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    "item_count": 18,
    "counts_by_type": {
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    "items": [
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            "id": "p53.1",
            "order": 1,
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            "bbox": {
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            },
            "text": "with KSU on the study."
        },
        {
            "id": "p53.2",
            "order": 2,
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            "text": "XV. RECORDS AND DOCUMENTATION",
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            "text": "15.1 General Requirements",
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            "text": "The OSP will be responsible for IRB records in accordance with 45 CFR § 46.115, which states that the University is required to prepare and maintain documentation of IRB activities including the following:",
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                    "text": "45 CFR § 46.115,",
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                    "text": "Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.",
                    "marker": "1."
                },
                {
                    "id": "p53.5.2",
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                    "text": "Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.",
                    "marker": "2."
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                    "text": "Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review.",
                    "marker": "3."
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                    "text": "Copies of all correspondence between the IRB and the investigators.",
                    "marker": "4."
                },
                {
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                    "order": 11,
                    "type": "list_item",
                    "bbox": {
                        "l": 86.64,
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                    "text": "A list of IRB members in the same detail as described in 45 CFR § 46.108(a)(2).",
                    "marker": "5."
                },
                {
                    "id": "p53.5.6",
                    "order": 12,
                    "type": "list_item",
                    "bbox": {
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                    "text": "Written procedures for the IRB in the same detail as described in 45 CFR § 46.108(a)(3) and (4).",
                    "marker": "6."
                },
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                    "text": "Statements of significant new findings provided to subjects, as required by 45 CFR § 46.116(c)(5).",
                    "marker": "7."
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                    "text": "The rationale for an expedited reviewer's determination under 45 CFR § 46.110(b)(1)(i) that research appearing on the expedited review list described in 45 CFR § 46.110(a) is more than minimal risk.",
                    "marker": "8."
                },
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                    "text": "Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in 45 CFR § 46.103(e).",
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            "text": "15.2 Minutes of IRB Meetings",
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            "order": 17,
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            "text": "The minutes of IRB meetings should document, among other things: separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB; the vote on all IRB actions including the number of members voting"
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            "id": "p53.8",
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            "type": "footer",
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            "text": "53",
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