Greater than Minimal Risk With No Direct Benefits:

If a project offers the child subject greater than minimal risk without prospect of direct benefit from the intervention or procedure, then CRP can approve it only if it meets the following criteria:

a. The risk represents only a  minor increase over minimal risk;

b. The intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in actual medical, dental, psychological, social, or educational situations;

c. The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition, information which is of vital importance for understanding or ameliorating the subjects’ disorder or condition; and

Examples of research that fall into this category might include biomedical sample gathering for the purpose of learning about (but not treating) a childhood disease or condition, stressful educational tests to determine the basis for developing practical methods of teaching children with special characteristics, and behavioral manipulations designed to elicit an understanding of a childhood psychological condition. In each of these hypothetical cases, the research provides the child subject with no direct benefit, but it may provide vital information with only minor increases in risk to the subject. Moreover, the research experiences reasonably resemble those the child might encounter in medical, educational, and psychological situations, respectively.



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