Engaging children in genomics research: decoding the meaning of assent in research

This article considers how to approach assent from children for genomics research. We examine the "protection" rationale for assent, which emerged in the context of a historical debate regarding whether it was ever acceptable to subject children to risks of research for the benefit of others. We also consider the "development" rationale for assent, which has been articulated for pediatric clinical practice, as an alternative approach for addressing this issue. We consider these rationales in light of the more recent literature on pediatric assent in the research context, and suggest that "engagement" is a more useful construct. This construct emphasizes that children have development capacities that should be respected and includes a limited role for assent to allow children to protect themselves. Engaging children does not require disclosure of all of the benefits and risks of genomics research that might be conveyed to an adult and may permit a degree of parental control over decisions. Using a construct that emphasizes respect can also justify asking children, as they approach adulthood, about their willingness to participate in ongoing genomics research, and yet also permit research to continue if some cannot be reached to obtain consent.