Participating in a research study
SickKids is a world leader in child health research. There are many research studies that are ongoing throughout the organization. This is one of the reasons why the quality of care is so high at SickKids. As a result, it is quite likely that your child may be approached to participate in a research study. There are several different kinds of research, including:
- studies that ask your child to answer a questionnaire about their condition
- studies that compare one kind of treatment to another, such as drugs, surgery, etc.
- studies that ask for a blood or tissue sample
Below are some frequently asked questions about participating in research. For any study you are asked to participate in, you will also receive an information form that has answers to these questions.
Does my child have to participate in a research study?
No, participating in research is completely voluntary. If you decide that you don’t want your child to be in a research study, your decision not to participate will not affect any aspect of your care at SickKids.
Who is performing the study?
You will receive an information form listing all the doctors and researchers who work on this study. Studies may be run by several groups of doctors and researchers.
Who Is paying for the study?
Research studies may be paid for by a government grant, a non-profit organization or a pharmaceutical (drug) company. For example, the Lung Association may grant money to carry out a research study done on children with asthma. The information form you will receive will list all the sponsors for the study. The study, however, is under the control and is the responsibility of the study doctors and researchers.
What is being tested in this study?
All studies have one main question that the doctors and researchers want to answer. For example, one study may test whether one drug works better than another drug for treating arthritis in children. You will receive a description of the questions the study is trying to answer in the information form.
Will regular care be a part of the study?
Yes. For example, all patients who break a bone must have an X-ray done to assess the condition of the bone (this would happen even if your child is not in a study).
As part of the study, will my child be given treatments or tests that are outside of their regular care?
Your child will receive some treatments or tests that are done on your child because they are in a research study. For example, if your child is in a study to test a new pain medicine, the doctors may need to take some blood tests (with a needle) to check for any side effects from this new pain medicine. These blood tests are done because your child is in the research study. All aspects of the study that are not part of regular care will be explained to you by the study doctor or researcher.
What are the risks or side effects of being in the study?
All risks or side effects will be clearly outlined to you before your child is enrolled in the research study. For example, if the research study is about testing a new medication, all potential side effects will be discussed. The information form will also include what you should do if these side effects occur.
Are there any benefits to being in the study?
There may be no direct benefits to your child if they participate in the research study. For example, the doctors and researchers may be testing out a new questionnaire that is focused on patients with a heart condition. This may not help your child directly but it will help the doctors gain a better understanding of what is happening to children who have a heart condition. This information could be published in a medical journal that could potentially help children and doctors all over the world.
How long will the study last?
All studies have an end point. For example, your child may be involved in a study that tests which type of pins work better in healing a broken bone. Even though the bone heals in six to eight weeks the doctors and researchers may want to see your child in two years time to evaluate any long-term effects from these pins.
Will there be any extra trips to the hospital if my child is involved in a research study?
Some extra trips may be required if your child is in a study. For example, if your child is using a new medicine to help them breath when they have an asthma attack, your child may have to visit SickKids every month for a breathing test. If your child is not in the study, they would only have to visit SickKids once every three months. The extra trips are because your child is involved in the research study.
Will my family be paid if my child participates in a research study?
Some studies may be able to pay you for expenses associated with your visit to SickKids. For example, some studies may pay for your parking. Other studies may not have any funds to pay their patients.
Who will see my child’s health or research information?
All of your child’s health and research information will be kept in confidence. Only doctors and researchers who are running the research study will have access to your child’s information. If the research study results are published in a medical journal, your child’s identity will not be revealed.
How do I finally decide to participate?
Before you decide to participate, you will receive an information form and a researcher or doctor will go through the information with you and answer any questions you may have. If the information is understood and you decide to participate, you will be required to sign a consent form.
Are there any alternatives to being involved in the study?
Ask the research study doctor or researcher about alternative treatments to being involved in the research study. For example, your child may be approached to be in a study that is testing whether a new type of drug works better in relieving pain after your child has an operation. If you don’t want your child to be in the research study, the research study doctor may tell you about other pain medications that have already been used for several years and are not part of the study.
Can I change my mind about my child’s participation in the study?
Yes, you can leave the research study at any time. Please tell the research study doctor or researcher that you do not want to be involved in the research study. They may ask if they can follow your child for observation. For example, if you don’t want your child to be in a research study about testing new pain medicine and you want to use the pain medication that has already been used for several years, the doctors may still ask your child to tell them how much pain they have as part of routine care.