Assent

Children under the age of 18 do not have the right to refuse standard treatment for their cancer. They do have the right to accept or reject experimental treatments. All clinical trials are considered to be experimental treatments. Regardless of whether the child will receive the standard treatment or an experimental treatment, they have rights to have the disease, treatment, and procedures explained to them at an age-appropriate level.

Assent means that children and adolescents are involved in decisions about their treatment. Doctors and parents are required to allow children to provide input to the extent of the children's abilities. According to the American Academy of Pediatrics (AAP), assent means that the child:

1. Is aware of the nature of his or her disease.

2. Understands what to expect from tests and treatments.

3. Has had his or her understanding assessed.

4. Has had an opportunity to express willingness to accept or reject the proposed treatment.

The AAP policy statement ("Informed Consent, Parental Permission, and Assent in Pediatric Practice", electronically available at http://www.aap.org/policy/00662.html) states, "In situations in which the patient will have to receive medical care despite his or her objection, the patient should be told that fact and should not be deceived." This applies to standard treatment.

Clinical trials, however, are research. As such, assent is required from children who are able to give it. The U.S. Code of Federal Regulations (CFR) 46.402 (b) requires that children must agree to participate in research. A child's failure to object does not constitute assent. Of course, the childs understanding will vary with age and maturity.

In short, parents can legally make decisions about standard care, but both parents and children have decision-making rights about participating in research. Thus, for older children and teens, informed consent to participate in a clinical trial means that physicians need both parental permission and the assent of the child.

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