Participating in a clinical trial is an important personal decision, and as with any medical procedure, there are always questions to consider. The following are among the most common.
Would this study be right for my child?
Choosing to participate in a clinical trial is an important personal decision. Our team works closely with your care providers to identify the right study for you and your child. However, before you participate in any study, it’s important to understand the research project – including the risks, benefits , requirements and goals of the study.
What is a clinical trial?
Clinical trials are medical studies that involve people like you. They help find new ways to prevent, detect, or treat diseases that are safe and effective. Children’s Health leads and supports many studies aimed at preventing, diagnosing, and treating disorders. Clinical trials are an important part of the research process. The idea for a clinical trial often starts in the lab. After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials. As studies about new treatments move through a series of steps called phases, researchers learn more information about the treatment, its risks, and its effectiveness. Each clinical trial has criteria describing who can join. Children as well as adults, healthy volunteers and patients, and people of a diverse range of ethnic and racial backgrounds can and are encouraged to participate in clinical trials. Clinical trials follow a plan, called a protocol, that describes what you will be doing and what you can expect from the research team. It is important to understand the risks and benefits of participation before joining. You also have rights and protections as a participant in clinical trials.
What are some of the types of clinical studies?
Treatment studies – test experimental treatments, such as investigational drugs or devices or new approaches to surgery or radiation therapy.
Behavioral studies – researchers study specific behaviors by interviewing or observing participants.
Observational studies – researchers may collect or review medical history information and study blood or other samples to learn more about participant's and associated diseases or conditions.
Diagnostic studies – conducted to find better tests or procedures for diagnosing a disease or condition.
What are your responsibilities during the study?
- Ask questions
- Show up for all scheduled appointments
- Follow instructions given by the researchers
- Keep all contact information updated
- Keep all materials provided by the study in a secure place at home, away from children who may not be able to read the labels
- Before taking additional medications, make sure the researchers are aware of all new, Homeopathic, prescribed or over the counter medications for your child.
- Make sure your pediatrician knows your child is participating in a study.
- Inform the researchers of all illnesses or injuries that occur during the study – even if they are not related to the study.
Are there benefits to participating?
The potential benefits from participating in clinical trials help prove whether a treatment is effective and/or can help determine the safe dosages required and the potential side effects that can occur with a new drug. You also gain the satisfaction of knowing that your participation in the study may lead to advancements that will benefit others in the future.
Are there risks to participating?
All medical procedures – even proven therapies – have risks. Every clinical trial is different, but anticipated risks will be reviewed with each potential participant as part of the informed consent process.
What are the requirements of participating?
Requirements vary depending on the study. Participants will need to meet certain eligibility and screening requirements in advance. If those criteria are met, there will be an initial screening examination at which time an informed consent document will be reviewed with the parent/guardian. Once admitted to the program, usually visits to Children’s Health to meet with medical professionals for examination or treatment will be part of the regimen.
What is informed consent?
Informed consent is a process that assures you have all the necessary facts about a clinical trial before deciding whether or not to participate. The medical professionals running the study will explain all details and answer all questions. The researchers will provide an informed consent document that provides the study details, purpose, duration, required procedures, risks and potential benefits. The participant then decides whether to sign the document, indicating they reviewed and understood its content. It is not a contract. Participants may withdraw from a trial at any time.
Do I need a doctor’s referral?
Participants often join clinical trials as a result of a referral from their own pediatricians, but that’s not always the case. You will, however, find it helpful to confer with your child’s physician and other members of your family or friends about deciding to join a clinical trial.
Will my insurance provider or I be charged for the costs of any part of this research study?
Any fees or charges related to the study will vary depending on the research study. The standard medical care that would be provided regardless of participation in a study will be your responsibility. A member of the study team will discuss the costs for any research charges with you before participating in a research study.
Will I be paid for participating?
Some studies will compensate subjects for time and inconvenience for participation in a trial, but for others, study participants are not paid. Generally, expenses associated with visits, such as travel costs or parking while in clinic for study procedures are reimbursed. A member of the study team will discuss if there is compensation as well as reimbursements during the informed consent process.
What about confidentiality?
The identity of participants in a research study is kept confidential. In addition, scientific publications that result from the research do not identify participants without specific prior approval.
How will my information be kept confidential?
Medical information collected during a study and the results of any test or procedure that may affect your medical care may be included in your medical record. The information included in your medical record will be available to health care providers and authorized persons including your insurance company. The researcher will inform you of certain organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis. The researchers will not, in any case, disclose information about you or your participation in this study unless it is included in the Authorization for Use and Disclosure of Protected Health Information for Research Purposes.
How will we be kept safe?
All research protocols implemented at Children’s Health are carefully examined and reviewed by the Institutional Review Board (IRB) of the UT Southwestern Medical Center. The IRB protects the rights and welfare of individuals recruited to participate in research activities and ensures that only safe, ethical and scientifically valuable research is being conducted.
How can I find a relevant study?
At any given time, Children’s Health has hundreds of studies underway. To see if there is a trial appropriate to you or a member of your family, please search for Clinical Trials on childrens.com to view brief descriptions of all current studies.
Where can I find more information about clinical trials?
For further help in guiding your decision, the National Institutes of Health provides a discussion about Clinical Trials, which addresses additional questions you may have.
What if I want to learn more about a clinical study?