We have two locations in downtown Louisville, Kentucky: Norton Children’s Hospital, 231 E. Chestnut St., where we enroll hospitalized patients in clinical trials. Most outpatient studies are conducted at Novak Center for Children’s Health, sixth floor, at 411 E. Chestnut St.
Research is a carefully planned study that helps doctors and scientists learn how to improve healthcare for children and families.
Research may help us learn more about:
By taking part in research, families may help advance medical knowledge and improve care for future generations.
Children’s bodies are not the same as adults’. Their bodies grow and develop in different ways, so doctors cannot assume that treatments that work for adults will work the same way for children. Research helps doctors learn the safest and most effective ways to diagnose and treat babies, children and teens. It also can help determine the right medicine doses and identify possible side effects.
Research involving healthy children is important, too. These studies help scientists better understand how children’s bodies grow and function, leading to ways to improve health and care for all children.
Taking part in a clinical research study helps doctors and scientists learn more about childhood diseases, develop new treatments and improve care for children. Research participation may provide information that could benefit your child and help improve care for other children in the future.
If you have questions or concerns, the research team is there to help. They can explain the study, answer your questions and provide additional information so you can make an informed decision.
Choosing whether to participate in research is a personal decision for every family. Research participation is not right for everyone, and it’s OK to decide that a study is not the best fit for your child or family. Your decision will always be respected.
Children who meet the study’s requirements may be eligible to participate in a research study. Each study has specific guidelines to help researchers determine who can take part.
These requirements may include:
Some factors, called inclusion criteria, determine who can participate in a study. Other factors, called exclusion criteria, may prevent someone from participating. These guidelines help researchers ensure the study is safe and that the results are as accurate and meaningful as possible.
The research team can explain a study’s eligibility requirements and help determine whether it may be a good fit for your child.
All research studies involve some level of risk or uncertainty. Depending on the study, participation may include surveys, medicines, vaccines, medical devices or other treatments.
Because every study is different, the possible risks will be explained before you decide whether your child will participate. Your child may experience side effects, discomfort or other reactions, or they may not notice any effects at all.
The safety and well-being of participants are top priorities. If your child experiences side effects or a reaction during a research study, appropriate medical care will be provided. The research team also will be available to answer questions and help you understand any potential risks before and during the study.
Research studies help doctors and scientists learn more about diseases, treatments and ways to improve care for children. The knowledge gained through research helps shape future medical care and can benefit families for years to come.
Some potential benefits of participating in a research study may include:
Because every study is different, the benefits can vary. The research team can explain what you and your child may expect from a specific study and answer any questions you have.
Before you decide whether your child will participate in a research study, it is important that you have all the information you need to make an informed decision. This process is called informed consent.
The research team will explain:
The details of the study, including potential risks and benefits, are outlined in a document called an informed consent form. Doctors, nurses and other members of the research team will review this information with you and answer any questions you may have.
Informed consent is not a one-time event. It is an ongoing process throughout the study to ensure you continue to receive important information. Signing the consent form does not obligate you to stay in the study. You can choose to withdraw your child from the study at any time.
Children ages 7 and older are asked to sign a simplified version of the consent form, called an assent. Out of respect for children, we want to make sure they consent to what we are asking them to do. For example, if a child is scared of blood draws and the study will need them to give a blood sample often, they may not want to do the study if they don’t see an immediate benefit. We are happy to talk with you and your child regarding how we can make clinical trials as comfortable as possible.
Yes, if you would like them to know. We want to make sure your child’s primary care provider is aware of your participation and will notify them after you sign the informed consent to take part in the study. We are happy to update any specialists seen by your child to ensure participation in the study will not conflict with other treatments. Your child’s health and well-being are our top priorities.
If you would like to keep your child’s participation private, we will not notify providers. Confidentiality is very important to our team.
The provider who was caring for your child’ current condition still will be involved. We are used to working closely with pediatric specialists. Being involved in a study may change the treatment your child receives, or it may add on to the standard of care they are already receiving. At the end of the study we will ensure your child has appropriate follow-up appointments to continue regular care and treatments as necessary.
Your child’s regular care will remain the same, as it currently is, if you decide not to join the study. Your child’s medical care and safety is still our priority, and we want to ensure their health is being taken care of.
No, your insurance should not be billed for research procedures. If you receive a bill or explanation of benefits (EOB) from your insurance company, let us know. If the study your child is participating in requires a procedure where insurance could be billed, your coordinator will review this with you during the consenting process.
Most studies are performed at no cost to patients or their caregivers. Depending on the study, your research coordinator will discuss any potential charges ahead of time.
It is very important to keep track of all study medications, supplies and forms to ensure study quality. However, we understand that occasionally accidents happen. If you misplace medication, contact your study coordinator immediately so they can replace the medication or supplies and get you back on track. Study medications must be tracked to ensure your child is getting the appropriate treatment. All study medications and supplies generally must be returned at the next scheduled visit, even if the bottles are empty.
Your child’s safety and well-being are our top priorities. Each study has a list of prohibited medications. Before taking a new medication, it is important to notify your coordinator of what your child has been prescribed. We want to make sure there are no medication interactions that could be a problem for your child.
Part of being in a research study is looking for side effects of medications. We want you to report any issues your child has so we can determine if it is related to the study treatment. Sometimes we know it may seem silly to report a headache or the common cold to the study team, but it may be more important than you think. We would rather have too much information than not enough, so we know your child is getting the best care possible.
Every research study is different, so the number of visits will depend on the specific study.
Before you decide whether to participate, the research team will explain what is involved, including:
Some studies may require only a few visits over a short period of time, while others may last several months or even years. Visits can range from about 30 minutes to several hours, and some studies may require an overnight stay.
The details of the study schedule will be included in the informed consent form and reviewed with you by the study coordinator. They will answer your questions and help you understand what to expect so you can decide whether the study is a good fit for your family.
The safety of children participating in research studies is a top priority. Clinical research must follow strict ethical and legal guidelines and is closely regulated by the federal government.
Researchers, doctors and study staff continuously monitor participants throughout the study to help ensure their safety and well-being. Before a study begins, it is carefully reviewed to help protect the rights and safety of participants. The research team will explain any potential risks, answer your questions and keep you informed throughout the study. If new information becomes available during the study, it will be shared with you so you can make informed decisions about your child’s participation.
Researchers may share study results through medical journals, scientific meetings and government agencies. When findings are shared, participants’ personal information is protected and kept confidential.
No. This is a myth about clinical trials and research studies. Research studies are designed to protect the health, safety and well-being of every participant.
Before a study can begin, it must go through a careful review process. Independent review boards and research oversight committees evaluate each study to help ensure it is ethical, follows strict safety standards and minimizes risks to participants.
The goal of pediatric research is not to “test” treatments on children without safeguards. Instead, researchers work to better understand how medicines and treatments can be used safely and effectively in children. This helps doctors provide the best possible care for young patients.
Throughout the study, the research team closely monitors participants and is available to answer questions and address concerns.
You receive detailed information about the study before deciding whether participation is right for your child. Choosing to participate is always voluntary, and your family’s decision will be respected.
Some research studies offer compensation for the time, effort and travel involved in participating. The amount and type of compensation, if any, will vary depending on the study. Not all research studies provide compensation. If compensation is offered, the details will be included in the consent form and reviewed with you before your child joins the study.
If you have questions about compensation or study-related costs, the research team will be happy to provide more information.
We hope research visits are as nonintrusive as possible in your life. If we can accommodate schedules, we absolutely try to combine visits or try to schedule the visits back-to-back as much as possible.
A research nurse is available via a 24-hour pager. If you have a question, medical issue or emergency while participating in a study, call (502) 629-5820, option 5. This will connect you to our 24-hour line. Leave a voicemail, and the nurse will return your call shortly.
To see a current list of research studies being conducted at Norton Children’s, click here or call (502) 629-5820.
To learn more about research at Norton Children’s, visit our research page to learn more.