{
    "document_id": 16423,
    "page": 29,
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    "item_count": 10,
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        "footer": 1,
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    "items": [
        {
            "id": "p29.1",
            "order": 1,
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            "bbox": {
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            "text": "concerns or questions to be discussed."
        },
        {
            "id": "p29.2",
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            "text": "DISAPPROVED. In the case of disapproval, OSP staff generates a letter describing the reasons for disapproving the protocol and provides it to the researcher. A study may be disapproved if the IRB has enough information to make the necessary determinations of approval in line with the federal criteria but believes the research protocol does not meet the criteria and is unable to provide suggested changes."
        },
        {
            "id": "p29.3",
            "order": 3,
            "type": "heading",
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            "text": "8.6 Approval Periods",
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        {
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            "text": "During the convened meeting, the IRB determines the approval period, as appropriate to the degree of risk but not less frequently than once per year for research retaining full Board review status. The IRB may set a shorter approval period for high-risk protocols or protocols with high risk/low potential benefit ratios. The approval start date is the date on which the protocol receives final approval from the IRB. The beginning and end date of the approval period will be provided in the approval letter and any stamps placed on informed consent documents."
        },
        {
            "id": "p29.5",
            "order": 5,
            "type": "heading",
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            "text": "8.7 Appeal Process",
            "attrs": {
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            "level": 3
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            "id": "p29.6",
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            "text": "If a researcher has concerns regarding an IRB decision, changes that the IRB has requested in a research protocol, or any other aspect of the submission and review process, the researcher may submit a formal appeal. The appeal will involve providing a letter to the OSP staff with a request for a change in the IRB's decision or processes and a justification for why the change is needed. The OSP staff will then submit the letter to the IRB and any additional materials needed for a full consideration of the appeal. The full IRB will consider and vote on a response to the appeal at the next scheduled meeting of the IRB. The IRB will provide the individual who submitted the appeal a letter notifying them of the IRB's response to the appeal and an explanation for the response. The IRB Chair should sign the letter."
        },
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            "id": "p29.7",
            "order": 7,
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            "text": "However, the IRB may not vote to approve an ad hoc change in the submission and review processes that contravenes written policies and procedures. If a change in policies and procedures is needed, the IRB may vote to begin the process of revising policies and procedures, in consultation with OSP staff, and obtaining approvals for amended policies, as needed, from the Provost, President, and Board of Regents."
        },
        {
            "id": "p29.8",
            "order": 8,
            "type": "heading",
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            },
            "text": "IX. INITIAL EXPEDITED REVIEW",
            "attrs": {
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        },
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            "id": "p29.9",
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            "type": "text",
            "bbox": {
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            "text": "Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. Federal regulations make provisions for certain categories of research to be reviewed through an expedited procedure if the research involves no more than minimal risk. Expedited review is intended to enable the institution to conserve administrative resources, provide timely reviews, and focus the convened meetings of the IRB on those research activities involving greater risks or ethical complexities. The IRB may also use the expedited review"
        },
        {
            "id": "p29.10",
            "order": 10,
            "type": "footer",
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            },
            "text": "29",
            "attrs": {
                "block_label": "number"
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