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Should Your Child Be in a Clinical Trial?

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Potential Benefit continued...

A child should not be deprived of a treatment in a clinical trial that is necessary for the child's health. For example, if the child has seizures, an experimental drug may be added on to a medication the child is already taking to help control seizures, or added onto another treatment that is known to work.

People often think that a clinical trial that tests an experimental drug is riskier than being treated in your doctor's office with an already approved drug, says Nelson. "Some research is riskier, but some is safer than being prescribed a drug in an off-label environment where you don't know the implications. Monitoring for adverse events would be much more intensive in a research study than in an off-label practice."

Informed Consent

FDA works to protect people in clinical trials and to ensure that they have reliable information as they decide whether to join a study. "A fundamental concept of research is that it cannot take place without informed consent," says Murphy. "Otherwise, it would be experimenting on people without their permission." Adult participants must sign an informed consent document before joining a clinical trial.

Children, however, cannot give informed consent because consent implies a full understanding of the potential risks and other considerations of a clinical trial. "Parents, as the child's advocates, must decide if they wish to give permission in place of informed consent," says Murphy. Then, depending on the child's age, maturity, psychological state, and other considerations, the child may be asked to "assent" or "dissent." This means the child can agree or disagree to participate in a study, which can be indicated simply by a nod of the head or a signature.

Depending on the child's health and the potential benefit of an experimental treatment, parents can override a child's dissent. For example, if the child has a life-threatening illness for which there is no effective approved treatment, the child's opinion is secondary to the parents' opinion, says Rodriguez . But if the child has a mild condition, such as otitis media, parents should not force the child to enroll in a clinical trial.

The basic parts of an informed consent document include:

  • purpose of the study and how long it's expected to last
  • description of the procedures and experiments
  • reasonably foreseen risks and benefits to the participant or to others
  • appropriate optional treatments if you decide not to participate
  • statement of confidentiality
  • statement that participation is voluntary
  • compensation, if paid, for participation and compensation for a research-related injury
  • 24-hour point of contact for an emergency