{
    "document_id": 14917,
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    "source_run_id": 15031,
    "item_count": 12,
    "counts_by_type": {
        "heading": 4,
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    "items": [
        {
            "id": "p58.1",
            "order": 1,
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            "text": "on the review process. OSP staff will provide guidance to the IRB in cases where coordination is needed or where there are additional requirements."
        },
        {
            "id": "p58.2",
            "order": 2,
            "type": "heading",
            "bbox": {
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            "text": "8.2 Primary/Secondary Reviewers",
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            "text": "The IRB Chair in consultation with the HRPP specialist assigns a primary and secondary reviewer for each protocol in advance of each full Board meeting. All members, including the IRB Chair, may serve as a primary or secondary reviewer. In selecting the primary reviewer, consideration is given to the individual's knowledge of the subject area embodied in the proposal. The primary and secondary reviewers conduct an in-depth review of all items required for IRB submission of a new application, including informed consent/assent documents and all supplemental materials."
        },
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            "id": "p58.4",
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            "text": "The primary and secondary reviewers are encouraged to contact the IRB Chair and OSP staff in advance of the Board meeting to request any additional information or clarification. OSP staff may contact researchers to obtain any necessary additional information before the meeting. The primary reviewer will lead discussion of the project they were selected to review. The OSP staff member serving as the HRPP specialist will provide a checklist to primary and secondary reviewers to ensure that all criteria for approval of research have been fulfilled. The completed checklist will be returned to OSP staff so it can become part of the complete project file."
        },
        {
            "id": "p58.5",
            "order": 5,
            "type": "heading",
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            "text": "8.3 Assistance from Consultants",
            "attrs": {
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        },
        {
            "id": "p58.6",
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            "text": "If none of the IRB member has adequate knowledge or experience to review a given protocol, a consultant with appropriate expertise and experience may be engaged to assist with conducting the review. Consultants may include ad hoc scientific consultants, with expertise in the relevant area of research, or cultural consultants, with specialized knowledge of the population that are the focus of the study. All ad hoc or cultural consultants will have access to the same information in the IRB review process as voting IRB members. However, consultants will not vote on protocols."
        },
        {
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            "type": "heading",
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            "text": "8.4 Avoiding Conflicts of Interest",
            "attrs": {
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            "level": 3
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            "id": "p58.8",
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            "text": "No IRB member, including the primary and secondary reviewers, may participate in the review of any project in which the member has a conflict of interest or vote on any project in which the member has a conflict of interest. It is the responsibility of each IRB member to recuse themselves in cases of conflict of interest."
        },
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            "id": "p58.9",
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            "text": "IRB members may consult with the IRB Chair and OSP staff to determine if a conflict of interest exists. OSP staff will ensure that ad hoc or cultural consultants do not have a conflict of interest related to the project under review."
        },
        {
            "id": "p58.10",
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            "type": "heading",
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            "text": "8.5 Outcomes of Review",
            "attrs": {
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        },
        {
            "id": "p58.11",
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            "type": "text",
            "bbox": {
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            },
            "text": "An IRB member makes a motion, another member seconds the motion, and then the"
        },
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            "type": "text",
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            "text": "26",
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                "block_label": "number"
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