Research activities that:
(1) Present no more than minimal risk to human subjects.
(2) Must fit one or more of the categories on the following Expedited Review Categories List.
(3) Minor changes in previously approved research during the period for which the approval is authorized
means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine
physical or psychological tests.
• Clinical studies of drugs and medical devices only under specific conditions
• Collection of blood samples by finger stick, heel stick, or venipuncture and does not exceed certain volume limitations
• Prospective collection of biological specimens obtained by non-invasive means (hair, nail clippings, routine dental extraction)
• Collection of data through non-invasive procedures routinely used in clinical practice, e.g., EKG, light exercise
• Materials collected that have been collected or will be collected solely for non-research purposes, e.g., medical treatment and diagnosis
• Collection of data from voice, video, etc., for research purposes
• Research employing surveys, etc.
• Continuing review under specific conditions, e.g., closed for enrollment