Informed Consent in Pediatric Patients
Informed consent is a discussion between the healthcare provider and the patient, or, for a child, the parent or guardian. This discussion covers:
- What the procedure or treatment is, how and where it is done, and how long it takes.
- The benefits and possible risks or side effects.
- The benefits and possible risks of other treatment options.
- The benefits and possible risks of not having any treatment.
After the discussion, you will be asked to sign a form stating that these things were reviewed with you.
Who Makes Decisions for Children Under 18?
In most cases, children under 18 cannot legally give consent for their own medical care. Parents are usually the decision-makers for their children and permit procedures and treatments. The parent giving consent must be able to understand the information and make a decision. This is called having decision-making capacity.
There are some exceptions. In many states, minors who are emancipated, married, or parents themselves can consent to their own care. Some states also allow older teens to consent to certain types of care. Ask your care team or social worker about the laws in your state.
If a child does not have a parent who can give consent, a legal guardian appointed by the court may make medical decisions. If a child is in foster care, foster parents usually cannot give consent. Depending on the case, the foster care agency, a state representative, a court, or sometimes the biological parents may make medical decisions. These laws vary from state to state.
Assent: Including Your Child in Decisions
Children who are old enough to understand their care may be asked to give assent. Assent means the child agrees to the treatment or procedure. Children may also dissent, which means they do not agree.
Many hospitals start asking for assent around age 7, but this depends on the child’s development and the hospital’s policies. For standard medical care, assent is not required by law, but many hospitals encourage children to take part in decisions as much as they are able. For clinical trials, federal rules require researchers to ask for the child’s assent when the child can give it. Pediatric social workers, psychologists, and child life specialists can help you figure out how much your child can understand and take part in decisions.
The Informed Consent Form
The parent giving consent will be asked to sign a consent form for each procedure, treatment, or clinical trial. Read the form and ask questions before you sign. The form documents that the treatment was explained to you and that you are agreeing to it freely. You may want to ask for a copy after you sign.
Informed consent is required by law, and state laws may shape how these forms look. You should never feel pressured or rushed. Take your time and ask questions. You can change your mind at any time, even after you sign or after treatment has started.
Getting the information in a way that works for you:
- If reading or writing is hard for you, tell the provider. They can explain things in other ways.
- Medical terms can be confusing. Ask your provider to explain anything you don’t understand.
- If English is not your main language, you have the right to a qualified medical interpreter at no cost. The interpreter should be part of the consent discussion. Ask for the form in your language, or have the interpreter read it to you.
Clinical Trials
If your child is asked to join a clinical trial, the research team must explain the study, its procedures, risks, and possible benefits to both you and your child, in a way your child can understand.
Whether one or both parents must give permission depends on the study’s level of risk. For many studies, including most cancer treatment trials where your child may benefit directly, permission from one parent is enough. For studies with more risk and no direct benefit to your child, both parents usually need to give permission. This does not apply if one parent has died, is unknown, cannot make decisions, is not reasonably available, or if only one parent has legal custody.
If your child turns 18 while on a clinical trial, they will be asked to sign their own consent to stay in the study. Read more about clinical trials.
Emergencies
Consent from a parent or guardian is not required when a child’s life or health is in immediate danger, as judged by the healthcare provider.
Resources for More Information
Informed Consent in Decision-Making in Pediatric Practice
http://pediatrics.aappublications.org/content/early/2016/07/21/peds.2016-1484
Assent Tips-Rochester Institute of Technology
https://www.rit.edu/research/hsro/assent_tips
National Cancer Institute; Children’s Assent
https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/childrens-assent