If your doctor offers you the option to participate in a clinical trial, you will first take part in a process called informed consent.  In this process you will learn about a specific clinical trial so that you may decide whether you want to participate. 

 

The researcher or nurse from the clinical trial team will review the informed consent form in detail with you.  This form explains a specific clinical trial’s purpose, procedure, risks, and benefits. 

 

An Informed consent form should include: the reason for the trial – what researchers wish to learn from the results of this trial, who is eligible to take part in the trial, what is known about the type of treatment being studied, the possible risks and benefits, other treatments that may be options, the trials design (randomized, single or double blind), types of tests, the number of doctors visits required, who is responsible for the costs, a statement about conflicts of interest, patient privacy, and patient rights. Should you decide to participate, you, the trial’s PI, and a witness must sign and date the informed consent form.

 

You will be encouraged to ask questions about terms or ideas that are confusing.  A family member or friend may help by attending your appointments with you to listen to the physician's explanations and ask additional questions and also record the answers.  You can also bring along tape recorders to review the information afterwards.

  

The informed consent process also continues throughout the study.  Patients will be told of any new discoveries regarding the progress of the trial, such as new risks.  At that time, you may asked to sign a new consent form to stay in the study.   

 

Again, even after signing, a patient can choose to withdraw from a trial at anytime, for any reason.