tent to provide consent, an alternative approach has been devised that relies on parental permission and, when appropriate, children’s assent to participation in research.
For adults agreeing to clinical research in their own right and for parents agreeing to a child’s participation in clinical research, studies suggest that truly informed consent or permission is unlikely to be completely achieved for all individuals in all research situations. Parents who are asked to provide permission for their child’s participation in clinical trials are, in particular, often making decisions under great stress and time pressure. Some prefer to trust the physician’s assessment rather than make their own, and investigators must be acutely sensitive to the influence that they wield in discussions with parents of ill or injured children. A significant minority of parents may misunderstand the purpose of research, especially when the research tests an intervention for a medical condition. Nonetheless, the goal of having parents provide informed permission remains an important protection for children, both when participation in research is initially sought and throughout the course of a study.
The capacity to make voluntary, informed decisions clearly evolves from birth through adolescence and into adulthood. It also clearly varies among individuals of the same age. The goal should be to involve children in discussions and decisions about research participation as appropriate, given their cognitive and emotional maturity and psychological state. Involving children in discussions and decision making respects their emerging maturity, helps them prepare for participation in research, and gives them an opportunity to express their concerns and objections—and, possibly, influence what happens to them.
This chapter has discussed some circumstances that may raise concerns about undue or even coercive influences on family decision making, for example, when a child’s physician is also the investigator seeking agreement to the child’s participation in research. Payments to parents or children related to research participation have also raised questions about the potential for undue influence. The next chapter examines these questions.