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            "text": "the subject, the principal investigator is required to notify the IRB of the change(s) within 48 hours. The IRB will review at the next convened meeting to determine if the change(s) instituted were consistent with the subject's continued welfare."
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            "text": "11.2 Minor Modifications",
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            "text": "Regulations permit the use of expedited procedures for review of minor changes to previously approved research during the period for which the approval is authorized. Modifications that alter the risk/benefit ratio so that risks are increased or benefits are decreased shall be reviewed at a convened meeting. Investigators are encouraged to contact the IRB Chair and the OSP staff with any questions prior to submitting a modification request if uncertain about the review type required."
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            "text": "Minor changes have no substantive effect upon an approved protocol or present no change to or reduce the risk to the subject. Examples of minor changes are: changes in research personnel that do not alter the competence of the research team; scientific or therapeutic changes that leave the research population at the same or lower risk than risk(s) already approved; changes in research procedures that have a minor impact on risks to human subjects; an increase in the number of study visits for the purpose of increased safety monitoring; changes to improve the clarity of research statements, enhance comprehension, to correct typographical errors, or to update templates, without altering the content or intent of the statement; clarification of discrepancies within the IRB materials submitted for initial review, such as discrepancies regarding the numbers of subjects, number and identity of research sites, and timing, nature, and duration of research procedures."
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            "text": "11.3 Major Modifications",
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            "text": "Major changes are changes that may increase the risk to human subjects or raise new questions concerning risks to human subjects. Examples of major changes that may increase the risk to subjects are: increasing the length of time a subject is exposed to experimental aspects of the study; changing the originally targeted population to include a more at-risk population (e.g., adding children or pregnant women to the study); adding procedures where the risk of the additional procedure is greater than a minimal risk; adding an element that may be the confidentiality of the subject; or increasing the number of participants to be treated by more than 25%, which may affect the study's statistical analyses."
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            "text": "11.4 Change in Principal Investigators",
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            "text": "When changing principal investigators, a protocol modification must be submitted to explain who the principal investigator was and who is being appointed the new principal investigator. The original principal investigator completes and submits the request for modification approval form. Changes in principal investigators may qualify for expedited review if no other modification is being pursued.",
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            "text": "42",
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