Clinical Trials: A Guide for Patients
What Is Informed Consent?
Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The doctors and nurses conducting the trial will explain the treatment to you, including its possible benefits and risks.
You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the researchers to explain parts of the form or the trial that are not clear. (See "Important Questions to Ask" below.)
You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.
Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.
The informed consent process is ongoing. After you agree to participate in a clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.
Who Can Participate In a Clinical Trial?
Every clinical trial is designed to meet a specific set of research criteria. Each study enrolls patients with certain conditions and symptoms. If you fit the guidelines for a trial, you may be able to participate. In some instances, you may be required to undergo certain tests to confirm your acceptability as a candidate.
What Is It Like to Participate in a Clinical Trial?
All patients face a new world of medical terms and procedures. Fears and myths of being experimented upon or being a guinea pig are common concerns of patients who are thinking about participating in a clinical trial.
Even though there are always going to be fears of the unknown, understanding what is involved in a clinical trial before agreeing to participate can relieve some of your anxieties.
This may help ease your concerns:
- The personal information gathered about you during the clinical trial will remain confidential and will not be reported with your name attached.
- If at any time throughout the trial you and your physician feel it is in your best interest to exit the trial and use other known treatments, you will be free to do so. This will not in any way affect your future treatment.
- Clinical trial participants typically receive their care in the same places that the standard treatments are given -- in a clinic or doctor's office.
- Clinical trial participants are watched closely, and information about you will be carefully recorded and reviewed.