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Ethical Conduct of Clinical Research Involving Children
necessary, further explanations. Such discussions should precede the presentation of a permission or assent form.
Recommendation 5.1: To focus attention on the process of requesting parents’ permission and children’s assent to research participation, investigators should provide and IRBs should review protocol descriptions of
who will request permission and assent;
how and when permission and assent will be requested;
who should be contacted if parents have questions or concerns about the research; and
for studies that extend over considerable periods of time, when and how permission and assent may be requested again, for example, as children reach important developmental milestones.
Although the research literature is limited and not entirely consistent, it supports a gradual expansion of the involvement of children in discussions and decisions about their participation in research. For younger children, the emphasis should be on providing basic information about what will happen, responding to their questions and concerns, and—particularly when the research does not offer the prospect of direct benefit—recognizing when children do not want to participate. As children mature, they can participate more fully in discussions and decisions about their participation in research. Older adolescents may not have the legal capacity to make decisions in their own right, but research generally suggests that the substance of the assent process can be similar to the substance of the consent process for adults if that process is properly designed to accommodate people of various educational, social, and cultural backgrounds.
Recommendation 5.6: In designing and reviewing procedures for seeking a child’s assent to participation in research, investigators and institutional review boards should aim to create assent processes that consider and respect the child and the family as a unit as well as individually. The process for requesting assent should
be developmentally appropriate given the ages and other characteristics of the children to be approached;
provide opportunities for children to express and discuss their willingness or unwillingness to participate;
clarify for parents and children (as appropriate) the degree of control that each will have over the participation decision; and
when appropriate, describe to children and parents the kinds of information about the child that will or will not be shared with the parents.