Children's Assent to Clinical Trial Participation
If you are considering enrolling your child in a clinical trial, this guide should help you better understand the concept of "assent" (a child's agreement to participate) as well as some of the larger issues surrounding young people's participation in trials.
If you are interested in learning more about the issue of children's participation in clinical trials, the National Library of Medicine has compiled a bibliography of resources on clinical research that also includes a section devoted to children's issues.
Portions of this guide are based on the article "Consent (Assent) for Research with Pediatric Patients" by Marion E. Broome, Ph.D., RN, FAAN.
What happens if the prospective participant in a clinical trial is not an adult, but a child or teenager? What, if anything, should be done to educate the young person about the trial and ensure that he or she is given a say in whether or not to participate?
At one time, it was assumed that young people lacked the ability to consent to participation in clinical research. Instead, parents or guardians went through the informed consent process on their behalf and gave what was known as "proxy consent."
Over the past couple of decades, medical and legal experts have given much thought to the special issues surrounding children's participation in clinical trials. In the eyes of the law, children under 18 are not adults; therefore, legal permission for their participation must be given by parents or guardians after going through the informed consent process on their behalf.
However, many people involved in treating young people believe that the child or adolescent should play a role in the decision to enter a research study. The American Academy of Pediatrics calls this "empower[ing] children to the extent of their capacity" and talks about this shift in thinking in "Informed Consent, Parental Permission, and Assent in Pediatric Practice." The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research established age 7 as a reasonable minimum age for involving children in some kind of assent process. It is felt that most children this age can understand information tailored for their knowledge and developmental level.
Health care providers want young people to know that they have a say in what happens to them and that their questions and input are valued. Encouraging their involvement in decision-making is done out of respect for their rights as individuals and the desire to give them a sense of ownership in what happens during the trial. Even though children cannot "consent," because true consent implies full understanding, they are now routinely asked whether they agree (assent) or do not agree (dissent) to participate. Their parents or guardians are no longer asked to give "proxy consent" but instead give "informed permission."
Parents reviewing written information about a clinical trial for their child can interact with the research team and learn how the study will work, its objectives, the possible benefits and risks of participating, and the child's rights and responsibilities. In this way, they can make a fully informed decision about whether or not to give "informed permission" for their child's participation in the clinical trial.
Tip for Parents and Guardians -- Informed Consent:
Be sure to check out Informed Consent, which provides essential background for understanding the concept of assent and describes the process you will go through before giving permission for your child to take part in a clinical trial.
Federal regulations state that parents and guardians must participate in an informed consent process --- just as they would do if they themselves were considering enrolling in a clinical trial --- and give legal permission for their child to enroll. This process must follow the guidelines established for the general requirements of informed consent.