K. Research with Children

Federal regulations require that all research conducted with children and/or adolescents must be reviewed (cannot be exempt). The exceptions to this rule are

1. Observations of children’s public behavior with no interaction with the children
2. Research conducted in educational settings of normal educational practices (e.g., on instructional strategies or curricula)
3. 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

Another requirement is that assent must be obtained from the child. Children (those under 18) should be given an explanation at a level appropriate to his/her age, maturity, experience and condition, of the general purpose of the research, procedures to be used, anticipated discomfort and inconvenience. Children should be asked if they wish to participate in the research or not, and failure to object should not, in the absence of affirmative agreement, be construed as assent.

The IRB proposal should include

1. How assent will be obtained from the child and whether or not the child’s parent and/or guardian will be present.
2. How assent will be documented. Children may either sign an assent form or verbally indicate a willingness to participate. A copy of either the assent form or a script of the explanation given to the child must be submitted with the proposal.