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Clinical Trials

About Clinical Trials FAQs Why Participate? Your Rights

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Clinical Research Study Rights

As a participant in a clinical research study, you have certain rights, including high quality healthcare and access to certain information. Before you begin the trial, you'll be given information on what the trial entails, what the benefits and risks of the trial might be, how long the trial will last, and other important details.

This process of learning about the trial is called Informed Consent. Basically, it means you have the right to as much information about the trial as you want. Informed Consent lasts through the clinical trial and even after the trial is over you still have the right to have any questions answered. (In many cases, Informed Consent is also the name of the form you sign to indicate that you have received all the information you require and give your consent to participate in the trial.)

Control Groups
A clinical research study has to compare the test treatment to existing treatments, which is why control groups are important. Control groups are composed of participants who receive established medical treatments during the trial. On occasion, this group may be given a placebo-a pill or treatment similar in appearance to the drug compound under study but without the active ingredient. To keep the test results as fair as possible, you may not be told whether you're in the control group or the experimental group. Be assured, however, even if you're in the control group, you'll still be receiving the best possible healthcare.

Questions to Ask Before Joining a Clinical Trial
You have the right to know what will happen to you during a clinical trial. However, asking the questions is up to you. Here are some questions to consider asking the investigators before committing to a clinical trial:

What is the time commitment for this trial (total, per visit, and outside visits)?
What is required during the course of this study?
Where will I receive treatment?
Can I still see my own doctor during this study?
Will I find out the results of the study?
Will I know if I am in the control group?
Is there pain involved with any of the treatments? If so, how will the pain be managed?
Does the experimental medication or treatment have any known side effects?
Am I at any risk for permanent damage or death?
What are the expected benefits of the experimental treatment for my condition?
Will I be limited in my activities while participating in this clinical trial?
What credentials do the people conducting the study hold?
Will I incur any costs by participating in this study?

Pediatric Clinical Trials
A child enrolled in a pediatric clinical trial is accorded all the rights and privileges of any participant in a medical trial. The main difference is that you, as the parent or guardian, will be the one asking the questions and making decisions for the child. You have a right to Informed Consent concerning your child's involvement in any pediatric clinical trial. Here are a few questions to ask before signing your child up for pediatric clinical trials:

Is the procedure painful?
Can my child still attend school during the trial?
Will my child be able to participate in his or her regular activities?
Will my child have to stop taking current medications?

Withdrawing from Clinical Trials
You can withdraw from a clinical research study or have your child removed from a pediatric clinical trial at any time.

You should note, however, that a clinical study would be in jeopardy if a substantial percentage of participants withdrew before its end. It's generally better to make the decision to participate or not before the clinical research study starts. If you must withdraw from a study, researchers appreciate knowing your reasons for leaving.