Failure to object should not be construed as assent. Benefit is a valued or desired outcome. Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child. Both probability and magnitude of possible harm may vary from minimal to significant.
Federal regulations define only minimal risk.
Minimal Risk 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 examinations or tests. In calculating the risks and benefits, the IRB should consider the circumstances of the subjects under study, the magnitude of risks or discomforts that may accrue from research participation and the potential benefits the research may provide to the subject or class of subjects. The Federal regulations permit four categories of research involving children. The categories are determined by the degree of risk and prospect of benefit to the participating child-subject. The panel must determine that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, and that the research will be conducted in accordance with sound ethical principles.