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Research presents
s that more than minimal risk to children is presented by an intervention or procedure that does not hold out thethe individual subject, or by ais not likely to contribute to the well-being of the subject, only if the IRB finds that:
(a) the risk represents a minor increase over minimal risk;
(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
(c) the intervention or procedure is likely toabout the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
(d) adequate provisions are made for soliciting assent of the children and permission ofor guardians, as set forth in §46.408.
§46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate athe health or welfare of children.
D
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