{
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            "text": "research at intervals appropriate to the degree of risk, but not less frequently than once per year. The IRB should decide the frequency of continuing review for each study protocol necessary to ensure the continued protection of the rights and welfare of research subjects. The IRB may set a shorter approval period for protocols that they have determined are high-risk or have a high risk to potential benefit ratio. The IRB should consider the following factors in determining the frequency of review: the nature of the study; the degree of risk involved; and the vulnerability of the study subject population."
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            "text": "10.4 Lapses in IRB Approval",
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            "text": "Continuing review of research must occur at intervals appropriate to the degree of risk but not less frequently than once per year. A lapse in IRB approval of research occurs whenever an investigator has failed to provide continuing review information to the IRB or the IRB has not conducted continuing review and re-approved the research, with or without conditions, by the expiration date of IRB approval. The investigator and IRB should plan ahead to ensure that continuing review and approval of research occurs prior to the end of the approval period specified by the IRB. However, it is the responsibility of investigators to provide in a timely manner the information needed by the IRB to perform 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"
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