expected language competencies and preferences of the groups to be included in the research. For emancipated and mature minors who are making decisions in their own right, the process for seeking assent should still be sensitive to the level of maturity of these adolescents (e.g., their attitudes about risk taking) and appropriate safeguards should be provided.

Discretion in Documenting Assent

As described above, federal regulations permit oral presentation of assent information and allow the IRB to use discretion about the way in which assent is documented. Although the guidelines on pediatric drug research adopted by ICH (and issued as FDA guidance) are more specific (requiring signatures on assent forms for participants of “appropriate intellectual maturity” [FDA, 2000b, p. 13]), they, too, allow some discretion and should not be rigidly interpreted.

On the basis of the literature reviewed in this chapter, the committee suggests that requiring a child’s signature on an assent form may be developmentally inappropriate for younger children (e.g., those under age 9 or 10 years). A signature requirement may confuse rather than inform a child, and a child may even experience this situation as intimidating or coercive.

Recommendation 5.7: Guidance and education for investigators and members of institutional review boards should make clear that federal regulations allow discretion—based on children’s developmental maturity—about the way in which information is presented to children and the manner in which assent is documented. Investigators and institutional review board members should apply that knowledge in determining what procedures will best serve the goals of assent for particular research protocols and populations.

While allowing for discretion with individual children or adolescents, IRBs and institutions can provide guidance about age-appropriate options for documenting assent. For example, in addition to developing sample age-appropriate information and assent materials for younger children, institutions can suggest that investigators use their judgment in determining when it is appropriate and respectful to ask younger children to sign simple assent forms. If investigators have developed an adult consent or permission form that is suitable for use with adolescents, the form could be used to document adolescent assent. Alternatively, then adolescents could sign a simpler assent form that includes age-appropriate information beyond that included on the form for younger children.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement