{
    "document_id": 14917,
    "page": 57,
    "width_pt": 612,
    "height_pt": 792,
    "rotation": 0,
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    "engine": "paddleocr_vl",
    "source_run_id": 15031,
    "item_count": 11,
    "counts_by_type": {
        "heading": 2,
        "text": 9
    },
    "build_ms": 2,
    "items": [
        {
            "id": "p57.1",
            "order": 1,
            "type": "text",
            "bbox": {
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            },
            "text": "involvement or consenting of human participants, or the use of statistical methods."
        },
        {
            "id": "p57.2",
            "order": 2,
            "type": "text",
            "bbox": {
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            "text": "The IRB must be concerned about potential for biased judgment or other abuse when IRB members and researchers have a financial obligation or interest that may pose a conflict of interest which competes with the obligation to protect the rights and welfare of human subjects. In cases where there may be a potential financial conflict of interest, the IRB will refer to KSU's policies regarding conflicts of interest. The IRB may request additional information and revisions of protocols to address conflicts of interest."
        },
        {
            "id": "p57.3",
            "order": 3,
            "type": "heading",
            "bbox": {
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            },
            "text": "VIII. INITIAL FULL BOARD REVIEW",
            "attrs": {
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            },
            "level": 3
        },
        {
            "id": "p57.4",
            "order": 4,
            "type": "text",
            "bbox": {
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            "text": "The IRB will review research protocols requiring full Board review at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concern is in a nonscientific area."
        },
        {
            "id": "p57.5",
            "order": 5,
            "type": "heading",
            "bbox": {
                "l": 69.6,
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            },
            "text": "8.1 Procedures",
            "attrs": {
                "block_label": "paragraph_title"
            },
            "level": 3
        },
        {
            "id": "p57.6",
            "order": 6,
            "type": "text",
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            "text": "Researchers seeking a full Board review of a project will submit an application package to the OSP at least one month before a scheduled meeting. In turn, OSP staff will conduct a preliminary screening of the application package, and once the screening has been completed and any issues with the screening have been addressed, OSP staff will provide the application package to the IRB at least one week before the meeting."
        },
        {
            "id": "p57.7",
            "order": 7,
            "type": "text",
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            "text": "A primary/secondary reviewer system will be used for new applications reviewed by the convened IRB. However, all IRB members will review all information on the agenda in advance of the meeting (including those protocols for which the IRB member is not the primary reviewer) to be familiar with the protocol, to be prepared to discuss the protocol at the meeting, and to be prepared to determine whether the research meets the regulatory criteria for approval."
        },
        {
            "id": "p57.8",
            "order": 8,
            "type": "text",
            "bbox": {
                "l": 68.4,
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                "r": 542.16,
                "b": 234.96
            },
            "text": "The full review of research must be substantive and meaningful with a recorded vote for, against, abstentions, and recusals from each study. The minutes of IRB meetings should document with sufficient detail the deliberations, actions, and votes for each protocol undergoing review by the convened IRB, in addition to a written summary of the discussion of issues related to each application and their resolution."
        },
        {
            "id": "p57.9",
            "order": 9,
            "type": "text",
            "bbox": {
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            "text": "Review by the full Board at a convened meeting is warranted in circumstances such as the following: the research protocol involves more than minimal risk of harm to subjects, which can include physical, emotional, social, psychological, or financial risks; a certificate of confidentiality is requested; the research involves recruitment of vulnerable populations; and/or a conflict of interest or potential conflict of interest exists."
        },
        {
            "id": "p57.10",
            "order": 10,
            "type": "text",
            "bbox": {
                "l": 68.64,
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                "r": 542.64,
                "b": 82.56
            },
            "text": "OSP staff will be responsible for determining if the review of a protocol requires coordination with other University committees or consideration of additional federal regulations and requirements other than those contained in 45 CFR § 46. For example, the agency funding a project may have additional requirements that will have an impact"
        },
        {
            "id": "p57.11",
            "order": 11,
            "type": "text",
            "bbox": {
                "l": 526.32,
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                "b": 61.68
            },
            "text": "25",
            "attrs": {
                "block_label": "number"
            }
        }
    ],
    "excluded_furniture": {
        "first": [],
        "last": []
    }
}