{
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            "text": "its continuing review functions, and any reminder notices regarding the need to do so from the OSP staff to investigators are a courtesy."
        },
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            "text": "Limits on Research after a Lapse",
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            "text": "If IRB approval lapses, all activities involving human subjects must stop after IRB approval expired, unless it is determined to be in the best interests of already enrolled subjects to continue participating in the research. The determination regarding whether it is in the best interests of already enrolled subjects to continue to participate in the research after IRB approval has expired may be made initially by the investigator, possibly in consultation with the subjects' treating physicians, psychologists or psychiatrists (if the investigator is not the subject's treating physician, psychologists or psychiatrists). The investigator should also submit a request for confirmation that the IRB agrees with this determination. Confirmation may be provided by the IRB Chair in consultation with OSP staff or other IRB members."
        },
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            "text": "Enrollment of new subjects cannot occur after the expiration of IRB approval. Continuing participation of already enrolled subjects in a research project during the period when IRB approval has lapsed may be appropriate, for example, when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects. This determination may be made for all enrolled subjects as a group or for each individual subject. If the investigator or IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects and obtaining or analyzing identifiable private information about human subjects."
        },
        {
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            "text": "When IRB approval of an ongoing research project lapses and the investigator wants to continue the project, the IRB should complete continuing review for the project as soon as possible. Investigators may resume the human subject research activity once continuing review and approval by the IRB has occurred. The IRB should document why the lapse in IRB approval occurred, and, if appropriate, any corrective actions that the investigator, institution, or IRB is taking to prevent any such lapse of approval of the project from occurring again in the future."
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            "text": "When IRB approval of an ongoing research project lapses and the IRB subsequently approves continuation of the project, the IRB may approve the project for one year and establish a new anniversary date for the expiration date of subsequent approval periods, or the IRB may approve the project for a period of less than one year so as to retain the original anniversary date on which prior approval periods expired."
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            "text": "Lapse in IRB Approval vs. Suspension or Termination of Approval",
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            "id": "p70.8",
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            "text": "When continuing review of a research project does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. Such expiration of IRB approval is not considered to be a suspension or termination of IRB approval."
        },
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            "text": "38",
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