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Clinical Research Information for Parents

Here is information about research studies that may help potential participants make an informed decision.

What is a research study?

Research studies are designed to answer a specific question about health or illness. A plan is developed to learn if a new medicine, device or procedure is better than what is already available, how well it works and if it is safe. Children’s bodies sometimes respond to medicines and treatments differently than adult bodies. Physicians need to learn if there are effects or safety concerns that are unique to infants and children.

Why participate in a research study?

Study participants may potentially benefit from new treatments. Even if the new treatment is not directly helpful, information learned may lead to better understanding of a diagnosis or disease, which may ultimately benefit others.

What protections are there?

All studies done at Cook Children’s are required to be reviewed and approved by the Cook Children’s Institutional Review Board (IRB) before the study begins, and at least annually for the duration of the study. The IRB consists of community members, physicians, scientists, clergy and others. The IRB’s role is to see that each research study has safeguards in place and is well designed so that study participant rights are protected. The IRB evaluates risks to participants to determine if the risks are reasonable when compared to the potential benefits.

Who can participate in a research study?

Since research studies are designed to answer specific questions, there are strict guidelines regarding who may be enrolled. The investigator will determine who meets those guidelines and will decide whom to invite to participate. No one is included in a research study without his/her written permission.

What happens during a research study?

The steps for conducting a research study are contained in a document known as a protocol. The protocol explains the strict guidelines that have been developed to answer the specific study questions while protecting participants. The research staff will discuss protocol details with a participant and will answer participant’s questions. It is important that participants be thoroughly informed before joining a study. There are common words seen in protocols that may be unfamiliar to you. These include:

How does someone decide to join a research study?

Participating in a study is an important decision that should be carefully made. No one joins a study without his/her written permission. Potential study participants should:

Potential study participants should ask:

No one is included in a research study without his/her written permission.

A participant who agrees to join a study will be asked to sign a consent form. This form should be signed if the participant:

Can a participant leave the study?

Participants may leave a study at any time. The participant should inform research staff of a desire to leave a study, then discuss treatment options with the study doctor.

For more information about Cook Children's pediatric care, community services or opportunities for charitable giving, please call 1-800-934-COOK (2665).

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