Deciding to Participate

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

Many parents may be 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.

Clinical studies are required to give you a consent form before you agree for your child to join a study. The consent form describes the research and many of your questions will be answered there. The consent form is required by law to explain:

That the study involves research
Why the study is being done
The length of time the subject will be in the study
The procedures to be followed and which are experimental
Potential risks or discomforts to the subject
Potential benefits to the subject or to others
Appropriate alternative procedures or courses of treatment
How privacy of records or confidentiality will be maintained
Whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where information may be found
Whom to contact for answers about the research and research subjects’ rights
Whom to contact in the event of a research-related injury to the subject
That participation is voluntary, refusal to participate will involve no penalty or loss of benefits and that the subject may stop the study at any time.

Questions to Ask

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 do the doctors think this treatment may work?

The Children and Clinical Studies website can help you to identify Questions You Should Consider Asking as part of this conversation.

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. It is important to understand the other options available for your child’s care.

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

Your Rights and Responsibilities

If your child does participate in the study, it is important to know what your rights and responsibilities are. 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.

What are your and your child’s rights?

You have the right to be informed as fully as possible, to understand the study, and to be given time to ask all of your questions and have them answered by the study investigators.
Your consent for your child to join a study must be voluntary and you must not be forced in any way to agree to join.
You have the right to have your child stop the study at any time and continue to receive his or her regular care. It will not change your relationship with your doctors and nurses if you choose not to join, or if you choose to stop the study.
You must not be given promises of benefits that are not likely to result from being in a study.
You must be given a copy of a signed and dated written consent form. The form must be written in simple language that you can understand.
The research team will tell you how you may reach them in case you have questions or concerns.

What are your and your child’s responsibilities?

Consider the extra time and effort that may be needed to be in a study.
When you decide that your child will be in a study, it is important to follow the study instructions very carefully. This will include returning for each study visit and letting the study team know if your child had any adverse effects from the treatment.
Keep in regular contact with the study team. Let the research team know if your address, email or phone number changes and how you can best be reached. Call the research team if you will not be able to go to one of the study visits. They will want to know that you are okay and will help you to find another time that is good for you. Talk with them if you have transportation, childcare or other needs. Often, the study team can help you to find other resources to help you during the study.