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Good Questions to Ask

It is difficult enough to decide to enroll in a study as an adult, but it is even harder to make that decision for a child, especially if the child is sick.

Clinical study documents have a lot of information, but there are questions that you may still have. And you need to ask them and ask them again if the answers aren’t clear to you.

There are many precautions in place to protect children in clinical studies. Safety is the most common concern for parents, along with what risks and benefits they can expect. But there are many other factors involved when joining a study, which parents need to look at and ask questions about. And sometimes when you ask a question, it might cause the research team to think about how to make the study better or easier for you and others. Don’t forget, the research team will expect you to ask! Here are some questions:

  • What will happen and how much time will it take?
  • How will it affect other family members?
  • Are there costs?
  • How do I know what questions to ask?
  • What if I have questions during the process?

Questions you should Consider Asking

There is a lot of information that is provided when thinking about enrolling in a clinical study, but you may have more questions. Here is a list of possible questions you might want to consider asking your research team. Remember that you should ask questions until you are comfortable with the information provided.

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The Study

  1. Why is the study being done?
  2. Why do researchers think the approach may be effective?
  3. Who is paying for and supporting the study?
  4. Who has reviewed and approved the study?
  5. How are study results and safety of participants being checked?
  6. How long will the study last?
  7. What will our responsibilities be if we participate?

Possible Risks and Benefits

  1. What are the possible benefits?
  2. What are the short-term risks, such as side effects?
  3. What are the possible long-term risks?
  4. What other options do people with similar conditions have?
  5. How do the possible risks and benefits of this trial compare with other options?

Participation and Care

  1. What kinds of therapies, procedures or tests will my child have during the trial?
  2. Will they hurt, and if so, for how long?
  3. How do the tests in the study compare with those my child would have outside of the trial?
  4. Will my child be able to take his or her regular medications while in the clinical trial
  5. Where will my child have his or her medical care?
  6. Who will be in charge of my child’s care?

Personal Issues

  1. How could being in this study affect the daily life of my child or my family?
  2. Can I talk to other people in the study?

Cost Issues

  1. Will I have to pay for any part of the trial such as tests or the study drug?
  2. If so, what will the charges likely be?
  3. If I have health insurance, what is it likely to cover?
  4. Who can help answer any questions from my insurance company or health plan?
  5. Will there be any travel or child care costs while my child is in the trial?

Tips for Asking your Doctor About Trials

When you talk with your doctor or members of the research team

  1. consider taking a family member or friend along, for support and for help in asking questions or recording answers;
  2. plan ahead what to ask but don’t hesitate to ask any new questions you think of while you’re there;
  3. write down your questions in advance, to make sure you remember to ask them all; and
  4. write down the answers, so that you can review them whenever you want.

Source: Modified from NCI/NIH

"As a parent you need to do your part fear should not really control your actions. So you should be proactive."

Jackie, mother of child in Fabry disease study

"Do research, ask questions, tons of questions. Even if it could be like the silliest questions ever. Knowing is knowledge."

Nicole, mother of child in heart defect study

"Just getting a comfortable relationship with the researchers is very important that's an important part of the protections."

Dr. David Wendler, Bioethicist