:"
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                    "text": "Complex protocols involving unusual levels or types of risks to subjects;",
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                    "text": "Protocols conducted by Pls who previously have failed to comply with federal regulations or the requirements or determinations of the IRB;",
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                    "text": "Protocols where concern about possible material changes occurring without IRB approval have been raised based on information provided in continuing review reports or from other sources.",
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            "text": "The IRB will determine which projects need verification from sources other than the investigators regarding material changes on a case-by-case basis. When the IRB finds the need for independently verified information, it will notify the investigator in writing. The IRB will not give final approval for a protocol until it has received and reviewed the independently verified information and found it to be satisfactory."
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            "text": "Frequency of Continuing Review",
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            "text": "In accordance with federal regulations, the IRB must conduct continuing review of"
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            "text": "38",
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