St. Jude is one of the leading pediatric research facilities in the world. The mission of the hospital is to find cures for children with catastrophic illnesses through research and treatment. Since the hospital opened in 1962 much progress has been made in the treatment of serious childhood diseases. Clinical research has made these advances possible.
Taking part in clinical research is a decision that should be discussed with family members and your child's doctor. We hope you will find the information in this section helpful in making the best choices for your child.
Taking Part in Clinical Research
What are my rights as a patient or patient family member?
When you take part in research, your privacy is protected. Your medical records are confidential although information may be shared with other hospitals, government agencies, or pharmaceutical companies. As required by law, this information will not include names or other personal identifiers. Your rights as a patient or family member are listed online and in the Patient/Parents Rights form given to you at registration. Please read them.
What is clinical research?
Clinical research is a scientific method used to learn more about childhood illnesses or conditions. It helps to develop and improve treatments. By agreeing to take part in clinical research, you may help improve treatments for serious diseases. For example, doctors and other research staff may look at how well a new drug works in children with leukemia. If the doctors see that the new drug works better than the standard treatment, it will continue being tested. Soon, it may become a standard treatment for other children.
What does clinical research mean to my child and my family?
The staff of St. Jude Children’s Research Hospital is very concerned about your child’s safety in our clinical research studies. If your child takes part in a clinical trial, your child will be protected in several ways:
- Your child must meet certain criteria (often called eligibility criteria) to make sure your child can qualify for the study.
- The staff will monitor your child carefully. The medical team will want to discuss fully all treatments and any problems that may arise.
- The staff should notice changes in your child’s health quickly because they are watching your child closely.
- The doctor will stop treatment if your child is too sick or is not getting better.
- The staff may perform certain tests to monitor your child more closely.
All clinical trials must be reviewed and approved by the St. Jude Institutional Review Board (IRB). The IRB includes doctors, researchers, community leaders, and other members of the institution. The members review the protocol to make sure the study is done fairly and is as safe as possible. The IRB also reviews each clinical trial every year for safety. An IRB can stop a clinical trial if the trial appears to be causing unexpected harm to the patients.
What is informed consent?
Informed consent is the process of learning about a clinical trial before deciding whether or not to take part. The process of informed consent is not about signing a piece of paper. It is about reading information, talking with your doctor or nurse, learning details of the study and asking questions.
You will learn about all of the following:
- The purpose of the study (why this study is being done.)
- What procedures will be performed, especially any that are experimental.
- Possible benefits of taking part in the study.
- Possible risks, side effects, or discomforts.
- Other treatment options, including current standard treatments for your child’s illness.
- The medical team’s promise to respect your privacy and keep your child’s medical records private.
- Who you should contact if you have more questions or want to learn more about your child’s rights.
- That taking part in the study is voluntary. You will not lose any rights to treatment if you refuse to let your child take part. You may also remove your child from the study at any time and ask for standard treatment.
What is assent and how is it different from consent?
For your child to take part in a clinical study, St. Jude doctors will ask one or both parents (or legal guardians) to give written permission. The staff will discuss the research study with your child, as well. If your child is 7 years old or older, the staff will tell your child about the treatment in words your child can understand. The staff will encourage your child to ask questions so your child will know what to expect.
After talking with the doctor, your child may be asked for his or her “assent” (agreement) to take part in the research study. Depending on where you live, patients who are 17 or 18 years of age or older are legal adults and may give their own written consent. At St. Jude, patients must be 18 to sign their own consent form. Patients who are 14-17 years of age sign an assent sheet.
What is expected of me?
We want you to ask questions. We try to make consent forms as easy to understand as we can. However, there may be words or ideas that are confusing to some readers. We want you to know what the study involves and what we will expect of you or your child. We also want you to take as much time as you need to make your decision.
Keep in mind that giving informed consent is not a one-time event. It is a process that lasts throughout the study. The staff will keep giving you updated information, and you will be able to ask questions and have your concerns addressed.
We also expect you and your child to help your medical team. We need you to:
- Follow the staff’s guidelines.
- Come to all appointments.
- Take note of pain and other side effects.
- Keep an up-to-date list of all medicines your child takes.
- Ask as many questions as needed to understand what is happening.
Your help will be important to your child’s health and the success of the clinical trial.
What will happen if I decide not to enroll my child in a clinical trial?
If you decide not to enroll your child as part of a clinical trial, your child may still receive care at St. Jude or will be referred to another hospital for appropriate treatment. In either case, St. Jude staff will assist you.
If you feel for any reason, at any time, that you wish your child to be removed from a study, you have the right to do so. Patients age 18 and older can remove themselves from a study at any time. If you do this, it is important that you talk to your doctor first about other options or treatments.
Who takes part in clinical research?
Taking part in research studies is voluntary. A doctor, nurse, or other staff member may ask if you and your child want to take part in a research study. This staff member will explain the study and who can take part in it. You might not need to make a decision right away if it is not an emergency. You will be given information to take home. We advise you to think about it and talk with other family members.
If you would like to talk to someone at the hospital, you can talk to your doctor, nurse, or the hospital Research Participant Advocate. The Research Participant Advocate makes sure patients and their parents understand basic rights regarding clinical research. This person helps and families understand the informed consent process. The Research Participant Advocate also serves as a liaison with the patient’s St. Jude doctor.
We encourage you to ask questions before you agree to let your child take part in a clinical study. Also, feel free to ask questions at any point during the enrollment process or during treatment.
Who can I contact for information?
If you have questions, your doctor, nurse, social worker, and the research participant advocate are here for you. The research participant advocate can help answer questions about your rights if you take part in a research study. To reach the research participant advocate, call 595-4644. If you are outside the Memphis area, dial 1-866-JUDE IRB (1-866-583-3472).