{
    "document_id": 14917,
    "page": 48,
    "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": "p48.1",
            "order": 1,
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            "bbox": {
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            "text": "Researchers seeking a determination of exempt status will complete an application for exemption and submit to the OSP. The HRPP specialist or another OSP staff member designated as alternate IRB member are the primary reviewers tasked with making exemption determinations. OSP staff may assign submissions to the IRB Chair or another IRB member to assist with or conduct the exemption review as needed or if specific expertise is required. OSP staff members who have a conflict of interest related to a specific application should assign the application to another reviewer."
        },
        {
            "id": "p48.2",
            "order": 2,
            "type": "text",
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            "text": "Following review, the IRB reviewer will make one of the following recommendations, and OSP will notify the researchers of the IRB reviewer's decision by email:"
        },
        {
            "id": "p48.3",
            "order": 3,
            "type": "text",
            "bbox": {
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            "text": "APPROVED. IRB approval indicates that the IRB reviewer(s) concluded the research protocols meet the federal criteria for approval. OSP staff process the determination and the researcher is provided with an approval letter and, if applicable and practicable, stamped informed consent/assent documents."
        },
        {
            "id": "p48.4",
            "order": 4,
            "type": "text",
            "bbox": {
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                "r": 542.16,
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            "text": "REVISIONS and/or ADDITIONAL INFORMATION REQUIRED. The IRB reviewer(s) withhold approval pending submission of revisions or additional information. OSP provides the request for revisions to the researcher, and the researcher responds and re-submits the application within 90 days of receiving the requested revisions."
        },
        {
            "id": "p48.5",
            "order": 5,
            "type": "text",
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            "text": "EXPEDITED or FULL REVIEW REQUIRED. The IRB reviewer may determine the protocol requires expedited or full review by the IRB."
        },
        {
            "id": "p48.6",
            "order": 6,
            "type": "text",
            "bbox": {
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            "text": "When the IRB has certified a project as exempt, the IRB does not require continuation or annual administrative reviews. The exemption approval can be in effect for up to three years. After three years, if the research is still ongoing, researchers are required to submit a new application for determination of exempt status."
        },
        {
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            "text": "The IRB or OSP staff will not consider any research exempt that involves prisoners, sensitive aspects of subject's behavior, sensitive surveys, or that takes place in settings where subjects have a reasonable expectation of privacy. The IRB or OSP staff will also not consider any research exempt that involves survey or interview procedures involving children or observations of public behavior of children, except for observations of public behavior when the principal investigator does not participate in the activities being observed. Furthermore, in most cases, the IRB or OSP staff will not consider any research exempt that involves a test article regulated by the FDA."
        },
        {
            "id": "p48.8",
            "order": 8,
            "type": "text",
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            "text": "At the time the protocols are deemed to be exempt, researchers will be reminded of the responsibility to report all modifications to protocols and unanticipated problems involving risks to subjects or others in accordance with the policies and procedures herein regarding protocol modifications and unanticipated problems."
        },
        {
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            "order": 9,
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            },
            "text": "VII. IRB REVIEW CONSIDERATIONS",
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        },
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            },
            "text": "7.1 Criteria for IRB Approval",
            "attrs": {
                "block_label": "paragraph_title"
            },
            "level": 3
        },
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            "type": "text",
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                "b": 61.44
            },
            "text": "16",
            "attrs": {
                "block_label": "number"
            }
        }
    ],
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        "first": [],
        "last": []
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