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. The NCI's Cancer Information Service also provides a
fact sheet on the topic of children's cancer centers.
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
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
A Guide to Understanding 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
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.
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