Scientific Publications by FDA Staff

Yale J Biol Med 2013 Sep 20;86(3):291-301

Parental Permission and Child Assent in Research on Children.

Roth-Cline M, Nelson RM

Grounded on the ethical principle of respect for persons, parental permission and child assent function together to protect the child and to foster the development of the child's self-determination. Although both parental permission and child assent involve the same components of information sharing, comprehension, and voluntariness, how these three components are understood and operationalized should differ depending on the developmental level of the child. For example, the amount of information that a child must comprehend to provide meaningful and developmentally appropriate child assent (or dissent) should be allowed to vary with the age and maturity of the child. By understanding child assent together with the important protections of parental permission, child assent does not need to be burdened with the same informational and process requirements. As a result, the age (as a proxy for developmental stage) at which a child is deemed capable of assent would be lower (i.e., 5 to 7 years old). By assuming a lack of capacity, the potential arises to dishonor and disregard a child's wishes by failing to solicit meaningful assent or dissent. Further research needs to be done on how best to obtain truly informed and voluntary parental permission and child assent for research participation.