Clinical Research

Frequently Asked Questions

What is medical research?

An organized way of learning more about health, and also about better ways to prevent and treat diseases in the future. Most studies seek to answer a question that hasn't been answered.

Through research studies, we've learned:

• which treatments are currently most effective for diseases
• a child can be protected against measles, mumps, and rubella with one shot instead of three
• ways we can help children who have behavioral problems

Why are children included in medical research?

When possible, research is done first on adults. But children often don't respond to medicine and other treatments the same way adults do, and some conditions, such as premature birth, occur only in children and can't be studied in adults.

Therefore, for children to benefit from new medicines and treatments, it's important to include children as participants in research studies. Many children today are benefiting from research that was done on children in the past. For example, the current treatments for many childhood cancers and for cystic fibrosis are based on past research. Hopefully, the research done on children today will help children in the future in a similar way.

What protections exist for people who are in medical research?

Each study is different, and it's important to understand the potential risks of any study. It is also important to know that certain steps are taken in every study to reduce risk and protect the participants.

• Researchers try to design studies that minimize potential risks to participants.
• Most research studies must be approved in advance by a committee of scientists, doctors, and people from the community to make sure the study is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the importance of what may be learned.
• Because children usually can't give informed consent for themselves, one or both parents, or the legal guardian, must give their permission before the child can be included in a study.
• In some cases, the child must also agree to be in the study. This is called "assent." The need for assent depends on the child's age, ability, and specifics of the study.
• All researchers monitor the safety of the participants during the study. Studies can be suspended, or stopped altogether, if the risks are greater than expected.

Why participate in medical research?

There are many reasons why parents allow their child to participate in research. However, each family's decision is a personal one. As you think about whether or not your child should participate in research, it might be helpful to know a few reasons why others choose to participate.

• For altruistic reasons- that is, to help others in the future
• To gain knowledge of a specific disease or condition
• In the hope that their child, and other children may benefit from better treatments
• Because the study may improve their child's health--even though this is just a possibility, and is not certain

What should I ask to help me decide whether I should participate in medical research?

It is important to make sure you understand the research, what will happen, and what are the potential risks and benefits.

Here are a few examples of questions that some people ask:

1. What is the purpose of this study?
2. Will I receive the results of the study? If so, when?
3. Have there been similar studies that used the same drugs, devices, etc.? What happened in those studies?
4. Why is my child eligible to participate in this study?
5. How long will the study last?
6. What procedures, medicines, and tests will my child have as part of the study?
7. How will these procedures, medicines, and tests differ from those my child would receive if he or she were not part of the study?
8. Does the study involve any risks of short-term or long-term harm? What are these risks? How likely is it these risks/harms will happen to my child? What happens if they occur?
9. Could my child's condition get worse during the study? What will happen if it does? Who will take care of my child? Who will pay for the treatment?
10. What are the possible short- and long-term benefits, if any, of the study?
11. How likely is it that my child will experience these benefits?
12. What other options are available if my child doesn't participate in the study?
13. Who would know that my child was in a research study?
14. Who can I contact to ask questions before I decide and during the study?
15. How can I get the results of the study when it is done?