Table I.
Topic | Excerpts from Script |
---|---|
Goals of Research and Treatment |
The goal of research is to develop scientific knowledge that can make a positive impact in the care of other patients in the future. The goal of treatment is solely devoted to the medical care of the individual patient. The care of each child will always take priority over the goals of research, but it is important to understand this difference. |
Possible Differences Between Research and Current Therapy |
Most of the drugs would be given to your child as part of current therapy whether or not you participate in a research study. In some research studies, treatment may be longer or shorter than current therapy or involve more trips to the hospital or clinic. |
Voluntariness | Participation in a research study is strictly voluntary. Once you have learned about a research study and all that it involves, you and your family can decide whether or not to participate. If you decide not to participate in the treatment study, your child can continue to receive treatment at this hospital. The doctors and nurses will be just as committed to caring for your child whether you decide to participate or not. |
Randomization | A participant in a Phase III research study will usually be assigned to the current therapy or one of several new groups by a process called “randomization,” which is like flipping a coin or picking a number from a hat. In most research studies for childhood leukemia, the treatment for your child will be determined by chance. Neither you nor your doctor will make the exact treatment decision if you decide that your child will be in one of these research studies. |
Right to Withdraw | If you decide to enroll your child in a research study, you may withdraw from that research study at any time without any explanation and without any penalty. |
Communicating Preferences for ICC |
If you would prefer a private room, is there a family member that you would like to stay with your child? You can also ask the doctor or nurse to arrange for someone like a child life specialist to stay in the room with your child. |
Consent Document | The doctor will be giving you a packet about the research study which is called an informed consent document. We encourage all parents to read this informed consent document or ask someone to read it to you. Please feel free to write on the document and ask the doctor about anything that is unclear. |
Question Asking | The doctors want you to ask questions, and they want to be sure that you understand the information they are giving you. So be sure to let the doctor know what questions you have. It may be easier to write down your questions before your meeting or jot down notes and questions as you talk. |