{
    "document_id": 14917,
    "page": 59,
    "width_pt": 612,
    "height_pt": 792,
    "rotation": 0,
    "pipeline_version": "paddleocr-vl-1.6+paul-48",
    "engine": "paddleocr_vl",
    "source_run_id": 15031,
    "item_count": 8,
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        "text": 7
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    "items": [
        {
            "id": "p59.1",
            "order": 1,
            "type": "text",
            "bbox": {
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            "text": "convened IRB votes for, against, or abstains from one of the following five actions:"
        },
        {
            "id": "p59.2",
            "order": 2,
            "type": "text",
            "bbox": {
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            "text": "APPROVED. IRB approval indicates the IRB has concluded that the research and consent/assent forms meet the federal criteria for approval. IRB approval verifies that the IRB agrees with the assessment of the protocol and/or specific findings as described in the application. OSP staff process the approval, and the researcher is provided with an approval letter and, if applicable and practicable, stamped informed consent/assent documents."
        },
        {
            "id": "p59.3",
            "order": 3,
            "type": "text",
            "bbox": {
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            "text": "MINOR REVISIONS and/or ADDITIONAL INFORMATION REQUIRED. This decision indicates that the IRB has approved the protocol pending submission of minor revisions and that the IRB has given the primary reviewer the authority to approve the minor revisions. OSP staff generates an email requesting revisions and returns the submission to the investigator. The investigator responds to the IRB's suggested revisions, making relevant changes in the application and re-submits to the OSP. OSP staff then provides the revised application to the primary reviewer. The reviewer may defer the response to a convened meeting for review by the full IRB, request additional information, or approve the protocol."
        },
        {
            "id": "p59.4",
            "order": 4,
            "type": "text",
            "bbox": {
                "l": 68.4,
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            "text": "TABLED. This decision indicates that the IRB withholds approval pending submission of major revisions and additional information. OSP staff drafts a letter and returns the submission to the investigator, outlining the reasons for tabling the protocol, and includes a description of the revisions or clarifications requested. For some studies, the IRB may appoint one or more members of the IRB to discuss the reasons with the investigator. In cases where the IRB decides to table discussion of an application, the IRB may also vote to invite the researcher requesting approval to a future meeting of the IRB in which the researcher will discuss or answer IRB concerns or questions. OSP will be responsible for extending the invitation to the researcher to attend the meeting and providing a list of the concerns or questions to be discussed."
        },
        {
            "id": "p59.5",
            "order": 5,
            "type": "text",
            "bbox": {
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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."
        },
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            "id": "p59.6",
            "order": 6,
            "type": "heading",
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            "text": "8.6 Approval Periods",
            "attrs": {
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            "level": 3
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            "id": "p59.7",
            "order": 7,
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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."
        },
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            "order": 8,
            "type": "text",
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            "text": "27",
            "attrs": {
                "block_label": "number"
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        }
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