Frequently Asked Questions
Common Questions About Participating in Research
There are many things to think about before deciding to take part in a research study. Here are answers to some commonly asked questions.
Clinical research helps doctors and researchers find new and better ways to understand, detect, control and treat illness and other medical conditions. Clinical research involves carefully planned studies that people volunteer to take part in. They help researchers learn more about health and find new medications and treatments. There are 2 main types of studies:
- Interventional studies (also called clinical trials) test new medicines and treatments in people to see how well they work and to make sure they are safe.
- Observational studies collect information about health and behavior. This is done through surveys, interviews or observing study participants over time.
Before a new medication or treatment can become a standard practice of care it must go through research phases.
Each research phase must:
- Answer a research question
- Meet safety rules before the next phase takes place
- Meet phase goals before the next phase takes place
It is useful to know what phase the study is in to help you understand the goals of the research. A person from the research team will be able to tell you this information.
- Phase 1: Researchers test a new medicine or treatment in a small group of people for the first time to see if it is safe, how it will be given and if there are side effects.
- Phase 2: The medicine or treatment is given to a slightly larger group of people to study if it is effective and further study its safety. Sometimes side effects happen to only a few people. This is why testing on a larger number of people is important.
- Phase 3: The medicine or treatment is given to large groups of people to confirm effectiveness and compare it to other already approved medicines or treatments.
- Phase 4: After the medicine or treatment has been approved for use, often more research is done to look for effectiveness in various groups of people (for example, in patients age 12 and older) and to see if there are side effects associated with long-term use.
Taking part in research can look a lot like the regular medical care your child receives at a doctor’s office, clinic or hospital. Sometimes doctors also do research. It is important to talk with your doctor and the research team about the differences between the research and your child’s regular medical care.
In medical care, the doctor or your care team develops a plan of care tailored for your child.
When your child takes part in a study, the research team follows a set plan called a study protocol. The goal of research is to add to medical knowledge that might lead to improved treatments for children in the future. Your child might or might not benefit directly from being in a research study.
Learn more on the How to Participate in a Research Study page.
Every study has a lead researcher called a principal investigator (PI), who is often a medical doctor. They oversee the research study. Some studies also have a research team that might include doctors, nurses, social workers, research coordinators and other healthcare professionals. The PI and research team closely monitor a participant’s health throughout the study.
Safety is our main priority at Seattle Children’s. All studies follow strict regulations and guidelines:
- We have an ethics board within Seattle Children’s that reviews studies to protect children who take part. This is called an institutional review board (IRB).
- The U.S. Food and Drug Administration (FDA) must approve the design of a study before any new medicine, treatment or device is tested with people.
- Some studies have added layers of protection. For example, the National Cancer Institute (NCI) monitors many of the studies we offer. If participants from another hospital in the study have side effects from the study treatment, NCI reports this information to us.
Before your child joins a study, the research team will explain any risks of participating. The potential risks and potential benefits are listed on the consent and assent documents that you and your child will review with someone from the research team before joining a study.
Being in a study is voluntary. Your child can stop participating in a study at any time without it affecting your regular medical care at Seattle Children’s.
You might be asked to fill out a survey to share why you decided to stop taking part in the study. Filling out the survey is voluntary.
Yes. Your child will go to any scheduled medical appointments while in a study.
It’s important to tell your child’s doctor that your child is in a research study. Ask your doctor to talk with the researcher team to make sure there is no conflict with the medicines or treatments your child is currently taking.
We have worked with many families from around the country and the world, and have many services in place to help support you if you are coming from elsewhere. These include:
- Housing options through Ronald McDonald House and special arrangements with local hotels and motels
- Transportation resources
- Support groups and other resources through our Family Resource Center
- School services so your children can continue their education in Seattle
- Interpreter services
It depends on the study. Some studies can be as simple as filling out an online questionnaire. Other studies require you to come in for regular study visits.
Most of the time, patients need to receive study treatments at Seattle Children’s. Sometimes treatments – or at least some parts of treatment – can be safely given by your child’s doctor or a specialist close to home. We are happy to talk with you and your local doctor about whether this might be an option for your child.
Check the list of Current Research Studies at Seattle Children's.
- You can search for many clinical trials available through Seattle Children’s on clinicaltrials.gov. Read our guide about searching for trials on ClinicalTrials.gov (PDF).
- For bone marrow transplants clinical trials, search Fred Hutch’s clinical trials page.
If a study is of interest to you, contact the person listed to find out more information. They can help you determine if your child is a good fit for a particular study.
The answer depends on the trial.
- In phase 1 and phase 2 trials, every participant gets the experimental therapy.
- In phase 3 trials, some participants get the experimental therapy and others get the standard treatment.
In a phase 3 trial, neither you nor the research team will decide which treatment your child gets. A computer program will randomly assign your child to one group or the other. Researchers do a phase 3 study when they have reason to think the experimental therapy may be at least as safe and effective as the standard. But there is no guarantee – they are doing the study to find out.
When your child takes part in a research study here, a team of people provides the many types of care your child may need aside from the treatment being studied. You may be connected with professionals from many other areas of the hospital, such as nurses, dietitians, child life specialists, social workers, pharmacists, palliative care specialists and others. We have a large network to help support your child and your family.
Taking part in research can raise financial questions for families. You might wonder: “Do we get paid to take part in a study? Do we have to pay for study treatments? Will our insurance pay?”
Patients and families usually do not get paid to take part in cancer clinical trials at Seattle Children’s.
In phase 1 and phase 2 studies of drugs, usually the drugs are provided at no charge. If your child has health insurance, the benefits may apply to other costs related to your child’s care.
Our staff is experienced at working with families and insurers to advocate for coverage. We can help you find out what your insurance will cover. You may also pay for care yourself or apply for financial assistance. Our social workers can also connect you to organizations that offer support to help meet the costs of care.