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 is clinical research?
Clinical research helps scientists learn more about illnesses or conditions so they can develop and improve treatments. Research is an organized process of collecting and analyzing information (data) in order to answer a question. Research follows carefully designed plans called protocols to evaluate new treatments. Other names for clinical research include clinical trials, experimental research, research studies and medical research.
What are the differences between medical research and medical treatment?
Clinical research is not the same as medical treatment. The goal of research is to gain knowledge and may lead to improved treatment for all children in the future. Research follows a plan (protocol) that must be followed closely. Medical treatment is designed to directly benefit an individual child, with changes and adjustments made just for that child. At times, the same patient may be receiving both standard medical treatment in addition to an experimental treatment.
What is an Institutional Review Board?
The Institutional Review Board (IRB) is a committee of scientists, doctors and other health care professionals that reviews every new clinical protocol to evaluate the benefits and risks of the research and to make sure patient rights are protected.
What is informed consent?
Informed consent is an ongoing process to help parents and children understand what is involved in taking part in a research study.
The research team will explain these items to you and your child:
- The purpose and description of the study
- The tests, treatment and procedures to be performed, including any that are experimental (new and not fully tested)
- How long the study will last
- Possible benefits of taking part in the study
- Possible risks, side effects or expected discomforts
- Other treatment options, including current standard treatments for your child’s illness.
- How your privacy will be protected
- Who you should contact if you have questions
- 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. Children aged 14 and older are considered to be on a level of understanding similar to an adult. 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 considered legal adults and must give their own consent to take part in research. 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 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 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 901-595-4644. If you are outside the Memphis area, dial 1-866-JUDE IRB (1-866-583-3472).