What is Informed Consent?
Informed consent means that as a research volunteer, you are given all the information available about a clinical trial so that you understand what is involved. It’s more than just a signature on a form. It’s the process of information exchange that may include subject recruitment materials, verbal instructions, question and answer sessions, and measures of subject understanding.
Your physician or nurse should explain the clinical trial to you, including any risks. Prior to participating in the study, you will be given an informed consent form. Be certain to read and consider it carefully. If something in the form is not clear to you, ask your physician or nurse to explain it to you. The informed consent should include the following:
- The reason for the trial.
- The treatment procedures and schedule.
- Any potential risks or benefits.
- Alternatives to participating in the trial.
- An explanation of your rights as a research volunteer.
It’s up to you to decide whether or not you want to take part in a clinical trial. If you decide to take part in the study, you will sign the consent form. Once you sign the form, you will be given a copy for your records. Please note that the informed consent contains important information you may refer to during the trial. If you decide you do not want to participate, you have the option to decline. If you choose not to participate in the trial, please know that your care will not be affected in any way.