Skip to main content

Table 2 Permissible research that poses more than minimal risk without direct benefit to the child-subject

From: Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context

45 CFR 46.406 (FDA 21 CFR 50.53 analogous). "Research in which the IRB finds that more than minimal risk is presented by an intervention or a procedure that does not hold out the prospect of direct benefit for the individual subject...(and in which):
(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 to yield generalizable knowledge about 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 of their parents or guardians, as set forth in ยง46.408."