As a parent or guardian, the decision to allow your child to participate in a clinical study may be a difficult one. Many parents are concerned that their child may not benefit from being in a study or that some tests may hurt or be uncomfortable. Parents want to know how much extra time or visits to the research site it will take to be in a study. The Children and Clinical Studies website can help you to identify “Questions You Should Consider Asking.”
- Why is this study being done?
- What are the risks of the study?
- What are the potential benefits of the study?
It is important to know what your responsibilities are once your child enters a study (See “Participating in a Clinical Study: Rights and Responsibilities.”) You will need to make sure that you and your child are following the study instructions in order to keep your child safe and for the study to have meaningful results. You will also want to know if there will be extra costs or visits to the study site. Some questions to ask are:
- How many children are in the study and when did it start?
- How long will the study last?
- How might this affect my daily life and my child’s?
- How many extra visits will I need to make to the hospital or study site?
- Will I be reimbursed for parking, travel expenses or childcare?
- Who will pay for the experimental treatment?
- Will it cost me anything to be in the study?
You will want to consider all of your choices when deciding if your child should enter a research study or not. You may want to let your child participate or you could allow your child to receive the standard care. An important question is:
- What are my other choices if I choose not to participate in the study?
Before deciding to join a study, it’s important to get information from people like the principal investigator and research coordinator, family members and friends, and your child’s regular doctor. Some hospitals or clinics offer the services of a social worker or patient advocate who is not directly connected with any study and who you can talk with as you make a decision. There are resources such as this website and the Children and Clinical Studies website to help you make a good decision. Depending on your child’s age and ability, his or her opinions will also be important—and your child’s assent may be necessary. Read the information and watch the video at “Do Kids Have a Say” and “What Do Kids Say About Being In a Study” for more details about children’s views of research.
There is no “right” or “wrong” answer about participating in research, only the answer that seems right for you and your child.