Do U.S. regulations allow more than minor increase over minimal risk pediatric research? Should they?

a Minimal risk is defined as risk that is not greater than the risks “ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (46.102 i/50.3 k). b Permission of one parent is sufficient for categories 404/50.51 and 405/50.52; permission of both parents, if reasonably available, is required for 406/50.53 and 407/50.54; the requirement for parental permission may be waived in cases that satisfy the conditions for waiver of informed consent. c Assent, defined as affirmative agreement, is required only if the IRB judges that the child is capable of providing assent; assent may be waived if the “intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research” (46.408 a/50.55) and also in cases that satisfy the conditions for waiver of informed consent. d The 407/50.54 categories cover research that is not approvable in sections 404/50.51, 405/50.52, or 406/50.53. Hence, a study might fall into the 407/50.54 categories even though it does not pose more than a minor increase over minimal risk. For example, a study that poses a minor increase over minimal risk but does not concern the subjects’ disorder or condition could be referred for review in the 407/50.54 categories. Section 46.407/50.54d Approvable by secretary/commissioner