For Parents

Why Participate in Research?

As a parent or guardian, the decision to allow your child to participate in a clinical study may be a difficult one.

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 cardiologist and regular doctor.

The Decision Process

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 what the side effects may be for certain study treatments and how much extra time or visits to the research site it will take to be in a study.

Some hospitals or clinics offer the services of a social worker or patient advocate who is not directly connected with any study and who can talk with as you decide. There are also online resources such as the Children and Clinical Studies website to help you make the decision that is right for you.

Depending on your child’s age and ability, his or her opinions will also be important – and your child’s assent may be necessary. Once a child reaches a certain age (in many cases age 13), their assent, or agreement, to participating in a clinical study is necessary.

There is no “right” or “wrong” answer about participating in research, only the answer that seems right for you and your child.

Questions to Consider:

Some studies involve observing a child over time and others test a medication, treatment or device. Most studies give you a consent form before you agree to join a study. This form describes the research and many of your questions will be answered there. Even if a formal consent form is not required, you should consider what questions you want answers to. And you need to ask them, and ask them again, if the answers aren’t clear to you. When you meet with a member of the research team, you will want to listen carefully and ask several questions about the study.

To begin, some questions you may ask are:
  • Why is this study being done?
  • Why does my child fit the needs of the study?
  • Why do the doctors think this treatment may work?
  • Has this treatment been tested before?

Some studies might divide the participants into groups. For example, if a new medicine is being tested, one group might get the “experimental medicine” and another group might get a medicine that is already used for the condition being studied. In this way, doctors can see if the medicines work differently or not. Sometimes there is no treatment for a certain problem. In this case, one group might get an “experimental treatment” and another group might get a placebo (no treatment).

In either type of study, the treatment you receive will likely be decided at random. Randomization is a fancy way of saying by chance. It’s similar to rolling dice or flipping a coin. It is often the best way that researchers have to end up with study groups that will be similar in age, ethnicity, and other characteristics, in order to better compare the results at the end of a study.

Questions you might ask are:
  • How will the study team decide who gets the experimental treatment?
  • What are the possible risks and side effects in this study?
  • How will my child’s safety be monitored in this study?
  • Could my child’s condition get worse and what happens if it does?
  • How will I know if the treatment is working?
  • How can I contact the research team if I have questions?
  • Will I ever find out if my child has received a placebo (no treatment)?

It is important to know what your responsibilities are once your child enters a study. 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 or my child’s daily life?
  • How many extra visits will I need to make to the hospital or study site?
  • Will I be reimbursed for parking, travel expenses, meals, or childcare?
  • Who will pay for the experimental treatment?
  • Who will pay for additional treatment needed due to possible side effects of the study?
  • Will it cost me anything to be in the study?
  • Who do I contact if I have questions?

You will want to consider all of your choices when deciding if your child should enter a research study or not. You do not have to join a research study unless you want to. You should never feel pressured or forced to join. Make sure you have ALL of the information you need to make the best choice for you and your child.

You may consider asking:
  • What are my other choices if I choose not to participate in the study?

Helpful Resources

The Children and Clinical Studies website provides important information to help you decide whether a clinical study is right for your family. Check out the following topics:

Additional Resources:

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