Research with children

Federal regulations require that all research with children, including adolescents, must be reviewed, except: observations of children’s public behavior with no interaction with the children; research conducted in education settings of normal educational practices (e.g., on instructional strategies or curricula); research using existing records or data, if these sources are publicly available or if the information is recorded in such a way that the child cannot be identified. If you are in doubt, consult the IRB chair.

In addition to obtaining parents’ or guardian’s consent, the child’s assent must be obtained. Children should be given an explanation—at a level appropriate to the child’s age, maturity, experience, and condition—of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. Children should be asked if they wish to participate in the research or not. Mere failure to object on the part of the child should not, in the absence of affirmative agreement, be construed as assent.

In the proposal, the investigator should indicate: 1) how assent will be obtained (what the investigator will say to the child and whether or not the child’s parent(s) or guardian(s) will be present); and 2) how assent will be documented. The child may either sign a very brief assent form or verbally indicate a willingness to participate. A copy of either an assent form or a script of the explanation given the child must be submitted to the IRB with the proposal. Please contact the IRB Chair for a copy of a sample assent form.