Common Questions Regarding Clinical Research

  1. What is clinical research and what is its purpose? 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 or diagnostic tests. Other names for clinical research include clinical trials, experimental research, research studies, and medical research.
  2. 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 and a research treatment; and this can be confusing. Sometimes your child may receive standard care in addition to the experimental research. It is important that you discuss the differences between medical research and medical treatment with your researcher.
  3. Why include children in research? Children are included in studies because they often respond differently than adults to the same medications or procedures, and often they need different amounts of a drug than an adult would need. Children also may have illnesses that are not seen in adults.
  4. Why do people take part in research studies? People may take part in research studies to help others, or hoping that the research will benefit them or their child, even though this is only a possibility.
  5. How can I learn more about research, especially a study my child might take part in? Your researcher can provide you with information regarding a clinical trial that your child may take part in. Also, it is helpful to have a copy of the informed consent document for the study to read before you meet with the researcher. You should talk with trusted friends, family, and your family doctor before making choices about your child’s care.
  6. What is the role of a Research Participant Advocate (RPA)? The RPA supports research participants’ rights. They will help you find answers to your questions and concerns about taking part in clinical research. The advocate will advise you about the informed consent process that is a part of every clinical research study. The RPA is a member of the Institutional Review Board (IRB), a committee that reviews the ethics and safety of research, where she reviews informed consent documents for clarity and accuracy.
  7. Who ensures that clinical research is safe? The safety of your child in our clinical research is a top priority for all St. Jude staff. A scientific committee looks carefully at each protocol. This committee determines that the questions to be answered in the study are of the highest importance. The St. Jude Institutional Review Board (IRB) also carefully reviews new clinical protocols. The IRB is a committee of scientists, doctors and members of the community who review each study and the informed consent process. The IRB’s job is to evaluate the benefits versus the risks of research and to make sure that your rights are protected. The IRB reviews each protocol yearly for safety.
  8. What is Informed Consent? Informed consent is an interactive process between you, your child, and the research team that will provide you with explanations of the research study. Informed consent is an ongoing, interactive process. We encourage you to ask questions before you agree for your child to take part in a clinical study. In addition, please don’t hesitate to ask questions at any point during the enrollment process or during the research study.
  9. What is the difference between Informed Consent and Assent? How old does my child have to be before he or she must also agree to be in a research study? For your child to take part in a clinical study, St. Jude doctors must ask one or both parents (or legal guardians) to give written permission. They will also discuss the research study with your child. Usually, children 7 years of age and older are provided age-appropriate explanations of treatment. They are encouraged to ask questions to better understand what to expect. Children aged 14 years and older are considered to be on a level of understanding similar to an adult. Following discussions with your doctor, your child will be asked for his/her agreement or “assent” to take part in the research study. Children aged 18 years or older are considered adults and must give their own consent to take part in research.
  10. What will happen if I decide not to enroll my child in a research protocol? If you decide not to enroll your child as part of a research protocol, 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 want to remove your child from a study, you have the right to do so. Participants aged 18 or over can withdraw from a study at any time.
  11. How much should my child be told regarding their illness and procedures which may happen? Children need to be able to trust their parents and receive honest answers to questions they may have regarding their illness and procedures that may occur. It is important to explain information to children in a way they can understand without overwhelming them. St. Jude’s Child Life Staff helps children understand medical procedures and their illness. They also can assist with answering questions to siblings’ questions.
  12. How long do I have to decide whether I want to be a part of a research study? You may not need to decide right away if your situation is not an emergency. We will give you information to take home and read. 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 speak with your research doctor, hospital staff or the hospital research participant advocate.
  13. What about confidentiality? Confidentiality involves keeping your child’s research and health information private. We keep your child’s research records confidential to the degree allowed by law. Information from your child’s medical records will not be given to anyone outside the hospital unless required by law. Government agencies such as the FDA oversee medical treatment of people as required by state or federal regulations. Sometimes, these government agencies may need to review parts of your child’s research records.