What is informed consent?

Informed consent is an interactive process between you, your child, and the medical team. Through this process you will learn all about the research study. You will be told all of the following:

• The purposes and description of the study
• The procedures to be performed (you will be told about any procedures or medicines that are investigational)
• The expected length of the study
• The benefits and any possible risks or discomforts
• The alternative treatments that are possible
• The hospital’s respect for your privacy
• Whom to contact for answers to questions
• The voluntary nature of participating in a study

St. Jude doctors will obtain permission from one or both parents or legal guardians for your child to take part in a clinical study. They will also discuss fully the research study with your child. Children 7 years of age and older will be told about the treatment in words they can understand. They are encouraged to ask questions so they will know what to expect. Teens, 14 years and older, are thought to be on a level of understanding similar to an adult. After talking with the doctor, your child may be asked for his/her agreement or “assent” to take part in the research study. Patients who are 18 years of age or older are considered adults and may give their own consent.

Informed consent is an ongoing process. Before, during, and even after the study you will be able to ask questions and have your concerns addressed.