Taking part in clinical research

 

Since 1962, St. Jude has sought cures for children with life-threatening diseases. Through research and treatment, we have made much progress toward that goal. Clinical research has made such advances possible.

Taking part in clinical research is a decision you should discuss with your family members and your child's doctor. The following information may help you in making the best choices for your child.

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Taking Part in Clinical Research

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What is clinical research?

Clinical research helps scientists learn more about illnesses or conditions so they can develop and improve treatments. The scientists follow carefully designed plans called clinical trials to evaluate new treatments. Other names for clinical research include protocols, experimental research, research studies and medical research.

What are the differences between clinical 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 (a clinical trial or protocol) that must be followed closely.

Medical treatment is recommended by a doctor to treat the disease or condition of an individual child. The benefit of that treatment is known, and any changes are made just for that child. At times, the same patient may receive both standard medical treatment and an experimental treatment. An experimental treatment is one that is new and not fully tested.

What is an Institutional Review Board?

The Institutional Review Board (IRB) is a committee of scientists, doctors and other health care professionals, and community members. This group reviews every new clinical trial 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, treatments and procedures to be done. These include any that are experimental
  • 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. This agreement is called consent. Patients who are 18 years old or older may sign their own consent forms.

The staff will discuss the research study with your child in words that are easy to understand. The staff will also encourage questions so your child knows exactly what to expect.

After talking with the doctor, children between 7 and 17 years of age may be asked for their “assent” (agreement) to take part in the research study. This assent form will be signed after you have given consent for your child to take part in the clinical trial. Children under age 7 are not usually asked for their assent, since they may not fully understand the study.

What will happen if I decide not to enroll my child in a clinical trial?

If you decide not to enroll your child in a clinical trial, your child may still receive standard medical care at St. Jude or will be referred to another hospital for appropriate treatment. In either case, St. Jude staff will help you.

If you feel for any reason, at any time, that you wish your child to be removed from a clinical research 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).