Is This Study Right for My Child?
Before agreeing to take part in a research study, it is important to decide whether or not the study is right for you, your child and your family. This page has questions that may be of importance to you. Each study is different and has different levels of risk, benefit and commitment of time.
Frequently Asked Questions
1. What is the purpose of this research?
It is important to understand the reasons why the study is being conducted. The study may be about a disease or condition that you or your child has or it may be about a common condition of children in general. If you don't have an interest in the research topic, then study may not be right for you.
2. What are you trying to learn?
Some studies involve the testing of new treatments while others try to understand how diseases affect the body.
3. Will I get the results of the study?
Usually results from routine laboratory tests and examinations can be given to participants. However, some tests are run years after the specimens are obtained and some are purely for research purposes. The meaning and importance of the results is then uncertain. When this is the case, the results will not be returned to you.
4. Who is conducting the study and who is paying for it?
Many of the studies that take place at CHOP also involve many other hospitals. Some studies are funded by the National Institutes of Health (NIH), some by pharmaceutical companies and some are funded by CHOP.
5. Who is allowed to take part in this study?
It is important to understand why your child is eligible for the study and how many other children will take part. If your child turns out not to be eligible, then you may want to find out if there are other studies that they could take part in.
6. What does the study involve?
Not every study is right for every child. To find out, it is important to understand the study procedures. Here are some important questions to ask.
- How long does the study last?
- How many visits are there?
- What tests, medicines and procedures will my child need if they take part?
- What will be different about the tests, medicines and procedures compared to their care if they don't take part?
7. Will all of the children receive the same treatment in this study?
In some studies, everyone gets the same treatment. More commonly, treatments are being compared.
8. What treatments will be compared in this study?
When treatments are compared this can involve the following:
- different dosages of the same drug,
- different drugs
- a drug compare to an inactive substance. This is called a placebo.
9. How will you decide which treatment everyone will get?
Many times, the new treatment turns out to be no better than the old treatment. It can be the same, better or worse. Only by doing a fair test can it proved that a new treatment works.For a study to be a fair comparison, participants need to be distributed equally so that no one can predict what group they are in and so assessments aren't biased. Assignment to treatment is usually made by a computer using a process called randomization. This is a bit like flipping a coin or drawing lots. It is common to "blind" the study so that the doctors and the participants can't tell what treatment they are on. This prevents bias (prejudice about what should work and what shouldn't).
10. In an emergency, can the research team or my child's caregivers find out which arm of the study my child is in?
If it is necessary for your child's treatment, the study can be "unblinded" to find out which treatment your child is on.
11. Does the study involve any risks of short-term or long-term harm?
There are always risks of harm, even if the risk is very tiny. There are risks to everything that we do in life - driving a car, riding a bike, walking to school, swimming, playing on a playground. It is important to understand the specific risks related to the study before agreeing to take part.
12. Do you know whether this study will help my child?
Since research is intended to determine whether new treatments work or don't work, no one can promise if there will be a benefit. The information and knowledge that results from a study is what helps doctors improve care in the future. Adults and children have taken part in the past in vaccine and drug studies and other types of research so that children alive today could benefit. Some studies are designed to learn about how diseases work and won't benefit your child.
13. What other options are available if my child doesn't participate in the study?
Sometimes the alternative to participating in a research study is just not to take part. Other alternatives could include standard treatment instead of experimental treatment, or your child might be eligible for more than one research study. It is important to consider the possible risks and the possible benefits (both short-term and long-term) of these alternatives. You can ask the research doctor to go over these options with you. You can also ask your regular doctor about your options and talk them over with your family or friends before you make a decision.
14. Who would I contact with questions if my child does participate in the study?
Before you decide to participate in a study, the study doctor and the study team members should answer all of your questions. They will let you know how to report any side effects your child might have, who to contact in an emergency, and how to take your child out of the study if you change your mind. You can also contact the IRB Office if you have questions about your rights or your child's rights as someone taking part in a research study. You can call the IRB Office at 215-590-2830 if you have questions or complaints about the study.