{
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    "item_count": 11,
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        "heading": 3,
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    "items": [
        {
            "id": "p78.1",
            "order": 1,
            "type": "text",
            "bbox": {
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            "text": "provision of additional information about newly recognized risks to previously enrolled subjects."
        },
        {
            "id": "p78.2",
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            "text": "When reviewing a report of an unanticipated problem, the IRB may also determine that the incident, experience, or outcome does not meet all three criteria for an unanticipated problem. In such cases, further reporting to appropriate institutional officials, funding agencies, and/or OHRP would not be required."
        },
        {
            "id": "p78.3",
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            "text": "Once the IRB has reached a decision in response to an unanticipated problem, OSP staff will provide the investigator with a summary of the IRB's evaluation and decision in writing. OSP staff will be responsible for providing a report about any adverse event that qualifies as unanticipated problem to KSU's Provost (or an another official designated as KSU's Institutional Official for the purposes of the FWA) in cases in which the event is related to research participation, presents greater risk to human subjects, and exceeds the frequency of occurrence initially anticipated in the research. If applicable, the OSP staff will also provide a report about the event to the funding agency and OHRP."
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            "text": "XIII. REPORTING OF NONCOMPLIANCE",
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            "text": "The ethical conduct of research is a shared responsibility, requiring cooperation, collaboration, and trust among investigators, the participants who enroll in research, IRB members, and OSP staff. As the body responsible for ensuring the protection of the rights and welfare of research subjects at KSU, the IRB addresses allegations of noncompliance with IRB requirements and/or federal regulations."
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            "text": "Anyone, including research participants, may submit concerns or allegations having to do with noncompliance involving human subjects research to the OSP verbally or in writing. OSP staff and the IRB may also identify concerns regarding noncompliance during the continuing review process. The OSP and IRB will maintain confidentiality regarding the identity of the person submitting an allegation to the extent possible."
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        {
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            "text": "13.1 Clarification of Terms",
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            "type": "heading",
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            "text": "Noncompliance",
            "attrs": {
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            "level": 3
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            "text": "Noncompliance consists of any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with either the research plan as approved by the IRB, federal regulations, or institutional policies."
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            "id": "p78.10",
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            "text": "Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times. Noncompliance may result from the action of the participant, principal investigator, or staff and may involve a range of issues from relatively minor, administrative, or technical violations to more serious violations which pose risk to subjects and/or violations of their rights and welfare. Complaints or reports of noncompliance from someone other than the principal investigator are handled as allegations until such time that the report is validated or dismissed."
        },
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            "type": "text",
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            "text": "46",
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