Child assent and parental permission for clinical research--some considerations.

Abstract

The success of our future efforts to understand and improve the ethics of pediatric informed consent may depend, in large measure, on our willingness and ability to conceive of child assent and parental permission as joint, mutually affective processes. Given current trends, our empirical efforts may need to unfold at the interface of assent and parental permission, rather than exclusively or even primarily in one domain or the other. This shift will permit researchers to identify those areas in which the two mechanisms function in concert--in the best interests of patients, parents, and clinicians--and those in which they do not. Targeting these problematic areas for intervention and improvement may result in a more effective consent process for clinical research involving minors.