Clinical & Translational Research Organization

For Parents

For Parents — Deciding to Participate

At Johns Hopkins All Children's Hospital, we understand that it is difficult being a parent of a child with a medical problem and even more difficult to decide whether it is in the best interest of your child to participate in a medical research study. We also know that clinical research is the only means that we have to evaluate treatments for illnesses and diseases.

Taking part in a study is entirely voluntary. It is never required and choosing not to take part will not change the standard procedures of care that your child will receive. If your child has an illness or disease where there is no known cure, participation in a research study may not provide a benefit to your child, but may help researchers learn more about the illness or disease, or ways to diagnose and treat the illness or disease. Your child is free to withdraw from a study at any time without affecting on-going or future medical care.

The National Institutes of Health (NIH) has developed a web based information resource for families entitled Children & Clinical Studies. This site features an award-winning video of children, parents, and health care providers discussing the participation of children in research. Tambien en Espanol.

Johns Hopkins All Children’s also developed the following information in conjunction with the V Foundation:

What is a clinical trial?

· A clinical trial is a research study that looks at whether a medical treatment is safe and helps people with a certain disease. 
· Because clinical trials are research, the studies follow strict scientific rules to protect
patients and help produce the most accurate results.
· Some clinical trials focus on treatment. These are usually called “therapeutic studies.”
· Some clinical trials are only to learn more about a disease but not its treatment. These are usually called "observational studies" or “biology studies.”
· Some clinical trials combine both treatment and observational/biology research questions.

Why are clinical trials important?

Clinical trials improve patient care by addressing questions about whether a new treatment works well and is safe for people or whether one treatment works better than another.

What are the possible benefits of a clinical trial? 

· The patient may have access to new treatments before they are widely available.
· The patient receives close monitoring, support and advice from those conducting the clinical trial.  
· The results of the trial may benefit both the patient and others with similar conditions. 

What are the possible risks of a clinical trial?

· The new treatment being studied is not always better than current standard care.
· Even if a new treatment works for some patients, it may not work for you or your child.
· A new treatment may have side effects or risks that doctors don't know about or expect.
· Health insurance doesn't always cover all patient care costs for clinical trials. If you are thinking about taking part in a clinical trial, check with the researchers and your insurance provider ahead of time about costs and coverage. 

Is my family’s privacy protected?

The health care team and Johns Hopkins All Children’s Hospital will protect you and your family’s private health care information. 

Can I withdraw from the trial at any time?

Yes. Enrollment is voluntary and you or your child can leave the study at any time. 

How do clinical trials work?

· If you or your child take part in a clinical trial, you may get tests or treatments in a hospital or clinic.
· Sometimes taking part in a clinical trial is different from regular care. For example, you
may have more tests and medical exams than you would otherwise.
· The purpose of clinical trials is research so the studies follow strict rules to both protect patients and help produce more accurate results.
· Clinical trials for children have the same or sometimes stricter safety rules as clinical trials for adults. 

Who can participate in clinical trials?

· Each clinical trial defines who can take part in the study. 
· Children (age 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. 

Can I or my child ever be removed from a clinical trial?

Patients can be removed from a clinical trial for the following reasons:
· They or their guardian voluntarily removes them from the trial.
· The team running the trial removes the patient. This may be due to safety reasons or because the treatment is not working. 
· You or your child’s treating team removes the patient from the trial because it is better for them. 

Overview Summary

· Clinical trials are a way doctors learn how best to treat their patients.
· There are potential risks and benefits for enrolling in a clinical trial.
· Enrolling in a clinical trial is voluntary.
· Ask your treating doctor if a clinical trial is right for you or your child.
 
This information is brought to you by: Johns Hopkins All Children’s Hospital Cancer & Blood Disorders Institute through the generosity of a grant from The V Foundation for Cancer Research.