{ "document_id": 14917, "page": 61, "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": 13, "counts_by_type": { "heading": 2, "link": 2, "list": 1, "list_item": 2, "text": 6 }, "build_ms": 2, "items": [ { "id": "p61.1", "order": 1, "type": "text", "bbox": { "l": 68.88, "t": 719.76, "r": 543.12, "b": 662.4 }, "text": "of conflict of interest, or for any other reason, the Chair will approach another IRB member to complete the review. Consultants may assist the IRB Chair and other IRB members in making decisions in expedited review, but expedited review cannot be performed solely by persons who are not voting members of the IRB." }, { "id": "p61.2", "order": 2, "type": "text", "bbox": { "l": 68.4, "t": 650.4, "r": 542.16, "b": 510.96 }, "text": "Expedited reviewers only approve research that meets the federal criteria for approval. Also, expedited reviewers ensure that the study's informed consent process and documentation meet the requirements as specified in 45 CFR § 46.116 and 21 CFR § 50.25. Expedited reviewers exercise all the authority of the IRB in completing their review, except that the reviewers may not disapprove research. A research activity may be disapproved only after full Board review. Expedited reviewers should take into account any protective measures included in the research design as part of the process of determining if the proposed research involves no more than minimal risk. However, some social and behavioral studies involve more than minimal risk, even though they include such protective measures." }, { "id": "p61.3", "order": 3, "type": "text", "bbox": { "l": 68.88, "t": 499.2, "r": 542.16, "b": 442.32 }, "text": "The expedited reviewer, with input from other IRB members and OSP staff as applicable, provides feedback for any clarification needed and documents the issues discussed on a reviewer checklist provided by OSP staff. The expedited reviewer records their determinations on the checklist and returns it to OSP staff." }, { "id": "p61.4", "order": 4, "type": "text", "bbox": { "l": 68.4, "t": 429.6, "r": 542.88, "b": 359.04 }, "text": "OSP will provide an updated list of research protocols approved under the expedited review procedure to the IRB at each scheduled meeting, and all IRB members will have access to all files containing expedited review applications and decisions. Any IRB member may request additional information from the Chair or OSP staff regarding the expedited determination of any particular protocol." }, { "id": "p61.5", "order": 5, "type": "heading", "bbox": { "l": 69.6, "t": 347.28, "r": 306.72, "b": 332.64 }, "text": "9.2 HHS Guidelines for Expedited Review", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p61.6", "order": 6, "type": "text", "bbox": { "l": 68.88, "t": 318.96, "r": 541.68, "b": 276.72 }, "text": "In accordance with 45 CFR § 46.110, HHS has established guidelines regarding the applicability of expedited review and categories of research that are eligible for expedited review. These guidelines are posted on the HHS website and are as follows:", "children": [ { "id": "p61.6.1", "order": 7, "type": "link", "bbox": { "l": 178.91, "t": 319.83, "r": 280.56, "b": 306.04 }, "text": "45 CFR § 46.110,", "attrs": { "uri": "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html%2346.110", "action_type": "/URI" } }, { "id": "p61.6.2", "order": 8, "type": "link", "bbox": { "l": 301.89, "t": 292.24, "r": 375.75, "b": 278.44 }, "text": "HHS website", "attrs": { "uri": "https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html", "action_type": "/URI" } } ] }, { "id": "p61.7", "order": 9, "type": "heading", "bbox": { "l": 70.08, "t": 264, "r": 137.52, "b": 248.64 }, "text": "Applicability", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p61.8", "order": 10, "type": "list", "bbox": { "l": 86.64, "t": 236.4, "r": 542.16, "b": 96.96 }, "text": "", "attrs": { "item_count": 2 }, "children": [ { "id": "p61.8.1", "order": 11, "type": "list_item", "bbox": { "l": 86.64, "t": 236.4, "r": 542.16, "b": 124.56 }, "text": "Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.", "marker": "A." }, { "id": "p61.8.2", "order": 12, "type": "list_item", "bbox": { "l": 86.64, "t": 112.08, "r": 541.2, "b": 96.96 }, "text": "The categories in this list apply regardless of the age of subjects, except as noted.", "marker": "B." } ] }, { "id": "p61.9", "order": 13, "type": "text", "bbox": { "l": 526.32, "t": 72.48, "r": 541.2, "b": 61.68 }, "text": "29", "attrs": { "block_label": "number" } } ], "excluded_furniture": { "first": [], "last": [] } }