WebOct 22, 2024 · CATEGORY 4 The collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. WebAug 10, 2024 · Category 4 indicates that data collected through non-invasive procedures (not involving general anesthesia or sedation) may be considered under this category, if …
Expedited Categories - Human Research Protection …
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Focus On: Continuing Review
WebNote: Expedited Category 1 should not be used for studies that involve use of a device only, (no testing or data collected on or about the device), as FDA regulations do not apply. Expedited Category 4 (collection of data through noninvasive procedures routinely employed in clinical practice) may be considered for studies that use, but do not ... WebExemption Categories. Exempt human subjects research is a subset of minimal risk research involving human subjects that does not require approval by an IRB; however, it does require a review and a final determination by a member of the Human Research Protection Program (HRPP). The categories of Exempt research are defined by federal … WebDec 13, 2024 · Expedited Category 4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety … san francisco horror house