Joining a clinical research study helps research learn more about specific pediatric diseases, helps discover new therapies and ultimately improves care for children. Please always feel free to speak to a member of the research team about any questions or concerns you may have. If they don’t have the answer, they will be happy to find out an answer for you.
More information on clinical trials and children:
If you want to learn more about current or past clinical trials across the United States, please visit ClinicalTrials.gov.
We have two locations: Norton Children’s Hospital, second floor is where most of our inpatient studies are conducted. Most outpatient studies are conducted at the Novak Center for Children’s Health, 6th floor. Please verify the location of your appointment with your coordinator.
A research nurse is available via a 24-hour pager. If you have a question, medical issue while on study, or emergency please call (502) 629-5820 and select option 5. This will send you to our 24-hour line. Please leave a voicemail and our nurse will return your call shortly.
Yes – if you would like. We want to make sure your child’s primary care provider is aware of your participation and will notify them after you sign the consent to take part in the study. We are also 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 is our top priority.
If you would like to keep your child’s participation private, we will not notify the primary provider. Confidentiality is very important to us and our team.
The physician that was caring for your child’ diagnosis will still be involved. We are used to working with pediatric specialists closely. Being involved in a study may change the treatment your child receives, but at the end of the study we will ensure your child has appropriate follow-up appointments to continue regular care/treatments as necessary.
Your child’s regular care will remain the same, as it is currently, if you decide against being in a study. Your child’s medical care and safety is still our priority, and we want to ensure their health is being taken care of.
The physicians are all pediatricians and/or pediatric specialists who have been trained to provide medical care for children. The nursing and study coordinators love working with children and their families. Many of our nurses have backgrounds working with children: some were trained at Norton Children’s Hospital before joining the research institute.
No, your insurance should not be billed for research procedures. If you receive a bill or Explanation of Benefits (EOB) from your insurance company, please 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 anything, please contact your study coordinator immediately so they can replace the necessary medications 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 it is an empty bottle.
Your child’s safety and well-being are our top priority. Each study has a list of medications that are prohibited to take while in a study. It is important to notify your coordinator if you have been prescribed a new medication – before taking it. 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 study is different. Usually, the trial consent form will include the number of visits you will be expected to attend. Your study coordinator will go over this information with you during the consenting process. It is important that you understand the expectations of the study and your required before it begins. Sometimes a study can be short, needing only two or three visits that may complete within a week. Some studies last for years with study visits weekly or every couple of months. Discuss this with your study coordinator and they will be happy to explain the expectations for any studies you may be interested in. Visits can be short – lasting about 30 minutes –or they can be longer such as a few hours or even overnight. This will be discussed with your study coordinator before you start a study.
Every study is different and is looking for different information. Some studies may involve collecting vital signs (heart rate and blood pressure), while some studies involve drawing blood and/or possibly radiology exams such as x-rays. Your study coordinator will review this information with you before beginning a clinical trial.
This is a myth about clinical trials and research studies. We don’t want anyone to feel like we are “testing” drugs on them or their child. Our job is to make sure that the medications we are researching are the best, most effective dose for your child. All studies must be approved by a human subject’s protection office and our Institutional Review Board (IRB) to make sure the risks are minimal, and we are not putting your child (medically or ethically) in harm’s way.
You may or may not directly benefit from research studies. Your participation may provide additional information that could benefit other children in the future. Some medication studies may offer a placebo, or fake drug, while some may offer a new investigational drug that we hope is better than the current options available. Because these medications are still being studied, we cannot guarantee that your child will respond to the treatment. Your child’s health and safety are always our priority, and we want to make sure they are being given the most appropriate treatment.
There are always risks involved with any medication and/or medical device. Until a medication or device is studied, we cannot guarantee that we know every potential risk factor. Allergic reactions are a possibility. All of our research studies are reviewed by our Institutional Review Board (IRB) to ensure that every study has minimal, if any, risk(s) involved for potential participants. It is important that you know the risks involved with your research study so you are able to make an educated decision regarding your participation. Your study coordinator will review any known risks with you before beginning a clinical trial.
We hope research visits are as non-intrusive as possible in your life. If we can accommodate your schedules, we absolutely try to do this. We may not always be able to combine your research visit with your regular clinic appointment, we can try to schedule the visits back-to-back as much as possible.
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 are okay with what we are asking them to do. For example, if a child is terrified of blood draws and the study they are participating in will need them to get a blood draw often, they may not want to do the study if they don’t see an immediate benefit to them. We are happy to talk with you and your child regarding how we can make clinical trials as comfortable as possible, and less scary.
See more FAQs about participating in research.