Investigator Knowledge and Skills

Developmentally appropriate and family-sensitive procedures for obtaining children’s assent and parents’ permission for a child’s participation in research require communication skills and knowledge of child psychology and family dynamics. Education in these skills may not be part of the standard training for clinical researchers, including some investigators who conduct studies that include children. Investigators and other team members who are experienced in communicating with children and families will usually be better prepared to undertake these procedures than those who work entirely or mainly with adults. Even experienced pediatric researchers may, however, benefit from formal training in both the regulations related to permission and assent and the means of implementing permission and assent as “a process, not a form.”

Recommendation 5.8: To increase investigator competence in communicating with children and parents about research participation, educational programs for investigators and research staff who expect to do research involving children should include training and evaluation in developmentally appropriate and family-sensitive processes for seeking permission and assent.

Directions for Research

Although the committee was encouraged to find some research on parental permission and child assent, much of that research involves very small numbers of participants and other limitations. The range of pediatric conditions and research experiences covered by studies of permission and assent is also fairly limited.

Better evidence about how parents and children of different ages comprehend various dimensions of research and research participation is needed to help investigators and IRBs devise ethical and effective processes for explaining research and seeking permission and assent. To the same end, more research is needed to describe how permission and assent are actually sought in different contexts, how processes vary, and what processes appear to better serve the goals underlying the requirements for permission and assent, given the variations in research purposes and populations.

Recommendation 5.9: Federal agencies, private foundations, and advocacy groups should encourage and support research on existing and innovative permission and assent processes and information materials to support improvements in these processes and guide the education of investigators and institutional review board members.



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