Participating in Research Studies

We understand that this is a very stressful time for you and your child. Your family faces many changes, questions, and decisions about treatment and making the best choices for your child. We at St. Jude want you to know that your child’s care is our greatest concern. We will explain all treatments and tests to you and to your child every step of the way. 

What is clinical research and what does it mean to my child and my family?

Clinical research helps scientists learn more about illnesses or health conditions so they can develop and improve treatments. Research studies involving people are called clinical trials. These trials follow carefully designed plans called protocols to decide if new treatments are safe and work well. If a treatment is found to be safe and effective after it has been carefully tested in many clinical trials, the treatment may be approved by the Food and Drug Administration (FDA).

Two St. Jude committees look carefully at each protocol before any research begins. The Scientific Review Committee makes sure that the study will add to our knowledge about the causes and cures for serious diseases. The Institutional Review Board (IRB) reviews the ethics and safety of each study, and protects the rights and welfare of those who take part in the studies. The IRB is made up of scientists, non-scientists, and community members.

How will I know what to expect before and during the research study?

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 purposes and description of the study
• The tests, treatments, and procedures to be performed, including any that are experimental (new and not fully tested)
• How long the study will last
• Possible benefits and risks, including expected discomforts
• Other treatments and options
• How your privacy will be protected
• Who to contact for answers to your questions
• That taking part in a study is strictly your choice

What are my rights?

If your child or you are asked to take part in a research study, you have the right to know the following:

• What kind of study it is and why it is being done
• What procedures will be used, as well as any drugs or devices to be used
• Any discomforts and risks that your child or you might have during the study
• The possible benefits, if any, you might expect from taking part in the research
• What other procedures or courses of treatment are offered
• How your child’s records will be kept confidential (private) or who might have access to them
• Any new details that might change your decision to stay in the study

You also have the right:

• to have a copy of the signed consent form;
• to be given the time to decide freely whether to agree or not to agree to take part in the study;
• to ask any questions about the study or procedures at any time; and
• to withdraw your child from the study at any time without affecting the care and services that your child would normally receive here.

If you have questions, please ask!

Please feel free to ask questions before you agree for your child to take part in a research study. We know that you and your child probably will think of other questions later. Please ask questions of your doctor, nurses, and social worker at any point during the study.

The hospital also provides a research participant advocate who advocates for the rights of research participants (people who take part in research studies). The research participant advocate will answer questions and advise you about your rights in research studies. She may be reached at 901-595-4644. The Institutional Review Board Chair also will answer questions about your rights. You can reach the IRB Chair at 901-595-4357 or by e-mail at hsp-1@stjude.org. Outside the Memphis area, call us toll-free at 1-866-JUDEIRB (1-866-583-3472).

To learn more about clinical research, please visit the Linda R. Hajar Family Resource Center located on the second floor of Patient Care Center. The Web sites listed below also provide useful information on health conditions, clinical research, and your rights if you choose to take part in research:

www.stjude.org/patientsandparents

http://cancernet..nih.gov

www.centerwatch.com/patient/backgrnd.html

www.curesearch.org