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doc14851 IRB_Modification_Form.pdf

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Page 1

30 item(s) JSON
footer (2) form_field (2) header (2) heading (5) link (4) table (1) table_cell (2) text (12)
Page 1
1 · HEADER
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4 · TABLE
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8 · HEADING
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10 · HEADING
11 · HEADING
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19 · HEADING
20 · TEXT
21 · TEXT
22 · TEXT
23 · TEXT
24 · TEXT
25 · TEXT
26 · FOOTER
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30 · FOOTER
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            "text": "Use this form to request IRB approval of the following:"
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            "text": "Proposed changes to your current IRB-approved protocol."
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            "text": "A proposed change which impacts an individual subject but does not change the overall protocol (i.e., exception and deviation)."
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            "text": "To report a change to the currently approved protocol which has already been implemented without prior IRB approval."
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            "text": "In emergency situations involving unanticipated problems involving risk to human subjects or others (contact ORI staff immediately at 502-597-6530)."
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            "text": "• Revise consent and assent forms, as needed, based on the proposed changes."
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            "text": "If you are adding new study personnel, confirm that all new members have completed the mandatory human-subject-protections CITI training BEFORE you submit your modification request."
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            "text": "Have the PI sign on the line provided at the top of the form (next page)."
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            "text": "• Attach two copies – one marked and one clean – of all documents affected by the modification (i.e., consent form). On the track-changes copy, underline or highlight each change being made."
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            "text": "Allow ample time for processing this modification request. NOTE: changes may not be implemented prior to receiving IRB approval."
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Page 2

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1 · HEADER
2 · HEADER
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5 · TEXT
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8 · FIGURE
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Page 3

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Page 4

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            "text": "Proposed Revision: add Jane Doe, MD, as co-investigator. Dr. Doe has completed human-subject-protections training, is a new faculty member who will work with subjects on this protocol, and is authorized to obtain consent."
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