Should Your Child Be in a Clinical Trial?
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
Making a Decision
Nelson urges parents to use the child's pediatrician as an advisor before enrolling in, and during, a clinical trial. "A pediatrician can help a parent evaluate the risks and potential benefits, assess the qualifications of the research team, clarify a child's understanding of the research, and support the parent and child throughout the research study."
Parents should also ask if their child's doctor is participating in the trial, adds Murphy, and, if so, what role the doctor has and if he or she is being reimbursed for participating.
Parents who are considering enrolling a child will be invited to the research site to talk with the study investigator or other scientist or health care professional on the research team. FDA experts offer some suggestions for this discussion:
- Write down a list of questions at home and take it with you when you meet with the investigator. Make sure you get all of your questions answered.
- Take notes during the discussion. Read the notes back to the investigator to make sure you heard everything correctly. Ask the investigator, "Can I tell you what I think this is about and you tell me if I'm right or not?"
- If you do not understand any part of the trial, ask more questions. You should feel that the study team is receptive to your questions and concerns.
- Ask what information is already known about the medical product that your child may be given. Studies may be in progress elsewhere and some data may be available.
- Ask for contact information if you would like to talk to other parents whose child is participating in the study. The study team can provide this information if they get permission from other parents to have you contact them.
- After being presented with information and an informed consent document, you do not have to sign it right away. Go home and think about it, talk it over with your family, your child's pediatrician, and other trusted people.
- Listen to your "gut." If you're not satisfied with the information given to you and the answers to your questions, don't enroll your child.