What is a clinical trial?
Who can participate in a clinical trial?
How does a clinical trial work?
What questions should be asked before choosing to participate?
What is informed consent?
What are the benefits and risks of participating in a trial?
What are some of the major central nervous system disorders studied in clinical trials?

 

Prior to participating, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent, a process that can help you decide if participating in a trial is right for you.

When you give written consent to participate in a clinical trial, you acknowledge that you understand and accept all aspects of the research study, including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between you and the research staff before, during and even after you decide to become a study volunteer.

To begin, the research staff is obligated to discuss all the pertinent information about the trial with you, its purpose, the procedures involved, the potential risks and benefits. It is your responsibility to ask questions if there is something you don’t understand. You can ask the researcher to repeat the information or explain it in another way using everyday words.

If English is not your first language, research centers can and should be able to produce documents or explanations for you in your preferred language. If not, you shouldn’t participate in the study.

In some instances, a single visit may not be enough time for you to fully understand the information provided. Therefore, it is essential to take the time you need to make an informed decision.

Once you have given consent to participate in a trial, you are entitled to the following rights:

To be told the purpose of the clinical trial.
To be told about the risks, side effects or discomforts that might be reasonable to expect.
To be told of any benefits that might be reasonable to expect.
To be told what will happen in the study and whether any procedures, drugs or devices are different from those used in standard treatment.
To be told about all options available to you and how they are better or worse than being in the clinical trial.
To refuse to participate, for any reason, after the trial has started.
To receive a signed and dated copy of the informed consent form.
To be told of any medical treatments available if complications occur during the trial.