Participating in Clinical Trials
What is a Clinical Research Study?
Research plays a very important role at Arkansas Children's Hospital (ACH). A research study is a carefully planned and institutionally approved collection of information to gain new knowledge that will help in diagnosis, treatment or prevention of diseases or disorders. Many ACH doctors conduct research to assure that medicines, vaccines and treatments are safe and effective ways to prevent illness or to help children get well and feel better.
What About Clinical Research Studies For Children?
Children can participate in a research study. There are guidelines explaining who can participate in a research study and these guidelines will vary from study to study. The parent or guardian needs to give permission for the child to participate. However, if the child is old enough to understand what the study is about, the child will be asked to give his or her approval to take part in the study. Clinical research participation is voluntary; the parent or child can withdraw at any time.
What Are Some Questions That I Should Ask?
- What is the purpose of the study?
- How will the study affect my child?
- How much time will it take?
- Who is doing the study?
- Who do I contact to ask questions?
- Will the study cost any money?
- Is there any risk (danger) for my child to participate in this study?
- What are my obligations as a parent and for my child?
What is the Clinical Research Study Process?
The clinical research study process depends on the focus of the study being conducted.
Studies that involve medications and treatments may require your child to take a pill, liquid, shot or other form the medication may come in. Some studies may look at the growth and development of your child and may include completing surveys and answering questions about your child. Other studies may look at specific diseases and disorders and may require that your child undergo tests and other evaluations that may include blood draws.
Regardless of the study and its method, a clinical research study includes a team of doctors, nurses and other health care professionals. They will give instructions for taking part in the study, check the health of the child at the beginning of the study and monitor the child carefully during the study.
What Can Children Obtain From Being in Clinical Research Studies?
- Play an active role in their health care.
- Gain access to additional treatments options.
- Obtain medical care at ACH facilities during the trial.
Your child may not receive any benefits from participating in clinical research but may help others by contributing to medical knowledge.
Protecting Your Child's Safety and Privacy
Your child's safety is the highest priority of every study at ACH. Measures are in place during the study to guard your child's safety. Research staff and doctors monitor each child's physical and medical condition throughout the study. Since clinical research participation is voluntary, a child can withdraw at any time.
All research studies are conducted with the approval and oversight of an ethics committee called the Institutional Review Board (IRB). Doctors, scientists and community members are members of the IRB. The IRB reviews the research study from planning to completion. Among its concerns are your child's health, well-being, rights and safety.
Information gained about your child while participating in a clinical study will be kept confidential. Your child's medical information will be kept private and only be identified by the research team with a unique study number or initials. For some research, your child's personal information will be shared with other trusted people, who are bound to confidentiality, such as the IRB, the Food and Drug Administration or the company/agency sponsoring the study. In this case, your child will be identified only by a study number or initials. Also, the IRB may need to look at your child's research file. Otherwise, your child's information will not be shared with others without your permission.