Informed Consent in Pediatric Patients

Informed consent is a discussion between the health care provider and patient explaining:

• Information about how and where a procedure or treatment is done and how long it takes.
• The benefits and possible risks or side effects of the treatment/procedure.
• The benefits and possible risks of other treatment options or alternatives.
• The benefits and possible risks of not having any treatment.
• After the discussion, an informed consent document is signed stating these things have been reviewed.

Who makes decisions for children under age 18?

Children under the age of 18 cannot give consent for medical procedures and treatments. Parents are typically the primary decision-makers for their children. Parents give permission for their child to undergo procedures and treatments. The parent giving consent must be deemed competent. They must be able to understand the information being presented.

In the absence of biological or adoptive parents to give consent, legal guardians (appointed by the court) may have decision-making capabilities. If a child has been placed into foster care, foster parents typically do not have decision-making abilities for foster children. However, the agency managing the foster care case or a representative of the state may have the ability to give consent for medical procedures; sometimes, the biological parents may retain decision-making rights for medical care. These laws vary from state to state.

Assent

In pediatrics, children who are old enough to understand medical discussions may be asked to give assent for care. Assent means that the child is agreeing to the treatment or procedure. Children can also dissent, which means they do not agree to participate. The age at which assent is requested varies by institution and can be as young as 7 years old. Assent is not required by law, but many institutions require children who are developmentally and cognitively able, to participate in decision making. You can ask for assistance in assessing your child’s ability to give assent from pediatric social workers, psychologists, and child life specialists.

The Informed Consent Document

The parent(s) giving consent will be asked to sign an informed consent document for each procedure, treatment, or clinical trial. Review the document and ask any questions before you sign. This form is to protect your autonomy (decision-making ability) and to confirm that you child is not being forced to receive any treatment or procedure. You may want to ask for a copy of the form after you have signed it.

Informed consent is the law. State laws can dictate the format of these forms, so they may vary from state to state. You should not feel pressured or rushed to provide consent. Take time to review the document and ask questions. You can change your mind about the treatment at any time, even after you have signed the consent or treatment has started.

If you struggle with reading or writing, tell the healthcare provider so that they use other methods to help you understand the treatment/procedure. Many medical professionals use medical terminology that the general public doesn’t understand, so do not hesitate to ask for further clarification of anything you do not understand. If English is not your primary language, a Certified Medical Interpreter should be present for the informed consent discussion and should translate the informed consent form for you.

Clinical Trials

If your child is being asked to participate in a clinical trial, the research study, procedures, treatments, risks, and potential benefits must be explained to the child and their parents. Typically both parents will need to provide consent for a child to participate in a clinical trial. There are exceptions to this rule, including if one parent has sole legal custody, the other parent is deceased or incompetent. The requirement of both parents to give informed consent may also be based on any risks associated with the trial; for example, if the risk of participation is very small, trial participation may be allowed even if only one parent gives informed consent. Read more about clinical trials.

Emergency Situations

Consent of parents or guardians is not required if there is an immediate danger to the life, health, and well-being of the child, as assessed by the health care 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