Informed Consent

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 the age of 18?

Children under the age of 18 are not permitted to 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- in other words, be able to understand the information being presented.

Assent

In pediatrics, children who are old enough to understand medical discussions are sometimes 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) providing 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 have not been forced to receive any treatment or procedure.

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, it is important to inform 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.

Questions to Ask Your Transplant Team Before Signing Consent for Your Child:

• What are my child’s choices other than transplant?

• What are the risks and benefits of transplant for my child?

• What does the evaluation process include?

• How long do most patients with my child’s blood and organ type wait at this hospital for this type of transplant?

• How long has this hospital and these surgeons been doing this type of transplant?

• How many of these types of transplants does this hospital or surgeons perform each year?

• Is my child allowed to be listed at more than one transplant center (e.g. multi-listing)?

• What are the organ and patient survival rates for my child’s type of transplant at this hospital and how does that compare with the survival rates of the rest of the country?

• How does the medical team decide whether or not to accept an organ for my child?

• How long will we have to stay in the hospital and the area after my child’s transplant?

• What is the extent of appointments and tests that my child will have to endure after his or her transplant?

• What are the costs should we expect associated with transplant and what financial assistance is offered?