When Assent Is Not Required
An assent process for children or young adults is not required if one or the other of the following situations exists (but parent or guardian consent is still required):
2. The clinical trial offers a treatment or procedure that "holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research." In other words, researchers are not required to ask for children's assent to participation if the study offers a treatment that is thought to be a better option than those currently available, or if it offers the only alternative.
In life-threatening situations, such as that of a child with cancer, the second situation listed above may be especially relevant. In the case of Phase III clinical trials, the trial will compare a standard treatment (with known risks and benefits) to an "experimental" new treatment. The experimental treatment is under study because it has not been proven and is not known whether the new treatment is better or worse than the standard treatment. (For information about the phases of clinical trials, see Clinical Trials Take Place in Phases.)
While the experimental treatment is always hoped to be better, researchers cannot make any firm conclusions about the benefits and risks of the new treatment until the clinical trial is completed and the results are carefully analyzed. Usually patients are randomized to either the standard or experimental arm of the clinical trial. In this situation, even though a child usually cannot receive the experimental treatment without participating in the clinical trial, the patient can always receive standard treatment without enrolling in a clinical trial.
There are occasionally medical diagnoses or circumstances, such as relapse of the cancer, for which the available treatment methods have an acknowledged poor outcome and enrollment in a clinical trial is the only means to receive a promising new treatment intervention. In such a situation, a child's assent is not required for a clinical trial, although permission from a parent or guardian is still required.
Tip for Parents and Guardians -- You Have Final Say:Some of the newest approaches to treating children's cancers are available only through clinical trials, and your doctor may recommend one as essential to your child's treatment plan. In such critical cases, you have the final say over whether or not your child will participate. Nevertheless, the child should still be actively involved in the decision-making process.
Although a legal requirement for assent is waived in these circumstances, the research team is still expected and encouraged to obtain a young person's assent, even if parents or guardians must give the final say. In all other cases, though, the young person's decision should be considered binding.
Other types of clinical trials may not be as critical to a young person's well-being. For example, some clinical trials may study the effects of support groups on children's or teens' recovery from cancer. While participating in such a study might help young people, it is not critical to their survival; therefore, they have the right to make the final decision about whether or not to take part.
Tip for Parents and Guardians -- Participation Not Required:Keep in mind that your child always has the right to receive treatment off a clinical trial (that is, to not participate in any clinical trial).