{ "document_id": 16423, "page": 5, "width_pt": 612, "height_pt": 792, "rotation": 0, "pipeline_version": "paddleocr-vl-1.6+paul-48", "engine": "paddleocr_vl", "source_run_id": 16535, "item_count": 22, "counts_by_type": { "footer": 1, "heading": 5, "link": 10, "text": 6 }, "build_ms": 3, "items": [ { "id": "p5.1", "order": 1, "type": "heading", "bbox": { "l": 70.08, "t": 705.84, "r": 187.2, "b": 691.68 }, "text": "1.2 What is the IRB?", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p5.2", "order": 2, "type": "text", "bbox": { "l": 68.64, "t": 678.24, "r": 542.64, "b": 593.52 }, "text": "The IRB is an independent research review committee mandated by the U.S. Department of Health and Human Services (HHS). Federal regulations require each institution to implement human subject research regulations at its institution whenever its agents conduct research involving human subjects. The IRB and research activities by KSU faculty, staff, and students are subject to review by a variety of federal agencies; chief among them is the Office for Human Research Protections (OHRP).", "children": [ { "id": "p5.2.1", "order": 3, "type": "link", "bbox": { "l": 436.479, "t": 678.604, "r": 447.653, "b": 664.805 }, "text": "", "attrs": { "uri": "http://www.hhs.gov/", "action_type": "/URI" } }, { "id": "p5.2.2", "order": 4, "type": "link", "bbox": { "l": 282.993, "t": 664.805, "r": 290.827, "b": 651.006 }, "text": "", "attrs": { "uri": "http://www.hhs.gov/", "action_type": "/URI" } }, { "id": "p5.2.3", "order": 5, "type": "link", "bbox": { "l": 171.803, "t": 609.609, "r": 431.051, "b": 595.811 }, "text": "Office for Human Research Protections (OHRP).", "attrs": { "uri": "http://www.hhs.gov/ohrp/", "action_type": "/URI" } }, { "id": "p5.2.4", "order": 6, "type": "link", "bbox": { "l": 426.551, "t": 609.609, "r": 434.385, "b": 595.811 }, "text": "", "attrs": { "uri": "http://www.hhs.gov/ohrp/", "action_type": "/URI" } } ] }, { "id": "p5.3", "order": 7, "type": "heading", "bbox": { "l": 70.08, "t": 581.52, "r": 181.68, "b": 567.36 }, "text": "1.3 The OSP's Role", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p5.4", "order": 8, "type": "text", "bbox": { "l": 68.64, "t": 553.44, "r": 541.68, "b": 456 }, "text": "OSP staff plays a crucial role in facilitating training, education, and communication regarding human subjects, and ensures that the HRPP responds to a changing research environment and remains relevant and effective. OSP staff is responsible for convening the IRB, reviewing and renewing the IRB's registration with OHRP and Federal Wide Assurance, and assisting the IRB with the review of research. One OSP staff member will serve as the designated HRPP specialist and IRB administrator, and up to two staff members will serve as alternate IRB members, as outlined in sections 3.6 and 4.2." }, { "id": "p5.5", "order": 9, "type": "heading", "bbox": { "l": 69.84, "t": 443.52, "r": 231.12, "b": 428.88 }, "text": "1.4 Federal Wide Assurance", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p5.6", "order": 10, "type": "text", "bbox": { "l": 68.64, "t": 415.92, "r": 541.68, "b": 290.4 }, "text": "KSU's IRB is registered with the OHRP and maintains a single Federal Wide Assurance (FWA) that commits the institution to complying with federal regulations related to human research protection, including maintaining written procedures for the review of research involving human subjects. This assurance is applicable to all funded and non-funded research conducted or led by KSU personnel. It stipulates that research by KSU personnel will be guided by ethical principles and the Federal Policy for the Protection of Human Subjects, known as the \" Common Rule \" (or 45 CFR § 46 Subpart A), as well as all other Subparts of 45 CFR § 46, which concern protections for pregnant women, fetuses, neonates, prisoners, and children in research.", "children": [ { "id": "p5.6.1", "order": 11, "type": "link", "bbox": { "l": 243.727, "t": 375.029, "r": 303.592, "b": 361.23 }, "text": "assurance", "attrs": { "uri": "https://ohrp.cit.nih.gov/search/FwaDtl.aspx", "action_type": "/URI" } }, { "id": "p5.6.2", "order": 12, "type": "link", "bbox": { "l": 243.951, "t": 333.633, "r": 297.131, "b": 319.834 }, "text": "“Common", "attrs": { "uri": "http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html", "action_type": "/URI" } }, { "id": "p5.6.3", "order": 13, "type": "link", "bbox": { "l": 296.255, "t": 333.633, "r": 325.435, "b": 319.834 }, "text": "Rule”", "attrs": { "uri": "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html", "action_type": "/URI" } } ] }, { "id": "p5.7", "order": 14, "type": "heading", "bbox": { "l": 70.08, "t": 277.68, "r": 302.16, "b": 263.28 }, "text": "1.5 Guiding Documents and Regulations", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p5.8", "order": 15, "type": "text", "bbox": { "l": 68.88, "t": 250.8, "r": 541.92, "b": 179.52 }, "text": "KSU's HRPP is rooted in and guided by the ethical principles outlined in two key historical documents, the Nuremberg Code and Belmont Report. These documents became the foundation for the \"Common Rule\" and 45 CFR § 46. These documents and the federal regulations founded on them are essential references for the IRB, OSP staff, and all KSU personnel conducting research involving human subjects.", "children": [ { "id": "p5.8.1", "order": 16, "type": "link", "bbox": { "l": 255.478, "t": 237.041, "r": 266.652, "b": 223.242 }, "text": "", "attrs": { "uri": "http://www.hhs.gov/ohrp/archive/nurcode.html", "action_type": "/URI" } }, { "id": "p5.8.2", "order": 17, "type": "link", "bbox": { "l": 280.075, "t": 237.041, "r": 369.19, "b": 223.242 }, "text": "Belmont Report.", "attrs": { "uri": "https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html", "action_type": "/URI" } } ] }, { "id": "p5.9", "order": 18, "type": "heading", "bbox": { "l": 69.84, "t": 167.52, "r": 130.08, "b": 153.36 }, "text": "Definitions", "attrs": { "block_label": "paragraph_title" }, "level": 3 }, { "id": "p5.10", "order": 19, "type": "text", "bbox": { "l": 68.88, "t": 139.92, "r": 541.68, "b": 111.6 }, "text": "The policies and procedures herein adhere closely to 45 CFR § 46 and adopt the definitions of terms in 45 CFR § 46.102. These include the following definitions:", "children": [ { "id": "p5.10.1", "order": 20, "type": "link", "bbox": { "l": 186.469, "t": 126.65, "r": 282.357, "b": 112.852 }, "text": "45 CFR § 46.102.", "attrs": { "uri": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102", "action_type": "/URI" } } ] }, { "id": "p5.11", "order": 21, "type": "text", "bbox": { "l": 69.84, "t": 98.64, "r": 542.16, "b": 84.24 }, "text": "Human subject is defined as a living individual about whom an investigator (whether" }, { "id": "p5.12", "order": 22, "type": "footer", "bbox": { "l": 532.8, "t": 72.24, "r": 541.44, "b": 62.16 }, "text": "5", "attrs": { "block_label": "number" } } ], "excluded_furniture": { "first": [], "last": [] } }